Medalliance SA reported completion of patient enrollment in the SAVE clinical trial with its Selution SLR 018 drug-eluting balloon. Eighty-four subjects have been recruited for this prospective multi-center, single-blinded, randomized controlled trial. These patients received either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or else high-pressure balloon angioplasty with no further lesion treatment.
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.
Awak Technologies Pte Ltd. and Singapore General Hospital (SGH) plan to launch a pre-pivotal clinical trial for their automated wearable artificial kidney peritoneal dialysis (Awak PD) device. Awak PD is a wearable and portable PD device designed for patients with end-stage kidney disease to have dialysis on the go. The research team is now recruiting subjects for the single-site, prospective, single-arm study.
Grand Pharmaceutical Group Ltd. acquired about 11% of the equity of Xeltis AG and will introduce Xeltis’ Axess to the greater China markets. Axess is a restorative hemodialysis access graft used for arteriovenous graft (AVG) patients with end-stage renal disease (ESRD).
The U.S. Department of Justice (DOJ) has filed a complaint in civil court against Fresenius Vascular Care Inc., of Berwyn, Pa., alleging the company had performed unnecessary procedures in nine clinics in the New York area. When paired with a recent Supreme Court case that went against Davita Inc., of Denver, this action may signal a source of pressure on dialysis services in the U.S., a set of developments that have already cost both these companies significantly on the stock market.
A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
With an FDA 510(k) clearance now in hand, Cloudcath Inc. is planning a phased launch of its remote monitoring platform for peritoneal dialysis (PD) patients. The company will make the system available on a limited basis in second half of 2022 “with broad U.S. availability increasing throughout 2023 and 2024,” Cloudcath CEO Aly ElBadry told BioWorld. The Cloudcath system continuously analyzes the dialysate fluid used in PD to detect early signs that a patient needs evaluation or intervention and then alerts both patients and clinicians.
Nextkidney BV has signed a deal to buy Dialyss Pte. Ltd. as it gears up to commercialize its home hemodialysis device Neokidney. The Singapore-based startup specializes in sorbent technologies for the regeneration of dialysate and has been a collaborator of Nextkidney’s for six years. The combined team will prepare for a clinical trial in Singapore, followed by a European multicenter trial and CE mark submission in 2023. Financial terms of the deal were not disclosed.
The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps.
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