Procept BioRobotics said today it treated the 1st patients in a clinical trial of its AquaBeam water ablation therapy system designed to treat prostate disease. The Water study is a phase III clinical study evaluating the safety and effectiveness of the system compared to transurethral resection of the prostate, the current standard of care for […]
Urology
Boston Scientific leads $40m round for NxThera
NxThera said today that Boston Scientific (NYSE:BSX) led a $40 million funding round for its Rezūm device, saying it plans to boost its sales footprint in the U.S. and Europe. Existing backers Aberdare Ventures, Arboretum Ventures, GDN Holdings and The Ally Bridge Group also participated, Maple Grove, Minn.-based NxThera said. The company said it also expanded a […]
Edap slips shareholders lawsuit
Edap (NSDQ:EDAP) said yesterday that the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer. EDAP shares plunged last year after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won […]
FDA clears Edap’s Ablatherm prostate device
Edap (NSDQ:EDAP) said today that it won 510(k) clearance from the FDA for its Ablatherm, less than a month after a similar device from rival SonaCare won a nod from the federal safety watchdog. The Ablatherm device, like SonaCare’s Sonablate 450, is designed to ablate prostate tissue using high-intensity focused ultrasound. After a years-long dance with the FDA that […]
StimGuard wins another IDE nod for bladder treatment trial
StimGuard said it won another FDA Investigational Device Exemption to run a clinical trial of its percutaneously implantable device to treat urgency urinary incontinence as a result of refractory overactive bladder syndrome. The StimGuard device utilizes a 1.3mm microchip neurostimulator designed to be implanted non-surgically with a needle. The stimulator communicates with a small external […]
U.K. halts use of Silimed breast implants amid contamination fears
(Reuters) — Sales of silicone implants made by Brazil’s Silimed and used in thousands of patients in Britain have been suspended due to safety concerns, British medical regulators and suppliers said today. The Medicines & Healthcare Products Regulatory Agency (MHRA) said it and other European regulators are testing Silimed’s products – which include breast, penile and testicular implants […]
Neotract touts UK NHS savings, better reimbursements
Neotract said today a new analysis from the U.K.’s National Institute for Health and Care Excellence reported a (UK £286) $443 savings per patient per day when using its UroLift system to treat enlarged prostates, compared to the most common surgical intervention. The NICE reported other benefits of the system, including preservation of sexual function, […]
Boston Scientific closes $1.6B Endo urology portfolio buy
Boston Scientific (NYSE:BSX) said today it closed its $1.6 billion acquisition of the Endo Health Solutions (NSDQ:ENDP) owned American Medical Systems urology portfolio, including its men’s health and prostate health businesses. The deal consists of a $1.6 billion up-front payment and a potential $50 million milestone payment based on 2016 sales, according to the companies. “This […]
FDA wants more from Edap on Ablatherm de novo bid
Edap (NSDQ:EDAP) today said the FDA wants more on its bid for de novo approval of its Ablatherm HIFU prostate cancer device, saying it needs to address 4 points raised by the federal safety watchdog before the process can resume. The news, following the French firm’s March announcement that it would abandon its pre-market approval application, […]
Stealthy Amphora Medical lands $13m
Amphora Medical said in a regulatory filing that it raised just more nearly $13 million for the radiofrequency ablation device it’s developing to treat overactive bladder. Eight unnamed investors put $12.8 million into the Maple Grove, Minn.-based company, according to the July 13 filing. Amphora Medical launched the Series A round in May 2013, initially raising about $6 million, […]
Procept BioRobotics closes $42m round for AquaBeam prostate device
Procept BioRobotics said today that it closed on a $42 million round for its AquaBeam “waterjet ablation” device for treating prostate cancer. Redwood Shores, Calif.-based Procept said the round was led by Novo Nordisk’s (NYSE:NVO) investment arm, Novo A/S, with new backer CPMG and existing investors also contributing. The AquaBeam device uses a high-pressure water jet […]