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PAVMW

PAVMW US Stock
$1.51
Open: $1.43 High: $1.52 Low: $1.31 Close: $1.37
Range: 2021-02-24 - 2021-02-25
Volume: 48,095
Market: Open
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PAVMW
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PAVMW News
Latest news about the PAVMW
  • PAVmed Announces Pricing of $45 Million Public Offering of Common Stock

    NEW YORK, Feb. 23, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of approximately 9.8 million shares of its common stock for gross proceeds of approximately $45 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by PAVmed. The Offering is expected to close on or about February 25, 2021, subject to customary closing conditions. In addition, PAVmed has granted the underwriter of the Offering a 30-day option to purchase up to approximately 1.5 million additional shares of its common stock. PAVmed intends to use the net proceeds from the Offering to repay all of the Company’s outstanding debt, including all outstanding convertible notes (subject to our agreeing with the holder of such debt on the terms of repayment), with the balance to be used for working capital and general corporate purposes. Cantor Fitzgerald & Co. is acting as sole book-running manager for the Offering. Lake Street Capital Markets LLC and Maxim Group LLC acted as financial advisors to the Company. The underwriter may offer the shares from time to time for sale in one or more transactions on the Nasdaq Capital Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On February 22, 2021, the last sale price of the shares as reported on the Nasdaq Capital Market was $5.55 per share. The Offering is being made pursuant to a shelf registration statement (File No. 333-248709) declared effective by the Securities and Exchange Commission (“SEC”) on September 17, 2020. A preliminary prospectus supplement relating to the Offering and the accompanying prospectus have been filed with the SEC. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. When available, copies of the final prospectus supplement and accompanying base prospectus relating to the Offering may be obtained from the SEC at http://www.sec.gov. Alternatively, copies of the final prospectus and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: prospectus@cantor.com. The final terms of the Offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, PAVmed’s ability to complete the offering; volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts: InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com

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  • The Daily Biotech Pulse: Aridis To Study Antibody Cocktail For Coronavirus Variants, Revance & Protalix Data Readouts

    Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Feb. 22) Acceleron Pharma Inc (NASDAQ: XLRN) Akari Therapeutics PLC (NASDAQ: AKTX) Annexon Inc (NASDAQ: ANNX) Applied Molecular Transport Inc. (NASDAQ: AMTI) AxoGen, Inc (NASDAQ: AXGN) Burning Rock Biotech Ltd (NASDAQ: BNR) Celcuity Inc (NASDAQ: CELC) (announced a $20 million common stock offering) Celldex Therapeutics, Inc. (NASDAQ: CLDX) Cerecor Inc (NASDAQ: CERC) Citius Pharmaceuticals Inc (NASDAQ: CTXR) DermTech Inc (NASDAQ: DMTK) Gemini Therapeutics Inc (NASDAQ: GMTX) Intra-Cellular Therapies Inc (NASDAQ: ITCI) (announced NDA submissions for two indications for Caplyta - as monotherapy and as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder) iTeos Therapeutics Inc (NASDAQ: ITOS) Mereo BioPharma Group plc – ADR (NASDAQ: MREO) Nantkwest Inc (NASDAQ: NK) Orthofix Medical Inc (NASDAQ: OFIX) PAVmed Inc (NASDAQ: PAVM) (reacted to its fourth-quarter results) Pharvaris BV (NASDAQ: PHVS) Pliant Therapeutics Inc (NASDAQ: PLRX) RedHill Biopharma Ltd (NASDAQ: RDHL) Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN) United Therapeutics Corporation (NASDAQ: UTHR) Vistagen Therapeutics Inc (NASDAQ: VTGN) Down In The Dumps (Biotech Stocks Hitting 52-week Lows Feb. 22) bluebird bio Inc (NASDAQ: BLUE) Pharming Group (NASDAQ: PHAR) Talis Biomedical Corp (NASDAQ: TLIS) Vallon Pharmaceuticals Inc (NASDAQ: VLON) Stocks In Focus Surface Oncology Exercises Option to License Vaccinex Platform-discovered Anti-CCR8 Antibody Vaccinex Inc (NASDAQ: VCNX) announced that Surface Oncology Inc (NASDAQ: SURF) will be exercising its option to license the anti-CCR8 antibody discovered via Vaccinex's ActivMAb antibody discovery and novel viral display platform. The antibody, SRF114, is a fully human IgG1 anti-CCR8 antibody that selectively depletes immuno-suppressive tumor T regulatory cells while sparing peripheral Tregs. The terms of agreement with Surface Oncology provided that Surface Oncology pay technology access and licensing fees in addition to research funding, and that Vaccinex will qualify for development milestone payments and royalties. In after-hours trading, Vaccinex shares were down 3.91% to $4.91, while Surface Oncology was up 12.33% to $10.20. Aridis to Study Inhaled Antibody Cocktail For Neutralizing Emerging Variants of The Novel Coronavirus Aridis Pharmaceuticals Inc (NASDAQ: ARDS) said it has augmented its inhaled AR-711 monoclonal antibody to COVID-19 with a second mAb, AR-713, that is designed to neutralize newly emerging COVID-19 mutated variants including those from South Africa, Brazil and Japan. Together, the enhanced dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk strains, the company said. In addition, Aridis announced preclinical development services support from NIAID. The preclinical development services support is also provided by the Coronavirus Immunotherapy Consortium. Aridis said it is on track to initiate the program's Phase 1/2/3 clinical trial in second half of 2021. In premarket trading Tuesday, the stock was up 11:45% to $8.08. Celldex to Expand The Study of CDX-0159 For Additional Dermatologic Indication Celldex said it will expand clinical development of CDX-0159 into prurigo nodularis, a chronic skin disease characterized by the development of hard, intensely itchy nodules on the skin. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. Frequency Therapeutics Announces Publication of Positive Phase 1/2 Study Data For Drug to Treat Hearing Loss Frequency Therapeutics Inc (NASDAQ: FREQ) announced the publication in Otology & Neurotology, results of its FX-322 Phase 1/2 study, showing hearing improvements in adults with acquired sensorineural hearing loss and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy. Findings from the Phase 1/2 study of FX-322, the company's lead product candidate to treat SNHL, showed statistically significant increases in word recognition and words-in-noise scores, the company added. View more earnings on IBB In after-hours trading, the stock was up 5.59% to $55. Related Link: The Week Ahead In Biotech: J&J Vaccine Adcom Meeting, Sarepta FDA Decision And Plenty Of Earnings Revance's DaxibotulinumtoxinA Injection Shows Mixed Results In Mid-stage Study In Upper Limb Spasticity Revance Therapeutics Inc (NASDAQ: RVNC) announced topline data from its JUNIPER Phase 2 study of DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe upper limb spasticity, showing mixed results. The company said the data validated efficacy and safety, while also achieving key co-primary endpoint on efficacy, with the 500-unit dose showing statistically significant difference from placebo in the Modified Ashworth Score improvement from baseline. On the Physician Global Impression Change assessment, all the three evaluated doses showed numerical improvement compared to placebo but did not reach statistical significance. Separately, the company reported a sharp increase in its fourth-quarter revenues to $11.1 million, with the increase primarily due to the commercial launch of the RHA Collection of dermal fillers and the HintMD fintech platform. The loss per share widened from 99 cents to $1.24, in line with the consensus. Protalix Reports Positive Late-stage Data For Drug to Treat Inherited Lysosomal Storage Disease Protalix Biotherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, announced positive topline results from the BRIGHT Phase 3 clinical trial evaluating pegunigalsidase alfa, 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. PRX–102 is Protalix' cell-expressed recombinant, PEGylated, cross-linked α–galactosidase–A product candidate. The stock was climbing 10.64% to $5.72 in premarket trading Tuesday. Oncolytics Presents Pre-clinical Data Showing Synergistic Effect of Pelareorep Combination With CART T Cells In Treating Cancer Oncolytics Biotech, Inc. (NASDAQ: ONCY) announced publication of an e-poster at the CAR-TCR Summit Europe 2021, which showed that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. The stock was gaining 13.94% to $3.76 in premarket trading Tuesday. Earnings ImmuCell Corporation's (NASDAQ: ICCC) product sales rose modestly from $3.63 million in the fourth quarter of 2019 to $3.74 million in the fourth quarter of 2020. The company reversed to a profit of 3 cents from a loss of 4 cents, while analysts, on average, estimated a loss of 4 cents per share. The company also said it has recently submitted the last of five significant technical sections required to achieve FDA approval to market Re-Tain, its mastitis product under development. A response from the FDA to this chemistry, manufacturing and controls technical section is expected during the third quarter of 2021 after the statutory six-month review period. The stock declined 12.61% to $10.26 in after-hours trading. Offerings PAVmed said it's commencing an underwritten public offering of its common stock. All of the shares to be sold in the offering will be sold by the company, subject to customary closing conditions. PAVmed said it intends to use the net proceeds to repay all of its outstanding debt, including all outstanding convertible notes, with the balance to be used for working capital and general corporate purposes. The stock slipped 12.43% to $4.86 in after-hours trading. On The Radar Earnings Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open) Epizyme Inc (NASDAQ: EPZM) (before the market open) Clovis Oncology Inc (NASDAQ: CLVS) (before the market open) Epizyme Inc (NASDAQ: EPZM) (before the market open) Adamas Pharmaceuticals Inc (NASDAQ: ADMS) (after the close) Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) (after the close) AtriCure Inc. (NASDAQ: ATRC) (after the close) Theravance Biopharma Inc (NASDAQ: TBPH) (after the close) Masimo Corporation (NASDAQ: MASI) (after the close) Insulet Corporation (NASDAQ: PODD) (after the close) Esperion Therapeutics Inc (NASDAQ: ESPR) (after the close) Myriad Genetics, Inc. (NASDAQ: MYGN) (after the close) Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the close) Inspire Medical Systems Inc (NYSE: INSP) (after the close) Penumbra Inc (NYSE: PEN) (after the close) Xencor Inc (NASDAQ: XNCR) (after the close) Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the close) MacroGenics Inc (NASDAQ: MGNX) (after the close) Medtronic PLC(NYSE: MDT) (after the close) See more from BenzingaClick here for options trades from BenzingaThe Week Ahead In Biotech: J&J Vaccine Adcom Meeting, Sarepta FDA Decision And Plenty Of EarningsThe Daily Biotech Pulse: Novavax Vaccine Supply Deal, Orphan Drug Designation For Travere, COVID-19 Boost For Quidel, Opko© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • PAVmed Announces Proposed Public Offering of Common Stock

    NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced that it is commencing an underwritten public offering of its common stock (the “Offering”). PAVmed also expects to grant to the underwriter for the Offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the public offering. All of the shares to be sold in the Offering will be sold by PAVmed, subject to customary closing conditions. PAVmed intends to use the net proceeds from the Offering to repay all of the Company’s outstanding debt, including all outstanding convertible notes (subject to our agreeing with the holder of such notes on the terms of repayment), with the balance to be used for working capital and general corporate purposes. Cantor Fitzgerald & Co. is acting as sole book-running manager for the Offering. The Offering is being made pursuant to a shelf registration statement (File No. 333-248709) declared effective by the Securities and Exchange Commission (“SEC”) on September 17, 2020. A preliminary prospectus supplement relating to the Offering will be filed with the SEC. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the Offering may be obtained from the SEC at http://www.sec.gov. Alternatively, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: prospectus@cantor.com. The final terms of the Offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, PAVmed’s ability to complete the offering; volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts: InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com

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  • PAVmed Provides Business Update and Preliminary Fourth Quarter 2020 Financial Results

