Christian Robertozzi, DPM, FACFAOM, FASPS, CHCQM.
For the past thirty-four years, I have practiced podiatric medicine in a rural community. I
served the podiatric profession both locally and nationally as chair of a multitude of
committees and boards, culminating as President of the New Jersey Podiatric Medical
Society 1993-1994, President of the American Podiatric Medical Association 2007-2008
and President of the Medical Staff of Newton Medical Center 2014-2015.
A significant part of my practice involves dealing with diabetics and the numerous
maladies they have with their feet. At the top of the list are ulcers, not uncommonly
infected. As you know this can result in limb loss as well as be a life-threatening
emergency. Over the years, the basic tenets of the treatment have remained the same;
debride the necrotic tissue, initiate antibiotics if infected, perform a culture and
sensitivity and alleviate pressure to the area. When the area is clean and the circulation
adequate, skin grafts or flaps are performed. Negative pressure wound therapy is a
significant adjunct to wound healing. In addition there are a multitude of skins
substitutes. These all hastened the closure of the wounds and get the patients back to
work sooner. There is a significant cost to this rapid closure.
For the last several months, I have initiated the use of PermeaDermC for the use of
chronic wounds instead of the other skin substitutes that have become commonplace in
this area. The first few wounds in which PermeaDermC has been applied are healing at
a rate which at least meets but in most cases exceeds the contemporary skin
substitutes. To date there have been no failures and these have all be non-compliant
From the hospitals perspective, replacing the “standard” with PermeaDermC is not only
a tremendous financial savings but also logistically easier as the shelf life is three years
not a few days. As we continue to learn more about PermeaDermC in the chronic
wound, the evidence is consistently showing that there will soon be a new standard of
Christian Robertozzi, DPM, FACFAOM, FASPS, CHCQM
David N. Herndon, M.D., FACS
I am writing as a clinical practitioner and scientist who has used Biobrane in my clinical practice with thousands of patients over the last 30 years, and as a clinical investigator who has had experience in the utilization of Biobrane and AWBAT™ during their development and in preliminary clinical research trials. I have been the President of the American Burn Association, the International Society of Burn Injuries, and the Society of University Surgeons. I have written over 900 peer reviewed articles, 150 chapters and ten books on burns.
I believe Biobrane has been one of the most important contributions to improving outcomes in second degree burns and decreasing donor site morbidity during the last three decades. Biobrane applied immediately to second degree wounds or donor sites has allowed them to heal more quickly and with less pain than any other available treatment. In 2008-2009 I had the opportunity to compare Biobrane to Aubrey Woodroof ‘s new invention AWBAT™ in clinical trials. In early 2010, I evaluated AWBAT™ Plus with its novel biological coatings. The latter stimulates cell attachment and proliferation and a host of other desirable healing properties (ePlasty September 15, 2010) and has all the salutary properties of Biobrane with the substantial clinical advantages of allowing more fluid to escape through the dressing giving it better adherence to the underlying burn or donor site. Wound healing of second degree burns and donor sites are even more rapid with AWBAT™ Plus than with Biobrane. Dr. Woodroof has continued to revise and improve wound treatment agents with his 2013 invention of PermeaDerm which is a variable porosity temporary skin substitute that enables the clinician to control porosity using precision rows of slits from zero to what is needed.
I have known Aubrey Woodroof professionally for over 30 years. We have collaborated in educational and professional endeavors. Dr. Woodroof has made great contributions to burn care through his inventions and tireless efforts to educate burn care professionals in their use.
David N. Herndon, M.D., FACS
UTMB Health, School of Medicine
Jesse H. Jones Distinguished Chair in Burn Surgery
Professor, Department of Pediatrics
Chief of Staff & Director of Research
Shriners Hospital for Children
Basil A. Pruitt, Jr., MD
"E. Aubrey Woodroof, Ph.D. (biochemistry), M.B.A., is an innovative researcher with a track record of success in designing and bringing to market biologic dressings for the treatment of burn patients and others with open wounds. Dr. Woodroof was the developer of Biobrane®, the first widely used collagen based bilaminate skin substitute. That membrane consisted of an inner layer (dermal analogue) of Type I porcine collagen gel which permitted ingrowth of host tissue to effect biologic union with the wound bed and an outer layer (epidermal analogue) of silastic that permitted transmission of water vapor to prevent sub-membrane formation of seroma and fluid collections and also served as a barrier to microorganisms and minor trauma. That membrane rapidly became the most commonly used skin substitute for temporary coverage of open wounds ranging from burns to defects in tissue caused by mechanical trauma and wounds produced by exfoliative skin diseases.
