Pavmed Inc. · NASDAQ:PAVM
Pavmed — Investor Presentation (April 2017)
34 slides from Pavmed's investor presentation, Apr 4, 2017
Slide 1: PAVmed Investor Presentation April 2017
1 TM NASDAQ: PAVM Lishan Aklog, MD Chairman and CEO APR 2017
Slide 2: Disclaimers
2 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 inc
Slide 3: Who are we?
3 Who are we? Nasdaq - Listed: PAVM High - Margin, High - Impact Single - Use Interventional Products Broad Spectrum of Clinical Conditions and Specialty Call Points Multi - Product Medical Device Company
Slide 4: PAVmed Highlights
4 PAVmed Highlights PROVEN LEADERSHIP TEAM Established Entrepreneurs with Deep Clinical and Industry Experience Strong Track Record of Value Creation UNIQUE PROVEN BUSINESS MODEL Capital Efficiency Speed to Market EXPANDING PIPELINE Innovative Products Addressing Unmet Clinical Needs Total Addressab
Slide 5: PAVmed's Leadership Team
PAVmed’s Leadership Team LISHAN MICHAEL AKLOG,MD GLENNON BRIAN DEGUZMAN, MD CHAIRMAN & CEO | fl VICE CHAIRMAN CHIEF MEDICAL OFFICER HARVARD © “8. Physics, magna Universityof -_B.A., Business . BS. Biol UNIVERSITY Tar New Hampshire — Adiministration @ BOSTON tology + M.D., cum laude STORZ stryker = E
Slide 6: PAVmed's History
6 PAVmed’s History 2008 - 2013 2015 2016 NASDAQ IPO COMPLETED FIRST FDA 510K SUBMISSION PAVMED FOUNDED SIXTH PRODUCT LICENSED FROM ACADEMIC CONSORTIUM 2014 R&D OF FIVE LEAD PRODUCTS INITIATED
Slide 7: Lead products
7 Lead products * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products. Caldus Disposable Tissue Ablation Devices PortIO Implantable Vascular Access Device CarpX Percutaneous Carpal Tunnel Device NextCath Self - Anchoring Short - Term Catheters
Slide 8: The PAVmed Business Model
8 The PAVmed Business Model
Slide 9: Record of capital efficiency and speed to market
9 Record of capital efficiency and speed to market 60months 23 months 0 12 24 36 48 60 Typical Company PAVmed Model Months $31 million $3 million $0 $10,000,000 $20,000,000 $30,000,000 Typical Company PAVmed Model Dollars * Typical Company data from Markower, et al. FDA Impact on US Medical Technolo
Slide 10: High Margin Product, Attractive Market: project selection criteria
10 High Margin Product Attractive Market Project selection criteria Commercial Opportunity Unmet Clinical Need Regulatory Profile Reimbursement Profile Technology Profile
Slide 11: Key business processes
11 Key business processes Light Infrastructure Low Fixed Costs Flexible Commercialization Strategy Regulatory Strategy Parallel Development Processes Outsourced Best - in - class Process Experts Capital Efficiency Speed To Market
Slide 12: Multi-product strategy
12 Multi - product strategy Risk Mitigation Non - binary Success Enhanced Value Creation Economies Of Scale Flexible, Dynamic Allocation Of Resources
Slide 13: Flexible commercialization strategy
13 Accelerate Revenue Growth Flexible commercialization strategy DIRECT SALES FORCE Call - point specific INDEPENDENT DISTRIBUTOR NETWORK Call - point specific REGULATORY CLEARANCE CORPORATE PARTNER Sales and Distribution Agreement CORPORATE PARTNER Licensing agreement Acquisition of product Initiat
Slide 14: Lead Product Development Pipeline
14 Lead Product Development Pipeline
Slide 15: Product addressable market, regulatory path and commercialization
15 PRODUCT ADDRESSABLE MARKET REGULATORY PATH COMMERCIALIZATION INITIAL CHANNEL TARGET DATE PortIO Implantable Intraosseous Vascular Access Devices Vascular Access Ports/ Emergency Intraosseous Access $500M/$125M 510(k) Independent Distributors Q2 2017 CarpX Percutaneous Device to Treat Carpal Tunne
Slide 16: PortIO Implantable Intraosseous Vascular Access Devices
16 PortIO Implantable Intraosseous Vascular Access Devices
Slide 17: Market Opportunity: vascular access devices
17 Long - term Short - term Week to Months Days to Week Chemotherapy, antibiotics, intravenous nutrition, biologics and other medications Acute in - hospital infusions, emergency, trauma Implantable Ports (“Port - a - Cath”) Tunneled Central Venous Catheter Peripherally Inserted Central Catheter (PI
Slide 18: Unmet Clinical Need – Current Device Limitations
