Wound Care

 
Dr. Ned Swanson, President & Chief Medical Officer and Dr. Nikolai Sopko, Chief Operating Officer, Chief Scientific Officer & Director, at PolarityBio, a late-stage biotechnology company developing regenerative multicellular biologics, specifically their lead autologous cutaneous cell therapy designed to treat complex chronic wounds joins eHealth Radio and the Health News Channel.
Listen to interview with host Eric Michaels & guests Dr. Ned Swanson & Dr. Nikolai Sopko discuss the following:
To begin, both of you bring strong clinical and scientific expertise to executive leadership. How have your respective backgrounds as medical doctors and researchers uniquely shaped your roles in driving PolarityBio through its late-stage clinical milestones?
PolarityBio has just reached a major corporate milestone with the submission of a Biologics License Application (BLA) for SkinTE. From a leadership perspective, what were the most significant operational and clinical hurdles your team had to overcome to prepare this asset for FDA review?
The company is fundamentally focused on regenerative multicellular biologics. How did the initial vision for this technology form, and how has it evolved under your joint leadership?


SkinTE is described as a first-in-class, autologous cutaneous multicellular therapy. In plain terms, how does using a patient’s own healthy skin biology differ from traditional advanced wound care therapies already on the market?
Chronic wounds like diabetic foot ulcers (DFUs) are notoriously complex and resistant to healing. What is the proposed biological mechanism of SkinTE?
Because SkinTE utilizes autologous multicellular units, it relies entirely on the patient's own tissue. What are the potential advantages of this autologous approach?
Your trial completed enrollment of 120 patients across multiple U.S. sites in just 14 months, significantly outpacing historical timelines for DFU trials. To what do you attribute this exceptionally fast clinical enrollment?


SkinTE has received both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA. How have these programs facilitated your interactions with the agency leading up to this BLA submission?
Looking beyond Wagner Grade 1 diabetic foot ulcers, what does your development pipeline look like for other complex chronic wound indications, such as venous leg ulcers and pressure injuries?


SkinTE will be the first new biologic commercially available for a common chronic wound indication in nearly 30 years, if approved. As you look toward the conclusion of this FDA review process, what will this milestone mean for the millions of patients currently facing the threat of severe morbidity and amputation, and what is your ultimate vision for how PolarityBio can potentially reshape wound medicine?
Ned Swanson, MD is the President & Chief Medical Officer of PolarityBio with a background in surgical innovation and biomedical engineering. He previously served as Co-Founder & Chief Medical Officer of PolarityTE from 2016 to 2021. Dr. Swanson received his MD from Harvard Medical School and trained in Plastic Surgery at Johns Hopkins. His foundational expertise is rooted in Bioengineering from the University of Pennsylvania.
Nikolai Sopko, MD, PhD is a Director, Chief Operating Officer, and Chief Scientific Officer of PolarityBio with a background in regenerative medicine. He previously served as Chief Scientific Officer and Vice President of Research & Development at PolarityTE. Dr. Sopko received his MD with honors from Case Western Reserve University and his PhD in Stem Cell Biology from the Cleveland Clinic through the National Institutes of Health Medical Scientist Training Program. He is a Board Certified Urologic Surgeon and completed his training as a Physician Scientist Scholar at Johns Hopkins.
Website: polaritybio.com
Social Media Links: Facebook: facebook.com/PolarityBio  Linkedin: linkedin.com/company/polaritybio1  X: @PolarityBio_ 
People also listened to this: Snuggle Shield: A Nurse & Mom’s Guide to Protecting Babies in Public

 
 
Dr. Des Bell, Chief Medical Officer at Omeza LLC, a medtech and consumer healthcare products company specializing in skin care and wound management products from the sea joins eHealth Radio and the Health News and Skin Care Channels.
 
Listen to interview with host Eric Michaels and guest Dr. Des Bell discuss the following:
Having served on the board of directors for American Board of Wound Management as well as the Association for the Advancement of Wound care and American Board of Wound Management Foundation, you are considered an expert in your field…why do you say that non healing wounds may be worse than many forms of cancer?
Why are these wounds non healing?
What type of issues do physicians face in wound care treatments today? 
What can be done to prevent these wounds from becoming chronic?
I understand you have created a non-profit organization called SALSAL to help advance wound care in America. Can you tell us a little bit about your mission?

Dr. Desmond “Des” Bell, DPM, CWS is Chief Medical Officer of Omeza, and has consulted with the Omeza founders since the company’s inception, helping develop the product line and overseeing its practical application. He serves as lead clinician in an approved test program for Omeza products at the Wound Management program at Memorial Hospital in Jacksonville, Florida.
Dr. Bell, a leader in limb preservation and lower extremity wound care, is a Board-Certified Wound Specialist (CWS, American Board of Wound Management).  A graduate of Tulane University and the Temple University School of Podiatric Medicine, Dr. Bell is the Founder and President of “The Save A Leg, Save A Life” Foundation (SALSAL), a non-profit organization dedicated to preventing unnecessary lower extremity amputations. He has previously served on the Board of Directors of the American Board of Wound Management and the American Board of Wound Management Foundation.  He has been the recipient of the Frist Humanitarian Awards at Specialty Hospital (2009) and Memorial Hospital (2018) in Jacksonville, Florida. Dr. Bell has also been elected as a Fellow of the Royal College of Physicians and Surgeons of Glasgow.
He is a frequent lecturer and author on the subject of wound care, peripheral arterial disease and diabetes, and is a founding editorial Board Member of “Today’s Wound Clinic”, as well as being a regular contributor to “Podiatry Today”. He is a nationally recognized speaker, with regular faculty roles at AMP, ASCENT and Modern Wound Care Management.
 
 
Website: omeza.com
Social Media Links: Facebook: facebook.com/omezaskin  Instagram: @omezaskin

 
 
Mr. David Davis, President and CEO at Shared Health Services who partners with hospitals to open and manage outpatient wound care and hyperbaric oxygen therapy centers across the United States joins eHealth Radio and the Health Care and Health News Channels.
 
Listen to host Eric Dye & guest David Davis discuss the following:
What is a chronic wound?
How many chronic wounds are there in America?
What types of wounds become chronic wounds?
Where, and how, are chronic wounds treated?
What is hyperbaric oxygen (HBO) therapy?
What are some of the diagnosis's that HBO is used to treat?
How does Shared Health Services work with hospitals?
 
David Davis, BS, RRT, CHT is a former United States Congressman, Joint Commission Surveyor and healthcare entrepreneur.  He holds a degree in Organizational Management from Milligan College, an A.S. in Respiratory Therapy from California College for the Health Sciences, and Certification in Respiratory Care from East Tennessee State University. During his 30 years in the health care industry, he managed several Respiratory Care Departments throughout the Southeastern U.S., started and managed a very successful multi-state home medical equipment company, Advanced Home Care, in 1986, served as a Joint Commission surveyor and founded Shared Health Services in 1996.  Known as a leader in his local community and in his home state, he has served as a Leadership Council Member for the National Federation of Independent Business; as Chairman, Medicare Part B, Tennessee Association for Home Care; as Clinical Adjunct Faculty Member, Respiratory Care Department, East Tennessee State University; and as a member of the American Association for Respiratory Care.
Shared Health Services is a wound care company who contracts with hospitals to help them open and manage successful outpatient wound care and hyperbaric oxygen centers. The mission of our Centers of Excellence is to heal chronic wounds, improve patient outcomes, help prevent limb loss and provide a profitable service for our contracted hospitals.
 
Website: www.sharedhealthservices.com Facebook: https://www.facebook.com/sharedhealthservices