Integra Lifesciences Holdings Corp. has entered a definitive agreement to acquire regenerative medicine-focused Acell Inc. for an up-front cash payment of $300 million and up to an additional $100 million upon the achievement of certain revenue growth milestones. The deal is expected to close in the first quarter of 2021, subject to the satisfaction of customary conditions.

FDA breakthrough device designation strengthens Osteoboost outlook

Bone Health Technologies Inc. may be on the verge of upstaging a common drug therapy, but don't tell them to break a leg. The San Francisco company's Osteoboost Vibration Belt received a U.S. FDA breakthrough device designation for technology that delivers gentle stimulation to reduce bone loss and prevent osteoporosis.

Foldax prepares to launch clinical study of biopolymer mitral heart valve

The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. The Tria valve is unique because it is made of a biopolymer material that is designed to be more durable than other valves, allowing the device to resist calcification and other stresses. Using the biopolymer materials also means that the valve can be manufactured robotically. “We’re trying to reinvent every aspect of the heart valve, from the material, to the design, to the manufacturing,” Foldax executive chairman Ken Charhut told BioWorld.

Spark Biomedical gets breakthrough nod for infant opioid withdrawal aid

The U.S. FDA has granted breakthrough device designation to Spark Biomedical Inc. for its Roo System, a transcutaneous electrical nerve stimulator to assist newborns with opioid withdrawal. The noninvasive neurostimulation device is modeled on the company’s Sparrow Therapy System for adult opioid withdrawal relief.

Federal attorney says speech discloses intended use while distribution is confirmatory

The U.S. FDA’s intended use rule has been in flux for the past half-decade, with yet another draft rule making the rounds for comment. Despite any concerns that speech regarding off-label use might again be seen as a primary driver of prosecution, Sara Bloom, senior litigation counsel at the U.S. Department of Justice’s District of Massachusetts office, said distribution of the product in question is frequently the key feature where federal prosecutors are concerned. Bloom said communication of off-label use often serves primarily as a confirmatory element of the manufacturer’s intent rather than as the decisive part of the prosecution’s case.

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