RENAL SOLUTIONS RECEIVES FDA CLEARANCE TO MARKET NEW SORBENT DIALYSIS CARTRIDGES

 

Warrendale, PA, October 2, 2003 – Renal Solutions, Inc., the leading provider of sorbent-based hemodialysis products and services, today announced receiving 510(k) clearance from the FDA to market their new and enhanced version of the SORB and HISORB sorbent regenerative hemodialysis cartridges.  These sorbent hemodialysis cartridges are enhanced versions of the current SORB and HISORB Cartridges and allow for higher dialysate flow rates and improved electrolyte dynamics.  The Sorbent Cartridge is a key component of sorbent hemodialysis systems. The cartridges regenerate dialysate so that only 6 liters of potable tap water are necessary for an entire hemodialysis treatment. “This FDA clearance of the new SORB and HISORB cartridges represents a major milestone in the process of developing and providing an array of new and exciting products available to the dialysis community.  This new technology will help to stimulate a paradigm shift making hemodialysis more feasible in the home environment,” said Peter M. DeComo, Chairman and CEO of Renal Solutions.

 

About the Company

www.renalsolutionsinc.com

Renal Solutions, Inc., a medical device and health-care service company, is developing a revolutionary technology/service solution for dialysis market and has a distinct competitive advantage as the only provider of dialysis products and services utilizing sorbent-based toxin removal technology.  Using sorbent dialysate regeneration; hemodialysis can be delivered in a variety of clinical settings. The sorbent hemodialysis system requires only 6 liters of potable tap water. This capability eliminates the need for complex technology to create a purified water source as with conventional dialysis technology.  The sorbent hemodialysis system is transportable and can be used anywhere 110V power and potable tap water can be accessed.  Renal Solutions is a privately held company focused on providing revolutionary products and service for renal failure patients that improve quality of life and aide in the reduction of the total cost of treatment. 

 

This press release contains forward-looking statements, which if not based on historical facts, involve risks and uncertainties.  Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control.  Events which could cause results to differ include, failure to meet on-going developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with the FDA/regulatory approval process, adverse changes to reimbursement, for the companies products/services and delays with respect to market acceptance of new products/services and technologies.  Other risks may be detailed from time to time but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.