Collaboration Encourages Innovation:

Setting New Standards in Wound Care With the WCCC Expert Panel Consensus Recommendations

Symposium for
Advanced Wound Care
Spring 2024
Orlando, FL

Key Numbers

Total Participants

Expert Stakeholder Panelists

Panel Discussions

Consensus Statements

Panelist Expertise

Panelist	Specialty/Background	Number of Years of Experience in the Professional Wound Care Community	Number of Years in Research	Approximate Number of Publications
1	Family Medicine, Undersea and Hyperbaric Medicine	35	30	80
2	Strategic Evidence, Diagnostic Imaging, Reimbursement, Medical Affairs	10	20	40
3	Economics	16	10	4
4	Wound Care, Hyperbaric Medicine, Family Medicine	13	10	17
5	Plastic and Reconstructive Surgery, FDA Drug Regulation	10	N/A	12
6	Market Access, Reimbursement, Business Development	38	N/A	1
7	Business and Commercialization	40	N/A	N/A
8	Vascular Surgery, General Surgery, Wound Care	15	13	70
9	Research and Development, Wound Care, Orthopedics	11	17	30
10	Family Medicine, Medical Devices	12	4	2
11	Regenerative Medicine, Tissue Engineering, Research and Development, Clinical Development, Medical Affairs	15	20	41
12	Biomedical Science of Skin Substitutes and Wound Healing	30	30	48
13	Wound Care, Vascular Surgery	30	20	150
14	Market Access, New Product Development, Market Adoption	10	N/A	N/A
15	Regulatory	20	13	5
16	Vascular Surgery, General Surgery	24	24	94
17	Clinical Research, Surgery	11	20	10
18	Podiatric Medicine and Surgery, Physical Therapy	13	N/A	N/A
19	Plastic Surgery, Wound Care	30	30	100
20	Wound Care Research, FDA Approval of New Devices and Clinical Assessment, Reimbursement	44	8	16
21	Regulatory Science	13	5	2
22	Industry, Product Development	12	12	3
23	Clinical Evidence, Product Development, Professional Education, Health Economics	25	10	5
24	Clinical Trial Design and Analysis, Health Economics Modeling, Systematic Reviewing, Epidemiology, Infectious Disease	20	20	150
25	Wound Care, Hyperbaric Medicine, Infectious Disease	24	30	36
26	Wound Care, Software, Data Analytics	10	10	200
27	Nephrology	20	10	20
28	Podiatric Surgery Wound Care Researcher Professor	30	27	200
29	Regenerative Medicine Research, Preclinical Testing, Clinical Trials	25	30	170
30	Business, Wound Care	37	N/A	N/A
Mean	-	21.4	15.1	51.9
Median	-	20	13	20

Panel Topics And Consensus Statements

Panel 1: Addressing Barriers to Wound Care

Consensus Statement 1: Investor hesitancy resulting from poorly executed clinical trials, poor clinical trial design, and/or insufficient endpoints, hinders innovation in wound care.

Consensus Statement 2: Improved and efficient methods of real-world data (RWD) collection (eg, an industry-wide registry) could help define accurate patient populations for clinical trial selection and improve the likelihood of success.

Panel 2: Alternative Primary and Co-primary Endpoints

Consensus Statement 3: Complete wound closure remains the gold standard in primary endpoints for clinical trial design.

Consensus Statement 4: If complete wound closure is unattainable, clinical trial designs can be carefully designed to incorporate alternative endpoints, targeting both a meaningful degree of wound area reduction and a clinically meaningful outcome for patients.

Consensus Statement 5: Innovative tools, devices, products, or diagnostics must accurately and reproducibly measure primary endpoints and provide reliable consistency across study results.

Panel 3: Generating and Reporting Evidence

Consensus Statement 6: The wound care community has a significant need for updated clinical trial reporting guidelines.

Consensus Statement 7: Established clinical trial reporting guidelines should be communicated with national and international journals, associations, and conferences for successful adoption. When the entire community agrees to use the same standard, the guidelines will carry the most weight in calibrating published studies.

Panel 4: Real-World Evidence (RWE) in FDA and Payer Decision-Making

Consensus Statement 8: Accurate and updated International Classification of Diseases (ICD)-10 codes for wound care are urgently needed.

