Mitralign has raised $39.8 million in a Series E round to help it get U.S. and EU approvals for its tricuspid valve repair system and to launch its mitral valve repair system in Europe. Transcatheter mitral valve repair and replacement were white-hot areas of strategic investment last year as major med techs worked to anticipate the best follow-up play to the massive success of transcatheter aortic valve replacement.
NeuSpera Medical had been working under the radar for some time on about $1 million in angel financing. Now, it's raised an $8 million Series A financing after bringing in a high-profile exec to lead its effort. The Santa Clara, CA-based startup is aiming for a futuristic field that already has substantial strategic interest: electroceuticals.
Nevro was up 7% in early trading on news that it beat Wall Street expectations for first-quarter sales--and that it raised 2016 guidance. This is only the third full quarter that the company has reported sales since its Senza Spinal Cord Stimulation System to treat chronic pain was approved by the FDA last May.
DePuy Orthopaedics has acquired a San Antonio, TX-based startup that stakes a claim to being the first U.S. manufacturer of Nitinol metal implants for musculoskeletal fixation. The company, BioMedical Enterprises, markets a slew of small bone fixation devices made of Nitinol that can change shape--a process that is controlled by temperature and that can provide continuous compression, which is thought to induce bone healing after fixation procedures.
Medtronic has presented data on its leadless pacemaker, Micra, showing consistent safety and efficacy at months after implant--even under extreme conditions. Micra was just approved by the FDA last month and is the first leadless, transcatheter pacemaker to be approved in the U.S.
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.