Market Dynamics

Market Landscape

CMS is rapidly moving toward a reimbursement structure that will eventually manage all ESKD patients under an “at-risk” insurance plan. The race to deliver the highest value is on. The design and cost innovations that Byonyks brings to the market will extend patients’ tenure on peritoneal dialysis as opposed to in-center haemodialysis, leading to cumulative savings ($15,000 per patient per annum). Numerous companies are working with commercial payers to improve value in the care of chronic kidney disease (pre-ESKD).

Currently, the peritoneal dialysis market is served by two national manufacturers.   This duopoly has yet to compete either on quality or price, leading to a nationwide demand for a new entry into the marketplace to disrupt the status quo.  Indeed, there have been progressive price increases that have further challenged the profitability of both large and small dialysis provider organizations which are already besieged by higher labor costs post-COVID.  The Byonyks solution, innovation at a competitive price, is generating heavy demand as evidenced by the ever-expanding list of interested early adopters. 

US Govt. Push towards Home Dialysis

The time to bring a solution to market is now. Recent U.S. regulatory change creates a paradigm shift towards kidney treatment at home that gives Byonyks an enormous tale winds. In 2019, the US Secretary of Health and Human Services signed an executive order where he targeted 80% of dialysis patients to receive a transplant [there are very few donors available to make that happen] OR to receive treatment at home over the next 3 years. Today the home dialysis treatment number is only 14%.

US is at 12% and Guatemala is at 56% PD patients. US needs to do better.

Alex Azar Former United States Secretary of Health and Human Service

Worldwide, 75% of End-Stage Kidney Disease (ESKD) patients have no access to dialysis therapy!*

Of all the 11 million kidney failure patients across the world, 8.4 million are unserved; They all die!​

This harsh reality persists in numerous countries across the globe, where countless individuals live in perpetual dread of mortality due to the absence of even the most fundamental treatment for kidney failure. Here at Byonyks, we empathize with the profound impact of a life deprived of cost-effective, home-based dialysis, and we’re committed to making a difference.

*Couser WG, Remuzzi G, Mendis S, Tonelli M. The contribution of chronic kidney disease to the global burden of major noncommunicable diseases. Kidney Int. Dec 2011;80(12):1258-1270.

*https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease#_ENREF_3

History of Peritoneal Dialysis