Despite that the device has been available for more than a decade under the 510(k) program, an FDA advisory committee voted narrowly that the benefits of the Surgimend device for breast reconstruction do not outweigh the risks. Another interesting feature of the application is that the pivotal study was based on real-world evidence (RWE), but while the FDA had direct access to the data, Integra Lifesciences Holdings Corp. did not, thus raising questions about whether RWE is necessarily useful for class III device premarket applications.

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.

Smith+Nephew plc has signed a definitive agreement to acquire the Extremity Orthopedics business of Integra Lifesciences Holdings Corp. for $240 million in cash. The deal, which is slated to close around the end of this year, gives the London-based company a catalog of devices, implants and instruments that generated $90 million in revenue in 2019.