Zydus Medtech, Braile Biomedica of Brazil ink global licensing pact to commercialise TAVI technology
Ahmedabad: 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 Zydus MedTech’s strategic expansion into the fastgrowing 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 will introduce
Braile Biomedica’s advanced balloon-expandable TAVI system to international markets.
Braile Biomedica 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. 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 release stated.
“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,” the release added.
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.”