Avita Medical (ASX:AVH) said today it won expanded coverage under the FDA’s compassionate use investigational device exemption program for its Recell autologous cell harvesting device. 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. With […]
Clinical Trials
Cardiovascular Systems touts 2-year Liberty 360 PAD study data
Cardiovascular Systems (NSDQ:CSII) yesterday released two-year results from the Liberty 360 study examining long-term clinical and economic outcomes for peripheral vascular interventions in treating patients with peripheral artery disease. Results from the trial were presented by Dr. Jihad Mustapha of Grand Rapids, Mich.’s Advanced Cardiac & Vascular Amputation Prevention Centers in a late-breaking presentation at the […]
Viveve wins FDA nod to continue Viveve II trial
Viveve (NSDQ:VIVE) said yesterday it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth. The approval came based off sufficient evidence to support continued enrollment and a lack of subject protection concerns which would preclude continuation, the […]
Northwell’s prosthetic leg could get amputees back in the swim
A New York State heathcare provider has developed a 3D-printed artificial leg to help combat veterans and other amputees to swim again. Northwell Health’s prosthetic, “The Fin,” is the first such prosthetic leg attachment to give amputee swimmers the ability to navigate from land to the water and back without having to switch prosthetics. Northwell has begun […]
Frequency Therapeutics launches clinical trial for hearing loss drug
Frequency Therapeutics said today that the first patients have been treated in a Phase I/II clinical trial to assess its first-in-class drug candidate for hearing restoration. The 24-patient trial is slated to include people with stable sensorineural hearing loss. Participants will receive an injection of Frequency’s FX-322 or a placebo in one ear, with a follow-up visit […]
Neovasc touts Reducer study data
Neovasc (NSDQ:NVCN) today touted results from a study of its Reducer device designed for treating refractory angina. The Reducer system is designed to alter blood flow in the heart’s circulatory system to increase perfusion of oxygenated blood to ischemic areas of heart muscle, and can be placed in a minimally invasive transvenous procedure, the Vancouver-based company said. […]
LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses […]
OncoSec inks research deal to analyze clinical trial participants
OncoSec Medical (NSDQ:ONCS) said today that it inked a research deal with Dr. Roger Lo and his research team at the University of California Los Angeles to study participants from the biotech company’s Pisces/Keynote-695 Phase IIb clinical trial. Dr. Lo and his team are slated to perform genetic, transcriptomic and methylomic analyses of patients from OncoSec’s […]
JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who […]
Stryker touts 3D-printed Tritanium cage study results
Stryker (NYSE:SYK) today released data from a pre-clinical study comparing spinal implants made form a variety of different materials exploring their bone-ingrowth and biological fixation capabilities. Results from the study were published in last months issue of The Spine Journal, the Kalamazoo, Mich.-based company said. The study examined the use of traditional PEEK cages, plasma-sprayed titanium-coated […]
Pulse Biosciences’ nano-pulse stimulation tested in skin cancer patients
Pulse Biosciences, Inc. (Nasdaq:PLSE) has begun a clinical study to evaluate nano-pulse stimulation (NPS) platform in a common skin cancer, basal cell carcinoma (BCC). NPS is a non-thermal therapy that uses ultra-short, nanosecond-pulsed electric fields that directly affect and disrupt intracellular structures. It has been shown to induce immunogenic cell death in pre-clinical cancer models, according […]