Nxstage Medical's Home Dialysis System Gets FDA Go-Ahead - Analyst Blog
One of the leading manufacturers of innovative dialysis products – Nxstage Medical, Inc. (NXTM) – recently secured the U.S. Food and Drug Administration (FDA) approval for its home nocturnal hemodialysis product – System One.
The Nxstage System One is cleared by the FDA to perform hemodialysis overnight while the patient is at home, making it the first and only hemodialysis machine cleared for this indication.
Shares of the Lawrence, MA-based company rallied 2.3% in the trading session following the news but closed lower at $18.06 the next day. One-year return of the stock stands at a striking 82.1%.
Home nocturnal hemodialysis offers several lifestyle and clinical advantages. Therapy during sleep allows the patient to pursue other activities during the day, thereby lessening the overall burden of the treatment. A longer, overnight therapy also allows greater flexibility in dialysis dose and schedule, thus enabling physicians to better match the dialysis prescription to individual patient needs.
The NxStage System One helps make home therapy, including home nocturnal hemodialysis, more accessible. FDA-clearance of the system will open home hemodialysis therapy to new segments of patients, and improve care for End Stage Renal Disease (ESRD) patients by expanding therapeutic options and flexibility.
The Nxstage System One received CE Mark approval back in Feb 2013, following which the company began marketing the system in the European countries in the second half of 2013. Notably, Nxstage Medical is actively preparing for a full U.S. market launch in support of this expanded indication in 2015.
Last month, the company launched Streamline Express – a gamma sterilized dialyzer for the in-center hemodialysis market. The device allows even distribution of fluids and solutes, hence making it more effective in the course of treatments. Attached with a blood tubing set, the dialyzer also helps reduce touch point contamination sites.
The single use Streamline Express dialyzer is definitely an improvement over the company’s previous dialyzer which was used in the System One machines. The previous dialyzer required a separate tubing set (cartridge).
However, Nxstage Medical is not the only player in the hemodialysis market. The System One product competes against the offerings of Gambro – a subsidiary of Baxter International Inc. (BAX), and Fresenius Medical Care AG & Co. KGAA (FMS).
Currently, Nxstage Medical carries a Zacks Rank #3 (Hold). ICU Medical, Inc. (ICUI) is a better-ranked stock in the medical products industry with a Zacks Rank #1 (Strong Buy).
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