Outset Medical gets FDA nod for dialysis accessory months after halting sales

Dive Brief:

Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines.
Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance.
BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog.

Dive Insight:

San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020.

The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply water before it’s used for dialysis. The feature adds another layer of prefiltration to the Tablo system, which already incorporates water purification, Thibault wrote.

It’s important for water to be filtered ahead of dialysis treatment to avoid exposing patients to pathogens.

Outset had previously sold the accessory but stopped distribution after receiving a warning letter last year flagging that it needed 510(k) clearance. RBC Capital Markets analyst Shagun Singh expects a “brief period to get TabloCart adoption back on track,” she wrote in a research note.

Last year, Outset indicated that the warning letter had a bigger impact on sales than anticipated, as customers were delaying purchases of Tablo consoles until the company received clearance for TabloCart with prefiltration, Singh wrote.

Outset filed an FDA submission in August. The clearance adds features that “increase the flexibility for nurses and health systems to serve patients from the ICU to the bedside,” CEO Leslie Trigg said in a news release.

Outset’s revenue grew 13% year over year to $130.4 million in 2023, with a net loss of $172.8 million.