Foldax, a medical devices company developing heart valves, has secured $20m in a Series D funding round, led by MemorialCare Innovation Fund (MCIF).

Existing investors including BioStar Capital, Kairos Ventures and Caltech, along with new investors Angel Physicians Fund (APF) and Sayan Bioventures also participated in the funding round.

In relation with the investment, MCIF managing director Brant Heise has been appointed as member of the Foldax board.

MCIF managing director Brant Heise said: “We are enthusiastic about the potential for Foldax’s technology to positively impact healthcare systems in our drive to enhance both clinical outcomes and quality of life for patients suffering from cardiovascular disease.

“The creativity demonstrated by the company in overcoming traditional obstacles has been striking, and we look forward to being part of its continuing innovation of the heart valve space.”

Foldax develops Tria heart valve in partnership with Caltech and CSIRO

The company intends to use the proceeds from the funding round to continue enrolment of patients to the recently completed EFS clinical trial of its surgical aortic Tria biopolymer heart valve.

Foldax is developing Tria valve technology, under a collaboration with Caltech and Australia’s science agency CSIRO. Tria has been designed to prevent calcification, endure stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants.

In addition, the company is planning to utilise the funding proceeds to initiate and enrol patients into the clinical trial for the surgical mitral valve, along with the development of the transcatheter aortic valve replacement (TAVR) device to conduct the first-in-human clinical trial.

Foldax claimed that its Tria valve incorporates a new, proprietary biopolymer with advanced valve design, dubbed LifePolymer.

In addition, Tria marks the first and only heart valve to be robotically manufactured, to reduce variability and enable high precision, with repeatability and quality, while improving the economics of heart valve manufacturing.

Foldax CEO Frank Maguire said: “We are pleased that our technology has attracted the interest of healthcare provider-based investors who have recognized its broad potential to improve the treatment of valvular disease.

“These partners will allow us to accelerate our development and clinical plan. Calcification is a root cause of heart valve failure, in both human and artificial tissue valves.

“We asked ourselves, if we could start from scratch, what would we do differently to solve this and other persistent heart valve problems? The result was the invention of a new biopolymer, a purpose-built valve design and the first use of robotic manufacturing in heart valves, which are brought together in the Tria valve.”