Predictive health company Potrero Medical today filed an SEC Form D/A disclosing the sale of nearly $5.5 million in equity. The amendment the equity offering which made its first sale on June 28. At that time, the offering was for a total of $15 million and, in July, the company announced that it sold $11.7 million […]
Axonics touts one-year data for r-SNM device, inks supply deal with Nebraska urology group
Axonics Modulation Technologies (NSDQ:AXNX) said today that results from its Artisan-SNM pivotal study highlighted durable outcomes and significant improvements in patients implanted with the Axonics r-SNM system for patients with urinary and bowel dysfunction. The announcement came one day after the company said it entered into an exclusive agreement to supply the Axonics r-SNM System to […]
Profound Medical inks $8m private placement deal
Profound Medical (TSX:PRN) last week grossed nearly $8 million from a private placement with a pair of investment banks. Mississauga, Ontario-based Profound, which developed the Tulsa-Pro MR-guided prostate ablation device, said it sold a total of 9.1 million units at 83¢ (C$1.10) apiece to Canaccord Genuity and Echelon Wealth Partners for gross proceeds of about $7.5 […]
Healthy.io raises $60m in Series C funding round
Healthy.io said today that it completed a Series C financing round worth $60 million and won FDA 510(k) clearance for its smartphone-based ACR test. The funding round was led by Corner Ventures and Joy Capital, as well as previous investors Ansonia Holdings, Aleph and Samsung NEXT. The Tel Aviv, Israel-based company plans to use the […]
RenalSense’s urine flow monitoring system wins CE Mark
RenalSense today announced that it won CE Mark approval from its Clarity RMS system that monitors urine flow in critical care and perioperative settings. The Clarity RMS system continuously measures urine flow and automatically transmits real-time data and notifications of fluctuations to help with rapid intervention while monitoring treatment efficacy and fluid management. Jerusalem-based RenalSense […]
Potrero Medical raises $11.7 million
Predictive health company Potrero Medical has raised $11.7 million of a proposed $15 million, according to a Securities and Exchange Commission filing. The Hayward, Calif.-based company’s Accuryn system is designed to use urinary catheters as diagnostic tools. The device provides real-time measurements of intra-abdominal pressure, urine output and core body temperature and can be integrated […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be assessed for […]
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
Medeon invests in ortho, urologic companies
Medeon Biodesign (TPEx:6499) said today that it recently led and closed investments in an orthopedics startup and a company whose device was designed to treat benign prostatic hyperplasia (BPH). Panther Orthopedics is a Silicon Valley startup working on fixation solutions for orthopedic extremity applications. Prodeon is a Taiwan-based company offering a simple, office-based treatment option […]
Taris Biomedical touts results of bladder cancer treatment study
Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from both […]
FDA wants tighter control of certain prostate ablation devices
The FDA appears poised to impose a tougher clearance process on manufacturers of high-intensity ultrasound systems for prostate tissue ablation. The agency has issued new draft guidance on clinical testing that manufacturers of these devices must conduct, in accordance with special controls. The draft guidance also outlines recommended clinical data to support 510(k) applications for […]
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