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. It also comes almost three months after London-based Smith+Nephew plc said it was going to pick up the extremity orthopedics business of Integra for $240 million in cash. Read More
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. Read More
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-based company's Osteoboost Vibration Belt received a U.S. FDA breakthrough designation for technology that delivers gentle stimulation to reduce bone loss and prevent osteoporosis with the goal of reducing the number of potentially devastating broken bones in the elderly. Read More
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. Read More
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. Patient enrollment is expected to begin in early 2021. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aroa Biosurgery, Hancock Jaffe Laboratories, Smith+Nephew, Twistrand Biosciences, Veracyte. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Laboratories, Apollo Endosurgery, Aroa Biosurgery, Avenda Health, Biotronik, Miach Orthopaedics, Okami Medical, Spark Biomedical, Transenterix. Read More
Keeping you up to date on recent developments in orthopedics, including: HSS bone study sheds light on complications after spinal surgery; Simplify Medical reports first implant of its cervical artificial disc in the U.S. following FDA 1-Level approval; Scientists say xenon improves properties of maxillofacial and orthopedic implants. Read More
