Pavmed Inc. · NASDAQ:PAVM
Pavmed — Investor Presentation (October 2018)
40 slides from Pavmed's investor presentation, Oct 12, 2018
Slide 1: PAVmed, Inc. Corporate Overview
PAVmed, Inc. Nasdaq: PAVM, PAVMZ Corporate Overview LISHAN AKLOG, MD DENNIS M. MCGRATH Chairman & CEO Executive VP & CFO 1
Slide 2: Disclaimers
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,
Slide 3: Highly Differentiated Multi-Product Medical Device Company
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 3
Slide 4: Lead Products
Lead Products ESTIMATED REGULATORY POTENTIAL UPCOMING PRODUCT MARKET CURRENT STATUS 1 PATH MILESTONES SIZE • Preparing for pre-submission • FDA 510(k) Clearance CarpX meeting for resubmission • First-in-Human (FIH) in Minimally Invasive Device to • Completing manufacturing New Zealand >$1B 510(k) Tr
Slide 5: Key Recent Developments
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 schedu
Slide 6: Growth Strategy
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 anima
Slide 7: Management Team
Management Team LISHAN AKLOG, MD CHAIRMAN & CEO DENNIS MCGRATH EXECUTIVE VP & CFO BRIAN DEGUZMAN, MD CHIEF MEDICAL OFFICER SHAUN O’NEIL CHIEF COMMERCIAL OFFICER 7
Slide 8: Capital Structure
Capital Structure PAVmed, Inc (Nasdaq: PAVM, PAVMZ) Insider Exercise/ Common Stock Ownership Conversion Price Equivalents Outstanding (Weighted Avg.) (Treasury) Common Stock 26,542,979 28% -- 26,542,979 Preferred Stock 942,357 -- $3.00 942,357 Warrants 18,449,240 23% $1.58 1,190,227 Options 3,330,14
Slide 9: Business Model
Business Model MULTI-PRODUCT PIPELINE RISK MITIGATION COMMERCIAL • Non-binary success OPPORTUNITY ECONOMIES OF SCALE ATTRACTIVE MARKET KEY BUSINESS • Unmet clinical need PROCESSES CORPORATE FLEXIBILITY • Regulatory pathway • Dynamic resource CAPITAL EFFICIENCY & allocation and HIGH-MARGIN PRODUCT SP
Slide 10: Multiple Pathways to Commercialization
Multiple Pathways to Commercialization Tailored to Maximize Value Creation TARGETED INITIAL COMMERCIALIZATION • Key Opinion Leaders • Independent Distributors CORPORATE CORPORATE FULL SELF ACQUIRER PARTNER COMMERCIALIZATION • Asset sale to strategic • Sales & distribution • Hybrid sales channel • No
Slide 11: CarpX
CarpX Minimally Invasive Device to Treat Carpal Tunnel Syndrome 11
Slide 12: Carpal Tunnel Syndrome
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 a
Slide 13: Carpal Tunnel Syndrome Market Opportunity
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 TRADITIONAL CARPAL TUNNEL ENDOSCOPIC SURGERY SURGERY IS INVASIVE IS LESS EFFECTIVE • Up t
Slide 14: CarpX – Minimally Invasive CTS Device
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
Slide 15: CarpX Procedure
CarpX Procedure Narrowed “waist” at Wire point of maximal constriction Wire Electrodes Insert device over wire and position Inflate balloon with contrast material electrodes relative to carpal bones Electrodes Wire Constriction relieved, no residual waist Test placement of electrodes relative Activa
Slide 16: CarpX in Action
CarpX in Action *PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 16
Slide 17: CarpX in Action
CarpX in Action *PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 17
Slide 18: CarpX – Advantages
CarpX – Advantages LESS INVASIVE MORE COST EFFECTIVE • Option to perform the procedure • Shift from OR to interventional lab truly percutaneously • Shorten procedural times • Less pain, scarring • Shorten time out of work • Accelerate time to full recovery Anticipate 1-2 weeks vs often >6 months FEW
Slide 19: CarpX – Preclinical Testing Results
CarpX – Preclinical Testing Results M Figure 2. Treatment site 1. Histopathology section at low magnification (contact image). SK=skin surface, FA=fascia, M-muscle. Figure 1. Treatment site #1. Red dashes represent device insertion. EN=de In Vivo Animal Testing EX=device exit ▪ < 1 mm maximum zone o
Slide 20: CarpX – Current Status
CarpX – Current Status 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 Ca
Slide 21: EsoCheck
mVIM + mCCNA EsoCheck Non-Invasive Device & DNA Biomarkers to Detect Esophageal Cancer Precursor 21
Slide 22: Esophageal Adenocarcinoma Cancer (EAC)
