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Corporate Overview LISHAN AKLOG, MD Chairman & CEO February - PowerPoint PPT Presentation

Corporate Overview LISHAN AKLOG, MD Chairman & CEO February 18, 2020 Nasdaq: PAVM, PAVMZ Disclaimers This presentation contains certain forward-looking statements that involve risks and uncertainties. Actual results and events may differ


  1. Corporate Overview LISHAN AKLOG, MD Chairman & CEO February 18, 2020 Nasdaq: PAVM, PAVMZ

  2. Disclaimers This presentation contains certain forward-looking statements that involve risks and uncertainties. Actual results and events may differ significantly from results and events discussed in forward-looking statements. • Factors that might cause or contribute to such differences include, but are not limited to, those discussed in “Risk Factors” in our Annual Report • on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission . We undertake no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the • date they were made. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities , nor shall there be any sale of securities in any jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. PAVmed has not yet received clearance from the FDA or any other regulatory agency for many of the products described in this presentation. 2

  3. Nasdaq: PAVM, PAVMZ Who We Are: • Highly differentiated, multi-product commercial-stage medical device company • Founded in 2014 by a team of successful entrepreneurs • Highly diversified and expanding portfolio of innovative products designed to address unmet needs across broad range of clinical conditions • Substantial addressable total market opportunities totaling > $3 Billion • Two commercial products and other near-term commercialization opportunities • Proven business model focused on efficient, cost-effective paths to commercialization • Robust IP portfolio of over 100 issued and pending patents across 17 families 3

  4. 82% 83% Solys diagnostics Non-invasive Non-invasive Esophageal Diagnostics Glucose Monitoring 4

  5. Experienced Management Team LISHAN AKLOG, MD DENNIS MCGRATH BRIAN DEGUZMAN, MD SHAUN O’NEIL RICH YAZBECK President & CFO Chairman & CEO Chief Medical Officer Chief Commercial Officer Chief Technology Officer

  6. Diversified Product Pipeline MINIMALLY INVASIVE GASTROENTEROLOGY INTERVENTIONS INFUSION THERAPY EsoGuard & EsoCheck EsoCure CarpX PortIO NextFlo Esophageal DNA Test Designed to Completely Disposable Minimally Invasive Implantable Highly Accurate Facilitate Detection of Dysplastic/ Esophageal Ablation Device to Treat Intraosseous Vascular Disposable Nondysplastic BE and EAC Device to Treat Carpal Tunnel Access Device Intravenous (IV) Emerging Dysplastic BE Syndrome Infusion Set Esophageal Cell Collection Device Innovations Noninvasive Glucose ESTIMATED >$2B >$750M >$1B >$750M >$1B Monitoring, MARKET SIZE Mechanical Circulatory Support (ECMO), EsoCheck: 510(k) Cleared Pediatric ear tubes 510(k) EsoGuard LDT: Available US de novo Clinical safety study 510(k) 510(k) REGULATORY EsoGuard IVD: PMA completed Clinical safety study Submission 1H21 Submission 2H20 STATUS Resubmission launch upcoming FDA Breakthrough Device ESOGUARD-BE-1 and 2 IVD pending clinical trials launched • BE = Barrett’s Esophagus • Multiple issued and pending • Multiple issued and pending • Multiple issued/pending • Multiple issued and pending patents patents patents patents • EAC = Esophageal Adenocarcinoma • Benchtop proof of concept with • First-in-human (FIH) clinical • Pre-clinical work completed • Constant flow rates across a • Multiple issued and pending patents ablation temperatures > RF safety study met target including unprecedented six- wide range of IV bag heights • Pilot study evaluating EsoCheck for OTHER follow-up and both primary month maintenance-free with accuracy rates Eosinophilic Esophagitis (EoE) launch comparable to electronic endpoints function in animals upcoming infusion pumps • 60-day implant duration • Formal M&A process ongoing clinical study launch upcoming

  7. CarpX Minimally Invasive Device to Treat Carpal Tunnel Syndrome 7

  8. Benefits of minimally invasive procedure — with the therapeutic results of open surgery CARPX FEATURES Balloon creates anatomic separation between electrodes and nerves/tendon and tensions ligament Radiofrequency (RF) cutting electrodes mimic traditional surgical mechanical cutting blades Very short burst of RF energy precisely cuts ligament relieving nerve compression Cutting Electrodes Balloon 8

  9. CarpX Minimally Invasive Carpal Tunnel Release Procedure Narrowed “waist” at point of Wire maximal constriction Electrodes Wire Insert CarpX device over wire and position electrodes Inflate balloon with contrast material relative to carpal bones Electrodes Wire Constriction relieved, no residual waist Confirm placement of electrodes relative to nerves Activate device, cutting ligament with <2 sec burst of 9 RF energy

