Exhibit 99.1
1 TM NASDAQ: PAVM Lishan Aklog, MD Chairman and CEO APR 2017
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 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 sought nor received clearance from the FDA or any other regulatory agency for any of the products described in this presentation. www.pavmed.com info@pavmed.com
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
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 Addressable Market >$4B NEAR - TERM VALUE CREATION MILESTONES Two products targeted for 2017 commercialization
5 PAVmed’s Leadership Team
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
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 DisappEAR Resorbable Antibiotic - Eluting Ear Tubes NextFlo Highly Accurate Infusion System
8 The PAVmed Business Model
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 Technology Innovation 2010 TIME AND CAPITAL TO FDA CLEARANCE
10 High Margin Product Attractive Market Project selection criteria Commercial Opportunity Unmet Clinical Need Regulatory Profile Reimbursement Profile Technology Profile
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
12 Multi - product strategy Risk Mitigation Non - binary Success Enhanced Value Creation Economies Of Scale Flexible, Dynamic Allocation Of Resources
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 Initiate Commercialization Remain Opportunistic To Maximize Value Creation
14 Lead Product Development Pipeline
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 Tunnel Syndrome Carpal Tunnel Syndrome $1B 510(k) Independent Distributors Q4 2017 NextCath Self - Anchoring Short - Term Catheters Percutaneous Interventional Radiology Drainage Catheters $200M 510(k) Corporate Distribution Agreement Q1 2018 DisappEAR Antibiotic - eluting Resorbable Ear Tubes Pediatric Ear Tubes $300M 510(k) Independent Distributors Q3 2018 Next Flo Highly Accurate Disposable Infusion System Inpatient Infusion Sets/ Disposable Infusion Pumps $500M/$1B 510(k) Corporate Distribution Agreement Q2 2018 Caldus Disposable Tissue Ablation Devices Fistulae $300M 510(k) Independent Distributors Q3 2018 Renal Denervation $1B CE Mark / Emerging Markets Independent Distributors Q1 2019 Lead Product Pipeline * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
16 PortIO Implantable Intraosseous 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 (PICC) Central Venous Catheter (CVC) Acute Intraosseous Device Vascular Access Devices ~7 million central vascular access devices (US) Implantable Ports ▪ ~400 - 500,000 implantable ports (US) ▪ ~$500M addressable market annually (US) Emergency Intraosseous Devices ▪ ~$130M addressable market annually (US) M ARKET O PPORTUNITY
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 Poor Veins Resource Utilization >10% with inaccessible scarred central veins Kidney failure patients on dialysis Prior chemotherapy or other need for access Patients with pacemaker and defibrillators leads Surgical insertion and removal Radiographic confirmation of tip placement Maintenance including regular flushes Infections are costly CMS “Never Events” Vascular Access Devices U NMET C LINICAL N EED – C URRENT D EVICE L IMITATIONS Limitations driven by intravascular component, 25% overall complication rate
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 Vascular Access * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
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 Infusion needle inserted through skin, septum and channel – directly accessing bone marrow cavity PortIO – The PAVmed Solution Target commercialization – End of Q2 2017 Initial targets – emergent vascular access and poor venous access patients * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
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 Effective More Versatile No need for regular flush No radiographic confirmation Shift procedures out of OR to less expensive locale Rapid, predictable, repeatable Near limitless number of potential access sites critical in patients those with poor veins * PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
22 CarpX Percutaneous Device to Treat Carpal Tunnel Syndrome
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’ compensation costs Inflammation and scarring of transverse carpal ligament ▪ Entrapment of the median nerve ▪ Hand pain, numbness and weakness
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 reoperation rate Increased nerve injury Higher costs Carpal Tunnel Syndrome M ARKET O PPORTUNITY Estimated $1 billion immediately addressable market Not considering ~1.5M patients/year who choose to defer surgery but might consider percutaneous approach (“silent sufferers”) U NMET C LINICAL N EED – C URRENT L IMITATIONS
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.
26 CarpX in Action
27 CarpX in Action
28 CarpX in Action
29 CarpX in Action
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 Expanded Indication FDA Clearance & Commercialization NextCath FDA 510(k) Clearance & Commercialization Caldus Fistulae FDA 510(k) Submission, Clearance & Commercialization Caldus Renal Denervation CE Mark Submission NextFlo FDA 510(k) Submission, Clearance & Commercialization DisappEAR FDA 510(k) Submission, Clearance & Commercialization 2018
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 conceptual phase projects through patent submission and early testing Explore synergistic acquisition targets
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 23 press release ▪ Structured to reward existing shareholders and provide incentives for long - term ownership ▪ 1 Share of Common Stock may be exchanged for... 1 Unit = 1 Share of Common Stock + 1 Series X Warrant exercisable at $6.00 ▪ No cash or other consideration required to participate
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 ▪ TriSpan – CFO/EVP Arthur Anderson ▪ CPA LaSalle University ▪ B.S. Accounting Board Member ▪ DarioHealth (Nasdaq: DRIO) ▪ Noninvasive Medical Technologies ▪ Cagent Vascular DENNIS M. MCGRATH
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 Addressable Market >$4B NEAR - TERM VALUE CREATION MILESTONES Two products targeted for 2017 commercialization