NeuroPace today released eight-year prospective clinical study data from trials of its closed-loop brain-responsive neurostimulation system, touting a 73% median seizure reduction among patients. Data from the trials was presented at the American Epilepsy Society’s annual meeting in Washington D.C. this week, the Mountain View, Calif.-based company said. The data came from 256 adult patients across […]
Clinical Trials
Viveve touts sub-analysis results from Viveve system vaginal laxity trial
Viveve (NSDQ:VIVE) today announced results from a sub-analysis of its Viveve 1 trial exploring the use of the Viveve system for treating vaginal introitus in women with sexual dysfunction, touting improvements on the Female Sexual Functions Index. The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. Sub-analysis results […]
Lilly launches trial for automated insulin delivery system
Eli Lilly (NYSE:LLY) yesterday dosed the first patient in a trial of its automated insulin delivery system. The system is a hybrid closed-loop platform that includes a connected insulin pump, a dosing algorithm and a continuous glucose monitor. Get the full story at our sister site, Drug Delivery Business News.
Imagin Medical launches first-in-human trial for i/Blue urological cancer imaging tech
Imaging solution developer Imagin Medical said today it launched the first-in-human study of its i/Blue Imaging System, with recruitment for the trial beginning at the University of Rochester Medical Center. The company is developing the ultrasensitive i/Blue Imaging System which it hopes will “establish a new standard of care” for detecting certain cancers and visualizing […]
Sanofi touts head-to-head comparison of long-acting insulin products
Sanofi‘s (NYSE:SNY) long-acting insulin glargine, Toujeo, met the primary objective of a head-to-head trial comparing it to Novo Nordisk‘s (NYSE:NVO) insulin degludec, Tresiba, the company reported today. The insulin-maker said it plans to report full results from the Bright trial sometime next year. The study’s primary objective was to determine if Toujeo had a similar effect […]
Rotation Medical touts consistent healing, tear mitigation in rotator cuff study
Rotation Medical today released results from a study of its Bioinductive Implant designed for repairing rotator cuff tears, touting the device’s ability to consistently heal such tears and mitigate tear progression. Results from the 33-patient study were published in the Journal of Shoulder and Elbow Surgery, the Plymouth, Minn.-based company said. In the trial, researchers investigated […]
Lung cancer expert: Smoking stigma still hurting patients, families and research
A number of therapies designed to treat patients with lung cancer have been approved this year, including products from Novartis (NYSE:NVS), Merck (NYSE:MRK) and Bristol-Myers Squibb (NYSE:BMY). That progress is exciting for Dr. Fred Hirsch, the head of the International Association for the Study of Lung Cancer. “We do have a lot of good things to tell the public these days – […]
Fractyl raises $44m Series D for Revita DMR tech
Fractyl Laboratories said today that it raised $44 million in a Series D round, led by an undisclosed investor and first-time investors GV, True Ventures and the IDO Fund. Returning investors included Deerfield Management Company, Bessemer Venture Partners and others. The company said it plans to use the round’s proceeds to fund the continued development of […]
Dexcom inks continuous glucose monitoring deal with UnitedHealth
Shares in Dexcom (NSDQ:DXCM) rose 4% today after the company announced a partnership with UnitedHealth (NYSE:UNH) to assess if data from a continuous glucose monitor can help people with Type II diabetes manage their condition in a cost-effective way. UnitedHealth is slated to use CGM data, as well as diet and exercise activity, in a study of 10,000 people […]
Insightec wins FDA nod for Exablate Neuro glioblastoma trial
Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma. The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by […]
Egalet’s extended-release, abuse-deterrent opioid succeeds in Ph3 trial
Shares in Egalet Corp. (NSDQ:EGLT) soared this morning in pre-market activity after the company reported that its abuse-deterrent, extended-release oxycodone candidate met the primary endpoint of a Phase III pain relief trial. The Wayne, Penn.-based company compared the efficacy and safety of its product to a placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back […]