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.
A new bacteriophage-based rapid test has the potential to identify the specific pathogen causing a urinary tract infection (UTI) at the point of care, enabling targeted use of antibiotics.
The test uses naturally occurring phages identified as predators of Escherichia coli, Klebsiella and Enterococci that are genetically modified to make any bacterium they invade bioluminescent.
In a proof-of-concept study, researchers at ETH Zurich, Switzerland, were able to reliably detect the pathogenic bacteria in a urine sample in less than four hours. That compares to the 18 – 30 hours it takes to culture samples in a central lab and to identify a specific microbe using conventional diagnostics.
Rockwell Medical Inc. has acquired the hemodialysis concentrates business of Evoqua Water Technologies LLC for $11 million up front in cash plus two $2.5 million milestone payments at 12- and 24-months following the close of the deal.
A Blacksmith Medicines Inc. patent describes the development of prodrugs of UDP-3-O-(R-3-hydroxymyristoyl)-N-acetylglucosamine deacetylase (LpxC) (bacterial) inhibitors reported to be useful for the treatment of complicated urinary tract infections (UTIs).
As prostate cancer progresses, tumors lose the androgen receptor (AR) on which initial treatment is based. Oftentimes, such patients also lose expression prostate-specific membrane antigen (PSMA), which is the target of approved agent Pluvicto (lutetium (177Lu) vipivotide tetraxetan; Novartis AG) as well as a number of experimental drugs. Such patients can no longer benefit from either androgen- or PSMA-directed therapy.
Olive Diagnostics Pvt. Ltd. is looking to raise $10 million in a series A funding round to extend sales and marketing activities, after getting CE approval for its urine analysis device that mounts on any toilet. Among other parameters the device, Olive KG, can measure red blood cells, proteins, nitrates, pH levels volume, pressure and frequency of urination.
A Mayo Clinic study demonstrated how the deficiency of the enzyme CDK12 or its regulation by cyclin K causes the expression of mutations related to resistance to endocrine therapy in prostate cancer. Prostate tumors with CDK12 deficiency are more aggressive, recurrent, produce metastases and are associated with castration-resistant prostate cancer (CRPC). CDK12 deficiency impairs DNA repair and increases genomic instability, causing an effect known as homologous recombination deficiency or BRCAness.
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