Dexcom (NSDQ:DXCM) touted data today showing that people with Type II diabetes who are using multiple daily injections of insulin can benefit from the use of continuous glucose monitoring. Those in the 158-patient study using Dexcom’s G4 Platinum CGM system experienced significant A1C reduction and spent more time in target range compared to a control group […]
Clinical Trials
Gamida Cell launches severe aplastic anemia trial
Gamida Cell said today that the first patient has been transplanted in a study of its CordIn product for patients with severe aplastic anemia or hypoplastic myelodysplastic syndrome. The product is designed for patients with rare genetic diseases who have no fully-matched donors for a bone marrow transplantation. Gamida Cell said it is also evaluating […]
Medtech stories we missed this week: Aug. 18, 2017
From Nemaura’s new Oceania distribution deal to Sanuwave’s promissory note expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Nemaura inks Oceania distribution deal for SugarBeat patch Nemaura announced in an Aug. 15 press release that it has signed a non-binding distribution deal with Device Technologies for […]
Novo Nordisk diabetes drug succeeds in late-stage trial
Shares in Novo Nordisk (NYSE:NVO) rose nearly 5% yesterday afternoon after the insulin-maker said that its once-weekly diabetes drug, semaglutide, succeeded in lowering glucose levels in a late-stage trial. The 40-week trial enrolled 1,200 patients and evaluated two dosages of semaglutide in combination with a standard-of-care-drug. The study compared its drug against Eli Lilly‘s (NYSE:LLY) dulaglutide […]
Opthea touts data from wet-AMD trial
Opthea (ASX:OPT) touted additional data today from the Phase I/IIa trial of its wet age-related macular degeneration therapy, OPT-302. The 50-patient Phase I/IIa trial recruited participants who were either treatment-naive or previously treated with an intravitreal anti-VEGF therapy. Researchers evaluated OPT-302 as a monotherapy and in combination with Lucentis (ranibizumab). In treatment-naive patients who received OPT-302 […]
Tandem launches pivotal trial for predictive insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it enrolled the first patient in an at-home pivotal trial of its t:slim X2 insulin pump combined with the company’s predictive low glucose suspend algorithm. Using DexCom’s G5 mobile continuous glucose monitor and Tandem’s predictive technology, the insulin pump is designed to halt insulin delivery when it predicts low […]
Ophthotech eye-drug trial fails to meet primary endpoint
Shares in Ophthotech (NSDQ:OPHT) dipped to $2.46 apiece this morning after the company announced that its Phase III wet age-related macular degeneration trial failed to meet its primary endpoint. The New York-based company said that the addition of Fovista (pegpleranib) to Eylea or Avastin, both anti-VEGF therapies, did not significantly improve visual acuity after 12-months compared […]
Medtronic launches DAPT study for Resolute Onyx DES
Medtronic (NYSE:MDT) said today that it’s launching a study of dual anti-platelet therapy and its Resolute Onyx drug-eluting stent. The 2,000-patient study is designed to compare a one-month course of aspirin and an anti-coagulant in conjunction with the Resolute Onyx device or the BioFreedom DES made by Biosensors International (PINK:BSNRY). The Resolute Onyx stent is made […]
Medtech stories we missed this week: August 11, 2017
From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions […]
Clearside Biomedical misses EPS estimate in Q2
Shares in Clearside Biomedical (NSDQ:CLSD) fell slightly today after the biopharmaceutical company missed earnings expectations on Wall Street with its second quarter results. The Alpharetta, Ga.-based company posted a net loss of -$13.8 million on sales of $130,000 for the 3 months ended June 30, for bottom-line loss of -169% compared with the same period last year. […]