Dialysis

Vantive to invest $1B in digital kidney support therapies

Tue, 03 Jun 2025 12:00:00 -0400

Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.

Baxter North Carolina facility recovering from Hurricane Helene

holland.johnson@clarivate.com — Tue, 22 Oct 2024 12:00:00 -0400

Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.

Xeltis vascular access graft may transform patient lives

Wed, 05 Jun 2024 12:00:00 -0400

Xeltis BV hopes that promising data from clinical trials on the performance of its synthetic vascular access graft implant will transform not only the lives of patients suffering from chronic kidney disease but also the company’s fortunes. “We're outperforming other solutions out there, that's the nice promise not only for the patient and for the families but also for potential strategics that might be interested in the company and play a role in the vascular space,” Eliane Schutte, CEO of Xeltis told BioWorld.

Nordson buying med infusion, cardio tech company Atrion for $800M

holland.johnson@clarivate.com — Tue, 28 May 2024 12:00:00 -0400

Nordson Corp. said it will buy Atrion Corp. for $460 per share in cash, representing a total equity value of approximately $815 million. The transaction enterprise value reflects a multiple of 20.2 times Atrion's 2023 EBITDA, and the $460 per share price represents a 15% premium to Atrion's 90-day average daily volume-weighted average stock price.

Medalliance unveils drug-eluting balloon for dialysis complications

Thu, 31 Aug 2023 09:00:00 -0400

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 snaps up Evoqua’s dialysis concentrates business

Fri, 14 Jul 2023 12:00:00 -0400

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 a step closer to marketing its wearable peritoneal dialysis device

Thu, 13 Jul 2023 12:00:00 -0400

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 partners with Xeltis to bring restorative hemodialysis access graft to China

Fri, 05 Aug 2022 13:00:00 -0400

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).

DOJ hits Fresenius for unnecessary procedures in crackdown on dialysis services

Thu, 14 Jul 2022 13:00:00 -0400

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.

Venostent’s Selfwrap wins breakthrough device designation

Fri, 27 May 2022 13:00:00 -0400

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 touts preliminary data for restorative hemodialysis access graft

Wed, 04 May 2022 09:15:00 -0400

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.

Cloudcath’s peritoneal dialysis remote monitoring system receives FDA clearance

Tue, 15 Feb 2022 13:00:00 -0500

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 acquires Dialyss to launch home dialysis device

Wed, 26 Jan 2022 13:00:00 -0500

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.

CMS to cover both adjunctive, non-adjunctive continuous glucose monitors in 2022

Tue, 28 Dec 2021 13:00:00 -0500

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.

Impedimed's Sozo digital health platform garners breakthrough device designation for renal failure

Tue, 31 Aug 2021 13:00:00 -0400

The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting.

Quanta secures $245M for FDA-cleared portable dialysis system

Wed, 23 Jun 2021 13:00:00 -0400

Quanta Dialysis Technologies Ltd. raised $245 million in a series D round led by Glenview Capital. The funds will be used to accelerate commercialization of the company’s SC+ portable hemodialysis system. Novo Holdings co-led the oversubscribed and upsized financing, with support from Blackrock, Eldridge, Sands Capital, Millennium Management, Monashee Investment Management LLC, Puhua Capital, Segulah Medical and Ancora, alongside Orlando Health, an integrated delivery network.

Fresenius is compiling the world’s largest genomic database for kidney disease

Tue, 23 Feb 2021 13:00:00 -0500

Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator.

Newco news: Ellen Medical develops portable and affordable dialysis machine

Fri, 19 Feb 2021 13:00:00 -0500

PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.

Patensee launches first-in-human trial of integrated surveillance system for fistula stenosis

Fri, 19 Feb 2021 13:00:00 -0500

Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.

Quanta wins FDA clearance for portable dialysis system

Fri, 22 Jan 2021 13:00:00 -0500

The portable hemodialysis market is heating up. For example, Quanta Dialysis Technologies Ltd. recently made a splash by receiving clearance from the U.S. FDA to market its portable hemodialysis system SC+. According to the Alcester, U.K.-based company, SC+ can deliver the higher dialysate flow rates typically used to provide conventional three-times-a-week prescriptions, while also offering the flexibility for more frequent, longer and gentler treatments tailored to patients’ needs.

Medtronic rolls out first acute dialysis machine for babies in the U.S.

Tue, 08 Dec 2020 13:00:00 -0500

Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.

Medtronic to scoop up Avenu Medical in latest tuck-in buy

Wed, 30 Sep 2020 13:00:00 -0400

Medtronic plc has unveiled its latest buy this year with the planned acquisition of Avenu Medical Inc., which focuses on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. The two did not disclose the terms of the transaction.

Portable dialysis-focused Outset Medical nails $277M in IPO

Fri, 18 Sep 2020 13:00:00 -0400

Outset Medical Inc. closed its Nasdaq IPO Thursday with gross proceeds of approximately of $277.9 million. The IPO, which launched Tuesday, included nearly 10.3 million shares of common stock at $27 per share and the full exercise of underwriters’ option to purchase more than 1.3 million additional shares. Shares of the San Jose, Calif.-based company’s stock, which is trading under the ticker OM, soared to more than $60 on the first day of trading amid enthusiasm for its portable dialysis machine.

Outset Medical posts hefty $242M IPO

holland.johnson@clarivate.com — Tue, 15 Sep 2020 13:00:00 -0400

Portable dialysis machine manufacturer Outset Medical Inc. saw its shares soar after the opening of its Nasdaq IPO. The stock rose as high as $61.60 before closing at $60.68, finishing the day with a market cap of nearly $2.5 billion. Trading under the ticker symbol OM, the company priced 8.95 million of its shares at $27 apiece, upsizing its previously reported plans to offer 7.6 million shares between $22 and $24. The offering is set to close Sept. 17.

Baxter wins de novo authorization for Theranova

Mon, 31 Aug 2020 13:00:00 -0400

Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.”

Neokidney, Debiotech partner to create new company and new home dialysis system

Wed, 17 Jun 2020 12:00:00 -0400

Lausanne, Switzerland-based Debiotech SA and Neokidney BV, of Amsterdam, have created Nextkidney SA to lead the development and commercialization of Neokidney, a lightweight, plug-and-play, home hemodialysis device.

FDA greenlights Outset Medical’s Tablo for home dialysis

Thu, 02 Apr 2020 13:00:00 -0400

With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.

Cloudcath raises $12M to back at-home peritoneal dialysis monitoring

Thu, 13 Feb 2020 12:00:00 -0500

San Francisco-based startup Cloudcath has raised a $12 million series A round to support commercialization of its first product that enables remote, real-time monitoring for at-home peritoneal dialysis patients. The expectation is that the notifications it offers to health care providers will enable earlier intervention to avoid complications, including infection. The Cloudcath system is pending U.S. FDA clearance.

Researchers develop artificial kidney capable of purifying blood to create its own ‘urine’

Tue, 24 Dec 2019 12:00:00 -0500

Roseville, Calif.-based US Kidney Research Corp., formerly Curion Research Corp., has been working on its waterless renal replacement technology since its inception in June 2015. Its latest research efforts using its novel blood purifying technology have led to the production of the first ‘synthetic urine,’ which mimics the body’s natural production and the kidney’s filtration capability.

Medtronic’s In.Pact AV DCB wins FDA nod

Thu, 21 Nov 2019 12:00:00 -0500

The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.