Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon. MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty. The PTA procedure, using Concept […]
Dialysis
Surmodics reaps $10m from Abbott on SurVeil balloon milestone
Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]
Baxter throws $500m behind CMS push for dialysis innovation
Baxter (NYSE:BAX) officials apparently think their company can benefit from a Trump administration and CMS proposal to provide extra reimbursement for new and innovative dialysis equipment and supplies. Just days ago, CEO Joe Almeida told analysts in an earnings call that the company planned to invest $500 million to significantly increase production capacity and meet new […]
Quanta Dialysis Technologies raises $48m
Quanta Dialysis Technologies (Alcester, U.K.) said today that it has closed on a £38 million ($48 million) Series C funding round. The money will support the British commercial launch of the company’s SC+ personal hemodialysis system as well as a 510(k) clearance submission to U.S. FDA later this year. The SC+, which received a CE […]
CVS launches trial for HemoCare home dialysis device
CVS Health (NYSE:CVS) launched a clinical trial of the home hemodialysis device it developed in conjunction with Dean Kamen’s Deka Research & Development, aiming to capitalize on the federal government’s plan to overhaul the way kidney disease is treated in the U.S. CVS said the 70-patient study is designed to evaluate the safety and efficacy of […]
Trump reveals plan to overhaul kidney disease care
The Trump administration yesterday revealed its plan to overhaul the way kidney disease is treated in the U.S., looking to increase early detection and emphasize transplants and home hemodialysis instead of in-clinic treatment via executive order. Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit earlier this week on news of the changes. The executive […]
DaVita, Fresenius slide on Trump threat to overhaul dialysis market
Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit today after a report surfaced that the Trump administration is readying an overhaul of the kidney treatment market. The president plans to issue an executive order tomorrow that would seek to incentivize kidney transplants and home hemodialysis in a bid to lower the […]
Fresenius invests in BioIntelliSense
Fresenius Medical Care (NYSE:FMS; ETR:FRE) today announced an investment in BioIntelliSense for an undisclosed amount. Denver-based BioIntelliSense is developing a medical-grade data services platform for continuous remote health monitoring, predictive analytics and algorithmic clinical insights. Through the agreement, Fresenius will use the advanced analytics and artificial intelligence to develop medical wearables for clinical pathways that allow […]
Fresenius to expand kidney research
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said this week that it is expanding its clinical research activities. Frenova Renal Research, previously a Fresenius Medical Care North America subsidiary, will now offer its services worldwide and will be integrated into a new global medical office headed by chief medical officer Dr. Frank Maddux. Frenova offers services for […]
Advent Access wins CE Mark for dialysis device
Singapore-based vascular access device company Advent Access said it has received the CE Mark for its av-Guardian technology designed to create vascular access for dialysis patients. The device-guided needling platform features the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins. The technology […]
Immunicom raises $11M for cancer treatment device
Biotech company Immunicom, which has developed a non-pharmaceutical, late-stage cancer treatment, has raised $11 million in a Series B investment round. Several private equity family offices participated in the round, increasing Immunicom’s overall capital raised to $20 million. The San Diego-based company won FDA breakthrough device designation in 2018 for its Immunopheresis therapy, which is […]