Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday.
Invitae Corp. continued its aggressive cost-cutting initiative with the sale of its reproductive health assets to Natera Inc. for $10 million in upfront cash and an additional $42.5 million in potential milestone payments and litigation credits. The assets include screening tests for carrier status and non-invasive prenatal screening.
In a boon to older women worldwide, Bone Health Technologies Inc. received U.S. FDA clearance for its Osteoboost device, which reduces loss of bone strength in postmenopausal women. It is the first device cleared for intervention to slow loss of bone density or osteopenia before it advances to osteoporosis.
In a potential godsend for women struggling with infertility and painful periods, Hera Biotech Inc. acquired the endometriosis diagnostic assets of Scailyte AG, consolidating the two leading tissue-based diagnostic programs for the disease. The combination of the companies’ non-surgical diagnostic options could significantly speed time to treatment for millions of women, who on average spend 10 years in search of the cause of chronic pelvic pain before being diagnosed with endometriosis.
Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment.
Investors bailed on many med-tech companies last year, fearing that the frenzy surrounding GLP-1 agonists would tank companies in the weight-loss, diabetes and orthopedics segments. Their concerns now appear overblown in many instances, with some of the most directly affected businesses reporting a “rising tide” associated with an increased focus on obesity treatment that has lifted their boats rather than sinking them.
Veracyte Inc. revealed plans to buy C2i Genomics Inc. at the J.P. Morgan Health Care Conference in San Francisco on Jan. 8, a move that will significantly expand its portfolio of cancer diagnostic and monitoring assays. The terms include $70 million in Veracyte shares to be paid at closing plus an addition $25 million payable in cash or Veracyte shares over the next two years if C2i achieves certain performance milestones.
Boston Scientific Corp. agreed to acquire neurostimulation company Axonics Inc. for $71 per share or $3.7 billion in total. Axonics focuses on stimulation of the sacral neve to treat overactive bladder and bowel dysfunction. It also offers a bulking agent to address stress urinary incontinence in women.
The deal is expected to close in the first half of 2024, pending approval of stockholders and regulators.
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.