Dialyze Direct, LLC, a leading provider of staff-assisted home hemodialysis services in skilled nursing facilities with geriatric populations, has signed an agreement to acquire Affiliated Dialysis Centers, LLC, an established dialysis provider with corporate headquarters in Glen Ellyn, IL.
An independent regional provider of dialysis services serving more than 400 patients in Illinois and Ohio, Affiliated Dialysis Centers will effectively double its current patient count under the purchase agreement with Dialyze Direct, said Dialyze Direct CEO Josh Rothenberg.
This acquisition “will propel us as a leader across the nation in staffing for hemodialysis in skilled nursing facilities,” said Alice Hellebrand,
Outset Medical (San Jose, CA) recently completed another round of financing, raising $132 million in Series D equity financing to help accelerate production and commercial expansion of the Tablo Hemodialysis System.
The lead investor in this round of financing was Mubadala Investment Company of Abu Dhabi. Other participating investors in Outset Medical, which launched in 2010, include Baxter Ventures, Fidelity Research and Management, and Warburg Pincus, an early investor.
Featuring real-time water purification and dialysis fluid production in a compact system on wheels, the Tablo dialysis technology can meet patients’ needs at home, in hospitals, and in dialysis centers, Outset
Reata Pharmaceuticals (Irving, TX) has received a $30 million milestone payment from its licensee, Kyowa Hakko Kirin as part of a corporate agreement.
In 2017, Kyowa Hakko Kirin reported positive results from the phase 2 TSUBAKI trial of bardoxolone methyl (bardoxolone) in patients with type 2 diabetes and chronic kidney disease. Initiation of the AYAME phase 3 clinical trial to assess the efficacy and safety of bardoxolone for the treatment of diabetic kidney disease in Japan was the trigger for the payment.
In July 2017, the FDA granted orphan drug designation to bardoxolone for the treatment of Alport syndrome and
As more consumers eschew plastic straws and water bottles, the dialysis manufacturing sector is taking a closer look at the possibilities of reusing resources used in dialysis, including water and plastic. Water is also being analyzed as a commodity that could be used more sparingly throughout dialysis.
John Agar, a nephrologist at University Hospital, Barwon Health, in Geelong, Victoria (Australia), noted that the “total feed water draw per treatment [approaches] about 500 liters (or about 132 gallons) in typical hemodialysis,” and that about 60% of the water is flushed away to drains (1).
The Committee for Medicinal Products for Human Use in the European Union recommended denial of a change to the marketing authorizations already in place for the drugs Opdivo (nivolumab) and Yervoy (ipilimumab), according to the European Medicines Agency.
Bristol-Myers Squibb (New York, NY) asked the committee to consider authorizing marketing for use of both drugs in combination to treat patients with untreated, advanced renal cell carcinoma.
According to the European Medicines Agency, “Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing whether Yervoy contributed
Healthy.io, based in Tel Aviv, Israel, has obtained U.S. Food and Drug Administration (FDA) marketing clearance for its first digital dipstick kit offering. The Dip.io is advertised on the company’s website as having the accuracy of “the standard lab-based urinalysis analyzer.”
The dipstick is being marketed in Europe and is certified by CE and International Organization for Standardization (ISO) 13485 for sale in the European Union. The urinalysis dipstick includes 10 determinations, including indicators for possible CKD, on the strip.
With the FDA nod, Healthy.io stated in its news release: “This approval opens the door for improved screening for kidney
Otsuka Pharmaceutical (Tokyo) has signed a merger agreement to acquire the clinical-stage biotechnology company Visterra (Waltham, MA) for about $430 million in cash.
The company is attractive to Otsuka because of its pipeline of programs, including those targeting IgA nephropathy and other kidney diseases, cancer, infectious diseases, and chronic pain. In IgA nephropathy, the antibody IgA builds up in the kidneys, affecting the glomeruli and causing irreversible scarring of nephrons. The National Institute of Diabetes and Digestive and Kidney Diseases notes that researchers have not found a specific cure for the disease.
A new company is forming to produce treatments for patients with chronic kidney disease (CKD). Subject to antitrust considerations, the merger of Akebia Therapeutics (Cambridge, MA) and Keryx Biopharmaceuticals (Boston, MA) is expected to be complete by the end of the year. The new company will be called Akebia Therapeutics.
The merger is valued at $1.3 billion, notes Pitchbook, a financial newsletter. Under terms of the merger, Akebia shareholders will own a bit more than half of the combined firm, the website FierceBiotech reported.
The strategy behind the merger is severalfold. First, the merger establishes a renal company with an
Manufacturers of two different diabetes drugs have reported positive results recently.
Jardiance (empagliflozin) consistently reduced the risk of new or worsening kidney disease versus placebo, reported a two-member diabetes pharmaceutical alliance.
Boehringer Ingelheim (Ridgefield, CT) and Eli Lilly (Indianapolis) joined forces in 2011 to form an alliance that centers on compounds in “several of the largest diabetes treatment classes,” the companies noted.
The companies shared findings from two new analyses from the long-term EMPA-REG OUTCOME trial of empagliflozin. One analysis showed that patients taking the drug consistently reduced the risk of new or worsening kidney disease when compared with patients
The U.S. Food and Drug Administration (FDA) has granted marketing approval for two catheter devices used in dialysis. Both the everlinQ endoAVF System, which uses two catheters, and the Ellipsys Vascular Access System with a single catheter are designed to create arteriovenous (AV) fistulas, using an energy source to forge the connection between blood vessels in a patient’s arm. Traditionally a central venous catheter for dialysis patients is created through a surgical process. An AV graft uses a tube or cadaveric blood vessel to create a bridge between artery and vein.
The FDA reviewed data for the everlinQ endoAVF System