The randomised and international clinical trial will enroll around 400 patients at up to 80 centres across the world
Medical device company Ancora Heart has secured $80m in equity financing to speed up pivotal clinical study of its AccuCinch ventricular restoration system.
The financing round saw participation from Sands Capital, Sio Capital and an undisclosed strategic investor along with all existing investors.
Ancora Heart will use the funds to expedite the CORCINCH-HF pivotal clinical trial of the AccuCinch, a system developed to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
AccuCinch is claimed to be the only completely transcatheter device that will help restore the structure and function of the enlarged left ventricle of the heart.
The prospective, randomised, open-label, multicentre and international clinical study will assess the safety and efficacy of the AccuCinch system.
Ancora Heart is planning to recruit around 400 patients at up to 80 centres across the world.
The study’s design allows PMA submission based on initial analysis of safety and clinical efficacy after the first 250 patients reaching six months of follow-up.
For the CORCINCH-EU study, the company intends to enroll 132 patients at up to 40 centres across Europe.
Ancora Heart president and CEO Jeff Closs said: “Ancora Heart is at an exciting stage as we continue with our pivotal clinical trial to support our PMA submission to the FDA, and this investment will help us prepare for potential launch and subsequent commercialisation.
“We are grateful to our new and returning investors for their support for our vision to provide a promising new treatment option for people suffering from heart failure.”
The AccuCinch system is designed for patients, whose HF has progressed beyond the ability of medications and pacemakers to manage symptoms.
The system is expected to help in filling the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant.