PAVmed, Inc. Nasdaq: PAVM, PAVMZ Corporate Overview LISHAN AKLOG, - - PowerPoint PPT Presentation

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PAVmed, Inc.

Nasdaq: PAVM, PAVMZ

Corporate Overview

LISHAN AKLOG, MD Chairman & CEO DENNIS M. MCGRATH Executive VP & CFO

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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

• ffer, 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 any

• f the products described in this presentation.

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HIGHLY DIFFERENTIATED MULTI-PRODUCT MEDICAL DEVICE COMPANY

Focus on high-margin, single-use products Interventional or acute care Broad spectrum of clinical conditions and specialty call points

4 PRODUCT ESTIMATED MARKET SIZE

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REGULATORY PATH CURRENT STATUS POTENTIAL UPCOMING MILESTONES CarpX Minimally Invasive Device to Treat Carpal Tunnel Syndrome >$1B 510(k)

• Preparing for pre-submission

meeting for resubmission

• Completing manufacturing

qualifications

• Pre-commercial activities

including physician engagement

• FDA 510(k) Clearance
• First-in-Human (FIH) in

New Zealand

• CE Mark Submission

EsoCheck Non-Invasive Device & DNA Biomarkers to Detect Esophageal Cancer Precursor >$1B 510(k) + LDT

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• Human study documenting >90%

accuracy published

• Large NIH-funded multi-center

clinical trial for Barrett’s screening indication enrolling, 90 patients to date

• CLIA certification in process
• Gen 2 510(k) testing in process
• Balloon sampling device

FDA 510(k) Submission

• CLIA certification for LDT
• Liquid media validation

from data on 80-100 patients PortIO Implantable Intraosseous Vascular Access Device >$750M de novo

• FDA presubmission guidance

received

• Pilot 7-day animal completed
• GLP 7-day animal protocol

approved by FDA

• Ongoing strategic engagements
• Complete GLP 7-day

animal study

• Strategic partnership

DisappEAR Antimicrobial Resorbable Ear Tubes ~$300M 510(k)

• Process to manufacture

tubes from commercially sourced silk blocks established

• Optimizing process for drug

coating vs. impregnation

• Initiate three-month

animal study to confirm resorption rates

Lead Products

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 1Company estimate 2Laboratory Developed Test

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Key Recent Developments

Progress towards major lead product milestones

CarpX (510k)

▪ 510(k) process proceeding with pre-submission meeting to be scheduled for resubmission following expiration of FDA review period for initial submission ▪ Plan to update investors once the FDA meeting date is scheduled ▪ Active pre-commercial engagement with physicians

PortIO (de novo)

▪ Successful 7-day pilot animal study based on FDA recommendations ▪ FDA approved protocol for 7-day GLP animal study, scheduled for next month ▪ Encouraging strategic discussions with market leaders

EsoCheck (510k, PMA)

▪ 510(k) process initiated ▪ Clinical trial enrollment progressing ▪ Active pre-commercial engagement with physicians

Strengthened balance sheet

▪ Raised $10.4 million gross proceeds from oversubscribed equity rights offering ▪ Adequate capital to reach major milestones in 2019

Strengthened management team

▪ Hired industry veteran to serve as Chief Commercial Officer ▪ Hired full-time Director of Investor Relations

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Growth Strategy

Advance lead products to commercialization

▪ CarpX – Push 510(k) clearance over finish line, complete FIH and CE Mark ▪ EsoCheck – Target 510(k) submission in Q4-2018 and CLIA certification in Q1-2019, accelerate clinical trial enrollment ▪ PortIO – Target completion of de novo animal study and IDE submission in Q4-2018, complete strategic partnership ▪ DisappEAR – Complete resorption study in animals for 2019 FDA 510(k) submission

Pursue strategic initiatives to enhance shareholder value

▪ Continue to evaluate product opportunities presented to us by clinician innovators and academic medical centers ▪ Explore M&A and strategic partnership opportunities synergistic with lead products and broader vision

