Zydus Medtech and Braile Biomedica of Brazil announce global licensing pact to commercialise TAVI technology

New Delhi: Zydus MedTech Private Limited, a wholly owned subsidiary of Zydus Lifesciences Limited specializing in medical technology development, has entered into a strategic partnership with Braile Biomédica Indústria, Comércio e Representações Ltda., (Braile Biomedica) – an innovative cardiovascular device manufacturer based in Brazil – to exclusively commercialize its Transcatheter Aortic Valve Implantation (TAVI) technology across Europe, India, and other select markets.

This agreement marks a significant step in Zydus MedTech’s strategic expansion into the fast-growing interventional cardiology segment. The global TAVI market, currently valued at over USD 6 billion, continues to witness strong growth driven by the increasing incidence of aortic stenosis and the rising demand for minimally invasive cardiac procedures.

Zydus MedTech, which is actively building its interventional cardiology portfolio, will introduce Braile Biomedica’s advanced balloon-expandable TAVI system to international markets, leveraging its commercial and regulatory expertise. Braile Biomedica – with a proven track record in cardiovascular innovation, particularly in Latin America – will manufacture and supply the product for these markets.

In addition to spearheading commercialization, Zydus MedTech will also retain rights to manufacture select components of the TAVI system. This collaboration provides operational flexibility while laying the foundation for further product innovation and development.

This agreement aligns with both companies’ shared commitment to delivering life-saving technologies to a broader patient population. The TAVI procedure is a recognized breakthrough in structural heart care, particularly for elderly patients or those at high surgical risk. By replacing the diseased aortic valve through a catheter-based approach – without the need for open-heart surgery – patients often experience significantly shorter recovery times and reduced procedural risks. The expansion of TAVI indications to all-risk patients has further accelerated its adoption.

What sets this TAVI solution apart is not just its clinical benefits, but also the technological and scientific foundation behind it. The system was developed based on the doctoral thesis of Dr. Domingo Braile, a pioneer of cardiac surgery in Brazil. Braile’s valve features a unique bovine pericardium sheet, used as a single piece rather than three separate leaflets, ensuring exceptional biocompatibility, durability, and performance.

The device must be collapsible, navigable through complex vascular anatomy, and fully functional upon deployment — all while maintaining structural integrity. This engineering precision and real-time deployment capability exemplify the fusion of innovation and performance, making it a next-generation, high-value product in cardiac care.

The synergy between Zydus MedTech’s marketing and regulatory strengths and Braile Biomedica’s deep technological expertise is expected to accelerate the global adoption of this life-saving therapy. Over the next three years, the partnership aims to launch a series of new innovations, supported by a robust clinical research program beginning next year in the regions covered under the agreement.

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Ltd., said “We stand united with Braile to improve patient outcomes and expand access to advanced, critical cardiovascular care globally. This innovative, cutting-edge technology will offer a minimally invasive approach that also supports faster recovery, reduced hospital stays, and greatly improved quality of life for patients.”

Patricia Braile, CEO of Braile Biomedica, said “This partnership with Zydus MedTech powerfully reinforces Braile’s mission to care for people and help save lives. Seeing our TAVI technology — the result of decades of dedication to cardiovascular innovation — reach new continents is the fulfilment of a purpose that has driven us for nearly fifty years. By joining forces with a partner that shares our values and commitment, we expand our global impact and bring hope and quality of life to even more patients around the world.”