Brazilian life-saving technology goes global: Braile Biomédica establishes international partnership with Zydus MedTech

Brazilian company Braile Biomédica, a leader in cardiovascular innovation, has announced an exclusive agreement with Indian firm Zydus MedTech to bring its Transcatheter Aortic Valve (TAV) technology to the global market — a less invasive valve treatment that has already been saving lives in Brazil and across Latin America.
The contract includes commercialization of the technology in strategic markets such as India, Europe, and other countries, reinforcing Braile’s role as a key player in exporting Brazilian medical technology.

TAVI (Transcatheter Aortic Valve Implantation) is a minimally invasive procedure performed via catheter, replacing traditional open-heart surgery. It is recommended for patients with severe aortic stenosis, especially those at high risk, offering faster recovery, shorter hospital stays, and significantly fewer complications. Beyond its clinical impact, the technology also presents a more cost-effective alternative for healthcare systems, freeing up hospital beds and optimizing resources.

National and international studies show that although the initial cost of the device is higher, TAVI leads to significant medium- and long-term savings due to reduced ICU and general ward stays, fewer postoperative complications, readmissions, and intensive rehabilitation. In Brazil, the technique has already demonstrated tangible benefits for the public health system (SUS), with patients staying an average of 2 to 3 days in the hospital, compared to 5 to 10 days for conventional open-heart surgery.

Developed by Braile since 2008, the technology has evolved over the years, culminating in its latest version, INOVARE SAFESYNC®, approved in 2023, which allows transfemoral access — making the procedure even less invasive. Incorporated into SUS in 2021 and expanded in 2024, TAVI is already a reality for hundreds of patients in Brazil and is expected to reach around 1,000 procedures in 2025 (up from 394 in 2024).

Key data highlighting TAVI’s impact in Brazil:

• Average procedure cost in SUS: R$ 57,000
• Recommended for patients aged 75+ with severe aortic stenosis
• States with the highest number of implants: São Paulo, Ceará, and Santa Catarina (60% of cases)
• Reference hospitals: Dante Pazzanese (SP), Incor (SP), HCor Messejana (CE), Hospital São Vicente de Paulo de Mafra (SC)

With a presence in over 40 countries, Braile combines its Brazilian expertise with Zydus’s global scale, which will bring regulatory and commercial capabilities to accelerate adoption of the treatment in new regions.
“Our purpose has always been to democratize access to life-saving technologies. This agreement allows us to expand that impact, bringing a solution born in Brazil to thousands of patients around the world,” says Patricia Braile, CEO of Braile.

Kasznar Leonardos specialized team provided legal counsel for the international deal, supporting everything from contract structuring to intellectual property protection related to the TAVI technology, ensuring security and balance in the partnership.

“Our role was to ensure that the international operation was built on solid legal foundations, guaranteeing not only contractual balance between the parties but also a trustworthy and sustainable environment for the partnership to achieve its strategic goals,” says Felipe Monteiro, partner and lead attorney on the case.