In recent years Dr. Woodroof has returned to the laboratory to develop second and now third generation collagen-based skin substitutes. He has designed a series of membranes in which pharmacologic agents are added to the collagen gel in the dermal analogue in order to reduce wound inflammation, promote vascularization and accelerate healing and has modified the epidermal analogue to enhance fluid transmission, further reduce sub-membrane fluid collection, and decrease hyperpigmentation and later scarring of the healed wound. Dr. Woodroof’s extensive experience and knowledge of skin substitutes and his use of state-of-the- art evaluation technology ensure optimum development of the new membranes which is anticipated to increase their effectiveness and expand indications for their use."
Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM
Past President, American Burn Association
Past President, International Society for Burn Injuries
Gail K. Naughton, Ph.D.
"Thank you for the opportunity to review your newest advancements in wound healing. Your contributions to burn care with your interactive wound healing dressings have been extraordinary and your most recent ideas offer a further advancement in the care of both acute and chronic wounds. The newest product design addresses the prevention of the pigmentation irregularities resulting from wound desiccation while still promoting the critical need for wound drainage. This design should support a strong patent position as well as significant patient benefits. In addition, with the exodus of TransCyte from the market there is a product void for the treatment of both partial and full thickness burns. In addition, the attributes of your new invention lend it for use in chronic wounds as well. There are currently two cell-based products on the market, Apligraft and Dermagraft, which are approved for venous and diabetic ulcers but not for pressure sores. I strongly believe that your product concept would offer a cost effective solution to all but the most severe full thickness ulcers and a completely new solution for the treatment of pressure sores. The pressures of health care reimbursement are driving product cost reductions, as well as reduction in care giver time per patient. In addition, there is a penalty in reimbursement for recurrent infections in health care facilities. This positions your invention well for the use in pressure sores where healing does not need to be the end point and where adherence of a dressing to the wound bed and long term prevention of infection is paramount. Your product should support the infiltration of the patient’s into the scaffold which would permanently anchor the dressing in place which providing drainage.
From a regulatory standpoint, I believe that the existing predicate devices would support your new product getting 510K approval in all burn applications. The approval of the product for the pressure sore indication would most likely require a full thickness wound model in rodents and a small clinical trial, with ultimate approval as a special 510K. Of course a meeting with your colleagues at CDER in the FDA will help to solidify the approval path.
The need for a product advance like the one that you created is huge. Research firm Kilogram Information projects the global market for wound care will rise to nearly $21.0 billion in 2015. The wound care industry is a highly diverse and competitive arena - including everything from standard products such as dry bandages to sophisticated hydrogels and alginate dressings, and encompassing artificial skin and anti-infectives used in wound care. The aging population and more prevalent conditions such as diabetes are driving wound care, and these trends are influenced by future demographic trends, economic uncertainty, the impact of health care reform, uninsured patient levels, reimbursement pressures from third party payers, the continuing shortage of nurses and physicians, and increasing technology and supply costs. Emerging wound care products and technologies are well-positioned to capitalize on the growth in patient numbers and the demand from healthcare systems to reduce hospital stays.
Market data estimates that more than 89 million patients are treated annually for all wound conditions. Of these wounds, more than six million are chronic wounds involving various types of skin ulcers that are often difficult and expensive to treat. In the U.S. there are approximately 3 million cases of pressure ulcers, 1 million cases of venous stasis ulcers, and 2 million cases of diabetic foot ulcers reported annually. The easiest classification of the different areas of wound care, treatment options include traditional, advanced, and active products. I have been in discussion with several high level scientists at 3M and they have reinforced their interest in evaluating/licensing new wound care products that offer a biologic component and can interact with the patient’s own cells to optimize healing.
In addition to the wound care area your new invention offers promise in the treatment of hernias as well as pelvic floor repair. As a member of the Board of Directors of CR Board since 2005, I have become intimately familiar with the need for advanced products in these areas that combine biological activity to induce tissue infiltration along with materials that prevent local inflammation and adhesions. I believe that your design can easily be adapted to offer a solution in these rapidly growing and critically important surgical areas.
In summary, I believe that your latest invention has tremendous potential in acute and chronic wounds and additional surgical repair areas. I would be delighted to continue to be involved with its development as an advisor or member of your Board of Directors."
Gail K. Naughton, Ph.D.
Chairman and CEO, Histogen
Dean Emeritus, College of Business Administration
San Diego State University