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

LISHAN AKLOG, MD Chairman & CEO

September 15, 2020

Corporate Overview

Nasdaq: PAVM, PAVMZ

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.

Disclaimers

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Innovation-driven, multi-product, commercial- stage medical device company

Nasdaq: PAVM, PAVMZ

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§ Highly diversified across broad range of clinical conditions § Expanding through both internal and licensed external innovations § Over 100 issued and pending patents across 17 families § Total market opportunity over $3 Billion § Proven track record § Capital-efficiency § Speed to market § Deep business, finance and M&A experience § Strong clinical and technical expertise § Proven track record of value creation and return to investors

PRODUCT PORTFOLIO BUSINESS MODEL LEADERSHIP TEAM

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Corporate Structure

Operating Subsidiaries

Non-invasive Esophageal Diagnostics

82%

Non-invasive Glucose Monitoring

83%

Executive Leadership Team

LISHAN AKLOG, MD Chairman & CEO DENNIS MCGRATH President & CFO BRIAN DEGUZMAN, MD Chief Medical Officer RICH YAZBECK Chief Technology Officer SHAUN O’NEIL Chief Commercial Officer RANDY BROWN Chief Operating Officer, Lucid DAVID WURTMAN MD Chief Medical Officer, Lucid

§ Medical Device Innovation § Commercialization § Market Development § Physician Engagement § Direct To Consumer § Regulatory Clearance § Clinical Trial Design and Execution § Reimbursement, Payment and Coverage § Corporate Financing And Capital Markets § M&A and Licensing BROAD EXPERTISE AND EXPERIENCE

Diversified Product Portfolio

GI HEALTH

Integrated suite of products designed to diagnose and treat complications of Gastroesophageal Reflux Disease (GERD) along the spectrum from non- dysplastic Barrett’s Esophagus (BE) to Esophageal Adenocarcinoma (EAC).

MINIMALLY INVASIVE INTERVENTIONS

Minimally invasive device to treat Carpal Tunnel Syndrome

INFUSION THERAPY

PortIO™

Maintenance-free implantable vascular access device Platform technology providing highly accurate flow for IV infusion sets and disposable infusion pumps

EMERGING INNOVATIONS

Solys – Noninvasive glucose monitoring FlexMO – Novel, versatile mechanical circulatory support (ECMO) cannula DisappEAR – Resorbable pediatric ear tubes NextVent – Full-featured, low- cost, single use ventilator

Commercially Available Products

§ Commercially launched as LDT Q4-2019 § CMS preliminary payment determination of ~$2000 § 15M target population per published society guidelines § FDA 510(k) cleared in Q2- 2019 as anatomically targeted non-invasive esophageal cell collection device § Alternative to invasive endoscopy Minimally I Invasive D Device t to T Treat Carpa pal T Tunnel S Syndr drome § FDA 510(k) cleared in Q2-2020 as a minimally invasive device alternative to open carpal tunnel release surgery § Estimate $1 billion market opportunity based on over 600,000 U.S. procedures annually and up to 1.5 million with symptoms who “suffer in silence” Minimally I Invasive D Device t to T Treat Carpa pal T Tunnel S Syndr drome § FDA 510(k) cleared in Q2-2020 as a minimally invasive device alternative to open carpal tunnel release surgery § Estimate $1 billion market opportunity based on over 600,000 U.S. procedures annually and up to 1.5 million with symptoms who “suffer in silence”

Minimally Invasive Device to Treat Carpal Tunnel Syndrome

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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

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Balloon & Electrodes

19 mm non-compliant nylon balloon Mounted eccentrically

• n flexible shaft

Sesquipolar Stationary Stainless-Steel Electrodes

Inflated with radiopaque contrast

Insulative Coating Exposed Metal Ridge

Active cutting electrode Passive return electrode

CarpX Minimally Invasive Carpal Tunnel Release Procedure

Insert CarpX device over wire and position electrodes relative to carpal bones

Wire Wire Electrodes

Confirm division of the TLC by full inflation of the balloon

Electrodes Wire

Inflate balloon with contrast material and Activate device, cutting ligament with <2 sec burst of RF energy

Narrowed “waist” at point of maximal constriction

Lateral view of TLC division

Constriction relieved, no residual waist

1. 2. 4. 3.

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

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Results

Balloon sampling device well tolerated with same accuracy as endoscopic brushings Assay highly accurate with >90% sensitivity and specificity

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
• Dr. Markowitz
• Dr. Chak
• Dr. Willis
• Dr. Moinova

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.

