StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT). Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve […]
Urology
Profound Medical prices $20m bought deal financing round
Profound Medical (TSX:PRN) yesterday announced an upcoming $20 million “bought deal” financing round. In the deal, the Mississauga, Ontario-based company said it will offer 20 million units at a price of $1 million per unit, for gross proceeds of $20 million. Each unit in the round will consist of a single common share and one-half of a […]
Teleflex’s NeoTract wins expanded FDA indication for UroLift prostate device
Teleflex (NYSE:TFX) subsidiary NeoTract said yesterday that it won expanded indications from the FDA for its UroLift prostate treatment. Previously approved for treating benign prostate hyperplasia in men 50 and over without an obstructive median lobe, the new indications open the treatment to patients 45 or older with an obstructive median lobe. UroLift uses tiny devices inserted into the urethra […]
Procept BioRobotics raises $118m for Aquablation prostate treatment
Procept BioRobotics said today that it raised $118 million in an equity round it plans to use on the commercialization of its Aquablation treatment for benign prostate hyperplasia. Redwood Shores, Calif.-based Procept said new backer Viking Global Investors led the round, joined by Perceptive Advisors and existing investors including CPMG. The Aquablation treatment combines Procept’s Aquabeam – […]
Zenflow raises $31m in Series A
Urology medical device maker Zenflow said today it closed a $31.4 million Series A round of financing to support the development of minimally invasive devices designed to treat obstructive urinary symptoms related to benign prostatic hyperplasia. The round was led by Invus Opportunities, F-Prime Capital Partners and Medical Technology Venture Partners and was joined by […]
NxThera touts 3-year Rezūm trial results
NxThera today released three-year results from a trial of its Rezūm convective water vapor wave energy system, touting effective and durable relief from lower urinary tract symptoms for patients with benign prostatic hyperplasia. The trial was co-authored by co-principal investigators Dr. Kevin McVary of Southern Illinois University School of Medicine and Dr. Claus Roehrborn of the […]
Aegea Medical raises $40m
Aegea Medical said today raised a total of $40 million in financing to support the development of its Adaptive Vapor Ablation technology designed for endometrial ablation. The Redwood City, Calif.-based company said the financing included $30 million from Perceptive Advisors and an additional $10 million from existing equity investors including Medtronic (NYSE:MDT), Alloy Ventures, Delphi Ventures, […]
Procept BioRobotics wins de novo nod from FDA for Aquabeam prostate treatment
Procept BioRobotics said today that it won de novo clearance from the FDA for its Aquabeam device for treating benign prostate hyperplasia, saying it plans to have the device on the U.S. market early next year. Redwood Shores, Calif.-based Procept said the federal safety watchdog used the 181-patient Water study to inform its decision. The trial, comparing Aquablation […]
CompactCath wins CE Mark for compact intermittent urinary cath
CompactCath said this week it won CE Mark approval in the European Union for its flagship CompactCath intermittent urinary catheter. The Palo Alto, Calif.-based company’s CompactCath device is a unisex catheter designed for use in both pediatric and adult patients. The 16-inch device features coiled packaging, which the company says makes it the only such […]
Cogentix touts MAC coverage extension for OAB neuromod treatment
Cogentix Medical (NASDAQ: CGNT) said today that Medicare Administrative Contractor Palmetto GBA extended granted coverage for percutaneous tibial nerve stimulation procedures to treat overactive bladder with the company’s PC Neuromod System. With the extension, patients with Medicare coverage in North Carolina, South Carolina, parts of Virginia and West Virginia will be eligible to receive PTNS therapy for up […]
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 […]