The iVAC 2L mechanical circulatory device is suitable for cardiac and non-cardiac surgery. Credit: National Cancer Institute / Unsplash.

Medical device firm PulseCath has entered into a strategic collaboration deal with Huadong Medicine to develop and commercialise the iVAC mechanical circulatory product in Greater China.

According to the terms of the agreement, Huadong Medicine will be permitted to distribute the iVAC technology in mainland China, Hong Kong, Macau and Taiwan (Greater China), as well as other selected Asian Pacific countries.

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The company will also get a licence for local manufacturing and development of the technology, while PulseCath will retain all rights in the rest of the world.

PulseCath stated that the collaboration with Huadong Medicine accelerates the development of the iVAC 2L mechanical circulatory device in Greater China.

The iVAC provides critical hemodynamic support during high-risk revascularisation procedures, in cases of acute myocardial infarction and cardiogenic shock as well as for high-risk patients.

This is suitable for acute coronary syndrome, cardiac and non-cardiac surgery, or heart failure complications.

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PulseCath marketing and sales vice-president Oren Malchin said: “This collaboration reflects iVAC pulsatile technology’s potential to deliver meaningful value to high-risk percutaneous coronary intervention (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 deal, PulseCath will receive a significant investment in its share capital and payment for regulatory activities as well as development activities.

Additionally, the company will be eligible to receive royalties in their commercial area on Huadong Medicine’s commercial sales of the iVAC.