The Santa Clara, CA-based company is developing the AccuCinch Ventricular Restoration System. Ancora Heart’s AccuCinch System procedure involves a flexible implant that is attached to the inner wall of the left ventricle. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall.
The equity financing will help with the continued development of the device, specifically it will help support the CORCINCH-HF pivotal clinical study.
“[Proceeds from the financing] will be used to conduct our pivotal study,” Jeff Closs president and CEO of Ancora Heart, told MD+DI. “We received FDA approval for the pivotal study last June. It was a rather interesting period of time with COVID-19, of course. With these new funds we’re trying to [do] some significant hiring to ramp up the clinical trials. “
Ancora Heart’s trial is designed to enroll up to 400 patients in 80 centers worldwide.
“The plan is to do a modular submission,” Closs said. “We’ll do a manufacturing piece; we’ll do a quality piece; and our preclinical [work].”
Ancora Heart’s CORCINCH-HF pivotal clinical study will allow an initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached twelve months of follow-up. The study will ultimately follow patients through five years post-treatment to track long-term results.
The AccuCinch System is designed to augment the existing care cardiologists provide their HF patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide an effective treatment option by filling the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant.
Original Article: (https://www.mddionline.com/cardiovascular/ancora-heart-has-raised-80m-address-hf)