Framingham biotech completes bleeding lesion trial
Courtesy
Terrence W. Norchi, Arch president and CEO.
Framingham medical device maker Arch Therapeutics reported it met the objectives of its clinical study for a device that treats bleeding skin lesions.
The company’s first clinical study found its product, the AC5 Topical Hemostatic Device, stopped bleeding 41 percent faster for the patients it was tested on versus patients in a control group. The study’s primary endpoint was to achieve safety throughout surgery and until the end of a 30-day follow-up period. The safety outcomes of both the AC5 and control groups were similar, with no serious adverse events reported.
The study was conducted at University College Hospital in Galway, Ireland and involved 46 patients. Skin lesions received either AC5 or a control treatment on a randomized basis. Patients were followed up with initially after seven days and finally after 30 days.
Further study details and data will be submitted to a peer-reviewed medical journal for publication, said Dr. Terry Norchi, president and CEO of Arch Therapeutics. Clinical regulatory steps for the European Union and the U.S. are in the planning stages.
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