For cost-effective proof of concept, the first product in the portfolio will be a device for up to 30-day use suitable for Bridge-to-Decision indication for patients ineligible for traditional blood-contacting ventricular assist devices. A second generation will include up to 1 year use for Bridge-to-Transplant indication to open up a bigger market for the device. A third generation will further expand the indication to Destination Therapy with 2+ year support.
A first-in-human study is expected to take place in 18 to 24 months. Prospective study sites have been identified.