A quadriplegic man has had limited motion restored to his arm and hand as a result of a novel neuro-prosthesis connected to electrical stimulators in his arm, according to a new study. The 53-year old patient, who was paralyzed from below the shoulders for 8 years as a result of a bicycle accident, has had […]
Clinical Trials
RepliCel touts tendon regeneration data for its fibroblast therapy
RepliCel Life Sciences (OTC:REPCF) touted data this week from its Phase 1/2 tendon repair study evaluating its type I collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles tendinosis. The clinical trial established a complete safety profile for RepliCel’s RCT-01 at 6 months and showed no serious adverse events related to the treatment or injection procedure. […]
Study: Knee replacement surgeries for OA patients less effective, more costly than thought
Knee replacement surgeries for patients with osteoarthritis provide minimal improvements in quality of life and are economically unattractive, according to a study released this week. Results from the study was published yesterday in The BMJ. Data from the study indicated that while the procedure was inefficient for patients with osteoarthritis, its effectiveness would rise if […]
FDA approves 1st-in-human trial for neural-enabled prosthetic hand
The FDA granted an investigational device exemption for the 1st-in-human trial of a neural-enabled prosthetic hand developed at Florida International University, backed by more than $2 million from the U.S. Defense Dept. The device is designed to stimulate nerves in the arm to provide sensation during use. It’s billed as the 1st fully implantable, wirelessly controlled Class-III […]
Burst Biologics to launch spinal fusion trial
Burst Biologics said today that it won regulatory approval to begin a clinical trial evaluating its BioBurst Fluid cellular allograft in spinal fusion patients. The company’s cellular allograft is derived from umbilical cord blood and has yielded promising results in spinal fusion procedures, according to the Boise, Idaho-based company. The prospective trial is slated to […]
Another InVivo spine injury patient converts
InVivo Therapeutics (NSDQ:NVIV) said today that a patient enrolled in January in its Inspire study has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. This is the 7th patient from the 11-patient group to have an AIS grade improvement with at least 1-month of follow-up. 2 other […]
EU regulators: We should suspend drugs at suspect Indian facility
This week, the European Medicines Agency recommended the suspension of more than 300 generic drug approvals and applications, after they uncovered “unreliable” tests conducted by Micro Therapeutic Research Labs. The India-based contract research firm is part of the country’s drug-testing industry, which has faced problems with international regulators in recent years. Get the full story […]
Organogenesis launches PuraPly antimicrobial clinical program
Organogenesis said today that it launched its PuraPly Antimicrobial clinical research program, which will evaluate patients treated with PuraPly AM for up to 12 weeks. The 1st studies have started enrolling patients, according to Organogenesis. The Canton, Mass.-based company’s PuraPly AM is a 510(k)-cleared device indicated for the management of acute and chronic wounds. The […]
Cardiologist Dr. Kereiakes: the Synergy bioabsorbable stent boasts flexibility & safety
Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
7 medtech stories we missed this week: March 24, 2017
From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Viveve Medical closes public offering Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 […]
Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system
Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids. The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device […]