BTC Health Signs New Exstent Distribution Deal Covering Australia and India for ExoVasc PEARS

Manish Choudhary

06 November 2026 11:23 AM AEDT

BTC Health Signs New Exstent Distribution Deal Covering Australia and India for ExoVasc PEARS

Image Source: Krish Capital Pty Ltd

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BTC Health Limited (ASX:BTC) has disclosed that its wholly owned investee company, BTC Cardio Pty Ltd, has signed a new exclusive distribution agreement with UK-based Exstent Limited for the ExoVasc® Personalised External Aortic Root Support (PEARS) device, expanding BTC Cardio's existing Australian territory to include India.

Key Points

BTC Cardio Pty Ltd has signed a new exclusive distribution agreement with Exstent Limited covering Australia and India for the ExoVasc® PEARS device
The new agreement replaces the April 2024 distribution agreement and carries an initial five-year term with automatic two-year renewals
PEARS revenue grew 20% to $1.10 million in FY26 across BTC Cardio's Australian operations
Sales in India are subject to import approval from India's Central Drugs Standard Control Organisation (CDSCO), with regulatory consultants engaged and discussions with Indian aortic surgeons under way
No upfront or milestone payment is payable to Exstent under the agreement

Terms of the New Distribution Agreement

The new agreement between BTC Cardio and Exstent Limited replaces the April 2024 distribution agreement and grants BTC Cardio exclusive distribution rights for ExoVasc® PEARS across Australia and India. The agreement has an initial term of five years and renews automatically for further two-year periods unless either party provides notice. India's inclusion under the agreement is subject to obtaining Indian regulatory approvals within an agreed timeframe, with provision for extension. The agreement is on commercial terms described as typical for distribution arrangements of this nature, and no upfront or milestone payment is payable to Exstent.

ExoVasc PEARS Device and Australian Revenue

ExoVasc® PEARS is a custom-made mesh support manufactured from each patient's CT scan and fitted around the aorta to prevent further dilatation. It is used in patients with an enlarged aortic root, including those with Marfan syndrome, and to support the pulmonary autograft in the Ross procedure. The patient's own aortic root and valve are preserved. BTC Cardio has served as Exstent's exclusive Australian distributor and sponsor since April 2024. According to the filing, PEARS revenue from the Australian business grew 20% to $1.10 million in FY26.

India Regulatory Process and Market Entry

Sales of ExoVasc® PEARS in India will commence once India's Central Drugs Standard Control Organisation grants import approval. BTC Cardio has engaged regulatory consultants to manage the approval process and has begun discussions with leading Indian aortic surgeons. Exstent will support the regulatory submissions. Executive Chair Dr Richard Treagus stated the company plans to work with leading surgical centres in India and will take the same approach used in Australia. BTC Health said it will update the market as the Indian regulatory process progresses.

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