Pathway to VAS Commercialisation & Sales

Cardio Life founders have extensive experience in ventricular assist device systems (VAS) commercialisation. Dr Peter Ayre has previously designed, tested and verified several VAS in animals and humans. Mr Pablo Solis has commissioned and validated several safety-critical VAS manufacturing processes and product testing for human use, and managed the cross-functional teams taking a VAS from concept to market. Under their guidance, Cardio Life is completing the preclinical verification of the EasyHeart™ VAS, which will be the smallest, full-output, centrifugal ventricular assist device (VAD) pump on the market.

Our commercialisation path is clear:

Finalise our EasyHeart™ VAS

Strengthening our R&D heart failure centre of excellence and product realisation team in Sydney, Australia. Effectively fast-tracking the conclusion of the preclinical verification phase, followed by human-grade production of the EasyHeart™ VAS. On completion of the pilot first-in-human implants in India and Australia, the company will raise Series A funding for a clinical trial for regulatory approval to enable commercial sales.

Obtain approval for commercial sales in India and Australia

A clinical trial in India and Australia will enable regulatory approval for commercial sales in India (CDSCO) and Australia (TGA). Before completing the clinical study, the company will conduct preparation activities for commercial sales in these two markets. Subsequently, the company will leverage these approvals in other international jurisdictions.