Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease. Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston. The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent […]
Clinical Trials
Sage Therapeutics’ chief scientist on discovering drugs and taking risks
When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk. But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY) significantly […]
ReWalk Robotics expands ReStore soft exo-suit trial
ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers. The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy […]
Endologix reports 1-year data from Ovation registry
Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men. The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system […]
PQ Bypass touts 1-year Detour study data
PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system. Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported. The study included lesions that were longer and more complex than typically seen in SFA […]
Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding
Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth. Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But […]
Study: Leadless pacers lead to less complications
Patients who’ve received leadless pacemakers experience fewer complications than traditional pacers, according to a new study from the Cleveland Clinic. Results from the study were published in the journal Heart Rhythm. Investigators in the multi-center study compared short and mid-term complications between 718 patients who received Abbott‘s (NYSE:ABT) Nanostim leadless pacer and 1,436 patients who received conventional […]
CEL-SCI wins $2.9M in CRO legal battle
Score one for the little guy. After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO. In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of […]
Eli Lilly touts data for concentrated insulin delivered via Insulet’s Omnipod tech
Eli Lilly (NYSE:LLY) touted data this week from a Phase III study evaluating its Humulin R U-500 concentrated insulin delivered via Insulet‘s (NSDQ:PODD) investigational Omnipod U-500 device. The company reported that people with Type II diabetes taking Humulin R U-500 using the Omnipod device experienced greater A1c reductions and needed less daily insulin compared to adults using […]
Avita Medical touts publication of pivotal ReCell trial data
Avita Medical (ASX:AVH) today released results from a pivotal clinical trial of its ReCell autologous cell harvesting device in treating deep partial-thickness second-degree burns. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, Avita said. Results from […]
Can placental tissue implants limit back and leg pain?
Regenerative technology company StimLabs has enrolled the first patient in a clinical trial using shelf-stable placental tissue to reduce complications following herniated disc surgery. The multi-center, randomized controlled trial will evaluate the safety and efficacy of Revita, StimLabs’ full-thickness placental allograft, which surgeons will place following lumbar microdiscectomy procedures. Microdiscectomy is a common, minimally invasive procedure […]