Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden.
Newco R1 Therapeutics Inc. has launched with an oversubscribed $77.5 million series A, providing the means to take AP-306, a potentially first-in-class hyperphosphatemia therapy through phase IIb development in patients with chronic kidney disease.
Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to go about their days without frequent, hours-long visits to a dialysis clinic or being hooked up to a filtration system at home.
Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from existing shareholders.
The U.S. Centers for Medicare & Medicaid Services ended the Treatment Choices model under the end stage renal disease payment payment system for several reasons, including its failure to deliver meaningful savings.
Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants.
The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
Concluding a two-year journey, Baxter International Inc.’s kidney care unit finally separated from the company and started a new life as Vantive, following the closing on Jan. 31 of its $3.8 billion sale to the Carlyle Group Inc.
Medtronic plc and Davita Inc. launched a new company this week centered on the assets and capabilities of Medtronic’s former Renal Care Solutions (RCS) division. Mozarc Medical US LLC brings Medtronic’s strategic plan to streamline its operations by spinning off several divisions one step closer to fruition.
Aquapass Medical Ltd. has readied a pre-submission plan for the FDA this month to advance technology designed to reduce hypervolemia or fluid overload in patients suffering from heart failure, kidney failure or lymphedema. Conjuring up images of an astronaut stepping out onto a NASA loading dock, the Microclimate Suit uses low humidity and fast flowing air on the patient’s skin to evaporate excess bodily fluids. The suit won FDA breakthrough device designation in December 2022.
