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

LISHAN AKLOG, MD Chairman & CEO

February 18, 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
• n 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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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

Nasdaq: PAVM, PAVMZ

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Non-invasive Esophageal Diagnostics

Solys

diagnostics

Non-invasive Glucose Monitoring 82% 83%

Experienced Management Team

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

EsoGuard & EsoCheck

Esophageal DNA Test Designed to Facilitate Detection of Dysplastic/ Nondysplastic BE and EAC Esophageal Cell Collection Device

EsoCure

Completely Disposable Esophageal Ablation Device to Treat Dysplastic BE

CarpX

Minimally Invasive Device to Treat Carpal Tunnel Syndrome

PortIO

Implantable Intraosseous Vascular Access Device

NextFlo

Highly Accurate Disposable Intravenous (IV) Infusion Set ESTIMATED MARKET SIZE >$2B >$750M >$1B >$750M >$1B US REGULATORY STATUS EsoCheck: 510(k) Cleared EsoGuard LDT: Available EsoGuard IVD: PMA FDA Breakthrough Device ESOGUARD-BE-1 and 2 IVD clinical trials launched 510(k) Submission 1H21 510(k) Clinical safety study completed Resubmission pending de novo Clinical safety study launch upcoming 510(k) Submission 2H20 OTHER

• BE = Barrett’s Esophagus
• EAC = Esophageal Adenocarcinoma
• Multiple issued and pending patents
• Pilot study evaluating EsoCheck for

Eosinophilic Esophagitis (EoE) launch upcoming

• Multiple issued and pending

patents

• Benchtop proof of concept with

ablation temperatures > RF

• Multiple issued and pending

patents

• First-in-human (FIH) clinical

safety study met target follow-up and both primary endpoints

• Multiple issued/pending

patents

• Pre-clinical work completed

including unprecedented six- month maintenance-free function in animals

• 60-day implant duration

clinical study launch upcoming

• Multiple issued and pending

patents

• Constant flow rates across a

wide range of IV bag heights with accuracy rates comparable to electronic infusion pumps

• Formal M&A process ongoing

Diversified Product Pipeline

Emerging Innovations

Noninvasive Glucose Monitoring, Mechanical Circulatory Support (ECMO), Pediatric ear tubes

MINIMALLY INVASIVE GASTROENTEROLOGY INTERVENTIONS INFUSION THERAPY

CarpX

Minimally Invasive Device to Treat Carpal Tunnel Syndrome

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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

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CarpX Minimally Invasive Carpal Tunnel Release Procedure

Insert CarpX device over wire and position electrodes relative to carpal bones Wire Wire Electrodes Confirm placement of electrodes relative to nerves Electrodes Wire Inflate balloon with contrast material Narrowed “waist” at point

• f

maximal constriction Activate device, cutting ligament with <2 sec burst of RF energy Constriction relieved, no residual waist

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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

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EsoGuard, EsoCheck and Lucid Diagnostics

LUCID LICENSED ESOGUARD & ESOCHECK FROM CWRU IN MAY 2018

Complementary technologies designed to facilitate diagnosis of nondysplastic and 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 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 EsoCheck EsoGuard

A Majority-Owned Subsidiary of PAVmed Inc

Nasdaq: PAVM

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CWRU

DYSPLASTIC BARRETT’S ESOPHAGUS (LGD, HGD)

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

ESOPHAGEAL ADENOCARCINOMA (EAC)

Most common esophageal cancer Intramucosal or Invasive

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

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GASTROESOPHAGEAL REFLUX (GERD)

Commonly known as reflux or chronic “heartburn”

NONDYSPLASTIC BARRETT’S ESOPHAGUS (NDBE)

Benign metaplastic transformation

• f lower esophageal lining from

repeated exposure to gastric fluid 50+ Million weekly GERD patients 9 Million visits per year 10 to 20 Million “High Risk”1 3 to 4 Million BE patients 3 to 6% of GERD patients 5-10% of “High Risk” GERD

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

~ 2% of NDBEs progress per year RF or Cryo esophageal ablation halts progression 500% increase over 30 yrs #1 rate of increase of any cancer Highly lethal ( < 20% 5-yr survival)

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

• Detect BE and monitor progression to

LGD/HGD so it can be ablated before progressing to EAC

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> 50 years White Male Obese Smoker Family History

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

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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

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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

• ver background
• TFF3 is an immunohistochemical test

which requires pathologist and not automatable

• Published sensitivity and specificity not

sufficient for widespread screening

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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
• ccurs
• Collect+Protect Technology prevents dilution

and contamination of BE cells

• Maintains high BE signal relative to background

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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 specificity1.. 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

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1 Moinova et al. Science Translational Medicine 2018;10(424)

The Lucid Solution

ESOGUARD IVD

Highly Accurate Esophageal DNA Test to Detect BE-EAC Spectrum

• Seeking designation as FDA registered In Vitro

Diagnostic (IVD) medical device through PMA pathway

• Proposed indication for use includes testing of

esophageal samples collected using its EsoCheck in ACG high-risk GERD patients

• Granted FDA Breakthrough Device designation for ACG

high-risk GERD patients at elevated risk for esophageal dysplasia

• Two Lucid-sponsored international multi-center IVD

clinical trials ESOGUARD-BE-1 and 2 launched in support

• f an FDA PMA application

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Introducing EsoCure

Esophageal Ablation Device

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DYSPLASTIC BARRETT’S ESOPHAGUS (LGD, HGD) ESOPHAGEAL ADENOCARCINOMA (EAC)

Endoscopic Ablation of Dysplastic BE

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GASTROESOPHAGEAL REFLUX (GERD) NONDYSPLASTIC BARRETT’S ESOPHAGUS (NDBE)

X

The ACG recommends endoscopic ablation as the preferred treatment modality for both low and high-grade dysplastic BE to prevent progression to EAC

Endoscopic Ablation of Dysplastic BE

Current BE Ablation Devices

• Radiofrequency (RF) or cryoablation
• Most require complex and expensive consoles

ranging from $30,000 to over $100,000

• May require multiple introductions and removals of

the endoscope, sizing catheter and ablation balloons

• Expensive, labor-intensive, time consuming and

uncomfortable to the patient.

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Medtronic Barrx™ Radiofrequency Ablation System

The PAVmed Solution

EsoCure™ with Caldus™ Technology

Completely Disposable Esophageal Ablation Device Designed to Treat Dysplastic BE

• Completely disposable, no capital equipment
• Thermal ablation balloon catheter delivered through

endoscope working port confirming circumferential contact and coverage of all visible BE tissue.

• Underlying Caldus technology circulates heated fluid

from device handle through balloon catheter maintaining high balloon temperature while keeping balloon volume, pressure and tissue contact constant

• Potential to make ablation of dysplastic BE safer, more

efficient and cost-effective than current technologies

• Therapeutic BE tool synergistic to the EsoGuard and

EsoCheck BE diagnostic tools.

25 EsoCure Endoscope Thermal Ablation Balloon With Caldus Technology Circulating Heated Fluid Direct Thermal Ablation of Esophageal Mucosa

Thank You!

CONTACT:

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

Nasdaq: PAVM, PAVMZ