Highlights

BTC Cardio signed a revised exclusive agreement with UK manufacturer Exstent, covering India alongside Australia.

ExoVasc PEARS is a custom-made mesh support created from an individual patient’s CT scan.

BTC Cardio has been the exclusive Australian distributor and sponsor since April 2024.

BTC has engaged regulatory consultants and begun discussions with Indian aortic surgeons.

Specialist medical products investor BTC Health Limited (ASX:BTC) is extending the geographic scope of its cardiac surgery portfolio through wholly owned investee BTC Cardio. The company distributes the ExoVasc Personalised External Aortic Root Support, known as PEARS, in Australia. A new exclusive distribution agreement adds India, with market entry dependent on obtaining the necessary Indian medical-device Import approval.

India Joins an Existing Australian Agreement

BTC Cardio signed a revised exclusive agreement with UK manufacturer Exstent, covering India alongside Australia. The arrangement replaces the April 2024 distribution agreement, begins with a five-year term and automatically renews for further two-year terms unless terminated with notice. No upfront or milestone payment is payable to Exstent. India’s inclusion depends on receiving relevant approvals within an agreed timeframe, with an extension mechanism available.

PEARS Preserves the Patient’s Aortic Root

ExoVasc PEARS is a custom-made mesh support created from an individual patient’s CT scan. It is fitted around the aorta to help prevent further dilation in patients with an enlarged aortic root, including those with Marfan syndrome, and can also support the pulmonary autograft in a Ross procedure. The treatment preserves the patient’s native aortic root and valve. BTC’s role is commercial distribution rather than manufacture of the implant.

Australian Sales Provide an Existing Base

BTC Cardio has been the exclusive Australian distributor and sponsor since April 2024. PEARS Revenue increased 20% to AUD 1.10 million in FY2026 as use among Australian surgical teams expanded. The Indian arrangement will build on that commercial experience, but the Australian historical result is not a forecast of Demand in India. The announcement provides no projected Indian sales figures or date for first commercial supply.

Approval Defines the First Indian Milestone

BTC has engaged regulatory consultants and begun discussions with Indian aortic surgeons. Exstent will support submissions to India’s Central Drugs Standard Control Organisation. Sales cannot begin until the regulator grants import approval. The timing of approval and subsequent adoption by hospitals are uncertain, making the current news an expansion of contractual rights rather than the commencement of an Indian revenue stream.