Arch Therapeutics wins EU nod for AC5 hemostat trial

Arch Therapeutics (OTC:ARTH) said it won approval for a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures.

Framingham, Mass.-based Arch said the endpoints for the single-blinded study of up to 50 patients include time to hemostasis and product-related adverse effects at 30 days. One arm of the trial will include patients taking blood thinning drugs, the company said.

The 1st patient is expected to enter the trial early next year, with data due within 2 quarters, according to the company.

Arch bills AC5 as designed to stop bleeding in seconds, rather than minutes, and conform to wound geometries while staying transparent, without the stickiness of other hemostats that makes them a challenge to use in laparoscopic procedures.

“This is an important milestone for the company as we continue to bring AC5 and our technology platform another step closer to market. We expect to apply for a CE Mark if the data from our study is supportive. We remain committed to completing subsequent clinical trials and expanding the indications for product use,” president & CEO Dr. Terence Norchi said in prepared remarks. “We were very encouraged by the preclinical data observed to date, and we believe that AC5 will have similar results in humans.”

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