Product News

Apligraf Demonstrates Significant Change In Chronic Wound Genomic Profile

Apligraf,^® – an FDA-approved, bioengineered living-cell therapy from Organogenesis Inc., Canton, MA, has reportedly become the first wound healing therapy to demonstrate a significant change in the genomic profile of a treated nonhealing wound, according to new research published in Science Translational Medicine. An analysis titled “A bioengineered living cell construct activates an acute wound healing response in venous leg ulcers” by a multidisciplinary research team at the University of Miami provides new insight into what happens to a wound’s genomic profile when Apligraf is applied to a chronic venous leg ulcer (VLU) compared to standard care with compression therapy alone. The analysis found the application of Apligraf in conjunction with compression therapy altered specific molecular and cellular responses in the wound environment, converting the chronic wound profile to resemble an acute, healing wound profile.

"This is the first time this type of detailed gene expression analysis has been conducted to evaluate the response to a wound healing modality," said Marjana Tomic-Canic, PhD, director of the Wound Healing and Regenerative Medicine Research Program at the University of Miami. "Our findings show that Apligraf can shift the gene expression profile of a chronic, nonhealing ulcer to resemble a profile similar to that of an acute, healing wound. This is important, as we now can use this as a guiding tool to understand healing of a chronic wound and mechanisms by which therapies can work."

The research consisted of a prospective, randomized, controlled clinical trial that analyzed VLUs with < 40% area reduction after four weeks of treatment with standard care with compression therapy. Biopsies were performed at the edge of the wound to define the profile of the nonhealing VLUs. Patients were then randomized into: 1) a group receiving treatment with standard-of-care therapy alone and 2) a group receiving treatment with Apligraf and standard-of-care therapy. At Day 7 after Apligraf was applied, biopsies were performed again to assess changes in the ulcer profile. Results of the biopsies from this study were compared to the existing data set for biopsies taken from acute, healing wounds.

The study concluded that, for the group treated with both Apligraf and standard-of-care therapy, Apligraf modulated inflammatory and growth factor signaling and activated keratinocytes at the wound edge, thus successfully shifting the wound environment from a chronic, nonhealing ulcer microenvironment to a distinctive healing milieu resembling that of an acute, healing wound.

According to a new report from The Sage Group, more than 3 million adults in the United States live with venous ulcers. The cost of venous disease represents a significant burden on patients and the U.S. economy, with venous ulcers alone costing at least $21 billion annually.

MediWound Granted U.S. Patent For Connective Tissue Disease Treatment

Officials at MediWound Ltd., a fully-integrated international biopharmaceutical company that seeks to address unmet needs in severe burn and wound management, have announced the awarding of a patent by the United States Patent and Trademark Office for the company’s proprietary injectable bromelain solution for enzymatic treatment of connective tissue diseases.

The new patent, titled “Proteolytic Extract from Bromelain for the Treatment of Connective Tissue Disorders,” provides broad protection for the product in the treatment of a variety of connective tissue diseases, such as Dupuytren’s contracture, Peyronie’s disease, and scar treatment, among others, officials said.

The product is an investigational sterile, injectable solution containing a mixture of the same pharmaceutical-grade proteolytic enzymes used in MediWound’s NexoBrid,^® which is approved in Europe and other geographies for burn debridement.

“We are particularly encouraged by the expanding role of our proprietary proteolytic enzymes as a treatment for a variety of connective tissue disorders,” said Gal Cohen, president and chief executive officer of MediWound. “This U.S. patent further bolters our intellectual property position and provides us with additional opportunities to build upon and/or monetize this core asset. Minimally invasive treatments have advantages over traditional surgical methods and are in line with the general medical trend of less invasiveness and increased convenience. The scientific rationale for [this product] to treat connective tissue disorders is based on its proteolytic properties, which allow it to dissolve the pathological contracture tissue even when using very low doses, and the potential of the reported anti-inflammatory/immunomodulatory activity of bromelain to reduce the high recurrence rate. We are encouraged by the potential for [the product] as a therapeutic for connective tissue disorders and look forward to filing an investigational new drug application for [the product] for the treatment of connective tissue disorders and to embarking on a clinical development program for this exciting opportunity.”

AmnioBand & AlloPatch Pliable Receive APMA Seal of Approval

A panel of podiatric physicians from the American Podiatric Medical Association (APMA) has granted MTF Wound Care, Edison, NJ, a Seal of Approval for the AmnioBand^® family of placental allografts and AlloPatch^® Pliable tissue forms.

The approval comes following an evaluation of each MTF Wound Care allograft in several areas, including safety, quality and effectiveness, according to officials with MTF Wound Care, a division of the Musculoskeletal Transplant Foundation (MTF) and a nonprofit organization offering advanced, safe, clinically proven and cost-effective allograft solutions.

"Receiving the APMA Seal of Approval gives podiatrists and clinicians the confidence that AmnioBand and AlloPatch Pliable are beneficial in healing patients' wounds," said Kim Rounds, vice president, MTF Wound Care. "Placing our tissues through the APMA's detailed evaluation demonstrates our commitment to be a partner of choice. We are proud of this notable accomplishment that recognizes the strength of our portfolio."

The APMA Seal of Approval is granted to products that are beneficial to foot health, according to APMA officials. Companies must provide comprehensive information on each product: objective data from clinical and/or laboratory studies, intended use, patents, composition, and evidence of quality control. A detailed review is conducted by each committee member, and a recommendation is then sent to the APMA board of trustees, which may either accept or reject the recommendation.

Case Series Validates Efficacy, Safety Of Medela`s NPWT Devices 

Medela Healthcare, McHenry, Il, recently released results of a case series that reportedly proved the clinical efficacy of Invia^® Liberty™ and single-patient-use Invia Motion™ negative pressure wound therapy (NPWT) systems. The NPWT devices were used in the head, neck, trunk, and lower extremities, and were applied in the operating room immediately following surgery. Four patients underwent graft placements, two underwent flap procedures, and one device was applied post-debridement for bridge therapy. In order to protect the surgical wound from an unfavorable healing environment, a silver contact layer was applied under the NPWT foam dressing in three cases. The NPWT foam dressing remained in place for 3-10 days.

The gratifying outcome of the seven patient cases proves Medela’s NPWT devices successfully managed the surgeon’s healing objectives and therefore validates Invia Liberty’s and Invia Motion’s relevance as alternative NPWT devices for several types of surgical wounds, according to company officials.