PAVmed, Inc. Nasdaq: PAVM, PAVMZ Corporate Overview LISHAN AKLOG, MD DENNIS M. MCGRATH Chairman & CEO Executive VP & CFO 1
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 any of the products described in this presentation. 2
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
Lead Products ESTIMATED REGULATORY POTENTIAL UPCOMING PRODUCT MARKET CURRENT STATUS PATH MILESTONES 1 SIZE • Preparing for pre-submission • FDA 510(k) Clearance meeting for resubmission CarpX • First-in-Human (FIH) in Minimally Invasive Device to • Completing manufacturing New Zealand >$1B 510(k) qualifications Treat Carpal Tunnel • CE Mark Submission Syndrome • Pre-commercial activities including physician engagement • Human study documenting >90% • Balloon sampling device accuracy published FDA 510(k) Submission • Large NIH-funded multi-center • CLIA certification for LDT EsoCheck clinical trial for Barrett’s Non-Invasive Device & DNA >$1B 510(k) + • Liquid media validation 2 screening indication enrolling, 90 LDT Biomarkers to Detect from data on 80-100 patients to date Esophageal Cancer Precursor patients • CLIA certification in process • Gen 2 510(k) testing in process • FDA presubmission guidance • Complete GLP 7-day received animal study PortIO • Pilot 7-day animal completed • Strategic partnership Implantable Intraosseous >$750M de novo • GLP 7-day animal protocol Vascular Access Device approved by FDA • Ongoing strategic engagements • Process to manufacture • Initiate three-month tubes from commercially sourced animal study to confirm DisappEAR silk blocks established resorption rates Antimicrobial Resorbable Ear ~$300M 510(k) Tubes • Optimizing process for drug coating vs. impregnation * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 1 Company estimate 4 2 Laboratory Developed Test
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 5
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 6
Management Team LISHAN AKLOG, MD C HAIRMAN & CEO DENNIS MCGRATH E XECUTIVE VP & CFO BRIAN DEGUZMAN, MD C HIEF M EDICAL O FFICER SHAUN O’NEIL C HIEF C OMMERCIAL O FFICER 7
Capital Structure 8
Business Model MULTI-PRODUCT PIPELINE COMMERCIAL RISK MITIGATION OPPORTUNITY • Non-binary success KEY BUSINESS ATTRACTIVE MARKET ECONOMIES OF SCALE PROCESSES • Unmet clinical need CORPORATE FLEXIBILITY • Regulatory pathway CAPITAL EFFICIENCY & • Dynamic resource SPEED TO MARKET allocation and HIGH-MARGIN PRODUCT • Outsourced best-in-class prioritization • Reimbursement process experts • Streamlined channel to • Technologic Complexity • Light infrastructure, low incorporate external • Cost-of-goods fixed costs innovation • Shortest path to INITIAL Regulatory Clearance MULTIPLE PATHWAYS TO COMMERCIALIZATION 9
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 agreement • Non-dilutive financing • Build organically or • Option to acquire acquire 10
Car arpX pX Minimally Invasive Device to Treat Carpal Tunnel Syndrome 11
Carpal Tunnel Syndrome C LINICAL O VERVIEW Incidence ▪ Over 600,000 US procedures annually 1 ▪ 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 1 Fajardo, et al . J Hand Surg 2012; 37(8):1599-1605 2 Estimate based on CTS prevalence data from Dale et al. Scand J Work Environ Health. 2013 Sep 1;39(5):495-505. 12
Carpal Tunnel Syndrome M ARKET O PPORTUNITY 600,000 1 current surgeries * x $1,500 minimum ASP = ~ $1 billion Additional 1.5M 2 “silent sufferers” who choose to defer surgery U NMET C LINICAL N EED – C URRENT L IMITATIONS TRADITIONAL CARPAL TUNNEL ENDOSCOPIC SURGERY SURGERY IS INVASIVE IS LESS EFFECTIVE • Up to 2 inch incision • Remains a surgical procedure • Performed in an OR • Higher recurrence and • At least 3-4 month, up reoperation rate to 6-9 month recovery • Increased nerve injury • Higher costs 1 Fajardo, et al . J Hand Surg 2012; 37(8):1599-1605 2 Estimate based on CTS prevalence data from Dale et al. Scand J Work Environ Health. 2013 Sep 1;39(5):495-505. 13
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. 14
CarpX Procedure Narrowed “waist” at point of Wire maximal constriction Electrodes Wire 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 Activate device, cutting ligament with to nerves using nerve stimulator <2 sec burst of RF energy * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 15
CarpX in Action * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 16
CarpX in Action * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. 17
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