    Announces majority-owned subsidiary Lucid Diagnostics intends to spin-off into a separate public company Lucid Diagnostics to launch major new multi-channel commercialization initiative for its EsoGuard Esophageal DNA Test Conference call to be held today at 8:30 AM EST NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (“Lucid”) and Solys Diagnostics Inc. (“Solys”), discussed preliminary financial results for the three and 12 months ended December 31, 2020 and made two strategic announcements regarding Lucid and its EsoGuard® product. “Following a strong fourth quarter of 2020 and start of 2021, including raising over $30 million from institutional investors, we find ourselves in the strongest financial position in our history and with the confidence and determination necessary to rapidly and effectively advance and expand our mission,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “In addition to providing an update on all areas of our business, we are making two important announcements regarding Lucid and EsoGuard consistent with that sentiment.” Conference Call and Webcast A conference call and webcast on today’s Business Update and Preliminary Fourth Quarter Financial Results will take place at 8:30 AM EST. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com. Lucid Diagnostics Spin-Off The Company announced that its majority-owned subsidiary Lucid Diagnostics intends to spin off into a separate public company if favorable market conditions continue to hold, either through an initial public offering (“IPO”) or a business combination with a healthcare special purpose acquisition corporation (“SPAC”). The Lucid board of directors determined that this long-contemplated step is necessary for Lucid to fulfill its long-term potential, unlock its present value, and execute on a major new commercial initiative. The Company believes that a Lucid spin-off that accomplishes the foregoing would also be in the best interests of PAVmed and its shareholders. PAVmed will remain Lucid’s largest shareholder following any spin-off transaction. Multi-Channel EsoGuard Commercialization Initiative The Company also announced that Lucid is launching a major new commercial initiative which seeks to accelerate EsoGuard commercialization by simultaneously targeting multiple sales and marketing channels and building Lucid’s own network of EsoCheck® operators to assure sufficient testing capacity and geographic coverage to accommodate demand. Lucid plans to retain and train a network of full-time nurses or other clinical personnel to serve as EsoCheck operators deployed at different types of venues, including leased space in physician practices, and potentially at free-standing EsoGuard testing centers in locales where testing volume and economics can support them. Lucid also intends to seek joint-ventures with laboratory testing companies as well as pharmacy mini-clinic networks to establish EsoGuard testing capacity at their facilities. Once sufficient EsoGuard testing capacity and geographic coverage has been established in a specific locale, Lucid plans to initiate multiple new sales and marketing channels, while continuing to aggressively drive adoption by gastroenterologists. These new channels include direct-to-consumer marketing, as well as sales and marketing directly targeting primary care physicians. A pilot program in one major metropolitan area is planned for the second quarter. Business Update Highlights PAVmed raised $30.4 million in gross proceeds from three common stock registered direct offerings with institutional investors in December and January, including a $13.4 million priced at-the-market offering in early January.Lucid initiated claims submission and billing for its EsoGuard Esophageal DNA Test after CMS payment of $1938.01 for EsoGuard CPT code 0114U became effective on January 1, 2021. Continues to await EsoGuard local coverage determination from Medicare Administrative Contractor, Palmetto GBA. Engaged two leading consulting firms to help secure private payor payment and coverage. Completed preliminary insurance plan medical director interviews.Lucid expanded full-time sales team from four to seven regional business managers overseeing, over 50 independent sales representatives. Recruiting a team of clinical specialists who will train clinicians and support existing accounts while freeing up other sales personnel to focus on opening new accounts.Lucid launched consumer marketing campaign introducing an animated EsoGuard “mascot” to educate consumers on the link between chronic heartburn and esophageal cancer and to create EsoGuard visibility and awareness as a foundation for future direct-to-consumer marketing.EsoGuard testing volume rebounded following winter slowdowns related to Covid-19 surge and facility limitations during period of mass workforce vaccination. Anticipate return to accelerating EsoGuard testing volume growth in the coming quarter.ESOGUARD BE-1 and 2 studies in support of future PMA submission and FDA IVD registration now have 40 of 60 study sites active and have enrolled approximately 70 patients total at U.S. sites. European site initiation postponed until second quarter due to travel restrictions. Target completion date adjusted to early 2022 due to cumulative Covid-related enrollment slowdowns.Lucid introduced an improved EsoGuard preservative buffer and received special 510(k) clearance to market a more user-friendly and precise EsoCheck accessory.PAVmed and Lucid successfully completed all EU-notified-body audits. Expect EsoCheck CE Mark approval and completion of EsoGuard EU IVDD self-certification in second quarter. Limited commercial launch in select EU countries planned for later this year.First U.S. carpal tunnel syndrome patient underwent successful CarpX® minimally invasive carpal tunnel release and returned to work within one week of the procedure, significantly shorter than recovery times following conventional surgery. Continuing steady and deliberate commercialization plan with a small team of world-class hand surgeons focused on optimizing the procedural steps and safety prior to broader commercialization effort later this year. Expect CarpX CE Mark approval in second quarter. Evaluating potential European distributors for future European commercial launch.PAVmed completed in-person site initiation visits for PortIO study at four Colombia, South America medical centers. Awaiting IRB approval and expect to begin enrollment next quarter. Remain engaged with FDA regarding US PortIO IDE study.PAVmed advancing NextFlo Intravenous Infusion system through design-controlled development and testing with FDA submission targeted for the third quarter. Ongoing M&A discussions and technologic diligence engagement with large strategic partner to license the NextFlo technology for disposable infusion pumps.PAVmed executed manufacturing services agreement for DisappEAR resorbable silk pediatric ear tubes with Canon Inc.’s United States manufacturing and technology center in Virginia. Received Canon-produced prototypes for upcoming animal testing pursuant to previously executed research and development agreement.Solys advanced research and development work on licensed non-invasive glucose monitoring technology, producing data in human volunteers and a diabetic rat model consistent with milestone accuracy parameters. In addition, developed and advanced its own proprietary non-invasive glucose monitoring technology which is not subject to the license agreement. Determined that it would be in PAVmed’s best interests to focus future efforts on its own proprietary technology, terminate the license agreement, and seek a mutually agreeable unwinding of the relationship, which is currently being negotiated. PRELIMINARY FINANCIAL RESULTS For the three months ended December 31, 2020, research and development expenses were $3.6 million and general and administrative expenses were $3.9 million. GAAP net loss attributable to common stockholders was $8.8 million, or $(0.17) per common share. As illustrated below and for the purpose of helping the reader understand the effect of derivative accounting and other non-cash income and expenses on the Company’s financial results, the Company reported a non-GAAP adjusted loss for the three months ended December 31, 2020 of $6.4 million or $(0.12) per common share. PAVmed had cash and cash equivalents of $17.3 million as of December 31, 2020, compared with $6.2 million as of December 31, 2019. Subsequently, in early January 2021, the Company closed on its $13.4 million registered direct offering for the sale of 6.0 million shares of common stock at $2.24 per share which was priced at-the-market under Nasdaq rules. The audited financial results for the year ended December 31, 2020 on Form 10-K will be filed with the SEC in the coming days and will be available at www.pavmed.com or www.sec.gov. Non-GAAP Measures To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP. Non-GAAP financial measures are presented with the intent of providing greater transparency to information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures. Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and 12 months ended December 31, 2020 and 2019 is as follows: For the three months ended December 31, For the year ended December 31, (ooo's except per-share amounts) 2020 2019 2020 2019 Net income (loss) per common share, basic and diluted $(0.17) $(0.19) $(0.73) $(0.55)Net loss attributable to common stockholders (8,813) (6,313) (34,563) (16,727)Preferred Stock dividends and deemed dividends 73 69 287 270 Net income (loss) as reported (8,740) (6,244) (34,276) (16,457)Adjustments: Depreciation expense1 7 4 23 14 Interest expense, net3 - 33 52 33 EBITDA (8,733) (6,207) (34,201) (16,410) Other non-cash or financing related expenses: Stock-based compensation expense2 585 393 2,044 1,571 Debt extinguishment3 1,897 1,165 6,497 666 Change in FV convertible debt3 (194) (482) 3,467 341 Offering costs convertible debt3 - 1,250 2,520 - Non-GAAP adjusted (loss) (6,445) (3,881) (19,673) (13,832)Basic and Diluted shares outstanding 52,487 33,223 45,564 29,212 Non-GAAP adjusted (loss) income per share ($0.12) ($0.12) ($0.43) ($0.47) 1 Included in general and administrative expenses in the financial statements 2 For the three months ended December 31, 2020 includes $450 of stock based compensation expense reported as general and administrative expenses and $136 reported as research and development expense. For the three months ended December 31, 2019 includes $310 of stock based compensation expense reported as general and administrative expenses and $84 reported as research and development expense. For the year ended December 31, 2020 includes $1,581 of stock based compensation expense reported as general and administrative expenses and $462 reported as research and development expense. For the year ended December 31, 2019 includes $1,162 of stock based compensation expense reported as general and administrative expenses and $408 reported as research and development expense. 3 Included in other income and expenses Conference Call and Webcast As announced last week, the Company changed the time for today’s conference call and webcast to 8:30 AM EST to accommodate the schedule of Lucid’s Strategic Advisor, medical diagnostics pioneer Stanley Lapidus. Mr. Lapidus will join PAVmed Chairman and Chief Executive Officer Lishan Aklog, M.D., and President and Chief Financial Officer Dennis McGrath on the call. Mr. McGrath will provide a financial update on the Company. Dr. Aklog will provide a business update and discuss Lucid’s growth strategy with Mr. Lapidus, who will provide his perspective on Lucid’s EsoGuard commercial opportunity, based on his similar experiences bringing early cancer detection technologies to market, including as the founder and former Chairman and CEO of Exact Sciences. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com. Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 13715663. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, our ability to complete our strategic initiatives, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; the effectiveness of our marketing initiatives; the establishment of government and private payment insurance coverage; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts: InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com

