Integra Lifesciences Holdings Corp. agreed to acquire Acclarent Inc. from Johnson & Johnson’s Ethicon Inc. subsidiary for $275 million in cash at closing with a further $5 million contingent on achievement of certain regulatory milestones.
Some U.S. FDA inspections go better than other ones, but the agency’s inspection of the Boston plant operated by a subsidiary of Princeton, N.J.-based Integra Lifesiences Holding Corp. was not one of those with a quick resolution. The agency said in a July 17 warning letter that Integra will have to obtain certification for the site in each of the next three years after finding considerable fault with operations, including one citation the agency said is a carryover from a warning letter issued in 2019.
With many of the big names in med tech focused on streamlining their portfolios and spinning off divisions as independent companies, M&A activity sputtered through most of 2022. As the year comes to a close, however, deal volume has increased, with a strong trend toward acquisitions of closely related companies and units that bolstered higher-growth product lines and offered short cuts to filling in significant gaps in portfolios.
Integra Lifesciences Holding Corp. agreed to acquire Surgical Innovation Associates Inc. (SIA) in a deal that could be worth $140 million, the companies reported. Integra will pay $50 million on closing, expected by the end of the year. The company will pay an additional $90 million contingent on achievement of certain revenue and regulatory milestones through 2026.
With one-quarter of China’s population affected by rolling shutdowns, manufacturers worldwide are preparing for a summer of supply chain nightmares. Shanghai and its normally bustling port have been closed now for a month and the nation’s COVID-Zero policy is now threatening Beijing. So far, though, the med-tech industry remains minimally affected, but the coming months may tell a different story.
General Electric Co. reported that it was dividing the company into three “well capitalized investment-grade companies with seasoned leadership teams.” The division of the huge conglomerate will start with the tax-free spin-off of GE Healthcare Ltd. in early 2023 and the renewable energy and power business in 2024 leaving the legacy GE as an aviation-focused enterprise. The company will take a one-time hit of $2 billion in connection with the split up.
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.