Corporate Overview LISHAN AKLOG, MD Chairman & CEO September 15, 2020 Nasdaq: PAVM, PAVMZ
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
Nasdaq: PAVM, PAVMZ Innovation-driven, multi-product, commercial- stage medical device company PRODUCT PORTFOLIO BUSINESS MODEL LEADERSHIP TEAM § Highly diversified across broad § Proven track record § Deep business, finance and M&A range of clinical conditions experience § Capital-efficiency § Strong clinical and technical § Speed to market § Expanding through both internal expertise and licensed external innovations § Proven track record of value § Over 100 issued and pending creation and return to investors patents across 17 families § Total market opportunity over $3 Billion 3
Corporate Structure Operating Subsidiaries 82% 83% Non-invasive Non-invasive Esophageal Diagnostics Glucose Monitoring 4
Executive Leadership Team BROAD EXPERTISE AND EXPERIENCE § Medical Device Innovation § Commercialization LISHAN AKLOG, MD DENNIS MCGRATH BRIAN DEGUZMAN, MD Chairman & CEO Chief Medical Officer President & CFO § Market Development § Physician Engagement § Direct To Consumer § Regulatory Clearance RICH YAZBECK SHAUN O’NEIL § Clinical Trial Design and Execution Chief Technology Officer Chief Commercial Officer § Reimbursement, Payment and Coverage § Corporate Financing And Capital Markets § M&A and Licensing RANDY BROWN DAVID WURTMAN MD Chief Operating Officer, Lucid Chief Medical Officer, Lucid
Diversified Product Portfolio GI HEALTH EMERGING INNOVATIONS Solys – Noninvasive glucose monitoring Integrated suite of products designed to diagnose and treat complications of FlexMO – Novel, versatile Gastroesophageal Reflux Disease (GERD) along the spectrum from non- mechanical circulatory support dysplastic Barrett’s Esophagus (BE) to Esophageal Adenocarcinoma (EAC). (ECMO) cannula DisappEAR – Resorbable MINIMALLY INVASIVE INFUSION THERAPY pediatric ear tubes INTERVENTIONS NextVent – Full-featured, low- cost, single use ventilator PortIO ™ Maintenance-free implantable Platform technology providing highly Minimally invasive device to treat vascular access device accurate flow for IV infusion sets Carpal Tunnel Syndrome and disposable infusion pumps
Commercially Available Products Minimally I Minimally I Invasive D Invasive D Device t Device t to T to T Treat Treat Carpa Carpa pal T pal T Tunnel S Tunnel S Syndr Syndr drome drome § Commercially launched as § FDA 510(k) cleared in Q2- § FDA 510(k) cleared in Q2-2020 as a minimally § FDA 510(k) cleared in Q2-2020 as a minimally LDT Q4-2019 2019 as anatomically targeted invasive device alternative to open carpal tunnel invasive device alternative to open carpal tunnel non-invasive esophageal cell release surgery release surgery § CMS preliminary payment collection device determination of ~$2000 § Estimate $1 billion market opportunity based on over § Estimate $1 billion market opportunity based on over § Alternative to invasive 600,000 U.S. procedures annually and up to 1.5 600,000 U.S. procedures annually and up to 1.5 § 15M target population per endoscopy million with symptoms who “suffer in silence” million with symptoms who “suffer in silence” published society guidelines
Minimally Invasive Device to Treat Carpal Tunnel Syndrome 8
Precision Bipolar RF Electrosurgical Cutting Tool Benefits of minimally invasive procedure with the therapeutic results of open surgery 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 along narrow line precisely cuts ligament relieving nerve compression 9
Balloon & Electrodes 19 mm non-compliant nylon balloon Mounted eccentrically on flexible shaft Active cutting electrode Insulative Coating Exposed Metal Ridge Passive return electrode Inflated with radiopaque contrast Sesquipolar Stationary Stainless-Steel Electrodes