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  • PAVmed Reschedules Business Update Conference Call on February 22, 2021 to 8:30 AM EST

    Conference call and live webcast was previously scheduled for 4:30 PM EST Lucid Diagnostics strategic advisor and medical diagnostics pioneer Stanley Lapidus to join call NEW YORK, Feb. 18, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced that the Company has moved the time of its business update conference call on Monday, February 22, 2021 to 8:30 AM EST to accommodate the schedule of PAVmed subsidiary Lucid Diagnostics Inc’s (“Lucid”) Strategic Advisor, medical diagnostics pioneer Stanley Lapidus. Mr. Lapidus will join PAVmed Chairman and Chief Executive Officer Lishan Aklog, M.D., and President and Chief Financial Officer Dennis McGrath on the call. Mr. McGrath will provide a financial update on the Company. Dr. Aklog will provide a business update and discuss Lucid’s growth strategy with Mr. Lapidus, who will provide his perspective on Lucid’s EsoGuard commercial opportunity, based on his similar experiences bringing early cancer detection technologies to market, including as the founder and former Chairman and CEO of Exact Sciences. Mr. Lapidus brings more than three decades of experience founding and leading breakthrough diagnostic companies. He founded and served as President of Cytyc Inc., whose ThinPrep® Pap test technology, which he invented, revolutionized early detection of cervical cancer. Mr. Lapidus also founded and served as President & CEO and later as Chairman of Exact Sciences, whose Cologuard® stool DNA test has revolutionized early detection of colorectal cancer. Exact Sciences became the fastest growing company in the history of the diagnostics industry and now is a leading provider of cancer screening and diagnostic tests. He currently serves on the Board of Directors of Binx Health Inc., Glympse Bio Inc., PathAI Inc, Fractyl Laboratories Inc. and T2 Biosystems Inc. He also serves as a Co-Founding Pillar of Pillar VC, and as Managing Director of his own incubator LapidDx Research. Mr. Lapidus has served as an Instructor at the Massachusetts Institute of Technology and is a Fellow of the American Institute of Medical and Biological Engineering. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name, “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the Investor Relations section of the Company’s website at www.pavmed.com. Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 13715663. The webcast will be available for replay on the Investor Relations section of the Company’s website at www.pavmed.com. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts:InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com ###

