Byonyks X1: Revolutinizing Dialysis – Now FDA Cleared and Planning to start Patients in the U.S.

A major regulatory milestone positioning Byonyks as a new entrant in home-based renal care

CHICAGO, Feb. 03, 2026 (GLOBE NEWSWIRE) — Byonyks, headquartered in Chicago, Illinois, has received U.S. FDA 510(k) clearance for its X1 Automated Peritoneal Dialysis (APD) Cycler. Byonyks, through its overseas licenses, has already demonstrated success with 10,000+ therapies worldwide and is now planning to enter the U.S. market. This milestone marks a significant step in the company’s mission to expand access to safe, reliable, and more affordable home-based dialysis technologies under the leadership of Founder and CEO Farrukh Usman.

“Why do we put a needle in the arm of our loved ones? Why do we drag our parents to a dialysis center 3 times a week? Why do they have to feel exhausted at the end of hemodialysis? These people can be treated at home, feel high energy when they get off the machine, and some can return to work and earn income for their families. We have proved that with our patient population.” Farrukh Usman, who lost loved ones on dialysis, left a lucrative career in Boston and started this company to change the world of dialysis.

Byonyks has developed expertise in manufacturing APD Cyclers and Tubing sets, maintains a technical support team, and is now developing operational infrastructure in the USA.

The FDA clearance authorizes commercial use of the X1 system in the United States and validates the device’s safety and performance under FDA medical device standards. The X1 Automated Peritoneal Dialysis (APD) Cycler is designed to deliver automated peritoneal dialysis therapy at home, supporting patients requiring long-term renal replacement therapy while reducing the burden of in-center treatment.

Peritoneal dialysis is a bloodless therapy performed at home, offering patients greater flexibility and an improved quality of life. It also helps preserve residual kidney function for longer. Data from the U.S. Renal Data System show that peritoneal dialysis has a 10% higher survival rate than in-center hemodialysis. Unfortunately, 85% of Americans on dialysis do not receive peritoneal dialysis.

“Every peritoneal dialysis device on the market is 10 to 30 years old. Can you imagine using a 20-year-old phone or car? The FDA’s clearance of X1 heralds a new era. X1 is just a start; the world needs a revolution in peritoneal dialysis, and we are working on it,” said Farrukh Usman, Founder and CEO of Byonyks. Team members at Byonyks are behind many successful dialysis machines and other medical equipment that are used in cities across America.

“This milestone is not limited to introducing a cycler,” said Rod Kenley, Chief Innovation Officer. Operating in the global renal care market, the company is advancing a portfolio of automated peritoneal dialysis systems to improve clinical outcomes and expand access to life-sustaining therapy worldwide. “Our advanced development programs are focused on significantly improving clinical outcomes for peritoneal dialysis patients and addressing many of the factors that limit long-term therapy success,” added Rod Kenley, who holds 100+ patents, established AAMI standards for dialysis, and contributed to the development of several revolutionary dialysis products.

Globally, approximately 86% of people who need dialysis lack access to it. “Byonyks is a dynamic company driven to improve the lives of patients through transformative innovation that expands global access to dialysis, improves biocompatibility, minimizes metabolic impact, reduces infection risk, and lowers the carbon footprint,” said Andrew King, MD, Chief Medical Officer at Byonyks.

Byonyks is a medtech company focused on developing state of the art, home-based dialysis technologies, operating in the global renal care market while expanding access to life-sustaining therapy worldwide.

https://byonyks.com/

Contact information: 
Maheen Sami
Head of Investor Relations
maheen@byonyks.com

Photos accompanying this announcement are available at

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