Nevro. Corp. closed the acquisition of privately held Vyrsa Technologies Inc., adding the company’s V1 implant for sacroiliac (SI) joint fusion to its product line for chronic pain. Nevro paid $40 million at closing and agreed to up to $35 million in additional payments contingent on the achievement of certain development and sales milestones.
Johnson & Johnson completed the previously unheralded acquisition of privately held Laminar Inc. for $400 million upfront, with undisclosed contingent payments depending on achievement of clinical and regulatory milestones starting in 2024. The deal provides the med-tech giant a potentially game-changing entree into the lucrative left atrial appendage (LAA) market.
Bright Uro Inc. raised $23 million in a series A fundraising round to support its pursuit of U.S. FDA 510(k) clearance and launch of its Glean urodynamics system. Glean offers catheter-less assessment of the function of the bladder and urethra that uses an inserted pressure sensor instead.
Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS).
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
Smith+Nephew plc struck a deal to acquire Cartiheal Ltd. for $180 million at closing and $150 million in contingent payments, seven months after Bioventus Inc. backed out of its agreement to buy the developer of the Agili-C cartilage regeneration platform for $450 million.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.
Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.