Continue to strengthen balance sheet

▪ Retire or refinance senior secured debt

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LISHAN AKLOG, MD

CHAIRMAN & CEO

DENNIS MCGRATH

EXECUTIVE VP & CFO

BRIAN DEGUZMAN, MD

CHIEF MEDICAL OFFICER SHAUN O’NEIL CHIEF COMMERCIAL OFFICER

Management Team

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Capital Structure

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Business Model

COMMERCIAL OPPORTUNITY

ATTRACTIVE MARKET

• Unmet clinical need
• Regulatory pathway

HIGH-MARGIN PRODUCT

• Reimbursement
• Technologic Complexity
• Cost-of-goods

KEY BUSINESS PROCESSES

CAPITAL EFFICIENCY & SPEED TO MARKET

• Outsourced best-in-class

process experts

• Light infrastructure, low

fixed costs

• Shortest path to INITIAL

Regulatory Clearance MULTIPLE PATHWAYS TO COMMERCIALIZATION

MULTI-PRODUCT PIPELINE

RISK MITIGATION

• Non-binary success

ECONOMIES OF SCALE CORPORATE FLEXIBILITY

• Dynamic resource

allocation and prioritization

• Streamlined channel to

incorporate external innovation

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Multiple Pathways to Commercialization

Tailored to Maximize Value Creation

TARGETED INITIAL COMMERCIALIZATION

• Key Opinion Leaders
• Independent Distributors

CORPORATE ACQUIRER

• Asset sale to strategic
• Non-dilutive financing

CORPORATE PARTNER

• Sales & distribution

agreement

• Option to acquire

FULL SELF COMMERCIALIZATION

• Hybrid sales channel
• Build organically or

acquire

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Car arpX pX

Minimally Invasive Device to Treat Carpal Tunnel Syndrome

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Carpal Tunnel Syndrome

CLINICAL OVERVIEW

Incidence

▪ Over 600,000 US procedures annually1 ▪ Up to 1.5 million with symptoms who “suffer in silence” 2

Mechanism

▪ Inflammation and scarring of transverse carpal ligament ▪ Entrapment of the median nerve ⇒ hand pain, numbness and weakness

1Fajardo, et al. J Hand Surg 2012; 37(8):1599-1605 2Estimate based on CTS prevalence data from Dale et al. Scand J Work Environ Health. 2013 Sep 1;39(5):495-505.

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TRADITIONAL CARPAL TUNNEL SURGERY IS INVASIVE ENDOSCOPIC SURGERY IS LESS EFFECTIVE

• Up to 2 inch incision
• Performed in an OR
• At least 3-4 month, up

to 6-9 month recovery

• Remains a surgical

procedure

• Higher recurrence and

reoperation rate

• Increased nerve injury
• Higher costs

Carpal Tunnel Syndrome

MARKET OPPORTUNITY

600,0001 current surgeries* x $1,500 minimum ASP = ~$1 billion Additional 1.5M2 “silent sufferers” who choose to defer surgery

UNMET CLINICAL NEED – CURRENT LIMITATIONS

1Fajardo, et al. J Hand Surg 2012; 37(8):1599-1605 2Estimate based on CTS prevalence data from Dale et al. Scand J Work Environ Health. 2013 Sep 1;39(5):495-505.

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CarpX – Minimally Invasive CTS Device

Key Features

Single-use precision radiofrequency (RF) energy cutting tool

▪ Connects to standard electrosurgical generator

Balloon creates anatomic separation

▪ Protects nerve and tendons by pushing them away from ligament

Balloon tensions ligament

▪ Facilitates cutting of ligament by stretching it and pushing electrode into it

Active RF electrode cuts ligament

▪ Short (< 1.5 second) burst of RF energy ▪ Automatically cuts off if complete cut detected by monitoring balloon pressure ▪ Can test for nerve proximity prior to cutting using nerve stimulator

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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CarpX Procedure

Inflate balloon with contrast material

Narrowed “waist” at point of maximal constriction

Insert device over wire and position electrodes relative to carpal bones

Wire Wire Electrodes

Test placement of electrodes relative to nerves using nerve stimulator

Electrodes Wire

Activate device, cutting ligament with <2 sec burst of RF energy

Constriction relieved, no residual waist

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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CarpX in Action

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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CarpX in Action

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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CarpX – Advantages

LESS INVASIVE MORE COST EFFECTIVE

• Option to perform the procedure

truly percutaneously

• Less pain, scarring
• Accelerate time to full recovery

Anticipate 1-2 weeks vs often >6 months

• Shift from OR to interventional lab
• Shorten procedural times
• Shorten time out of work

FEWER COMPLICATIONS EXPANDED MARKET

• Better nerve protection
• Minimal risk of infection
• Lower threshold for intervention

for patients “suffering in silence”

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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CarpX – Preclinical Testing Results

In Vivo Animal Testing

▪ < 1 mm maximum zone of thermal injury ▪ Limited to cut edges of ligament completely sparing nearby tissues and structures including nerves and blood vessels (encircled in red) ▪ Any rise in temperature limited to 1mm and transient (< 20 sec)

