BTC Health Opens India Market for Growing PEARS Business

India Added to Five-Year PEARS Agreement

BTC Health Limited (ASX:BTC) has secured a larger territory for its ExoVasc PEARS business, adding India to BTC Cardio’s existing exclusive Australian distribution rights. The new agreement with UK-based Exstent Limited runs for an initial five years, renews automatically for further two-year periods and replaces the April 2024 arrangement.

The deal gives BTC Cardio a longer-term position in Australia while opening a new market without an upfront or milestone payment to Exstent. The company described the remaining commercial terms as typical for a distribution agreement of this kind.

Australian PEARS Revenue Reaches $1.10 Million

The India expansion builds on an Australian business that is showing measurable traction. PEARS revenue grew 20% to $1.10 million in FY26, with the procedure now an established part of BTC Cardio’s cardiac surgery portfolio.

ExoVasc is a custom-made mesh support manufactured from a patient’s CT scan and fitted around the aorta to help prevent further dilatation. It is used in patients with an enlarged aortic root, including some people with Marfan syndrome, and to support the pulmonary autograft in the Ross procedure. The approach preserves the patient’s own aortic root and valve.

CDSCO Approval Sets the India Launch Gate

India is not yet a revenue market for BTC Cardio. Sales can begin only after the Central Drugs Standard Control Organisation grants import approval, and the announcement gives no timetable for that decision or forecast for Indian revenue.

BTC Cardio has engaged regulatory consultants, begun discussions with leading Indian aortic surgeons and will receive support from Exstent on regulatory submissions. India’s inclusion is subject to approval being obtained within an agreed timeframe, although the agreement includes provision for an extension.

Indian Opportunity Comes Without Sales Commitments

The company points to India’s large population and established cardiac surgery sector, particularly high-volume hospitals in major cities. That provides a plausible setting for a specialist product such as PEARS, but the filing does not disclose minimum purchase commitments, expected hospital numbers, pricing or the potential contribution to BTC’s financial results.

The immediate value of the announcement is therefore strategic rather than financial: BTC has secured distribution rights in a new geography and extended its Australian arrangement, while the regulatory process determines whether and when the Indian opportunity becomes commercial.

Regulatory Progress Becomes the Next Catalyst

The next meaningful milestones are the CDSCO submission and approval process, continued engagement with Indian surgeons and the start of sales if authorisation is granted. Subsequent updates will need to show whether Australian adoption can be replicated in India, or whether the new territory remains an option with limited near-term earnings impact.