Devices & Diagnostics, Startups

Wound closure firm eyes $8M, pivotal study for bioscaffold to help heal diabetic foot ulcers

About 15 percent of the 26 million Americans with diabetes will develop foot ulcers, according […]

About 15 percent of the 26 million Americans with diabetes will develop foot ulcers, according to a 2005 study published in the Journal of the American Medical Association, and as many as 7 percent of those cases lead to amputation.

That’s the problem MxBiodevices is trying to address with its E-Matrix bioscaffold that’s designed to encourage wound healing in patients with diabetic ulcers without exposed tendon or bone.

Injected under the wound bed in a 10-minute in-office procedure, the nanoscaffold forms an extracellular-like matrix that provides a favorable environment for the patient’s cells to initiate wound healing.

The nice thing about commercializing this product is that the technology has already been approved in the U.S. and Europe for other indications, co-founder Ron Hill said. Pioneer Surgical Technology received 510(k) clearance for its use in orthopedic and spine applications in 2009. Hill and co-founder Marilyn Thompson were previously vice president of research and development and director of and finance and administration at Pioneer Surgical, respectively.

Hill said feasibility and pilot studies have already been performed in humans for the treatment of diabetic foot ulcers, so a single, 300-patient pivotal study is the remaining step for PMA approval.

“The nice thing about the DFU clinical outcomes that the FDA is looking for is that the endpoint for efficacy is the number of wounds that close by 12 weeks,” Hill said. That will make the study relatively short, even though the company will also do a six-month follow-up to show the resilience of response.

To fund that study and its PMA application, the company is looking for $8 million in funding.

Among its direct competitors in treating ulcers, MxBiodevices counts artificial skin products by Shire and Organogenesis and a growth factor gel by Healthpoint. Other treatments currently available for advanced diabetic foot ulcers include negative pressure wound therapy and moist wound dressings. These technologies work alongside a growing number of technologies designed to detect foot ulcers early.

Hill said there are other wound closure applications that a future strategic partner might be interested in licensing the technology to address, but for now the startup is staying focused on the diabetic foot ulcer market. MxBiodevices was founded in 2009 in Greenville, North Carolina.

[Doctor examining foot photo from BigStock]

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