Senseonics (NYSE:SENS) today shared its full-year financial outlook and laid out expectations for a new product launch this year. The Germantown, Maryland-based company said the FDA review of its next-generation, 365-day, once-per-week calibration Eversense implantable continuous glucose monitor (CGM) is advancing as planned. It expects the progress to enable 510(k) clearance in the near future […]
Implants
Glaukos to exchange $230M in senior notes for common stock
Glaukos (NYSE:GKOS) announced today that it entered into exchange agreements to repurchase approximately $230 million. The company entered into separate, privately negotiated exchange agreements with certain holders of 2.75% convertible senior notes due 2027. Pursuant to these agreements, the company agreed to repurchase $230 million of existing convertible notes for aggregate consideration of shares of […]
FDA says Vivani Medical can begin study of long-term GLP-1-eluting implant
Vivani Medical (Nasdaq:VANI) announced today that the FDA approved an investigational new drug (IND) application for its long-term GLP-1 implant. The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month […]
Glucotrack has more data backing implantable glucose monitor, plans for human trials this year
Glucotrack announced the completion of a second long-term preclinical study for its implantable continuous blood glucose monitor (CBGM). The study further validates the CBGM’s sustained accuracy, the company says. It demonstrated a mean absolute relative difference (MARD) — a measurement of CGM accuracy — of 4.7% at day 90. MARD measures the average difference between […]
Medtronic, Arecor team up to develop insulin for implantable pumps
Arecor and Medtronic say they partnered to create a new type of insulin that would allow for the use of new insulin pump designs. These new insulin pumps in mind would sit under the skin, rather than on the surface of the skin. The research collaboration aims to develop a novel, high-concentration, thermostable insulin for […]
Glucotrack expands CGM tech to spinal epidural space
Glucotrack (Nasdaq:GCTK) announced today that it plans to expand its glucose monitoring technology to measure glucose in the epidural space. Rutherford, New Jersey-based Glucotrack said CGM taking readings in the spinal epidural space could integrate with existing treatments for painful diabetic neuropathy (PDN). Specifically, Glucotrack sees spinal cord stimulation (SCS) technology as a potential integration […]
OM1, Medtronic partner on drug-eluting implant study
OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]
Ascensia, Senseonics announce new CGM cost savings
Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program. The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM. […]
Vivani prices $15M offering to support long-term drug delivery implant
Vivani Medical (Nasdaq:VANI) announced today that it entered into a securities purchase agreement worth $15 million in proceeds. The company entered the agreement with an institutional investor. It covers the purchase of just shy of 4 million shares of common stock and warrants to purchase common stock. Alameda, California-based Vivani priced the shares at $3.80 […]
FDA submission for 365-day CGM from Senseonics is ‘imminent’
Senseonics (NYSE:SENS) shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. The company also reported an “imminent” submission of its latest, longest-lasting continuous glucose monitoring (CGM) technology. Shares of SENS fell 3.5% to 69¢ apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of […]