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  • First U.S. Patient Undergoes Successful Minimally Invasive Carpal Tunnel Release Using PAVmed’s CarpX® Device

    CarpX® Minimally Invasive Carpal Tunnel Device PAVmed, Inc NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, today announced that the first U.S. patient recently underwent successful carpal tunnel release using its CarpX® minimally invasive carpal tunnel device. CarpX relieves the symptoms of Carpal Tunnel Syndrome (CTS) in a rapid, minimally invasive, office-based procedure that speeds patients' recovery. CTS is a common workplace-related condition that causes chronic pain to patients and, as the top driver of workmen's compensation claims, imposes high costs on society. The patient presented with symptoms of carpal tunnel syndrome to Dr. Edward J. Armbruster of Mercer-Bucks Orthopaedics, P.C., in greater Philadelphia, who performed minimally invasive carpal tunnel release using the CarpX device. In marked contrast to typical recovery times of up to several months following conventional carpal tunnel release surgery, the patient returned to work as a truck driver within one week of the procedure. “This is a very exciting development and the most significant advance in minimally invasive carpal tunnel release since endoscopic techniques were introduced some 30 years ago” said Dr. Armbruster. “I found that the CarpX balloon creates significantly more space in the carpal tunnel after the transverse carpal ligament is divided than traditional techniques, which could potentially result in superior outcomes for patients. As a busy hand surgeon, I strongly believe that CarpX will change how future carpal tunnel surgery will be performed, providing patients with a less invasive option with significantly shorter recovery times than existing carpal tunnel release options.” “We continue to find that CarpX performs as designed, combining balloon technology to protect critical structures together with radiofrequency energy to cut the transverse carpal ligament precisely, offering procedure times comparable to traditional techniques after a very short learning curve,” said Dr. Brian deGuzman, PAVmed’s Chief Medical Officer, who oversees training and proctoring of early CarpX users and was present as an observer during this procedure. CarpX has the potential to lower healthcare costs and increase the numbers of patients treated for CTS by offering a more attractive option to the large number of patients who chose to “suffer in silence” to avoid a prolonged recovery from traditional carpal tunnel surgery. “We thank Dr. Armbruster for leading the team of world-class hand surgeons participating in our initial U.S. CarpX commercial launch,’’ said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “We continue to take a steady and deliberate approach to this initial launch, focusing on training, proctoring and procedural streamlining, to lay the foundation for expanded utilization later this year. This initial U.S. commercial experience along with our clinical trial results in New Zealand affirm CarpX’s potential to establish a new standard of care in the treatment of carpal tunnel syndrome by dramatically reducing recovery times and improving outcomes compared to traditional open surgery. We believe this represents an estimated billion-dollar U.S. market opportunity.” About CarpX CarpX is a patented U.S. Food and Drug Administration (FDA) 510(k) cleared single-use disposable minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery times (CarpX animation). CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to percutaneous and minimally invasive revolutions in the treatment of other conditions. The balloon catheter device is inserted under the scarred ligament in a minimally invasive fashion, tensioning it while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure. Carpal tunnel syndrome exacts a major clinical and economic burden on society with an estimated 600,000 patients undergoing carpal tunnel surgery each year and over one million who suffer in silence because of the long recovery times associated with traditional invasive carpal tunnel release. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts: InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com Attachment CarpX® Minimally Invasive Carpal Tunnel Device

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  • Global Cardiovascular Devices Market Now Project to Exceed $71 Billion By 2027

    Cardiovascular devices are the medical devices which are used to diagnosis and treat the heart diseases and other heart-related problems. These devices play essential role prevention and treatment of cardiovascular diseases. The cardiovascular devices include implantable cardioverter defibrillators, implanted heart rhythm monitors, pacemakers, and various other devices. The cardiovascular devices market is currently witnessing considerable demand across the globe. Increasing awareness about the various cardiovascular diseases and increasing geriatric population across the world are the primary factors driving the growth of the market. As per the estimation of the World Health Organization (WHO), cardiovascular diseases are the number one cause for death globally and taking around 17.9 million lives every year. Thus, the rising prevalence of cardiovascular diseases is one of the key factors fueling the growth of the market. A report by FiorMarkets projected that the global cardiovascular devices market is expected to grow from USD 42.61 billion in 2019 to USD 71.05 billion by 2027, at a CAGR of 6.6% during the forecast period 2020-2027. Active healthcare and tech stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Medtronic plc (NYSE: MDT), Boston Scientific Corporation (NYSE: BSX), TransEnterix, Inc. (NYSE: TRXC), PAVmed Inc. (NASDAQ: PAVM).

