Simergent Announces FDA Clearance of the Archimedes™ Home Dialysis System

• Archimedes™, a novel automated peritoneal dialysis system which is now FDA 510(k)-cleared, enables bloodless dialysis for End Stage Kidney Disease (ESKD) patients in the home or clinic setting.
• Following a successful human factors usability study affiliated with Northwestern University and Indiana University, the company is planning a U.S. launch of Archimedes in 2026.

OKLAHOMA CITY and CHICAGO, Oct. 14, 2025 /PRNewswire/ -- Simergent, a privately held company dedicated to advancing treatment for patients with kidney failure, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's Archimedes™ automated peritoneal dialysis (APD) system for the treatment of patients with End Stage Kidney Disease (ESKD) in clinical and home settings.

"Innovative, patient-centric technologies like Archimedes™ that simplify care, reduce patient burden, and enhance the home dialysis experience have the potential to transform kidney care and enable more patients to successfully adopt home therapies. Congratulations to the Simergent team on receiving FDA 510(k) clearance for the Archimedes™ automated peritoneal dialysis cycler," stated Dr. Jeffrey Perl, expert nephrologist in peritoneal dialysis care and Editor-in-Chief of the Peritoneal Dialysis International journal.

Archimedes™ is a home dialysis system with a user-friendly interface designed for patient and clinic users with a wide variety of educational and socioeconomic backgrounds. Its 4-hour battery life and integrated mobile cart allows unparalleled in-home mobility while performing dialysis. The patented fluid delivery and measurement technology requires no pump, which supports quiet operation for this nocturnal therapy. Archimedes™ incorporates a patented shroud to support aseptic tubing/bag connections. Its fast 5-minute therapy setup time allows patients to spend less time waiting for the system to perform pre-therapy checks.

"At Simergent, we believe that patients should be allowed to perform dialysis in the comfort of their own homes and not be limited to daytime treatment at a dialysis clinic nor limited to treating in their bedroom at home. Our Archimedes™ system enables in-home mobility to add some normality to patients' lives, helping reduce the burden of dialysis care," commented Steve Lindo, CEO and co-founder of Simergent. "This device gives clinicians a much-needed tool in their toolkit to offer patients a more flexible treatment option with reduced drain suction pressures compared to traditional devices. In addition, it offers hospitals an option to treat patients using their own nursing staff due to our intuitive guided user interface and simple disposable tubing setup. The FDA's clearance validates our approach to patient-centric kidney care."

Archimedes™ will launch in the U.S. in 2026.

About Simergent

Simergent is a medical technology company based in Oklahoma City, OK and Chicago, IL developing innovative devices and digital health systems to improve care for people living with kidney disease. The company's flagship Archimedes™ automated peritoneal dialysis system enables physicians to have confidence that patients can perform treatment in a safe, effective, and accessible manner in their own homes. Simergent's mission is to empower patients to live fuller lives — receiving dialysis at home, on their own schedules — while aiming to address value-based care and improving the user experience. In market research published in the American Society of Nephrology's Kidney360 journal, peritoneal dialysis patients rated the Archimedes system's features with a 98% appeal score — significantly higher than comparable devices' features.

In the U.S., the Archimedes™ system is Rx only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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SOURCE Simergent