18 Occlusion Infection Up to 35% incidence of device occlusion More serious complications (thrombosis, embolism) Requires clot - busting medications or a repeat procedure Up to 10% incidence of infections Half are life - threatening bloodstream infections Chemotherapy patient especially high - risk
Slide 19: Intraosseous Vascular Access
19 Infusion directly into the bone marrow cavity ▪ Rapid, direct drainage into central venous circulation Well established over decades ▪ Trauma, esp. military ▪ Pediatric emergency setting Bioequivalent to intravenous infusion Low complication rates Expanding non - emergency use Intraosseous Vascul
Slide 20: Implantable Intraosseous Port
20 I MPLANTABLE I NTRAOSSEOUS P ORT NO INTRAVASCULAR COMPONENT Subcutaneous, implantable intraosseous vascular access Self - tapping/drilling hollow bone screw, septum, body with internal conical needle guide but no reservoir, Implanted into cortical bone over a guide through a small skin incision I
Slide 21: PortIO – The PAVmed Solution
21 PortIO – The PAVmed Solution Target commercialization – Q2 2017 Initial targets – emergent vascular access and poor venous access patients Fewer Complications Less Invasive Fewer occlusions Potential for fewer, less serious infections Simple, near - percutaneous insertion and removal More Cost Ef
Slide 22: CarpX Percutaneous Device to Treat Carpal Tunnel Syndrome
22 CarpX Percutaneous Device to Treat Carpal Tunnel Syndrome
Slide 23: Carpal Tunnel Syndrome Clinical Overview
23 Carpal Tunnel Syndrome C LINICAL O VERVIEW >3M office visits per year Over 600,000 U.S. procedures annually ▪ Additional up to 1.5 million with symptoms who “suffer in silence” Most common cumulative trauma disorder Half of all occupational injuries in the U.S. over $20 billion in annual workers’
Slide 24: Carpal Tunnel Syndrome Market Opportunity and Unmet Need
24 Traditional Surgery is Invasive Endoscopic Surgery is Less Effective Up to 2 inch incision Open surgical procedure performed in an operating room Post - operative pain At least 3 - 4 month recovery Remains a surgical procedure performed in an operating room Higher recurrence rate Higher reoperati
Slide 25: CarpX – The PAVmed Solution
25 CarpX – The PAVmed Solution Target commercialization – Q4 2017 PERCUTANEOUS DEVICE TO TREAT C ARPAL T UNNEL S YNDROME NO SURGICAL INCISION * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
Slide 26: CarpX in Action
CarpX in Action SK PAVmed
Slide 27: CarpX in Action
27 CarpX in Action
Slide 28: CarpX in Action
28 CarpX in Action
Slide 29: CarpX in Action
29 CarpX in Action
Slide 30: Product Pipeline Roadmap
30 Product Pipeline Roadmap PortIO Expanded Indication FDA IDE Submission Q1 - 2017 CarpX FDA 510(k) Clearance & Commercialization NextCath FDA 510(k) Submission Q4 - 2017 CarpX FDA 510(k) Submission Q3 - 2017 PortIO FDA 510(k) Clearance Q2 - 2017 PortIO FDA 510(k) Submission Q4 - 2016 PortIO Expand
Slide 31: Growth Strategy
31 Growth Strategy Advance lead products to commercialization ▪ PortIO, CarpX, DisappEAR, NextFlo, NextCath and Caldus, ▪ Prepare commercialization infrastructure for initial products Expand product pipeline ▪ Ongoing discussions with innovative clinicians and academic medical centers ▪ Advancing co
Slide 32: Financing and Capital Markets Activities
32 Financing and Capital Markets Activities Convertible Preferred Offering ▪ $3 Million Private Placement ▪ 1 Unit @ $6.00 = 1 Share Preferred Stock + 1 Series A Warrant ▪ 2 Closings to date for $2.5 Million ▪ Recent S - 1 registering derivative securities Exchange Offering ▪ Announced in February 2
Slide 33: New Chief Financial Officer
33 New Chief Financial Officer Executive VP and CFO Medical Device Industry Veteran 30 years of corporate finance experience PhotoMedex (Nasdaq: PHMD) ▪ President and CFO ▪ CEO ▪ CFO/VP Finance and Administration AnswerThink Consulting Group (Nasdaq: ANSR) ▪ Think New Ideas (Nasdaq: THNK) CFO ▪ TriS
Slide 34: PAVmed Highlights
34 PAVmed Highlights PROVEN LEADERSHIP TEAM Established Entrepreneurs with Deep Clinical and Industry Experience Strong Track Record of Value Creation UNIQUE PROVEN BUSINESS MODEL Capital Efficiency Speed to Market EXPANDING PIPELINE Innovative Products Addressing Unmet Clinical Needs Total Addressa