Outset Medical, Inc.

Outset Medical, Inc. (NASDAQ: OSET) is a medical technology company pioneering transformational dialysis solutions through its proprietary Tablo Hemodialysis System. The company designs and manufactures an integrated dialysis platform that combines water purification, on-demand dialysate production, and advanced software connectivity in a single compact console. Unlike traditional hemodialysis machines that require separate infrastructure and are typically specialized for specific care settings, Tablo operates seamlessly across acute care hospitals, post-acute facilities, and home environments, requiring only a standard electrical outlet and tap water to function.

The Tablo system comprises three core components: the console with integrated purification and touchscreen interface, a proprietary single-use pre-strung cartridge designed for simplified treatment setup in under twelve minutes, and the Tablo Data Ecosystem featuring cloud-based platforms including TabloHub for provider management, MyTablo for patient access, and TabloDash for internal analytics. The data ecosystem enables remote device monitoring, automated clinical recordkeeping, and predictive maintenance through continuous streaming of over 500,000 performance data points per treatment.

Outset's primary market focus has been acute care facilities, where the company reports experience working with nearly 1,000 hospitals. The company is expanding into post-acute care settings including skilled nursing facilities and long-term acute care hospitals, as well as home-based dialysis markets. The company manufactures Tablo consoles and the majority of cartridges at its facility in Tijuana, Mexico, operating under a quality management system certified to ISO 13485 standards. Cartridge components are sourced from approximately thirteen suppliers globally, while console production requires approximately one hundred worldwide suppliers.

Tablo received FDA 510(k) clearance for acute and chronic care facility use and subsequently for home use in March 2020, with design modifications cleared in July 2022. In January 2026, the FDA granted clearance for the company's next-generation Tablo platform. The company holds thirty-three issued U.S. patents and seventy-six issued patents internationally, with expiration dates ranging from June 2027 through April 2042. The company competes against larger, vertically integrated manufacturers including Fresenius Medical Care, DaVita, Medtronic, and B. Braun, differentiating through clinical versatility, operational efficiency, and comprehensive service infrastructure.