Huadong Medicine and PulseCath Announce Strategic Collaboration to Develop and Commercialize the iVAC mechanical circulatory
PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, and Huadong Medicine Co.
Today announced that the companies have entered into an exclusive collaboration to develop and commercialize the iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries.
The collaboration agreement between PulseCath and Huadong provides Huadong Medicine with a license to distribute iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China) and selected other Asian Pacific countries as well as for local manufacturing and development. PulseCath will retain all rights in the rest of the world.
“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,” said Oren Malchin, PulseCath’s Vice President for Marketing and Sales. “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 United States.
Under the terms of the agreement, PulseCath will receive a significant investment in the company’s share capital and is eligible to receive a further investment as a result of potential development and regulatory milestones. In addition, PulseCath will receive a payment for regulatory activities and production in China dedicated to Greater China and selected other Asian Pacific countries. PulseCath is also eligible to royalties on iVAC’s commercial sales by Huadong Medicine in their commercial region.
Huadong Medicine will be responsible for the development as well as regulatory submissions and commercialization of iVAC in Greater China and selected other Asian Pacific countries. Huadong Medicine will also have the opportunity to participate in global clinical studies of PulseCath conducted by PulseCath. PulseCath will continue to be responsible for the development and commercialization of iVAC in Europe, the United States, and other geographies.