PAVmed, Inc. Corporate Overview - Nasdaq: PAVM, PAVMZ LISHAN AKLOG, MD
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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
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)
Treat Carpal Tunnel qualifications
• CE Mark Submission
Syndrome • Pre-commercial activities
including physician engagement
• Human study documenting >90% • Balloon sampling device
accuracy published FDA 510(k) Submission
EsoCheck • Large NIH-funded multi-center • CLIA certification for LDT
Non-Invasive Device & DNA >$1B 510(k) + clinical trial for Barrett’s
2
• Liquid media validation
Biomarkers to Detect LDT screening indication enrolling, 90
from data on 80-100
Esophageal Cancer Precursor patients to date
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
DisappEAR tubes from commercially sourced animal study to confirm
Antimicrobial Resorbable Ear ~$300M 510(k) silk blocks established resorption rates
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
2 4
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
CHAIRMAN & CEO
DENNIS
MCGRATH
EXECUTIVE VP & CFO
BRIAN
DEGUZMAN, MD
CHIEF MEDICAL OFFICER
SHAUN
O’NEIL
CHIEF COMMERCIAL
OFFICER
7
Capital Structure
8
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 SPEED TO MARKET
prioritization • Reimbursement • Outsourced best-in-class
process experts
• Streamlined channel to • Technologic Complexity
incorporate external • Light infrastructure, low
• 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
• Non-dilutive financing agreement • Build organically or
• Option to acquire acquire
10CarpX
Minimally Invasive Device to Treat Carpal
Tunnel Syndrome
11Carpal 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.
12Carpal 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 to 2 inch incision • Remains a surgical
• Performed in an OR procedure
• At least 3-4 month, up • Higher recurrence and
to 6-9 month recovery reoperation rate
• Increased nerve injury
• Higher costs
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.
13CarpX – 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.
14CarpX 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 Activate device, cutting ligament with
to nerves using nerve stimulatorCarpX in Action
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
16CarpX in Action
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
17CarpX – 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
FEWER COMPLICATIONS EXPANDED MARKET
• Better nerve protection • Lower threshold for intervention
• Minimal risk of infection for patients “suffering in silence”
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
18CarpX – 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 of thermal injury
▪ Limited to cut edges of ligament
completely sparing nearby tissues and
structures including nerves and blood
vessels (encircled in red) Figure 2. Site #1. Tunnel represents the device pathway under the skin. Blo
Representative histologic images showing minimal thermal
nerve fibers located adjacent to the severed fascia are normal and unaffect
▪ Any rise in temperature limited to 1mm Figure 3. High magnification of the rectangular region highlighted in Figure 2. Blood vessels
and nerve fibers located below the severed fascia are normal and unaffected.
injury (red circles) limited to cut edges of ligament (fascia)
and transient (< 20 sec) Page 9 of 25
Page 10 of 23
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 Representative X-ray images showing excellent anatomic
separation of key nerves, protecting them from electrode
thermal zones
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
19CarpX – 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 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
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
1 Based on Company Estimates.
20mVIM + mCCNA
EsoCheck
Non-Invasive Device & DNA Biomarkers to Detect
Esophageal Cancer Precursor
21Esophageal 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; 66:7-30
3Mariotto et al. J Natl Cancer Inst 2011; 103:117-128. 22
4Dulai et al. Gastroenterology 2002; 122:26-33.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
• Treatment with OTC meds • Precursor to dysplasia and • Can be prevented if
can mask pathology esophageal cancer Barrett’s detected and
• Can be treated with ablation treated prior to progression
if detected early to cancer
1El-Serag et al. Gut 2014; 64(6):871-880.
23Screening 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.
24EsoCheck – 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 • mVIM - well established biomarker in
• Patient swallows capsule colon cancer
• Balloon inflated in the stomach • mCCNA – newly discovered biomarker
• Balloon pulled back, swabbing the • IP protection of modified genes
lower esophagus for cells (composition of matter) and algorithms
• Balloon deflated protecting sample of • Low-cost, automatable
cells from dilution or contamination • Returns simple binary result
25EsoCheck – In Action
26EsoCheck 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
27EsoCheck – 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 vsEsoCheck – 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 with balloon sampling device and sample sent to
reference laboratory under Laboratory Developed Test (LDT) EsoCheck
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 mVIM + mCCNA
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)
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
29EsoCheck – 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 high risk population
• Laboratory Developed Test (LDT) ◆ ACG-recommended population consisting of 20
designation of EsoCheck Assay at million > 5-year history of GERD with 2 risk
factors
reference lab (Q1-2019)
• CE Mark submission (Q2-2019) • Current NIH-funded EsoCheck trial
ClinicalTrials.gov: NCT00288119
▪
◆
COMMERCIAL ◆ Case-control and Detection arms
• Target US launch late Q1-2019 ◆ Enrolled ~100 patients at 8 centers
• EsoCheck Kit provided to clinicians, • Lucid considering parallel studies to
◆ Balloon sampling device support PMA
◆ Cytolyte vial ◆ Detection study in US
◆ Mailer ◆ PCP-targeted detection study in Europe
• Assay • Target milestones
◆ 3-4 day turnaround ◆ FDA Pre-Submission (Q1-2019)
◆ Binary result reported based on > 1% of DNA ◆ Target clearance (Q1-2021)
for mVIM or mCCNA1
◆ Lab bills payor under Proprietary Laboratory
Assay (PLA) code
30EsoCheck – 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 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 mVIM + mCCNA
▪ 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.
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
31PortIO
Implantable Intraosseous Vascular Access Devices
32Vascular Access Devices
Used to deliver medications, fluids, nutrition and other substances
ER INPATIENT HOMEVascular 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% of patients2 • Surgical insertion &
• Pacemaker/Defibrillator removal
Leads and catheters • Maintenance with regular
• Dialysis patients flushes
1CKutar. The Oncologist 2004;9:207-2016.
2Mickley. Eur J Vasc & Endovasc Surgery 2006; 32(4):439-444.
34
.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 regulatory agency for any of these products.
35PortIO – 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 access needle
Hollow Titanium Silicone
Titanium Hub w/ Septum
Bone Screw Internal
Insertion Conical
Kit Needle
Guide
*
PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
36PortIO – Market Opportunity
ER INPATIENT HOME
Duration Duration DurationPortIO – 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 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
*
PAVmed has not yet received clearance from the FDA or any other regulatory agency for any of these products.
38PROVEN 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
39Contact Us
PAVmed Inc.
One Grand Central Place
Suite 4600
New York, NY 10165
212-949-4319
info@pavmed.com
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