Wound healing company MxBiodevices is on the hunt for $8 million to take its experimental treatment for diabetic foot ulcers through pivotal clinical trials.
The Greenville, NC company has a novel way to treat diabetic foot ulcers from inside the wound. Unlike current treatments that are topical, MxBiodevices has developed an injectable scaffold that called E-Matrix that provides a structure that promotes wound healing.
The company is targeting the diabetic market, which totals between 24 and 26 million people in the United States. Of those, an estimated 15 percent develop diabetic foot ulcers. Current treatments won’t work for some of those people; each year about 240,000 patients who have diabetic foot ulcers must have their foot amputated.
Ronald Hill, CEO and co-founder of the company, says the number of diabetics worldwide is projected to reach 330 million in 2015.
“It’s a $3 billion U.S. market, a $3 billion European market,” Hill said Wednesday during a presentation at CED’s Life Science Conference.
Besides bandages and wound dressings, the injectable scaffold’s direct competition includes artificial skins, such as Dermagraft, a Shire product expected to reach $200 million in sales.
Hill said the wound treatment would be regulated by the Food and Drug Administration as a medical device. It has already gone through preclinical studies and company plans to take the treatment through the FDA’s premarket approval process, which requires a single clinical trial involving 300 patients.
MxBiodevices holds exclusive rights to the patented injectable tissue repair technology. Hill expressed confidence of getting FDA approval. Another Greenville company, Pioneer Surgical, has already secured FDA clearance on the scaffold technology for orthopedic and spine applications.
MxBiodevices expects to secure PMA approval within three years. The company will seek an international commercialization partner and projects it can reach $11 million in sales within two years of approval.