After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. quickly returned to buy the organ preservation company. On Aug. 25, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.
The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Testing labs captured in enforcement action; Ethicon wins injunction against AIM over sutures; TGA updates class I ARTG listing requirements.
Transmedics Group Inc. reported a proposed public offering of $60 million of its shares of common stock (NASDAQ:TMDX). The Andover, Mass.-based company expects to grant underwriters a 30-day purchase option for additional shares of its common stock up to 15% of the number of shares sold in the offering. J.P. Morgan and Morgan Stanley are jointly managing the proposed offering with Canaccord Genuity acting as lead manager.
