Organogenesis lauds Apligraf CE data

Organogenesis said today that a comparative effectiveness analysis of its Apligraf skin substitute has shown improved outcomes over competitor MiMedx‘s (NSDQ:MDXG) Epifix.

The study, published this week in Wound Repair & Regeneration, examined healing rates of patients with diabetic foot ulcers treated either with Apligraf or Epifix.

Data from the 218-patient, 99-center retrospective study showed a 97% increased probability of healing for the Apligraf compared to Epifix, and significantly reduced healing time. Median healing time with the Apligraf was 13.3 weeks and 26 weeks with the Epifix, according to the study.

“Diabetes mellitus affects more than 22 million people in the U.S., and diabetic foot ulcers are one of the most severe and costly complications. With health care reform, real world comparative effectiveness studies are increasingly important, to better understand which products work best in large and diverse patient populations typically encountered in clinical practice.  Product efficacy in controlled clinical trials may not equate to effectiveness in general clinical practice, which is why these types of analyses are so valuable,” lead author Dr. Robert Kirsner, of the University of Miami Miller School of Medicine, said in a press release.

Frequency of wound closure was 48% for Apligraf and 28% for Epigraf at 12 weeks, and 72% versus 47% at 24 weeks, respectively, according to the study.

“Throughout our company’s history, Organogenesis has demonstrated our commitment to advancing the science of wound healing through rigorous research. Over the years we’ve worked with top clinicians and scientists to ensure patients and providers have evidence-based tools and information.  With this new first-of-its kind analysis, we are proud to continue contributing to the ongoing scientific discussion of wound healing by studying the real world effectiveness of our products. We look forward to continuing the conversation,” CEO Gary Gillheeney said in prepared remarks.

Results from the retrospective study were drastically different from an earlier randomly controlled trial of the 2 skin substitutes, according to Kirsner and his co-authors. The previous study, published last November in the International Wound Journal, reported 85% of Epigraf patients achieved complete healing after 4 weeks, 95% after 6 weeks, with a median healing time of 13 days.

The more recent study found only 17% of Apligraf and 9% of Epigraf patients achieved complete healing at 6 weeks, with a median healing time of 93 and 182 days, respectively.

Study authors said possible explanations existed for the differing results. The earlier study had a smaller 20-patient per treatment group sample size, was geographically limited to 3 centers in Virginia and examined a smaller median wound size, study authors reported.

In February, MiMedx dropped a lawsuit it had filed against Organogensis alleging tortious interference related to business with the U.S. Veteran’s Affairs Dept., so it could widen the scope of its investigation of its rival. Organogenesis responded to the suit, calling the MiMedx lawsuit “frivolous” and saying its tough stance forced MiMedx to back down.

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