Ten patients with severe degenerative mitral valve disease are now enrolled in Harpoon Medical’s ongoing Early Feasibility Study at two clinical study sites in Europe. The company will showcase the results of the Early Feasibility Study, including a 100 % procedural success rate, over 850 total implant days and echocardiographic data on the first two patients with trace MR during their six-month follow up visit, at the upcoming 2015 Transcatheter Cardiovascular Therapeutics (TCT) Conference (11–15 October, San Francisco, USA).
Harpoon also announced that it has received investments for US$1.4m of convertible debt as part of a US$2m bridge financing expected to be completed before the end of the month. The funds will be used to support the ongoing Early Feasibility Study and start a larger clinical trial, scheduled to begin enrolling patients before the end of the year, to support CE mark approval.
“Conventional mitral valve surgery performed by a skilled surgeon is safe and effective, but it is an invasive procedure with significant morbidity,” said James S Gammie, founder of Harpoon Medical and chief of Cardiac Surgery at the University of Maryland School of Medicine. “We developed the Harpoon device to address the demands of patients seeking a less invasive treatment option for mitral valve disease. The early results have exceeded our initial expectations. The Harpoon Medical approach achieves reduction of MR that is equivalent to open cardiac surgery with an outstanding safety profile and a dramatically less invasive procedure. This is an extremely exciting technology that will transform the treatment of degenerative mitral valve disease.”
“I am very excited about the progress we have made since forming the Harpoon Medical a little over two years ago,” said Bill Niland, Harpoon Medical’s president and chief executive officer. “Based on the company’s progress and the initial results from the Early Feasibility Study, our current investors are providing additional capital to accelerate the clinical program while we work to raise a larger Series B Round.”