Framingham biotech co. close to data in first clinical study
Courtesy
Terrence W. Norchi, Arch president and CEO.
Arch Therapeutics is in the midst of its first clinical trial, an assessment of the safety and performance of its bleeding control device in humans, the company said.
The Framingham-based company has enrolled 46 patients in its randomized controlled single-blind study to test its AC5 Surgical Hemostatic Device, which can be used to control bleeding and loss of other fluids, in order to provide quicker and safer surgical and interventional care.
The study is taking place in Ireland, and results should be available at some point this summer, after 30-day follow up assessments and subsequent statistical analysis are completed.
Dr. Terrence W. Norchi, president and CEO of Arch Therapeutics, said this is another step on towards regulatory approval of AC5.
“We are eager to obtain the data when the statistical analysis is available, and we look forward to reporting the results later this summer,” Norchi said in a statement.
Arch is collaborating on the study with CURAM, Science Foundation Ireland Centre for Research in Medical Devices and the Clinical Research Facility based at National University of Ireland Galway.
Arch Therapeutics has five employees -- one part time and four full time -- and a spokesperson said the company makes extensive use of third-party contractors, consultants and advisers.
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