StrataGraft® skin tissue
The Company’s flagship product, StrataGraft® regenerative skin tissue, is a viable, full-thickness product being developed for severe burns and other complex skin defects. It was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers. Unlike first generation products, this resorbable tissue is easily sutured or stapled and remains intact in the wound bed, providing critical barrier functionality during the wound healing process.
StrataGraft is produced using unmodified NIKS® cells grown under standard operating procedures (SOPs). Because the continuous NIKS skin cell line has been thoroughly characterized, StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.
There is an urgent need for new treatment options for burns. Severe burns and other major traumas to the skin are life-threatening injuries that require immediate surgical intervention. Currently, the standard of care for patients with severe second and third degree burns involves skin transplants called autografts, in which skin is mechanically harvested from healthy donor sites and relocated to trauma sites on the same patient. These donor sites are painful, and are prone to infection and scarring. When insufficient donor site tissue is available, burns are typically covered with cadaver skin or other synthetic dressings, and later autografted when it becomes feasible. Despite intense research efforts, to date there has not been a cell-based or synthetic product developed that has been able to accomplish clinical outcomes similar to autografting.
According to the American Burn Association, an estimated 1.1 million people suffer burns annually in the USA. Of these, approximately 40,000 patients are hospitalized for treatment, and 30,000 are admitted to 127 specialized burn centers located throughout the country. The cost burden of severe burns on the health care system is significant – mean per-patient hospital charges alone range from $27,000 to $156,000 for burns affecting less than 30% Total Body Surface Area, and can exceed $500,000 for more significant burns.
StrataGraft® offers important prospective benefits to this target market, including:
Elimination of painful autograft donor sites in patients with deep partial thickness burns (clinically confirmed);
Elimination of or reduced tissue harvesting in patients with full thickness burns (to be clinically investigated);
Reduced patient pain, discomfort and infection risk during acute episode of care
Elimination of infection risks associated with the use of contaminated cadaver skin for temporary wound coverage;
Faster overall healing timeframes for large size burns that currently require multiple surgeries;
Shorter hospital stays, earlier and/or fewer surgeries, and reduced post-discharge care resulting in lower costs to healthcare providers and payers.
Stratatech's initial Phase I acute safety trial of StrataGraft skin tissue enrolled 15 patients with third degree, full-thickness burns. The outcomes of this first-time-in-human study provided important insights into the safety and immunological parameters of this novel product, and provided guidance for further clinical evaluation. Two papers have been published reporting the details of the study and the related immunological assessment, respectively.
Most recently, a proof-of-concept clinical trial in patients with second degree, deep, partial-thickness burns was completed in October 2014. Of 28 evaluable per-protocol patients, 27 (96%) achieved complete wound closure by Day 90 with a single application of StrataGraft tissue. The sole outlier closed in following weeks. Moreover, no StrataGraft DNA was detectable at Day 90, confirming the patients had regenerated their own skin. The outcome of one patient is show below. This is the first biological therapy to achieve a clinical outcome comparable or superior to autografting! Results are being submitted for publication.