Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
5. InVivo prices $28m offering, shares slide
InVivo Therapeutics shares plunged today after the company priced a $28 million offering it plans to use to fund the Inspire clinical trial of its neuro-spinal scaffold.
Each unit of the $7.50-per-share offering consists of a share of common stock and half of a 5-year warrant with an exercise price of $10, Cambridge, Mass.-based InVivo said. The offering also includes an underwriters over-allotment of 560,000 shares and 280,000 warrants that’s worth another $4.2 million if fully exercised. Read more
4. Baxter launches trial for Vivia home hemodialysis system
Baxter said today that it’s launching a clinical trial of the Vivia home hemodialysis device it’s co-developing with famed inventor Dean Kamen’s DEKA Research & Development Corp.
The Vivia system is designed to provide shorter but more frequent dialysis rounds than conventional dialysis. The device has already won CE Mark approval in the European Union for use with Baxter’s Sharesource remote monitoring system, the company said. Read more
3. GI Dynamics to press on despite missed trial endpoints
GI Dynamics said today that it still plans to pursue FDA approval for its EndoBarrier weight loss device, despite missing safety and efficacy endpoints in a pivotal U.S. trial of the gut liner.
Lexington, Mass.-based GI Dynamics shut down the trial last July after the FDA ordered it to cease enrolling patients due to a higher-than-expected rate of hepatic abscess. The EndoBarrier is a plastic sleeve designed to promote weight loss and relieve the symptoms of diabetes by slowing the uptake of nutrients from food. Read more
2. Spirox closes $45m Series C for ENT devices
Spirox said today that it closed the books on a Series C round worth $45 million for the new device it’s developing to treat nasal obstructions.
Spirox, which pulled down an $18.5 million Series B nearly a year ago, said the latest round was led by private equity giant KKR and joined by new investor HealthQuest Capital. Existing backers Aisling Capital, Aperture Venture Partners and Venrock also participated, the Menlo Park, Calif.-based company said. Read more
1. Johnson & Johnson bails on Sedasys anesthesia device
Johnson & Johnson reportedly confirmed last week that it’s discontinuing its Sedasys computerized anesthesia system, 3 years after a hard-won pre-market approval from the FDA.
The federal safety watchdog denied approval for Sedasys back in 2008, prompting J&J to take another run at a PMA, which was also denied. After a rare appeal of that denial in March 2010, the FDA in May 2013 finally approved the device, which is designed to automate mild to moderate sedation during endoscopy procedures. Read more