Arch Therapeutics Closes In On CE Mark For Novel Blood Control Agent
Securing the CE mark for its topical hemostatic agent has taken Arch Therapeutics longer than expected, but the company now predicts filing for a CE mark by the end of 2016, and is looking for a partner to help commercialize it in Europe.
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Arch Therapeutics has begun enrolling a 46-patient randomized trial to support a CE mark for its AC5 topical hemostatic agent by sometime in the summer, Arch Therapeutics president and CEO Terence Norchi told Clinica.
The late-breaking clinical trial presentations at this year’s Transcatheter Cardiovascular Therapeutics conference in Boston included new results from trials of three different minimally invasive approaches to treat uncontrolled hypertension.
This edition of Medtech Insight’s regular round-up of heart-tech news covers some highlights of this years’ Transcatheter Cardiovascular Therapeutics (TCT) meeting in September, including the latest trials of Abbott's Amulet left-atrial appendage closure device and Medtronic's Intrepid transcatheter mitral valve replacement.