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  • PAVmed to Hold Business Update Conference Call on February 22, 2021

    NEW YORK, Feb. 09, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced that the Company will host a business update conference call on Monday, February 22, 2021 at 4:30 p.m. Eastern time. During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer of the Company, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, the Company’s President and Chief Financial Officer, will discuss fourth quarter 2020 financial results. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com. Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 13715663. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com. About PAVmed PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Contacts: InvestorsMike HavrillaDirector of Investor Relations(814) 241-4138JMH@PAVmed.com MediaShaun O’NeilChief Commercial Officer(518) 812-3087SMO@PAVmed.com Katie GallagherLaVoieHealthScience(617) 792-3937PAVmed@lavoiehealthscience.com

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  • PAVmed Closes $13.4 Million Common Stock Registered Direct Offering Priced At-the-Market under Nasdaq Rules

    NEW YORK, Jan. 08, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced the closing of its previously announced registered direct offering (the “Offering”) of 6.0 million shares of common stock at a price of $2.24 per share which was priced at-the-market under Nasdaq rules. The estimated net proceeds to PAVmed from the Offering are expected to be approximately $12.4 million after deducting the placement agent’s fees and other estimated offering expenses. PAVmed plans to use the net proceeds for working capital, general corporate purposes, and to repay a portion of certain of the Company’s outstanding convertible notes.Maxim Group LLC acted as the sole placement agent in connection with the Offering.The Offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-248709) declared effective by the Securities and Exchange Commission on September 17, 2020. A prospectus supplement relating to the Offering was filed with the Securities and Exchange Commission on January 7, 2021. Copies of the prospectus supplement relating to the Offering, together with the accompanying base prospectus included in the registration statement, may be obtained from the Securities and Exchange Commission at www.sec.gov, or from the Company at One Grand Central Place, Suite 4600, New York, New York 10165, Telephone (212) 949-4319. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • PAVmed Announces Registered Direct Offering of its Common Stock Priced At-the-Market under Nasdaq Rules

    NEW YORK, Jan. 06, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced it has entered into agreements for the sale of 6.0 million shares of common stock at a price of $2.24 per share for gross proceeds of approximately $13.4 million in a registered direct offering (the “Offering”) priced at-the-market under Nasdaq rules. The estimated net proceeds to PAVmed from the Offering are expected to be approximately $12.4 million after deducting the placement agent’s fees and other estimated offering expenses. The Offering is expected to close on or about January 8, 2021 subject to the satisfaction of customary closing conditions.Maxim Group LLC is acting as the sole placement agent in connection with the Offering.The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-248709) declared effective by the Securities and Exchange Commission on September 17, 2020. A prospectus supplement relating to the Offering is being filed with the Securities and Exchange Commission. Copies of the prospectus supplement relating to the offering, together with the accompanying base prospectus included in the registration statement, may be obtained from the Securities and Exchange Commission at www.sec.gov, or from the Company at One Grand Central Place, Suite 4600, New York, New York 10165, Telephone (212) 949-4319. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, PAVmed’s ability to complete the offering; volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • PAVmed Closes Additional $8.1 Million Common Stock Registered Direct Offering

    NEW YORK, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced the closing of its previously announced registered direct offering (the “Offering”) of approximately 5.1 million shares of common stock at a price of $1.60 per share. The estimated net proceeds to PAVmed from the Offering are expected to be approximately $7.4 million after deducting the placement agents’ fees and other estimated offering expenses. PAVmed plans to use the net proceeds for working capital, general corporate purposes, and to repay a portion of certain of the Company’s outstanding convertible notes.Maxim Group LLC acted as the lead placement agent and Lake Street Capital Markets LLC acted as co-placement agent in connection with the Offering.The Offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-248709) declared effective by the Securities and Exchange Commission on September 17, 2020. A prospectus supplement relating to the Offering was filed with the Securities and Exchange Commission on December 18, 2020. Copies of the prospectus supplement relating to the Offering, together with the accompanying base prospectus included in the registration statement, may be obtained from the Securities and Exchange Commission at www.sec.gov, or from the Company at One Grand Central Place, Suite 4600, New York, New York 10165, Telephone (212) 949-4319. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • PAVmed Announces Pricing of Additional $8.1 Million Common Stock Registered Direct Offering

    NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced it has entered into agreements for the sale of approximately 5.1 million shares of common stock in a registered direct offering with predominantly existing institutional investors at a price of $1.60 per share for gross proceeds of $8.1 million. The estimated net proceeds to PAVmed from the registered direct offering are expected to be approximately $7.4 million after deducting the placement agents’ fees and other estimated offering expenses. The offering is expected to close on or about December 22, 2020 subject to the satisfaction of customary closing conditions.Maxim Group LLC is acting as the lead placement agent and Lake Street Capital Markets LLC is acting as co-placement agent in connection with the offering.The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-248709) declared effective by the Securities and Exchange Commission on September 17, 2020. A prospectus supplement relating to the offering is being filed with the Securities and Exchange Commission. Copies of the prospectus supplement relating to the offering, together with the accompanying base prospectus included in the registration statement, may be obtained from the Securities and Exchange Commission at www.sec.gov, or from the Company at One Grand Central Place, Suite 4600, New York, New York 10165, Telephone (212) 949-4319. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, PAVmed’s ability to complete the offering; volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • What Type Of Shareholders Make Up PAVmed Inc.'s (NASDAQ:PAVM) Share Registry?

    The big shareholder groups in PAVmed Inc. ( NASDAQ:PAVM ) have power over the company. Insiders often own a large chunk...

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  • PAVmed Announces Registered Direct Offering of its Common Stock

    NEW YORK, Dec. 11, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced it has entered into agreements for the sale of 5.6 million shares of common stock in a registered direct offering at a price of $1.60 per share for gross proceeds of approximately $8.9 million. The estimated net proceeds to PAVmed from the registered direct offering are expected to be approximately $8.3 million after deducting the placement agents’ fees and other estimated offering expenses. The offering is expected to close on or about December 15, 2020 subject to the satisfaction of customary closing conditions.Maxim Group LLC is acting as the lead placement agent and Lake Street Capital Markets LLC is acting as co-placement agent with respect to certain institutional investors for this offering. The Company did not engage a placement agent for securities purchased by select investors.The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-248709) declared effective by the Securities and Exchange Commission on September 17, 2020. A prospectus supplement relating to the offering is being filed with the Securities and Exchange Commission. Copies of the prospectus supplement relating to the offering, together with the accompanying base prospectus included in the registration statement, may be obtained from the Securities and Exchange Commission at www.sec.gov, or from the Company at One Grand Central Place, Suite 4600, New York, New York 10165, Telephone (212) 949-4319. Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, PAVmed’s ability to complete the offering; volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • Is PAVmed Inc. (PAVM) A Good Investment Now?

