PulseCath Forms Strategic Collaboration With Huadong for the iVAC Device in China

September 17, 2021—PulseCath B.V., a developer of percutaneous ventricular assist devices for high-risk percutaneous coronary interventions (PCI), and Huadong Medicine Co., Ltd., announced that the companies have entered into an exclusive collaboration to develop and commercialize PulseCath’s iVAC 2L percutaneous ventricular assist device technology for mainland China, Hong Kong, Macau, Taiwan, and selected other Asian Pacific countries. PulseCath is based in Arnhem, the Netherlands. Huadong is headquartered in Hangzhou, China.

The collaboration agreement provides Huadong Medicine with a license for distribution of iVAC technology in these markets as well as local manufacturing and development. PulseCath will retain all rights in the rest of the world. Huadong Medicine will also have the opportunity to participate in global clinical studies conducted by PulseCath. PulseCath will continue to be responsible for the development and commercialization of iVAC in Europe, the United States, and other geographies.

Furthermore 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. PulseCath will receive a payment for regulatory activities and production in China dedicated to 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.

Oren Malchin, PulseCath’s Vice President for Marketing and Sales, commented in the press release, “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.” He continued, “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.”

Finally, Mr. Malchin noted that PulseCath plans to seek regulatory approval in the United States, stating, “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.”