A Majority-Owned Subsidiary of PAVmed Inc

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Complementary technologies designed to facilitate diagnosis of nondysplastic and dysplastic 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 Granted FDA Breakthrough Device designation for EsoGuard

• n samples collected using

EsoCheck in high-risk patients at elevated risk for esophageal dysplasia arising from GERD

The Barrett’s Esophagus (BE) to Esophageal Adenocarcinoma (EAC) Spectrum

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1 Per ACG Guidelines Chronic GERD plus three risk factors among 50 years, White, Male, Obese, Smoker, Family History

Gastroesophageal Reflux (GERD)

Commonly known as reflux or chronic “heartburn”

50+ Million weekly GERD patients 9 Million visits per year 10 to 15 Million “High Risk”1

Nondysplastic Barrett’s Esophagus (NDBE)

Benign transformation of lower esophageal lining from repeated exposure to gastric fluid

3 to 4 Million BE patients 3 to 6% of GERD patients 5-10% of “High Risk” GERD

Pre-cancerous progression from NDBE to low-grade dysplasia (LGD) to high-grade dysplasia (HGD)

Dysplastic Barrett’s Esophagus (LGD, HGD)

~ 2% of NDBEs progress per year RF or Cryo esophageal ablation halts progression to EAC

Esophageal Adenocarcinoma (EAC)

Most common esophageal cancer, Intramucosal or Invasive

700+% increase over 40 years #1 rate of increase of any cancer Highly lethal (>80% 5-year mortality)

Esophageal Cancer Statistics

https://seer.cancer.gov/explorer/

Estimated New Cases in 2020 % of All New Cancer Cases 18,440 1.0% Estimated Deaths in 2020 % of All Cancer Deaths 16,170 2.7% 5-Year Survival

19.9%

2010-2016

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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.

Esophageal Adenocarcinoma has increased

• ver 700%

in the past 4 decades

2016 American College

• f Gastroenterology

(ACG) Guidelines

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> 5 years of GERD Two additional risk factors:

Detect BE and monitor progression to LGD/HGD so it can be ablated before progressing to EAC Recommends screening in high-risk GERD patients

>50 years old White Male Obese Smoker Family History

Am J Gastroenterol 2016; 111:30–50; doi:10.1038/ajg.2015.322; published online 3 November 2015

UPPER ENDOSCOPY (EGD)

• EGD is invasive, costly and requires

sedation

• Performed in ambulatory

surgery/endoscopy center

• Patient and colleague must take day off
• Widespread screening for BE using

EGD not practical or cost-effective and therefore not performed

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BE-to-EAC Screening

BE-to-EAC Screening

ACG Guidelines Target vs. Currently Screened Populations

Total Patient Volume 50+ Chronic GERD Patients Patients Undergoing EGD Screening

25% 9% 93%

Chronic GERD Patients

46M 34M

50+ and 2 BE RFs Chronic GERD Patients

31M 0.9M

58%

50+ Male and 1 BE RFs Chronic GERD Patients

13M

Less than 10%

• f high-risk GERD

patients currently undergo EGD screening

Sources: DRG; GIE Journal ; Deloitte Analysis, on file Lucid Dx

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The BE-to-EAC Screening

The Unmet Clinical Need

< 10% of ACG-recommended patients are screened < 10% of EAC patients have BE diagnosed before EAC Tragic missed opportunity to monitor BE and treat LGD/HGD

Less than 10%

Over 80% of EAC patients will die within five years of diagnosis Increasing BE screening rate from < 10% to 25% will prevent several thousand EAC deaths per year

Over 80%

Widespread BE-EAC screening requires an effective and efficient non-invasive office-based test

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Colon Cancer Screening BE / EAC Screening

50+ Male Patients with Chronic GERD*

*Plus presence of one or more other identified risk factors as defined in the 2016 ACG guidelines

Target Screening Population Earlier Adults aged 50+, now expanded to 45+*

*Guidelines issued by multiple organizations in the US which differ with regard to frequency of screening and other identified individual risk factors

Traditional Screening Modalities Endoscopy <10%2 Screening Rate Colonoscopy 60%1 Screening Rate*

*Rate based on adults who had a colonoscopy within the past 10 years (as recommended in different guidelines)

New Screening Modalities Fecal Immunochemical Test (FIT) Fecal Occult Blood Test (FOBT) Cologuard EsoGuard / EsoCheck

• 1. National Cancer Institute 2. Deloitte Research, on file Lucid Dx

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Commercial Strategy — LDT vs. IVD

Future

FDA Approved IVD FDA Cleared LDT

Current

FDA Approved IVCT

EsoGuard LDT

Highly Accurate Esophageal DNA Test

• Laboratory Developed Test (LDT)
• Partnership between Lucid and ResearchDx

commercial laboratory in Irvine, CA (dba PacificDx)

• ResearchDx performs EsoGuard Assay on

patient samples shipped from clinician site

• ResearchDx also manufactures

Specimen/Mailer Kit

• PacificDx issues patient report with binary

EsoGuard result

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Assay Specimen Vial & Mailer Kit

