Foldax® Announces Launch of TRIA™ Mitral Valve in India

World’s First Approved Polymer Heart Valve Now Available at Select Centers

GOA, India–(BUSINESS WIRE)–#TRIAheartvalves–Foldax^® Inc., a leader in the development of innovative polymer heart valves, in conjunction with its local manufacturing partner Dolphin Life Science LLP, today announced the launch of the TRIA™ Mitral Valve in India, marking the first time a polymer heart valve has been made commercially available to patients anywhere in the world.

Traditional valves made from animal tissue are prone to calcification and degradation, limiting their durability and often leading to repeat surgeries, especially for younger patients. Mechanical valves, while durable, are prone to thrombosis and require lifelong anticoagulation therapy that can impact a patient’s long-term quality of life. Foldax’s vision for its novel polymer heart valves is to address the limitations of tissue and mechanical valves by making its valves durable, with the future goal of avoiding the requirement for lifelong anticoagulation.

Mitral valve disease is a concern in India, with rising surgical volumes and increased need for long-term treatment solutions. The TRIA™ Mitral Valve is positioned to offer a new option for patients seeking a durable solution without the lifestyle limitations of mechanical valves.

“We are honored to work with India’s top cardiovascular surgeons and Dolphin Life Science to bring next generation medical solutions to the Indian population,” said Laxmikant Khanolkar, Senior Vice President of Foldax Asia and MEA. “This is the first in a series of heart valve solutions we intend to introduce into the market.”

As part of the launch, Foldax has initiated the Evolve™ Training & Certification Program to ensure high-quality outcomes and surgeon preparedness. Physicians who complete training will be certified to implant the valve at participating hospitals.

*The TRIA Mitral Valve in the United States is limited to investigational use only. The TRIA Mitral Valve is approved for use in India by CDSCO.

About Foldax

Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves with the potential to last a lifetime, addressing limitations of tissue and mechanical valves.

www.Foldax.com.

About Dolphin Life Science

Headquartered in India, Dolphin Life Science partners with global innovators to introduce advanced medical technologies that elevate standards of care. With a focus on structural heart, interventional cardiology, and critical care, Dolphin is transforming access and delivery of cutting-edge therapies across the Indian healthcare landscape.

www.dlsi.in

Contacts

MEDIA CONTACT:
Dr. Manisha Jadhav

Manisha.jadhav@foldax.com
+919623243509