PulseCath has entered into strategic collaboration with Huadong Medicine for the development and commercialisation of its iVAC technology in Greater China.

Through the collaboration, Huadong Medicine obtains license to distribute iVAC mechanical circulatory product in mainland China, Hong Kong, Macau, and Taiwan, and other Asia Pacific countries.

Hangzhou-based pharmaceutical company will also receive rights for local manufacturing and development, while PulseCath retains the global rights in the remaining regions.

Huadong Medicine will carry out the development, regulatory submissions and commercialisation of iVAC in Greater China and other select Asia Pacific countries.

It is also allowed to take part in global clinical studies conducted by PulseCath.

PulseCath will continue its efforts in the development and commercialisation of iVAC technology in Europe, the US, and other geographies.

PulseCath marketing and sales vice president Oren Malchin said: “With extensive regional experience, the right development and regulatory capabilities, and access to a deep local network of hospitals and clinics across Greater China, Huadong Medicine is an ideal partner for us.

“This collaboration reflects iVAC pulsatile technology’s potential to deliver meaningful value to high-risk PCI patients as well as our ability to translate our work in cardiac assist devices into long-term relationships that create sustainable value for PulseCath and our partners.

“We look forward to working closely with Huadong Medicine to develop and commercialize the iVAC technology in Greater China as we continue to advance the iVAC product family, develop new products, conduct further clinical studies and support our application for FDA approval, which we expect for 2022 in the US.”

Under the terms of the agreement, PulseCath will receive a significant investment in its share capital. It will also obtain additional investment based on potential development and regulatory milestone payments.

The company is eligible to receive a payment for regulatory activities and production in China, dedicated to Greater China and other select Asia Pacific countries.

Also, it is eligible to royalties on commercial sales of iVAC technology by Huadong Medicine in their commercial region.