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.

Calyxo Inc. cleaned up with a $32.7 million series C financing round to support further development of the Cvac system for kidney stones. Questa Capital and CRG led the round, which brought the company’s total funds raised to $47.2 million.

The FDA has approved Medtronic plc’s next-generation sacral neuromodulation (SNM) system, Interstim X, giving patients a recharge-free option with a 10-year+ lifespan. This newest member of the Interstim portfolio joins the rechargeable Interstim Micro as a treatment for overactive bladder (OAB), chronic fecal incontinence (FI) and nonobstructive urinary retention.

Easyendo Surgical Inc. has won the South Korean Ministry of Food and Drug Safety’s (MFDS) latest breakthrough device designation for its robotized ureteroscope. The device, currently known as Easyuretero, is the first of its type to be developed in South Korea. The next goal for Easyendo will be regulatory approval, said the MFDS. Daejeon, South Korea-based Easyendo is already working towards winning that approval. “We are now preparing to start clinical trials in South Korea, and discussing the start date and scope of the trials with MFDS,” an Easyendo spokesperson told BioWorld.

The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.

Merz Therapeutics GmbH is partnering with Israeli startup Vensica Therapeutics Ltd. on the development of an ultrasound-assisted delivery catheter to deliver Xeomin (incobotulinumtoxinA) to the bladder wall. The catheter, currently in clinical trials for the treatment of overactive bladder (OAB), is expected to be available in the U.S. by 2025.

TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.

PARIS – Affluent Medical SAS aims to raise $40 million on the Euronext Paris regulated market to finalize the development of three minimally invasive prostheses in urology and interventional cardiology. The Aix-en-Provence, France-based med-tech will issue 3,387,210 new shares. Affluent has already received subscription pledges exceeding $24 million, including $12 million from funds managed by Paris-based Truffle Capital.