  10. CarpX Status • First-in-human (FIH) 510(k) clinical safety study completed • Met target follow-up and both primary endpoints • 510(k) Resubmission pending • Multiple issued and pending patents 10

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  12. EsoGuard, EsoCheck and Lucid Diagnostics Nasdaq: PAVM A Majority-Owned Subsidiary of PAVmed Inc CWRU LUCID LICENSED ESOGUARD & ESOCHECK FROM CWRU IN MAY 2018 Complementary technologies designed to facilitate diagnosis of nondysplastic and EsoCheck dysplatic Barrett’s Esophagus (BE) – precursors of highly lethal esophageal adenocarcinoma (EAC) – as well as EAC itself, in patients with chronic heart burn or gastroesophageal reflux disease (GERD) Highlighted as one of the year’s significant advances in cancer prevention in the NCI’s 2020 report to Congress EsoGuard Granted FDA Breakthrough Device designation for EsoGuard on samples collected using EsoCheck in high-risk patients at elevated risk for esophageal dysplasia arising from GERD 12

  13. The Barrett’s Esophagus (BE) to Esophageal Adenocarcinoma (EAC) Spectrum GASTROESOPHAGEAL NONDYSPLASTIC BARRETT’S DYSPLASTIC BARRETT’S ESOPHAGEAL REFLUX (GERD) ESOPHAGUS (NDBE) ESOPHAGUS (LGD, HGD) ADENOCARCINOMA (EAC) Commonly known as reflux or Benign metaplastic transformation Pre-cancerous progression from Most common esophageal cancer chronic “heartburn” of lower esophageal lining from NDBE to low-grade dysplasia (LGD) Intramucosal or Invasive repeated exposure to gastric fluid to high-grade dysplasia (HGD) 50+ Million weekly GERD patients 3 to 4 Million BE patients ~ 2% of NDBEs progress per year 500% increase over 30 yrs 9 Million visits per year 3 to 6% of GERD patients RF or Cryo esophageal ablation #1 rate of increase of any cancer halts progression 10 to 20 Million “High Risk” 1 5-10% of “High Risk” GERD Highly lethal ( < 20% 5-yr survival) 13 1 Per ACG Guidelines Chronic GERD plus three risk factors among 50 years, White, Male, Obese, Smoker, Family History

  14. The BE-to-EAC Screening Imperative 2016 AMERICAN COLLEGE OF GASTROENTEROLOGY GUIDELINES • Recommends screening in high-risk GERD patients 1. > 5 years of GERD 2. Three additional risk factors > 50 years White Male Obese Smoker Family History • Detect BE and monitor progression to LGD/HGD so it can be ablated before progressing to EAC 14

  15. The BE-to-EAC Screening Imperative UPPER ENDOSCOPY (EGD) • EGD is invasive, costly and requires sedation • < 10% of high-risk GERD patients currently undergo EGD screening • Widespread screening for BE using endoscopy not practical or cost- effective 15

  16. The BE-to-EAC Screening Imperative THE UNMET CLINICAL NEED • < 10% of EAC patients have had BE diagnosed before EAC • Tragic missed opportunity to monitor BE and treat LGD/HGD • Increasing high-risk GERD screening rate from 10% to 25% should prevent several thousand EAC deaths per year • Requires effective and efficient non- invasive office-based screening test 16

  17. The BE-to-EAC Screening Imperative CYTOSPONGE + TFF3 • Medtronic’s Cytosponge + Trefoil Factor 3 is NOT the solution to the unmet need • Cytosponge does not target BE anatomy • Cytosponge does not provide protected sample necessary to pick up BE signal over background • TFF3 is an immunohistochemical test which requires pathologist and not automatable • Published sensitivity and specificity not sufficient for widespread screening 17

  18. The Lucid Solution ESOCHECK Esophageal Cell Collection Device with Collect +Protect™ Technology • FDA 510(k)-cleared • Rapid office-based non-invasive alternative to endoscopy • Targeted sampling of distal esophagus where BE occurs • Collect+Protect Technology prevents dilution and contamination of BE cells • Maintains high BE signal relative to background 18

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  20. The Lucid Solution ESOGUARD LDT Highly Accurate Esophageal DNA Test • Commercially available Laboratory Developed Test (LDT) • NGS-based molecular assay of methylated markers at 31 sites on 2 genes Vimentin and CCNA1 • 408-patient published study detected BE-to-EAC spectrum with > 90% sensitivity and specificity 1. . Additional 300+ patients enrolled in NCI-sponsored trials • CPT billing code through CMS Clinical Laboratory Fee Schedule (CLFS) process securing gap-fill designation under discussions with Medicare contractors • Multiple Issued and pending patents including composition of matter and bioinformatic algorithms 20 1 Moinova et al . Science Translational Medicine 2018;10(424)

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