First Patients Enrolled in Prospective Randomized Multi-Center Comparative Clinical Study Evaluating Restrata® for the Treatment of Venous Leg Ulcers

ST. LOUIS, Feb. 10, 2022 /PRNewswire/ -- Acera Surgical, Inc. (Acera), a leading bioscience company developing and commercializing a portfolio of fully synthetic materials for regenerative medical applications, today announced its first patient enrollment in a multicenter, head-to-head clinical study evaluating Restrata® for the treatment of non-healing venous leg ulcers (VLUs). William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine is the study’s lead investigator. The study will be the first level 1 clinical comparison between Restrata and a biologic skin substitute.

Venous leg ulcers (VLUs) are a chronic ulcer type which affect 3% of the world population, including over 2 million people annually in the US.^1,2 VLUs are a major cause of morbidity and poor quality of life resulting from venous insufficiency in the lower limbs. This type of wound presents clinical challenges as VLUs may require many months of treatment before healing is achieved.³ The US economic burden of VLU treatment was close to $15 billion in 2014⁴.

Dr. Bradley P. Abicht, DPM, FACFAS, Section Chair of Podiatry at Gundersen Health System in La Crosse, Wisconsin commented, “Our team is excited to participate in this head-to-head, prospective clinical trial to further develop Restrata as a novel approach for difficult-to-treat venous leg ulcers. Our practice has been pleased with the outcomes of Restrata when used to treat very complex lower extremity wounds of varying etiology.”

Dr. John Park, MD, Vascular Surgeon at Nebraska Methodist Hospital in Omaha, Nebraska remarked, “I am very delighted to be part of this trial and to enroll our center’s first patient as it will provide important evidence comparing the efficacy of Restrata versus a leading competitor for the treatment of venous leg ulcers. I applaud Acera Surgical for conducting this study since it is the first of its kind in a VLU population.”

The study is a prospective, randomized multi-center trial comparing wound closure between Restrata, the synthetic hybrid-scale fiber matrix, with a living cellular skin substitute in the treatment of venous leg ulcers. The primary outcome measurement of the trial will be the number of study participants with 100 percent epithelialization (closure) of the wound within a 16-week period.

Nick Gallucci, Acera’s Chief Commercial Officer, said, “Over the course of our short history, Acera Surgical has demonstrated our commitment to proving the benefits of synthetic wound healing through investment in high quality research. Today’s health care environment demands high quality outcomes for patients while improving the efficacy of health care delivery. We are extremely excited about the response to Restrata we are getting from across the wound care spectrum, both physicians and administrators alike.”

About Restrata®
Restrata is a fully synthetic hybrid-scale fiber matrix, indicated for use in a variety of wounds including surgical wounds, trauma wounds, and chronic wounds such as diabetic foot ulcers and venous leg ulcers. Restrata is manufactured with synthetic bioresorbable polymers and possesses a fibrous structure with high porosity. The product architecture, which is similar to native extracellular matrix, allows for cell ingress and retention, as well as neovascularization of the newly forming tissue without the need for added growth factors. As the wound healing process progresses, Restrata completely degrades via hydrolysis, leaving native tissue in its place. Restrata is shelf stable and carries a two-year shelf life.

About Acera Surgical, Inc.
Born from research and bold patient-focused innovation, Acera is a bioscience company developing engineered synthetic solutions for a variety of regenerative medical and surgical applications. At Acera, we are Revolutionizing Healing and Changing Lives. Additional information about Acera, its technology and products may be found at www.acera-surgical.com.

1. Lazarus G, Valle MF, Malas M, Qazi U, Maruthur NM, Doggett D, Fawole OA, Bass EB, Zenilman J. Chronic venous leg ulcer treatment: future research needs. Wound Repair Regen 2014;22:34–42.
   
2. Margolis, D.J., et al., Venous leg ulcer: incidence and prevalence in the elderly. Journal of the American Academy of Dermatology, 2002. 46(3): p. 381-386.
   
3. Ballard JL, Bergan JJ. Chronic venous insufficiency. Diagnosis and treatment. London: Springer–Verlag, 2000.
   
4. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. J Med Econ 2014;17(5):347–56.

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SOURCE Acera Surgical, Inc.