The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company.
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.
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.
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 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.
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.
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 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.”
Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially.