    Out of thousands of stocks that are currently traded on the market, it is difficult to identify those that will really generate strong returns. Hedge funds and institutional investors spend millions of dollars on analysts with MBAs and PhDs, who are industry experts and well connected to other industry and media insiders on top of that. Individual investors can piggyback […]

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  • PAVmed Reports Third Quarter 2020 Financial Results and Provides Business Update

    Conference call to be held today at 4:30 p.m. Eastern time NEW YORK, Nov. 17, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (“Lucid”) and Solys Diagnostics Inc. (“Solys”) and discussed financial results for the three and nine months ended September 30, 2020.“During the third quarter of 2020 and subsequent weeks, we have seen commercial activity accelerate as we gain solid traction for PAVmed’s lead products in the medical community,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Our expanding commercial team has delivered exponential growth in EsoGuard® testing and EsoCheck® procedures, despite the challenges of the pandemic, as well as growing, palpable enthusiasm among physicians for these devices for their potential to save lives through early detection of precursors of highly lethal esophageal cancer. With final U.S. Center for Medicare and Medicare Services (“CMS”) payment determination now secured, we look forward to translating this into a solid, growing revenue stream when CMS payment becomes effective in the New Year.”RECENT ACCOMPLISHMENTS * Secured U.S. Center for Medicare and Medicare Services (“CMS”) Clinical Laboratory Fee Schedule Test Code Final Determination for EsoGuard® Esophageal DNA Test (CPT code 0114U) of $1,938.01, effective January 1, 2021. * Expanded sales management team to 5 professionals (CarpX® national sales manager and 4 Lucid regional sales managers) and independent sales network to 38 representatives. * Rapidly accelerated EsoGuard testing and EsoCheck procedural activity, doubling their rates approximately every 4-6 weeks. * Expanded EsoGuard marketing activities and disease-related educational activities targeting physicians and consumers, including a widely distributed Access Health segment aired on the Lifetime Network, highlighting the relationship between Gastroesophageal Reflux Disease (GERD), Barrett’s Esophagus (BE) and highly lethal esophageal cancer (EAC), as well as the role of EsoGuard in early detection and cancer prevention. * Received U.S. Patent and Trademark Office trademarks for EsoGuard® and CarpX®. * Completed European Union (EU) CE Mark regulatory submission for EsoCheck and confirmed that EsoGuard falls under the self-declaration category of the EU IVDD requirements, clearing the path to European commercialization of both products. * Achieved multiple critical PAVmed and Lucid quality management system milestones, including passing stage 2 audits for both, receiving ISO 13485:2016 certification for Lucid and recommendation for certification for PAVmed, clearing the path for EU CE Mark submissions for EsoCheck, CarpX, PortIO™, NextFlo™ and all future PAVmed and Lucid products. * Recruited hand surgeon advisory board to perform initial U.S. procedures and serve as trainers, proctors, educators, and ambassadors for the CarpX minimally invasive device to treat carpal tunnel syndrome. Completed initial cadaver training in advance of first U.S. commercial cases. * Accelerated enrollment at 21 active U.S. sites for ESOGUARD BE-1 and 2 clinical trials in support of FDA registration of EsoGuard/EsoCheck as an In-Vitro Diagnostic (IVD) device with 33 patients enrolled and tested to date, with no serious adverse events recorded. * Completed enrollment in pilot clinical trial evaluating EsoCheck in Eosinophilic Esophagitis (EoE) patients at the University of Pennsylvania. * Completed initial diabetic rat model prototype testing of Solys non-invasive glucose monitoring system, achieving R&D plan milestone as defined in license agreement. * Continued to expand and advance extensive intellectual property portfolio of 150 issued and pending, owned, assigned or licensed patents across PAVmed and its subsidiaries. * Received approximately $7 million in net proceeds from a private placement of Senior Secured Convertible Promissory Notes with an existing institutional investor.UPCOMING KEY ACTIVITIES AND MILESTONES * Initiate claims submission and billing at $1,938.01 for each EsoGuard test performed under CPT code 0114U, effective January 1, 2021. * Continue to expand sales management team and independent sales representative network for both EsoGuard/EsoCheck and CarpX. * Continue to drive acceleration in EsoGuard testing and EsoCheck procedural activity, targeting both large medical centers and small-medium practices. Continue to optimize sales and training activities as pandemic-related restrictions wax and wane. * Perform initial U.S. CarpX procedures by initial cohort of trained experts and subsequently expand clinical and commercial activities to broader group of hand surgeons and other proceduralists. * Secure CMS local coverage determinations for EsoGuard and extend payment and coverage process to private payors. * Secure EsoCheck and CarpX CE Mark approvals and EsoGuard CE Mark self-certification. Launch EsoGuard, EsoCheck and CarpX in Europe. * Accelerate enrollment at U.S. sites for ESOGUARD-BE-1 and 2 screening and case control clinical trials. * Launch additional Lucid-sponsored clinical trials of EsoGuard and EsoCheck to support commercial activities including American Foregut Society sponsored EsoGuard Registry, BE EGD Yield study and population study of active measures to enhance BE-EAC screening using EsoGuard. * Launch clinical trial of EsoCheck with BE progression markers at Fred Hutchinson Cancer Research Center in Seattle. * Continue to explore role of EsoCheck in diagnosing and managing Eosinophilic Esophagitis (EoE) based on results of University of Pennsylvania pilot study and potential EoE biomarkers under development. * Complete M&A process and consummate licensing agreement for NextFlo™ technology in disposable infusion pumps. * Complete device qualification and FDA 510(k) submission for NextFlo Intravenous Infusion System. Commercially launch NextFlo IV Infusion system at targeted large medical centers following FDA 510(k)-clearance. * Secure FDA clearance for an Investigational Device Exemption (IDE) to begin a clinical safety study in the U.S. evaluating PortIO™ Intraosseous Infusion Device in dialysis patients with a one-week implant duration to support its de novo application. * Enroll first patients in PortIO long-term clinical study in Colombia, South America to demonstrate up to 60-day maintenance free implant durations in humans. * Complete development work and animal testing of EsoCure™ Esophageal Ablation Device in support of FDA 510(k) submission in 2021. * Continue to advance development of Solys non-invasive glucose monitoring system towards accuracy milestones sufficient for FDA regulatory submission and commercialization.FINANCIAL RESULTS For the three months ended September 30, 2020, research and development expenses were $2.6 million and general and administrative expenses were $2.9 million, in-line with the previous quarter. GAAP net loss attributable to common stockholders was $5.6 million, or $(0.11) per common share. As illustrated below and for the purpose of helping the reader understand the effect of derivative accounting and other non-cash income and expenses on the Company’s financial results, the Company reported a non-GAAP adjusted loss for the three months ended September 30, 2020 of $4.5 million, or $(0.09) per common share.PAVmed had cash and cash equivalents of $8.3 million as of September 30, 2020, compared with $6.2 million as of December 31, 2019.The unaudited financial results for the three and nine months ended September 30, 2020 as reported to the SEC on Form 10-Q can be obtained at www.pavmed.com or www.sec.gov.Non-GAAP MeasuresTo supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.Non-GAAP financial measures are presented with the intent of providing greater transparency to information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and nine months ended September 30, 2020 and 2019 is as follows:  For the three months ended September 30,  For the nine months ended September 30,  (ooo’s except per-share amounts) 2020  2019  2020  2019                Net income (loss) per common share, basic and diluted  ($0.11)  ($0.10)  ($0.57)  ($0.36) Net loss attributable to common stockholders   (5,557)   (3,153)   (25,751)   (10,414) Preferred Stock dividends and deemed dividends   74    68    215    201  Net income (loss) as reported   (5,483)   (3,085)   (25,536)   (10,213) Adjustments:                 Depreciation expense1   7    4    17    10  Interest expense, net3   -    -    53    -  EBITDA   (5,476)   (3,081)   (25,466)   (10,203)                   Other non-cash or financing related expenses:                 Stock-based compensation expense2   586    330    1,458    1,177  Debt extinguishment3   663    407    4,600    666  Change in FV convertible debt3   (367)   (379)   5,521    341  Offering costs convertible debt3   50    -    660    -  Non-GAAP adjusted (loss)   (4,544)   (2,723)   (13,227)   (8,019) Basic and Diluted shares outstanding   48,381    31,031    45,564    29,212  Non-GAAP adjusted (loss) income per share  ($0.09)  ($0.09)  ($0.29)  ($0.27) 1 Included in general and administrative expenses in the financial statements2 For the three months ended September 30, 2020 includes $448 of stock based compensation expense reported as general and administrative expenses and $138 reported as research and development expense. For the three months ended September 30, 2019 includes $269 of stock based compensation expense reported as general and administrative expenses and $61 reported as research and development expense. For the nine months ended September 30, 2020 includes $1,132 of stock based compensation expense reported as general and administrative expenses and $326 reported as research and development expense. For the nine months ended September 30, 2019 includes $853 of stock based compensation expense reported as general and administrative expenses and $324 reported as research and development expense.3 Included in other income and expensesConference Call and WebcastThe Company will hold a conference call and webcast today at 4:30 p.m. Eastern time. During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer of the Company, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, President and Chief Financial Officer, will review third quarter 2020 financial results.To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 13712132. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard® Esophageal DNA Test, EsoCheck® Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • PAVmed, Inc. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / November 17, 2020 / PAVmed, Inc.