Consensus Statement 9: Standardized, universal data entry metrics are needed to help calibrate results between RWE and randomized controlled trials (RCTs).

Panel 5: Defining Standard of Care (SOC) in Wound Care

Consensus Statement 10: As the FDA does not regulate SOC or the practice of medicine, professional practice organizations must define their own SOC.

Consensus Statement 11: The SOC should be specific and granular, with reasonable parameters to eliminate trial inconsistencies while allowing flexibility for patient-specific needs.

Consensus Statement 12: The entire Wound Healing Collaborative Community and its stakeholders must be held accountable for consistently implementing the established SOC.

Participants

Yi Arnold, PhD, MBA

Global Head, Divisional Medical Affairs, Tissue Technologies
Integra LifeSciences

John I. Azeke, PhD

Biomedical Engineer & Lead Reviewer
Plastic Surgery Skin and Wound Devices Team 3
CDRH/OPEQ/OHT4/DHT4B
US FDA

Marissa Carter, PhD, MA, MAPWCA

President
Strategic Solutions, Inc.

Cynthia Chang, MD

Division Director
Division of Plastic and Reconstructive Surgery Devices
Center for Devices and Radiological Health, US Food and Drug Administration

Peggy Dotson, RN, BS

WCCC Treasurer/Secretary

Vickie Driver, DPM, MS, FACFAS

Professor, Washington State University

Chair Person, Board of Directors, WCCC

Bill Ennis, DO, MBA, FACOS

Chief Medical Officer
Healogics

Caroline Fife, MD

Chief Medical Officer
Intellicure

Lisa Gould, MD, PhD

Plastic Surgery/Wound Team
South Shore Hospital

Beate Hanson, MD, MPH

Global Chief Medical Officer
Convatec

John Harper, PhD

Chief Scientific Officer & SVP
Research and Product Development
MiMedx

Maribel Henao, DPM, MSPT, BSMAS

Senior Director, Medical Affairs
Organogenesis

Tim Jacobson

CFA, CEO
NOxy Health Products

Dheerendra Kommala, MD

Chief Medical Officer
ECRI

John Lantis, MD

Chief of Surgery
Mount Sinai West Hospital

Amy Law

VP Health Economics, Outcomes Research and Market Access
Solventum

Katie Mowry, PhD

Vice President, Research and Development
Organogenesis

Alisha Oropallo, MD

Professor of Surgery, Zucker School of Medicine, Hofstra/Northwell

Professor, Feinstein Institutes for Medical Research

Director, Northwell Comprehensive Wound Healing Center and Hyperbarics

Matthew Pine

CEO
Intellicure

Monique Rennie, PhD

Global Director Medical Affairs, Wound Care
Mölnlycke Health Care

Joseph Rolley, BS, MSIA

Principal
JTR Business Consulting, LLC

Kira Rupprecht, MBA

Reapplix

Randy Schwartz, BA

Principal
Med Market Consultants LLC

Michael Steadman

CEO
Urgo Medical

Cristin Taylor, DPT, MSHS, PA

Senior Director Medical Affairs Advanced Wound Care
Convatec

William Tettelbach, MD, FACP

CMO, RestorixHealth

President, American Professional Wound Care Association (APWCA)

CMO, Onsite Advanced Care, Salt Lake City, UT

Marjana Tomic-Canic, PhD

Vice Chair of Research and Director of Wound Healing and Regenerative Medicine Research Program at University of Miami Miller School of Medicine

Shabnam Vaezzadeh, MD, MPA

CEO, Global Medical Affairs Executive
Exquisite Biomedical Consulting

Dev Verma, MD

Medical Officer
Division of Dermatology and Dentistry
Center for Drug Evaluation and Research
US FDA

Lucian Vlad, MD

Clinical Associate Professor, Atrium Health Wake Forest Baptist Wound Care

Director, Wound Care & Hyperbaric Fellowship

Co-Chair, AAWC Educational Committee

Director, American Board of Wound Healing and Surgery

Howard Walthall, JD

CEO
ProgenaCare Global, LLC

Emma Wright, PhD, BSc

Chief Medical Officer
Mölnlycke Health Care