Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products in orthopedics, sports medicine and wound care, announced today that data, published in Ostomy Wound Management, shows that the use of Grafix® on a variety of chronic wounds resulted in an overall closure rate of 76% by 12 weeks, including 68% of Venous Leg Ulcers (VLUs) and 85% of Diabetic Foot Ulcers (DFUs) treated. The publication is available in the December 2013 issue of Ostomy Wound Management and on its website.
“The overall healing rate of 76% among recalcitrant wounds demonstrates the profound effect Grafix had on my patients,” said Dr. Matthew Regulski, lead author and Medical Director of the Wound Institute of New Jersey. “Many of these patients had failed multiple advanced treatments and were without other options. The ability to not only close these wounds quickly but keep them closed, with no wound recurrence out to almost 2 years, saved these patients from additional morbidities associated with non-healing chronic wounds such as infection, hospitalization, and even amputation.”
The study evaluated the use of Grafix in 67 chronic wounds (66 patients), including 34 VLUs, 27 DFUs, and 6 other chronic wounds. Patients evaluated in this study had a mean wound duration prior to treatment of 38 weeks indicating the truly refractory nature of these wounds. Additionally, 75% of the patients in this study had failed at least one advanced wound therapy prior to receiving Grafix. Among the patients that closed, the mean time to closure was 5.8 weeks with an average of 3.2 applications. Additionally, no Grafix-related adverse events were reported and no wound recurrences were observed among patients that closed with a mean follow-up of 20.4 months.
“This data is a nice compliment to our multi-center, randomized, controlled trial in DFUs, which showed that Grafix had overwhelming efficacy with a relative effect of 191% when compared to control treatment,” said Dr. Doug Jacobstein, Senior Director of Medical Affairs at Osiris. “We are pleased to offer patients, including those with limited treatment options, a novel, cellular treatment with conclusive clinical evidence. More importantly, healing wounds quickly with fewer treatments is cost-effective, and better for patients, physicians, and payors.”