Tablo® Hemodialysis System Cartridge Receives FDA 510 (k) Clearance for Production in North America
Cartridge manufacturing at the new site localizes production, lowers costs and mitigates future supply chain risks
Departure Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company reducing the cost and complexity of dialysis, today announced that the United States Food and Drug Administration (FDA) has granted 510 clearance (k) for a new method of sterilizing the cartridge used in its Tablo® hemodialysis system, allowing full production in North America. The Tablo Cartridge is a single-use, disposable product that works in conjunction with the console to deliver dialysis therapy. Its “one touch” design makes it quick and easy to set up and remove therapy.
The new FDA clearance allows Outset to start production of cartridges through a manufacturing partner in Mexico, making it easier to locate the cartridge, in addition to the Tablo console, in North America. Additionally, the new location reduces the need for costly, limited capacity air transport of cartridges, simplifying distribution and logistics for the company, its customers and patients.
“This clearance is an important milestone on our roadmap for continued gross margin expansion,” said Leslie Trigg, President and CEO of Outset. “In addition to reducing costs, we are also better able to optimize our manufacturing process and mitigate current supply chain challenges with respect to lead time, capacity and logistics. ”
Another benefit of FDA clearance is the ability to start using an environmentally friendly method of sterilizing cartridges. The electron beam is a non-ionizing technology that can be produced on demand and does not involve toxic or potentially explosive chemicals. Further details on Outset’s sustainability efforts can be found in the company’s recently released report. ESG report.
About Outset Medical, Inc.
Outset is a medical technology company developing unique technology to reduce the cost and complexity of dialysis. The Tablo hemodialysis system, approved by the FDA for home hospital use, represents a significant technological advance that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a unique business solution that can be used across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. Integration of water purification and on-demand dialysate production enables Tablo to serve as a wheeled dialysis clinic, with two-way wireless data transmission and a proprietary data analysis platform fueling a new holistic approach to dialysis care. Tablo is a registered trademark of Outset Medical, Inc.
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include statements regarding Outset’s strategy, plans and objectives. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results and other events to differ materially from those expressed or implied in such statements. These risks and uncertainties include the risks described in the Risk Factors section of Outset’s latest annual report on Form 10-K and the quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Outset disclaims any obligation to update these forward-looking statements.