Atrial fibrillation can be difficult to diagnose, but patients with untreated AF are 5 times more likely to have a stroke and three times more likely to develop heart failure. Now, the FDA has approved a pair of implantable cardioverter defibrillators from Medtronic specifically for previously undiagnosed and/or asymptomatic AF patients, as well the monitoring and treatment of recurrent AF.
Kohlberg & Company has acquired a majority stake in spinal surgery startup Amendia. The private equity firm has expanded the executive and board roster of the Marietta, GA-based company, including the addition of former Stryker CMO and CSO Scott Bruder to the board, who is a Kohlberg adviser.
Orthopedic implant player Stryker has extended its acquisition tear to a purchase of limb salvage company Stanmore Implants. This is the fifth acquisition of companies or assets that Stryker has announced this year--with two of those being billion-dollar deals and the other three smaller acquisitions.
Nuvectra completed its spin-off from Greatbatch in mid-March. Now, in its first disclosed financing, the micro-cap public company has raised $45 million in debt from financiers who are more typically venture debt providers, Oxford Finance and Silicon Valley Bank.
Cartiva got a go-ahead in the path toward a potential PMA approval for its Synthetic Cartilage Implant (SCI) to treat osteoarthritis at the base of the great toe. The FDA's Orthopaedic and Rehabilitation Devices Panel voted in support of Cartiva SCI efficacy, safety and that its benefits outweigh its risks. The SCI implant could offer an alternative to a joint fusion approach.
G-Therapeutics raised €36 million ($41 million) in a Series A round and debt to finish developing and start clinical trials for its Implantable Neuro-stimulation System to restore lower limb function, including walking, to patients suffering from paralysis due to spinal cord injury.
iStar Medical raised a €10 million ($11.4 million) Series B round to fund a study to support a CE mark for its latest product. Its MiniJect is an injected implant that is designed to reduce intraocular pressure in glaucoma patients by improving aqueous humor outflow from the anterior chamber to the suprachoroidal space.
Founded more than 20 years ago, glucose monitor implant startup Senseonicsy is now hoping that it can get regulators to sign off on its continuous glucose monitor Eversense that's based on a tiny implant to track diabetics for up to 90 days. That's much longer than the typical 5- to 7-day span that's available for popular patch-based CGMs.
Corvia Medical has scooped up a potential buyer with a purchase option deal, but the Massachusetts-based startup is remaining hush-hush on the identity of the strategic partner and the deal terms. The deal likely hinges on the outcome of an upcoming trial for its transcatheter InterAtrial Shunt Device to treat heart failure, or the subsequent FDA approval for which it's expected to provide the basis.
Johnson & Johnson's orthopedic arm, Depuy Synthes, has detailed a pair of deals aimed at preparing for its future of that segment. One, with Israeli med tech Rainbow Medical, is slated to develop a treatment for degenerative disc disease (DDD) that could delay or even reverse the degenerative process. The news comes shortly after J&J disclosed a massive medical device business restructuring in January that would slash 3,000 jobs and save the company $1 billion.