Pathway to VAS Commercialisation & Sales

Dr Ayre has previously tested and verified several ventricular assist systems (VAS) in animals and humans and Mr Solis has commissioned and validated critical ventricular assist device (VAD) manufacturing processes in compliance with international standards.  Under their guidance Cadio Life is completing the pre-clinical verification of the EasyHeart™ VAS, which will be the smallest, full-output, centrifugal VAD pump on the market.

In Stage 1 we plan to:
a) Establish an R&D and product realisation team in Australia. 
b) Conclude the preclinical verification phase.                                             c) Transfer EasyHeart™ Indian production to Cardio Life’s new production facility in India, and obtain regulatory approval for producing human implant systems.
d) Complete pilot first-in-human implants in India and Australia.
e) Raise Series A funding for CDSCO regulatory approval for up to a 100-patient clinical trial in India.

Stage 2:
a) Conduct up to 100-patient regulatory clinical trial by 2028.
b) File for and obtain Indian (CDSCO) regulatory approval for human use in by 2028.
b) Prepare for and implement commercialisation in the Indian market – launch at start of Q4-2028