Orthocell (ASX:OCC) said today that it won ethics approval for a human study evaluating its CelGro collagen soft tissue repair device for peripheral nerve regeneration. The study is slated to enroll 20 patients at St. John of God Hospital at the end of the calendar year. Researchers will evaluate the safety, tolerability, and effectiveness of CelGro […]
Clinical Trials
St. Jude Medical launches pediatric trial for Amplatzer Duct Occluder II AS cardiac implant
St. Jude Medical (NYSE:STJ) said today that it’s launching a pediatric clinical trial of a version of its Amplatzer cardiac implant for treating a congenital heart defect. The 50-patient ADO II AS study is designed to enroll 2 patient cohorts: at least 15 patients weighing 4.4 lbs. (2kg) or less and at least 25 patients weighing more […]
Doctors still order imaging for low back pain, against recommendations
(Reuters) — Many doctors who order CT or MRI scans for patients with low back pain do so fearing that patients will be upset if they do not get imaging and because there is too little time to explain the risks and benefits of the tests, a new study found. The Choosing Wisely campaign, launched by […]
U.S. diabetics have worsening blood sugar
(Reuters) — The number of U.S. diabetics with healthy blood sugar levels has declined in recent years, a study suggests. Researchers analyzed data on 1.6 million adults with diabetes from 2006 to 2013. During this period, the proportion with HbA1c below 7% declined from 56% to 54%, and the share with HbA1c at or above 9% […]
Sleep apnea may increase diabetes risk
(Reuters) — Obstructive sleep apnea is linked with an increased risk of developing Type II diabetes, new research shows. The findings support recommendations from the International Diabetes Federation that patients with 1 condition be screened for the other, too, the research teams notes in the journal Sleep Medicine. Sleep apnea occurs when a person’s airway becomes partially or […]
Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial
Intersect ENT (NSDQ:XENT) said today that its Resolve sinus implant met both primary endpoints in its Resolve II pivotal trial. The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure. Get the full […]
Endonovo Therapeutics raises $10 million
Endonovo Therapeutics (OTC:ENDV) said today that it landed a $10 million funding agreement with an institutional investor. The funding consists of $1 million in convertible notes, with $600,000 already received and $400,000 to be received upon SEC registration approval, and up to $9 million through a securities purchase agreement after 30 days from its SEC registration date. […]
Medtronic touts cryoballoon cost savings data from Fire & Ice trial
Medtronic (NYSE:MDT) today released new economic analysis data from the Fire and Ice trial comparing cryoballoon catheter ablation with radiofrequency ablation, touting advantages of cryoballoon treatment over RF. Data from the trial was presented at the Asia Pacific Heart Rhythm Society’s Scientific Sessions in Seoul. Primary results from the trial were published in The New […]
Study: Endovascular aneurysm repair shows higher long-term mortality
Endovascular repair of abdominal aortic aneurysms showed a higher mortality rate over the long term compared with open surgical repair, according to a study published yesterday in The Lancet. The study, “Endovascular versus open repair of abdominal aortic aneurysm in 15-years’ follow-up of the UK endovascular aneurysm repair trial 1,” was based on data from the […]
FDA inks deal with CluePoints to use data to sniff out sloppy or fraudulent clinical trials
The FDA said today it inked a cooperative research and development agreement with statistical monitoring company CluePoints to identify clinical trial sites that don’t meet the agency’s standards. The CluePoints platform is designed to use “statistical algorithms to determine the quality, accuracy and integrity of clinical trial data during and after studies are conducted,” the company said. […]
Novocure enrolls 1st patient in phase III brain metastases trial
Novocure (NSDQ:NVCR) said that the 1st patient has been enrolled in a Phase III pivotal trial of its tumor-treating field technology in combination with radiosurgery to treat brain metastases from non-small-cell lung cancer. The St. Helier, N.J.-based company’s tumor treating fields (TTFields) are low-intensity, intermediate-frequency, alternating electric fields designed to disrupt cell division within cancer cells. Novocure’s commercial product, Optune, […]