CarpX Minimally Invasive Carpal Tunnel Release Procedure 1. 2. Insert CarpX device over wire and position Inflate balloon with contrast material and Activate device, cutting electrodes relative to carpal bones ligament with <2 sec burst of RF energy Narrowed “waist” at point of Wire maximal constriction Electrodes Wire 4. 3. Lateral view of TLC division Confirm division of the TLC by full inflation of the balloon Constriction relieved, no residual waist Electrodes Wire
CarpX Regulatory Status • Completed First-in-Human FDA clinical safety study in December 2019 • All patients met primary effectiveness endpoint – complete division of TCL • All patients met primary safety endpoint – no device-related serious adverse events • Excellent results of other pre-specified outcome assessments, similar or better than expected results from traditional open surgery • Short learning curve, procedures times fell to same or less than traditional open surgery • FDA 510(k) Marketing Clearance Received on April 20, 2020 Commercial Status • Commercially launched August 2020 • Building sales channel with established independent representatives 12
Dr. Markowitz Dr. Chak Dr. Willis Dr. Moinova Study Design Case-control study of patients referred for endoscopy: • 322 patients underwent endoscopic brushing sampling and EsoGuard assay (mVIM+ or mCCNA+) to set and validate assay cut-offs • 86 patients underwent EsoCheck balloon sampling and EsoGuard assay Results Assay highly accurate Balloon sampling device well with >90% sensitivity and tolerated with same accuracy as specificity endoscopic brushings 14
A Majority-Owned Subsidiary of PAVmed Inc In May 2018, PAVmed licensed the molecular diagnostic assay and cell collection device technology from Case Western Reserve University into a newly created subsidiary Lucid Diagnostics. Lucid developed and commercialized these technologies as EsoGuard and EsoCheck. 15
Highlighted as one of the year’s significant advances in cancer prevention in the NCI’s 2020 report to Congress Granted FDA Breakthrough Device Complementary technologies designed to facilitate diagnosis of designation for EsoGuard nondysplastic and dysplastic Barrett’s Esophagus (BE) , on samples collected using precursors of highly lethal esophageal adenocarcinoma (EAC) , EsoCheck in high-risk as well as EAC itself, in patients with chronic heart burn or patients at elevated risk for gastroesophageal reflux disease (GERD) esophageal dysplasia arising from GERD 16
The Barrett’s Esophagus (BE) to Esophageal Adenocarcinoma (EAC) Spectrum Gastroesophageal Reflux Nondysplastic Barrett’s Dysplastic Barrett’s Esophageal (GERD) Esophagus (NDBE) Esophagus (LGD, HGD) Adenocarcinoma (EAC) Commonly known as reflux or Benign transformation of lower Most common esophageal Pre-cancerous progression from esophageal lining from repeated chronic “heartburn” cancer, Intramucosal or Invasive NDBE to low-grade dysplasia exposure to gastric fluid (LGD) to high-grade dysplasia (HGD) 700+% increase over 40 years ~ 2% of NDBEs progress per year 50+ Million weekly GERD patients 3 to 4 Million BE patients #1 rate of increase of any cancer 9 Million visits per year RF or Cryo esophageal ablation halts 3 to 6% of GERD patients progression to EAC Highly lethal (>80% 5-year mortality) 10 to 15 Million “High Risk” 1 5-10% of “High Risk” GERD 17 1 Per ACG Guidelines Chronic GERD plus three risk factors among 50 years, White, Male, Obese, Smoker, Family History
Esophageal Cancer Statistics 5-Year Survival Estimated New Cases in 2020 18,440 % of All New Cancer Cases 1.0% 19.9% Estimated Deaths in 2020 16,170 2010-2016 % of All Cancer Deaths 2.7% https://seer.cancer.gov/explorer/
Esophageal Adenocarcinoma has increased over 700% in the past 4 decades 19 Thuy-Van P. Hang, MD; Zachary Spiritos, MD, MPH; Anthony Gamboa, MD; Zhengjia Chen, PhD; Seth Force, MD; Steve Keilin, MD; Nabil Saba, MD; Bassel El-Rayes, MD; Qiang Cai, MD, PhD; Field Willingham, MD, MPH. THE EPIDEMIOLOGY OF ESOPHAGEAL ADENOCARCINOMA IN THE UNITED STATES. Program No. P0265. ACG 2018 Annual Scientific Meeting Abstracts. Philadelphia, Pennsylvania: American College of Gastroenterology.
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