Circulatory support specialist Thoratec Corporation, has acquired the DuraHeart® II (“DH-II”) ventricular assist system from Terumo Corporation for an upfront cash payment of $13 million. Together with potential future milestone payments, based on regulatory approvals and product sales, this could end up at $43.5 million.
Now that it has its hands on DH-II, Thoratec says it will apply its resources and expertise in mechanical circulatory support in order to advance the program through product development and clinical trials. First-in-human implants are expected in 2016, to be followed by clinical trials in the U.S. and abroad. Following clinical trials, a newly agreed distribution partnership between Thoratec and Terumo should optimize patient access to the DH-II technology in Japan and other parts of Asia.
DH-II is an ultra-compact, full-support, centrifugal flow chronic VAD utilizing a unique technology foundation known as “force balance” suspension. The device utilizes primary magnetic forces, balanced by hydrodynamic support, to achieve consistent gaps across the operating range of the pump, independent of pump speed. This approach is designed to create a pumping mechanism with excellent blood-handling characteristics. According to the Thoratec press announcement, preclinical testing has shown a favorable profile for DH-II with respect to hemolysis, bleeding, and thrombosis.
As part of the agreement, a team of Terumo employees will transition to Thoratec and will continue to be based in Ann Arbor, Michigan.
“Thoratec is committed to delivering a steady cadence of innovative new products to the VAD market in the coming years,” said Gary F. Burbach, President and Chief Executive Officer of Thoratec. “DuraHeart II brings a differentiated approach to mechanical circulatory support to Thoratec’s R&D portfolio and will be an integral component of our product development strategy, along with continued evolution of the HeartMate II® system, next-generation pump platforms including HeartMate IIITM and HeartMate PHPTM, which are expected to begin pivotal CE Mark trials in the second half of 2013, and breakthrough cross-platform technologies such as our fully implantable system.”
“Terumo believes that the transfer of the development of DuraHeart II to Thoratec is the best and fastest way to commercialize the technology and to ensure access for patients in Japan, the U.S., and the rest of the world. We are pleased that Thoratec recognizes the value of the DuraHeart II platform and will be applying its expertise and resources to develop and bring this exciting product to market,” said Yutaro Shintaku, President and Representative Director of Terumo Corporation.
Thoratec anticipates that the acquisition will add incremental ongoing operating expenses, primarily related to research and development, of approximately $6-7 million in the second half of 2013. Additionally, Thoratec will recognize transaction-related expenses, including the amortization of intangible assets, which will be quantified in the company’s second quarter earnings report and following the completion of the purchase price allocation for the transaction.
Source: Thoratec Corporation, PR Newswire