Harpoon Medical said it launched an early feasibility study of its minimally invasive mitral valve repair device, with aims to use the study to support CE Mark approval in the European Union.
The Baltimore, Md.-based company is developing a device to “transform the treatment of mitral regurgitation,” by eliminating the need perform an invasive breastbone separation and the use of a heart-lung machine during mitral valve procedures.
The technology it is developing could reduce the time required for mitral valve surgery from 3-6 hours to 60 minutes, according to Harpoon Medical.
“Conventional mitral valve surgery performed by a skilled surgeon is safe and effective, but it is an invasive procedure with significant morbidity. 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,” founder Dr. James Gammie said in a press release.
Harpoon Medical said it enrolled 10 patients with severe degenerative mitral valve disease in the study at 2 European clinical sites.
The company said it plans to release the results, including over 850 implant days and ECG data on the 1st 2 patients, at an upcoming conference in October.
“I am very excited about the progress we have made since forming the Harpoon Medical a little over 2 years ago. 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,” CEO Bill Niland said in a press release.
The company said it received a $1.4 million investment of convertible debt as part of a $2 million bridge expected to complete before the end of the month.
Last September, Harpoon Medical raised $3.8 million in a Series A funding round in support of its mitral repair devices. Financing was led by Epidarex Capital and joined by Maryland Venture Fund, the Abell Foundation and “medical device executives, doctors and successful business executives in the Maryland area,” Harpoon said.