Elutia (Nasdaq:ELUT) announced today that it agreed to sell its bioenvelope technologies to Boston Scientific for $88 million. Gaithersburg, Maryland-based Elutia agreed to sell its EluPro and CanGaroo drug-eluting bioenvelopes in the cash deal. It designed these technologies to protect patients receiving implantable medical devices. Elutia says the deal underscores the value of its proprietary […]
Implants
Roche wins CE mark for Susvimo drug-eluting eye implant
Roche announced today that it received CE mark approval for its port delivery platform containing its Susvimo therapeutic. The device, known as Contivue in Europe, comprises the eye implant through which Susvimo is delivered, plus four ancillary devices to initially fill, insert, refill and remove the implant if required. Susvimo (ranibizumab injection) 100 mg/mL remains […]
Senseonics to take over commercial efforts for Eversense 365 from Ascensia
Senseonics (NYSE:SENS) announced today that it entered into an agreement with Ascensia Diabetes Care to take over commercialization efforts for its products. The companies entered into a mutually executed memorandum of understanding. This agreement transitions all commercialization and distribution of the Eversense 365 long-term implantable continuous glucose monitor (CGM) and future products from Ascensia to […]
Abbott wins CE mark for Esprit drug-eluting, dissolving scaffold
Abbott (NYSE: ABT) announced today that it received CE mark for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit BTK offers treatment for people with peripheral artery disease (PAD) below the knee (BTK). Abbott designed it to keep arteries open and deliver the drug everolimus to support vessel healing. Following the therapy, the stent completely […]
Glucotrack to submit long-term CGM implant for FDA IDE this year
Glucotrack (Nasdaq:GCTK) today announced multiple developments in the timeline for its long-term continuous blood glucose monitor (CBGM). The Rutherford, New Jersey-based company plans to file an FDA investigational device exemption (IDE) submission in the fourth quarter of this year. It also remains on track to implant the first patients in a long-term, multi-center feasibility study […]
Vivani closes $10M financing, advances GLP-1 implant
Vivani Medical (Nasdaq:VANI) announced that it brought in $10 million in equity financing as it progresses its drug delivery technology. Alameda, California-based Vivani develops NanoPortal technology, which steadily delivers medication over extended periods of time. The company aims to guarantee correct patient doses while avoiding potential safety concerns around fluctuating drug release profiles. It can also […]
Lifecare preps next-gen CGM implant for CE mark submission
Lifecare announced today that it has formal preparations underway to submit its implantable continuous glucose monitor (CGM) for CE mark. Bergen, Norway-based Lifecare said in a news release that it began its work on CE mark approval six weeks ago. It aims to bring its CGM system to Europe as a regulated medical device by […]
Senseonics posts Street-beating Q2 with 37% sales growth
Senseonics (NYSE:SENS) shares remained relatively unmoved today on second-quarter results that beat the consensus sales forecast. Shares of SENS rose 1% to 49¢ apiece in post-market trading after the earnings release on Wednesday, Aug. 6. They fell 8% to 45¢ apiece in mid-morning the next day. The Germantown, Maryland-based long-term implantable CGM maker reported losses […]
Johnson & Johnson wins FDA priority review for drug delivery system
Johnson & Johnson (NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200. TAR-200, an intravesical gemcitabine-releasing system, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. A healthcare professional places TAR-200 into the […]
Lifecare takes next steps in CGM implant development
Lifecare said on social media that it completed a significant milestone in the development of its continuous glucose monitor (CGM) implant. The Norway-based company says it completed the initial electromagnetic compatibility (EMC) testing of electronics developed for its next-generation CGM implant. EMC testing ensures that the implant can operate reliably when surrounded by mobile phones, […]