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 care 3 Seldom detected early4 1Pohl & Welch. J Natl Cancer Inst. 2005; 97:142-146. 2Siegel,et al. CA Cancer J Clin 2016; 66:7-3
Slide 23: GERD / Barrett's Esophagus
GERD / Barrett’s Esophagus GASTROESOPHAGEAL BARRETT’S ESOPHAGEAL REFLUX (GERD) ESOPHAGUS (BE) ADENOCARCINOMA • “Heartburn”, “Acid Reflux” • Lower esophageal lining • Nearly all EAC patients • 15-30% of Western transformed from exposure shows evidence of prior populations1 to acid Barrett’s esophagus
Slide 24: Screening for Barrett's Esophagus
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 <
Slide 25: EsoCheck – Noninvasive BE Biomarker Test
EsoCheck – Noninvasive BE Biomarker Test mVIM + mCCNA HIGHLY ACCURATE DNA BALLOON DNA SAMPLING BIOMARKER ASSAY DEVICE • Vitamin pill-sized silicone-covered • Methylated DNA Assay, similar to ones capsule containing small deflated already used in FDA-cleared tests balloon attached to thin catheter •
Slide 26: EsoCheck – In Action
EsoCheck – In Action 26
Slide 27: EsoCheck Clinical Results
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 w
Slide 28: EsoCheck – Market Opportunity
EsoCheck – Market Opportunity Gastroesophageal Reflux (GERD) ▪ Over 20 million weekly GERD patients 1 US Market 2 ▪ 9 million physician visits per year Barrett’s Esophagus (BE) ~45M 3 White men over 50 yrs 5 ▪ 3-4M patients in US ▪ ~ 10 % of symptomatic reflux patients undergoing EGD have BE vs <1%
Slide 29: EsoCheck – Regulatory/Commercial Strategy
EsoCheck – Regulatory/Commercial Strategy 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 w
Slide 30: EsoCheck – Regulatory/Commercial Strategy
EsoCheck – Regulatory/Commercial Strategy Phase I Phase II Initial Commercial Product Widespread Screening Test 510(k) Balloon + LDT Assay PMA Submission ▪ REGULATORY ▪ REGULATORY • 510(k) submission of Gen2 EsoCheck • PMA for widespread BE screening balloon sampling device (Q4-2018) indication in h
Slide 31: EsoCheck – Current Status
EsoCheck – Current Status 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 consult
Slide 32: PortIO
PortIO Implantable Intraosseous Vascular Access Devices 32
Slide 33: Vascular Access Devices
Vascular Access Devices Used to deliver medications, fluids, nutrition and other substances ER INPATIENT HOME <24 Hours <7-10 days <6 weeks <1 year Peripheral IV Central Venous Tunneled Central Catheter (CVC) Venous Catheter Intraosseous Peripherally Inserted Central Implantable Port Device Catheter
Slide 34: Vascular Access Devices
Vascular Access Devices UNMET CLINICAL NEED – CURRENT DEVICE LIMITATIONS Limitations driven by intravascular component OCCLUSION INFECTION • Up to 35%1 • Up to 10%1 • Clot-busting medications or • 50% life-threatening a repeat procedure bloodstream infections POOR VEINS RESOURCE UTILIZATION • >10% o
Slide 35: Intraosseous Vascular Access
Intraosseous Vascular Access Infusion directly into the Bone Marrow Cavity Decades of experience using temporary needle access ▪ Trauma, esp. military ▪ Pediatric emergencies ▪ Bioequivalent to intravenous route Teleflex EZ-IO Device *PAVmed has not yet received clearance from the FDA or any other r
Slide 36: PortIO – Implantable Intraosseous Port
PortIO – Implantable Intraosseous Port Key Features ▪ Implanted into bone ✓ Tip positioned in bone marrow ✓ No Intravascular Component Implantable Port ▪ Functionally identical to Huber Access Needle traditional implantable port ✓ Resides under the skin ✓ Patient can bathe/swim ✓ Standard Huber acce
Slide 37: PortIO – Market Opportunity
PortIO – Market Opportunity 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
Slide 38: PortIO – Current Status
PortIO – Current Status 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 ME
Slide 39: Proven Leadership Team
PROVEN PROVEN EXPANDING LEADERSHIP BUSINESS PRODUCT TEAM MODEL PIPELINE Strong Track Record Speed to Market Near-term of Innovation and Milestones Capital Efficiency Value Creation Total Addressable Multiple Pathways to Market over $3B Commercialization 39
Slide 40: Contact Us
Contact Us PAVmed Inc. One Grand Central Place Suite 4600 New York, NY 10165 212-949-4319 info@pavmed.com 40