Human Cadaver Testing

▪ Complete and reliable cutting of ligament with no adverse events noted in multiple cadavers ▪ Multiple surgeons successfully performed multiple procedures after an initial training session ▪ Excellent anatomic separation created by balloon, safely displacing key nerves away from cutting electrode far beyond thermal zones

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

Figure 2. Site #1. Tunnel represents the device pathway under the s

Representative histologic images showing minimal thermal injury (red circles) limited to cut edges of ligament (fascia) Representative X-ray images showing excellent anatomic separation of key nerves, protecting them from electrode

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FDA 510(k) Pathway

FILED FDA 510(K) PRE-MARKET NOTIFICATION SUBMISSION ▪ Existing carpal tunnel release system as predicate ▪ Submitted robust and complete response to request for additional testing to document limited thermal spread and addressing all issues raised showing CarpX at least as safe as predicate, consistent with substantial equivalence standard ▪ Review period expired before consensus could be reached between branches ▪ In process of filing package for pre-submission meeting prior to 510(k) resubmission, per FDA recommendation

US Commercialization Strategy

▪ Initial launch using independent distributors ▪ Hand Surgery/Interventional Radiology Key Opinion Leaders ▪ Hybrid Sales with regional managers overseeing distributors ▪ Accelerating pre-commercial physician engagement

OUS Strategy

▪ Plan First-in-Man in Q4-2018 in New Zealand ▪ Preparing for European CE Mark Submission in Q4-2018 ▪ Active discussions with distributors in Europe, South America and Asia

CarpX – Current Status

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 1 Based on Company Estimates.

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EsoCh

• Check

ck

Non-Invasive Device & DNA Biomarkers to Detect Esophageal Cancer Precursor

mVIM + mCCNA

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Esophageal Adenocarcinoma Cancer (EAC)

Fastest growing cancer in US1 Lowest survival rate2

▪ 5-year survival < 20% ▪ Death toll exceeds ovarian cancer

Among highest cost of care3 Seldom detected early4

1Pohl & Welch. J Natl Cancer Inst. 2005; 97:142-146. 2Siegel, et al. CA Cancer J Clin 2016; 66:7-30 3Mariotto et al. J Natl Cancer Inst 2011; 103:117-128. 4Dulai et al. Gastroenterology 2002; 122:26-33.

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GERD / Barrett’s Esophagus

GASTROESOPHAGEAL REFLUX (GERD) BARRETT’S ESOPHAGUS (BE) ESOPHAGEAL ADENOCARCINOMA

• “Heartburn”, “Acid Reflux”
• 15-30% of Western

populations1

• Treatment with OTC meds

can mask pathology

• Lower esophageal lining

transformed from exposure to acid

• Precursor to dysplasia and

esophageal cancer

• Can be treated with ablation

if detected early

• Nearly all EAC patients

shows evidence of prior Barrett’s esophagus

• Can be prevented if

Barrett’s detected and treated prior to progression to cancer

1El-Serag et al. Gut 2014; 64(6):871-880.

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Screening for Barrett’s Esophagus

Current Standard – Upper Endoscopy

▪ Invasive, costly and requires sedation ▪ Relies on pathology so cannot be automated ▪ Only recommended in high-risk symptomatic GERD and Minimal overall impact in preventing EAC

 ~40% of new EAC patients have GERD symptoms1  < 10% of new EAC patients have prior diagnosis of BE2

▪ Widespread BE screening with EGD not practical or cost-effective

Unmet Clinical Need

▪ Non-invasive alternative to endoscopy to detect BE and prevent progression to EAC ▪ Must be highly accurate ▪ Efforts to date (e.g., CytoSponge) depend on cytology and have other limitations ▪ Biomarkers superior for screening because can be automated, not dependent on individual pathologist

CytoSponge

1Chak et al. Cancer 2006; 107:2160-2166. 2Lagergren et al. NEJM 199; 340:825-831.

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EsoCheck – Noninvasive BE Biomarker Test

BALLOON DNA SAMPLING DEVICE HIGHLY ACCURATE DNA BIOMARKER ASSAY

• Vitamin pill-sized silicone-covered

capsule containing small deflated balloon attached to thin catheter

• Patient swallows capsule
• Balloon inflated in the stomach
• Balloon pulled back, swabbing the

lower esophagus for cells

• Balloon deflated protecting sample of

cells from dilution or contamination

• Methylated DNA Assay, similar to ones

already used in FDA-cleared tests

• mVIM - well established biomarker in

colon cancer

• mCCNA – newly discovered biomarker
• IP protection of modified genes

(composition of matter) and algorithms

• Low-cost, automatable
• Returns simple binary result

mVIM + mCCNA

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EsoCheck – In Action

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EsoCheck Clinical Results

Study Design

▪ Patient referred for endoscopy ▪ 322 patients underwent endoscopic brushing sampling and EsoCheck assay (mVIM+ or mCCNA+) to set and validate assay cut-offs ▪ 86 patients underwent EsoCheck balloon sampling and EsoCheck assay