Patient Report

• FDA registered In Vitro Diagnostic (IVD)
• Seeking clearance through PMA pathway
• Two international 60-site IVD clinical trials
• ESOGUARD-BE-1 and 2
• Launched in support of an FDA PMA application in 2022
• Proposed indication for use

“Testing of esophageal samples collected using EsoCheck in ACG high-risk GERD patients”

• Granted FDA Breakthrough Device designation

“ACG high-risk GERD patients at elevated risk for esophageal dysplasia”

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EsoGuard IVD

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Targeted Distal Esophagus Cell Collection Novel, proprietary, non endoscopic Collect + Protect Technology Fast Procedure Circumferential

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Highly Visible Distance Markers

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A non-invasive five-minute office-based procedure to collect cells from the esophagus

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EsoCheck Device High-Volume Manufacturing

San Diego | Tijuana

Warehousing & Logistics

Memphis, TN

Return Mailer Kit Mfg

Irvine, CA

Manufacturing & Logistics

EsoCheck Device Manufacturing

Foxboro, MA

Sage Product Development

Transitioning to high volume manufacturing to support up to 1M devices per year

EsoGuard Commercial Strategy

Incentivized by positive EsoGuard results :

Disease States

• Confirmatory EGD
• Surveillance
• Intervention

They own:

Procedures Patients

Gastroenterology (GI)

EsoGuard Commercial Strategy — GI and Beyond

Phase 1

Any patient in GI office not there for EGD, or refuses EGD Use cases:

• Pre/Post Colonoscopy
• Motility Clinic
• Esophageal Manometry
• Esophageal PH testing
• GERD/ BE Clinic

Phase 2

Drive additional referrals from GI’s own IM / PCP referring MDs

• Educate on GERD / BE /

EAC relationship

• Educate on new/novel 5-

minute office-based test

• Refer to GI
• POC w/ Traveling

‘clinician’

Phase 3

Drive additional referrals to GI from MDs outside of GI’s referring network and direct from patients

• Seller promotes to ALL

internal med offices in area

• Patient learns about it
• nline, print, social, DTC

and requests test

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Commercial Strategy - Hybrid Sales Coverage

North East West Coast Mid-West South East

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Consumer Education March 2020 June 2020 April 2020 Sales Training Physician Education

EsoGuard Commercial Strategy — Marketing

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EsoGuard Commercial Strategy — Marketing

Reimbursement

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Sept 2019

PLA Meeting

EsoGuard Reimbursement

Nov 2019

CPT Code Issued

Jan 2020

CPT 01444U Active

Feb 2020

Palmetto GBA

March 2020

Submission of payment dossier

June 2020

Submission of coverage dossier

April 2020

GAPFILL Submissions to Novitas, (NGS), First Coast

Future

Private Payers – Submission, Denial(s) Procedure Coverage

June 2020

~$2000 Preliminary Payment Determination

Lucid Highlights and Upcoming Milestones

45 MAY 2018

• Lucid founded as PAVmed subsidiary
• EsoGuard/EsoCheck licensed from

FEB 2020

• EsoGuard/EsoCheck granted FDA Breakthrough

Device designation

• ESOGUARD BE-1 & BE-2 IVD trials launched

APR 2019

• Applied for EsoGuard CPT Code
• Fred Hutch research and license option agreement for

progression markers secured JUN 2019

• Research Dx CLIA/CAP laboratory engaged

JUN 2020

• EsoGuard secures preliminary CMS Gapfill Payment

determination

• EsoCheck 510(k) cleared
• Stan Lapidus, founder, former Chairman & CEO of

Exact Sciences joins as Strategic Advisor OCT 2019

• EsoGuard/EsoCheck IVD FDA Pre-Submission

Meeting AUG 2020

• UPenn EsoCheck EoE trial launched

Late 2020

• EsoGuard CMS coverage determination
• EsoGuard CPT Code 0114U issued
• EsoGuard CMS final payment determination
• CMS Clinical Laboratory Fee Schedule (CLFS) process

completed securing Gapfill designation JAN 2021

• EsoGuard CMS payment effective

DEC 2019

• EsoGuard CLIA/CAP Certification completed and

commercially launched as Laboratory Developed Test (LDT)

• First commercial procedures performed at Jefferson

LATE 2021

• ESOGUARD BE-1 & BE-2 IVD trials complete

enrollment H1 2022

• EsoGuard/EsoCheck IVD PMA Submission

Thank You!

CONTACT:

Mike Havrilla Director of Investor Relations (814) 241-4138 JMH@PAVmed.com www.pavmed.com

Nasdaq: PAVM, PAVMZ