The U.S. FDA’s recent approval of Boston Scientific Corp.’s Tenacio pump, a component for its AMS 700 inflatable penile prosthesis (IPP), is an “exciting milestone” for the company, Ronald Morton, chief medical officer, Urology, at Boston Scientific told BioWorld. The AMS 700 IPP is a treatment option for men with erectile dysfunction and is designed to deliver a more intuitive experience for patients when using the device.
Using minimally invasive focal therapies to treat prostate cancer are much more cost-effective and can improve patients’ quality of life compared to surgery or radiotherapy, according to a study published in the Journal of Medical Economics.
Bright Uro Inc. raised $23 million in a series A fundraising round to support its pursuit of U.S. FDA 510(k) clearance and launch of its Glean urodynamics system. Glean offers catheter-less assessment of the function of the bladder and urethra that uses an inserted pressure sensor instead.
The FDA has cleared Versameb AG’s IND application for VMB-100, a potency-enhanced mRNA encoding human insulin-like growth factor-1 (IGF-1), for the treatment of stress urinary incontinence.
Easymotionskin Tec AG is seeking patent protection for a wearable product that delivers transcutaneous electromyostimulation (EMS) of pelvic floor musculature through the body’s perineum, for the non-invasive treatment of incontinence, particularly stress incontinence. The invention is said to be suited to nearly all patients, including those patients who cannot insert anal or vaginal probes that provide pelvic floor training by EMS.
Stimvia s.r.o. (previously Tesla Medical s.r.o.) is in the process of securing $10 million in investment in a series A financing round that will allow the company to conduct a pivotal clinical study addressing overactive bladder, using Uris, its neuromodulation system, CEO Lukas Doskocil told BioWorld.
Laborie Medical Technologies Inc. continued a string of recent deals with an agreement to acquire Urotronic Inc. for $255 million cash up front with an additional $345 million in payments contingent on meeting specified commercial and reimbursement milestones. Laborie already held a minority interest in the manufacturer of the Optilume drug-coated balloon technology for treatment of urethral strictures and benign prostatic hyperplasia (BPH).
Amber Therapeutics Ltd. has acquired Bioinduction Ltd. as well as its neuromodulation therapy platform, Picostim Dyneumo. Amber is currently using the platform, an implantable system to deliver its closed-loop therapy for mixed urinary incontinence, Amber-UI, in a first-in-human study. With early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy, it made sense to acquire the hardware which allows for the therapy to work, CEO Aidan Crawley, CEO and co-founder of Amber told BioWorld.
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
Dicot AB has received clearance from the Swedish Medical Products Agency to begin a first-in-human trial with LIB-01, a potency agent to treat erectile dysfunction and premature ejaculation.
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