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  • PAVmed to Hold Business Update Conference Call on November 17, 2020

    NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced that the Company will host a business update conference call on Tuesday, November 17, 2020 at 4:30 p.m. Eastern time. During the call, Lishan Aklog, M.D., Chairman and Chief Executive Officer of the Company, will provide a business update including an overview of the Company’s near-term milestones and growth strategy. In addition, Dennis McGrath, the Company’s President and Chief Financial Officer, will discuss third quarter 2020 financial results. To access the conference call, U.S.-based listeners should dial (877) 407-3982 and international listeners should dial (201) 493-6780. All listeners should provide the operator with the conference call name “PAVmed, Inc. Business Update Conference Call” to join. Individuals interested in listening to the live conference call via webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.Following the conclusion of the conference call, a replay will be available for one week and can be accessed by dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from outside the U.S. To access the replay, all listeners should provide the following pin number: 13712132. The webcast will be available for replay on the investor relations section of the Company’s website at www.pavmed.com.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™ Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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  • INVESTIGATION ALERT: Fields Kupka & Shukurov LLP Is Investigating PAVmed Inc. for Potential Breach of Fiduciary Duty Claims

    NEW YORK, NY / ACCESSWIRE / October 6, 2020 / Fields Kupka & Shukurov LLP is investigating potential breach of fiduciary duty claims involving the board of directors of PAVmed Inc.

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  • PAVmed to Present at the Cantor Fitzgerald Virtual Global Healthcare Conference on September 15, 2020

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical device company, today announced that Lishan Aklog, M.D., Chairman and Chief Executive Officer of the Company, will present at the Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 15, 2020 from 8:00 a.m. to 8:30 a.m. Eastern time. Individuals interested in listening to the presentation webcast may do so by visiting the investor relations section of the Company’s website at www.pavmed.com.About PAVmedPAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™ Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn.Forward-Looking StatementsThis press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.Contacts:Investors Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.comMedia Shaun O’Neil Chief Commercial Officer (518) 812-3087 SMO@PAVmed.com

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