Results

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

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Gastroesophageal Reflux (GERD)

▪ Over 20 million weekly GERD patients1 ▪ 9 million physician visits per year2

Barrett’s Esophagus (BE)

▪ 3-4M patients in US3 ▪ ~ 10 % of symptomatic reflux patients undergoing EGD have BE vs <1% of patients without reflux symptoms4

Market

▪ Target ASP $1000 (Cologuard $649) ▪ Target gross margin 85% ▪ Immediately addressable market 10% of GERD patients = $2 billion ▪ Total addressable market all white men

• ver 50 years of age = $45 billion

▪ OUS market similarly sized

EsoCheck – Market Opportunity

1El-Serag et al. Gut 2014; 64(6):871-880. 2Peery et al. Gastroenterology 2012; 143:1179-1197. 3Runge et al. Gasterentrol Clin North Am 2015; 44(2):203-201. 4Modiano et al. Ther Clin Risk Manag 2007; 3(6):1035-1145. 5US Census Bureau. Annual Estimates of the Resident Population by Sex, Age,

Rac...April 1, 2010 to July 1, 2016. factfinder.census.gov.

2M GERD Patients GERD population of 20M ~45M White men over 50 yrs5

US Market

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Phase I: Initial Commercial Product (510k+LDT)

▪ Target launch: Q1-2019 ▪ 510(k) submission of Gen2 EsoCheck balloon sampling device Q4-2018 ▪ Complete CLIA certification of CWRU reference laboratory for DNA biomarker assay in Q1-2019 ▪ Market EsoCheck kit with balloon sampling device and sample sent to reference laboratory under Laboratory Developed Test (LDT) designation ▪ CE Mark submission: Q2-2019

Phase II: Expanded Indication (PMA)

▪ Target clearance: Q1-2021 ▪ PMA submission seeking specific indication for widespread BE screening in high risk population ACG-recommended population consisting of 20 million white males >50 years with >5-year history of GERD. ▪ Large NIH-funded multi-center trial of Gen 2 EsoCheck device + Assay (Two arms: case-control assay revalidation and detection) currently actively enrolling at 8 centers (ClinicalTrials.gov: NCT00288119)

EsoCheck – Regulatory/Commercial Strategy

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

EsoCheck

mVIM + mCCNA

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EsoCheck – Regulatory/Commercial Strategy

Phase I Initial Commercial Product 510(k) Balloon + LDT Assay

▪ REGULATORY

• 510(k) submission of Gen2 EsoCheck

balloon sampling device (Q4-2018)

• Laboratory Developed Test (LDT)

designation of EsoCheck Assay at reference lab (Q1-2019)

• CE Mark submission (Q2-2019)

▪ COMMERCIAL

• Target US launch late Q1-2019
• EsoCheck Kit provided to clinicians,

◆ Balloon sampling device ◆ Cytolyte vial ◆ Mailer

• Assay

◆ 3-4 day turnaround ◆ Binary result reported based on > 1% of DNA

for mVIM or mCCNA1

◆ Lab bills payor under Proprietary Laboratory

Assay (PLA) code

Phase II Widespread Screening Test PMA Submission

▪ REGULATORY

• PMA for widespread BE screening

indication in high risk population

◆ ACG-recommended population consisting of 20

million > 5-year history of GERD with 2 risk factors

• Current NIH-funded EsoCheck trial

◆ ClinicalTrials.gov: NCT00288119 ◆ Case-control and Detection arms ◆ Enrolled ~100 patients at 8 centers

• Lucid considering parallel studies to

support PMA

◆ Detection study in US ◆ PCP-targeted detection study in Europe

• Target milestones

◆ FDA Pre-Submission (Q1-2019) ◆ Target clearance (Q1-2021)

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Lucid Diagnostics

▪ PAVmed subsidiary (82%) ▪ Managed by PAVmed pursuant to a Management Services Agreement working closing with CWRU faculty inventors/consultants ▪ Retained veteran biopharma executive with extensive clinical trial experience as clinical/regulatory consultant ▪ Raising capital to support Phase I, strategic planning with bankers on Phase II

Phase I (510k + LDT)

▪ Target launch Q1-2019 ▪ 510(k) application for Gen2 EsoCheck balloon sampling device on target for Q4-2018 submission ▪ CLIA certification of CWRU reference laboratory for DNA biomarker assay for Q1-2019 completion and Laboratory Developed Test (LDT) designation

Phase II (PMA)

▪ NIH trial has enrolled 90 patients to date ▪ Early experience indicates better tolerance and higher DNA yields, results from first 100 patients expected to validate switch to liquid medium ▪ Finalizing regulatory strategy that leverages ongoing NIH trial but supercharges it with regard to enrollment rate, site support and CRO control. Considering separate streamlined detection study in US and PCP-targeted trial in Europe. ▪ Planning FDA pre-submission meeting in early 2019 to finalize study design. Estimate 600-800 patients across all studies towards PMA will suffice.

