Zydus Medtech brings Brazil’s breakthrough heart valve tech to India and Europe in global expansion move

Zydus Medtech signs global TAVI licensing deal with Brazil’s Braile Biomedica

Zydus MedTech Private Limited, a wholly owned subsidiary of Zydus Lifesciences Limited, has entered into a global licensing agreement with Brazil-based Braile Biomedica to commercialise its Transcatheter Aortic Valve Implantation (TAVI) technology. The strategic partnership gives Zydus Medtech exclusive rights to market the minimally invasive heart valve solution in India, Europe, and other select international markets, marking a major expansion in the group’s interventional cardiology footprint.

The deal underscores Zydus Medtech’s broader strategy to deepen its presence in structural heart therapy solutions, a rapidly growing segment in global cardiovascular healthcare. Braile Biomedica, which has led cardiovascular innovation in Latin America for nearly five decades, will continue to manufacture the balloon-expandable TAVI system while also collaborating with Zydus on new product development initiatives.

What is TAVI and why is it transforming heart care?

TAVI, or Transcatheter Aortic Valve Implantation, is a procedure designed to replace a narrowed aortic valve in patients with aortic stenosis using a catheter-based approach, avoiding open-heart surgery. This technique offers significant benefits for elderly patients or those at high surgical risk, including reduced procedural complications, faster recovery times, and shorter hospital stays. Originally approved only for inoperable patients, the technology has steadily expanded to include all-risk categories, driving broader global adoption.

The worldwide TAVI market has surpassed USD 6 billion in value and continues to grow at double-digit rates, supported by an ageing population and increased awareness of less invasive treatment options. Market leaders such as Edwards Lifesciences and Medtronic dominate this space, but regional innovation has created opportunities for newer entrants to compete with differentiated solutions tailored to varied anatomical and clinical needs.

What makes Braile Biomedica’s TAVI solution unique?

Braile Biomedica’s TAVI valve is based on the doctoral research of Dr Domingo Braile, a pioneer of cardiac surgery in Brazil. It incorporates a single-sheet bovine pericardium structure, diverging from the conventional three-leaflet design, to improve durability, biocompatibility, and structural integrity. This distinct design ensures more seamless valve function while maintaining robustness during catheter-based deployment across complex vascular anatomy.

The device is engineered to remain collapsible, navigable, and fully functional upon deployment. Braile’s emphasis on engineering precision and real-time deployment capabilities enables the valve to adapt to diverse patient populations while supporting the demanding performance requirements of interventional cardiologists.

This innovation also reflects Braile Biomedica’s understanding of the clinical realities in under-resourced and high-volume settings, particularly in Latin America. These insights, now being channelled into a global expansion plan with Zydus, could provide emerging markets and advanced healthcare systems with an accessible, high-performance TAVI solution.

How does the partnership support Zydus Medtech’s global ambitions?

Zydus Medtech has been steadily building its interventional and structural heart device portfolio. This licensing agreement gives the company both commercial control in key markets and partial manufacturing rights for selected TAVI components. By leveraging its regulatory experience and growing clinical network in India and Europe, Zydus is expected to play a key role in navigating the complex approval pathways required for this class of medical devices.

The collaboration also includes a planned clinical research programme starting next year, which aims to further validate the product’s performance across different patient risk groups and anatomical variations. Over the next three years, the companies intend to roll out a range of innovations under the TAVI platform, expanding access while refining the technology based on clinical insights.

In public statements, both parties framed the partnership as a mission-driven initiative. Dr Sharvil Patel, Managing Director of Zydus Lifesciences, said the agreement aligns with the company’s goal of improving patient outcomes through faster recovery and reduced hospitalisation. Patricia Braile, CEO of Braile Biomedica, expressed that the expansion fulfils the company’s long-standing commitment to saving lives through innovation.

Why is the timing critical for India and emerging markets?

India is witnessing a rising incidence of non-communicable diseases, particularly cardiovascular conditions, including aortic stenosis. However, access to advanced interventional procedures like TAVI remains limited due to high costs and dependence on imported devices. By securing rights to commercialise and co-manufacture this technology, Zydus Medtech could improve local availability and affordability.

Moreover, the Government of India has been increasing its support for indigenous medical device development and clinical research infrastructure, with schemes like the Production Linked Incentive (PLI) scheme for medical devices and the National Medical Devices Policy. Zydus’s partnership with Braile Biomedica could benefit from these initiatives while advancing clinical standards in the structural heart space.

Emerging markets in Asia, Africa, and parts of Europe with underpenetrated interventional cardiology services also stand to benefit from the deal. The TAVI system’s adaptability and cost-effectiveness may give it an edge over legacy Western products that were developed with highly centralised, high-cost care settings in mind.

How is the stock market reacting and what should investors consider?

As of April 17, 2025, Zydus Lifesciences Limited (BSE: 532321, NSE: Zyduslife) has not yet reflected any major stock price movement directly linked to the Braile Biomedica licensing deal. However, sentiment surrounding the company remains cautiously optimistic. Analysts view this partnership as a long-term value creator given the robust growth in the TAVI segment, which is increasingly viewed as a key pillar of future cardiovascular intervention.

Zydus Lifesciences has already demonstrated its capabilities in biosimilars, vaccines, and chronic therapy segments. By entering the global structural heart device space with a differentiated TAVI platform, the company may improve revenue diversification and clinical relevance, especially in high-growth emerging markets and Europe.

From an investment perspective, market participants may consider maintaining a ‘Hold’ position on Zydus Lifesciences stock. The full impact of the deal on earnings will depend on execution success, regulatory approvals, and the ability to scale manufacturing and distribution efficiently across markets. Investors should watch closely for upcoming clinical trial data, product launch timelines, and any follow-up licensing or R&D partnerships.

What does this mean for the future of interventional cardiology?

The global interventional cardiology landscape is evolving quickly with increased emphasis on value-based care, minimally invasive techniques, and personalised medicine. TAVI is increasingly recognised as a cornerstone in this transformation, particularly as device performance improves and access broadens across healthcare systems of varying maturity.

Zydus Medtech’s entry into the TAVI space not only diversifies its portfolio but also places it in direct competition with global cardiovascular device players. While the firm has yet to establish the same scale or branding in cardiology as multinational leaders, strategic partnerships like this help bridge technological gaps while building long-term capabilities in R&D, clinical science, and manufacturing.

With global demand expected to surge, competition may intensify around affordability, access, and adaptability of TAVI systems. Zydus Medtech’s collaboration with a well-established regional innovator like Braile Biomedica positions it to compete on these very parameters, while also contributing to the global trend of decentralised innovation — where emerging markets become sources, rather than just recipients, of medical technology breakthroughs.

As the partnership unfolds, its success will likely depend on execution speed, clinical data outcomes, regulatory milestones, and the ability to scale efficiently in highly diverse markets. However, the deal offers a significant step forward in aligning engineering innovation with global cardiovascular care needs, setting the stage for the next wave of growth in transcatheter valve therapies.