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.

Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.

Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation.

Vasc-Alert LLC’s surveillance technology successfully predicts which dialysis patients are at risk of experiencing stenosis, a study published in the Journal of Vascular Access shows. Patients assigned high scores by the company’s algorithm had seven times the risk of stenosis and blockage compared to those with low-risk scores.

The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.

Outset Medical Inc. dropped 38% during intraday trading to reach its lowest point since going public in mid-2020 following its announcement that it began holding shipments of its Tablo hemodialysis system for home use in late May pending U.S. FDA clearance of a 510(k) submission for changes made to the device since its original clearance in March 2020. The stock which closed June 13 at $20.43, recovered some ground to close June 15 at $14.58, which is still 78% off the stock’s high in November 2020.

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.

The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead.