There is a remarkable level of activity in the area of regenerative tissue technologies that has already resulted in products that have improved patient’s lives. In the past year alone, the National Institutes of Health have announced major funding opportunities in this area. Dozens of skin substitutes or facsimiles have been developed to date but none have yet achieved the replication of full-thickness autologous tissue – the gold standard when it comes to healing wounds.
The regenerative medicine market value, according to SmartTrak, is projected to be $765 million this year. This demonstrates a desire to unlock fascinating new discoveries and approaches to achieve real full thickness skin through regenerative technologies. It’s a critical time for physicians and patients to pay attention now, and here’s why.
1. Growing Chronic Wound Challenges
Chronic wounds are a major problem that result in significant pain, suffering and economic adversity. The Association for the Advancement of Wound Care compiled data showing that nearly five million Americans suffer from chronic wounds or ulcers and that these non-healing wounds equate to $12 billion annually in direct and indirect costs.
2. Demand for Innovation
Despite significant progress over the past decade in dealing with chronic wounds the problem continues to worsen each year given the demographics of an aging population. Amniotic membranes, as well as shark cartilage, cow skin and pig skin derivatives, have all been used to heal ulcers via tissue regeneration, with varying degrees of success.
This success has been limited by the fact that these products tend to be expensive and have unpredictable efficacy. They seem to be stopgap measures on the way to achieve the “gold standard.” What does it mean to go for the gold?
Common sense tells us that nothing may work to heal an open wound as effectively as the patient’s own skin, taken from a healthier part of the body. This approach is otherwise known as skin-grafting, and has been used by medical practitioners since ancient times. The ultimate version of this is full-thickness grafting, which delivers the “entire” skin architecture to the wound site. Unfortunately, although it may be useful in certain isolated cases, full thickness grafting for wound management is severely handicapped by the associated complications and costs that make it largely impractical as therapy for the vast majority of wounds that refuse to heal.
Full-thickness skin-grafting is problematic for a number of reasons. The need for general anesthesia and the use of an OR is an immediate hindrance. Healthcare Bluebook calculates the average cost of a skin graft at more than $17,000 and this dollar figure does not account for the pain, suffering and scarring associated with procedures performed under the traditional paradigm.
The most significant problem for a highly co-morbid patient with wound-healing challenges is simple – in order to harvest the full thickness graft, surgeons have to create a new full thickness wound that in turn may become chronic. In many cases patients may simply end up trading one chronic wound for another, and, as often happens, if the graft itself fails at the recipient site due to poor vascular supply or other problems, the patient could potentially end up with two open non healing wounds. Even if the donor site does heal, because all the skin in the area is removed, it is still associated with significant pain and scarring
When taking all of these factors into account, it is unsurprising that the use of the “gold standard” of full-thickness skin-grafting is followed more in theory than in practice.
3. Breakthroughs in Wound Healing Could Help with Old Problem
A renewed interest in Tissue Regeneration in academic laboratories could soon result in a change in what is ‘State of the Art.’ Professor Rox Anderson and his team at the Wellman Center for Photomedicine at Massachusetts General Hospital (MGH) have performed groundbreaking research for decades to better understand the effect of light energy in solving skin and wound related problems. Examples include Photothermolysis, or laser ablation, and fractional resurfacing, both of which are now clinical standard of care in treating a wide array of scars and related issues. More recently, they’ve adapted many of the principles and techniques to develop technologies beyond lasers and light.
Significantly, Medline recently acquired SevenOaks Biosystems, a venture-backed tissue regeneration company. SevenOaks has developed a novel, yet practical approach to autologous tissue regeneration based on path-breaking research licensed from Prof. Anderson’s lab.
This technology is called ART™ or ‘Autologous Regeneration of Tissue,’ and after nearly a decade of R&D, is now ready to be introduced into clinical practice. At the push of a button, ART™ obtains and then delivers to a wound hundreds of full-thickness ‘tissue microcolumns’ within a few minutes. ART™ achieves this using only local anesthesia and results in minimal donor-site morbidity with harvest sites appearing to heal in days compared to weeks with traditional skin-grafting methods. These unadulterated full-thickness tissue microcolumns contain growth factors, stems cells and adnexal elements – all critical contributors to tissue regeneration.
“This technology will for the first time provide the opportunity to harvest full-thickness autologous skin while causing minimal donor-site trauma in order to use the tissue for regenerative purposes in many different types of wounds,” said Anderson.
Medline will soon share exciting news about the ART™ platform from SevenOaks Biosystems and how this novel approach to tissue regeneration that leverages the advantages of full-thickness tissue, could create new care options in the United States. These advancements could help address many of the challenges in the delivery of optimal wound care in today’s complex healthcare system.