EsoCheck – Current Status

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

mVIM + mCCNA

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Por

• rtIO

IO

Implantable Intraosseous Vascular Access Devices

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ER INPATIENT HOME <24 Hours <7-10 days <6 weeks <1 year

Peripheral IV Central Venous Catheter (CVC) Tunneled Central Venous Catheter Intraosseous Device Peripherally Inserted Central Catheter (PICC) Implantable Port (Port-a-Cath)

Vascular Access Devices

Used to deliver medications, fluids, nutrition and other substances

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OCCLUSION INFECTION

• Up to 35%1
• Clot-busting medications or

a repeat procedure

• Up to 10%1
• 50% life-threatening

bloodstream infections

POOR VEINS RESOURCE UTILIZATION

• >10% of patients2
• Pacemaker/Defibrillator

Leads and catheters

• Dialysis patients
• Surgical insertion &

removal

• Maintenance with regular

flushes

Vascular Access Devices

UNMET CLINICAL NEED – CURRENT DEVICE LIMITATIONS

Limitations driven by intravascular component

• 1CKutar. The Oncologist 2004;9:207-2016.
• 2Mickley. Eur J Vasc & Endovasc Surgery 2006; 32(4):439-444.

.

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Infusion directly into the Bone Marrow Cavity Decades of experience using temporary needle access

▪ Trauma, esp. military ▪ Pediatric emergencies ▪ Bioequivalent to intravenous route

Intraosseous Vascular Access

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

Teleflex EZ-IO Device

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Key Features

▪ Implanted into bone

✓ Tip positioned in bone marrow ✓ No Intravascular Component

▪ Functionally identical to traditional implantable port

✓ Resides under the skin ✓ Patient can bathe/swim ✓ Standard Huber access needle

PortIO – Implantable Intraosseous Port

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

Huber Access Needle Implantable Port Silicone Septum Hollow Titanium Bone Screw Titanium Hub w/ Internal Conical Needle Guide

Insertion Kit

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ER INPATIENT HOME Duration Duration Duration <24 Hours <7-10 days <6 weeks

<1 year

Estimated Market Size 1 Estimated Market Size 1 Estimated Market Size 1 ~$150M (Current IO pts) ~$200M (Poor vein pts) ~$500M Advantages Advantages Advantages

• Near limitless access sites
• Less prone to dislodgement
• Near limitless access sites
• Simple bedside insertion
• More cost effective
• Near limitless access sites
• Less invasive
• More cost effective
• Less prone to occlusion
• Fewer, less serious infections

PortIO – Market Opportunity

Separate unique opportunity in large dialysis patient population

Current IO Devices PortIO

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 1 Based on Company Estimates

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FDA de novo Pathway

FILED FDA DE NOVO PRE-SUBMISSION PACKAGE ▪ Initial indication targeting inpatient use for up to 7 days ▪ Can serve as own predicate for 510(k) submissions for expanded 6- week/outpatient and 6-month/home use indications HELD IN-PERSON FDA PRE-SUBMISSION MEETING ▪ Requested 7-day animal study showing local healing and no marrow toxicity ▪ Expect request for small single-arm human safety trial 7-DAY ANIMAL STUDY IN PROCESS ▪ Successful pilot completed ▪ FDA approved GLP animal study protocol ▪ GLP study to begin next month

Monetization Strategy

▪ Pre-clearance engagements with natural strategic partners initiated ▪ Encouraging strategic engagements with market leaders

PortIO – Current Status

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.

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PROVEN BUSINESS MODEL

Speed to Market Capital Efficiency Multiple Pathways to Commercialization

EXPANDING PRODUCT PIPELINE

Near-term Milestones Total Addressable Market over $3B

PROVEN LEADERSHIP TEAM

Strong Track Record

• f Innovation and

Value Creation

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Contact Us

PAVmed Inc. One Grand Central Place Suite 4600 New York, NY 10165 212-949-4319 info@pavmed.com