Healthcare Industry News:  hemodialysis 

Devices FDA

 News Release - June 8, 2006

Renal Solutions(TM), Inc. Announces FDA 510(k) Clearance of the Allient(R) Sorbent Hemodialysis System for Chronic and Acute Hemodialysis

WARRENDALE, Pa., June 8 (HSMN NewsFeed) -- Renal Solutions, Inc., the exclusive provider of advanced sorbent hemodialysis products and services for treatment of patients with renal failure, announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of the Allient® Sorbent hemodialysis System, including the SORB(TM) series and HISORB(TM) series cartridges, for chronic and acute hemodialysis applications. The FDA clearance of the Allient System addresses recent system enhancements which enable improved reliability and performance.

"Our new approval further demonstrates that Renal Solutions is on the leading edge of innovation and improvement in hemodialysis delivery," said Peter M. DeComo, Chairman and CEO of Renal Solutions. "By combining advanced hemocompatible materials in the Pulsar(TM) Blood Pump with the inherent benefits of sorbent therapy, Renal Solutions is poised to introduce new dialysis treatment options with the latest technology," Mr. DeComo stated.

Dr. James Antaki of the Carnegie Mellon University (CMU) Laboratory on Innovation and Optimization of Medical Devices has been closely involved with performance optimization of the Pulsar(TM) Blood Pump. "We are successfully capitalizing on over 20 years of experience in improving multiple aspects of blood pump design and function," said Dr. Antaki. "The unique, pressure- limited, two chamber Pulsar(TM) Pump is the first significant step forward in dialysis blood pump design in several decades," Dr. Antaki continued.

The Allient System opens new treatment options to dialysis professionals and patients by virtue of its ability to provide short, standard or extended duration hemodialysis therapy using just 1 & 1/2 gallons of ordinary drinking water. Numerous clinical studies have shown that an increased cumulative dialysis dose results in better patient outcomes. The Allient System provides the increased dose advantage without the need for an independent water system or large volumes of sterile fluid. This translates into increased transportability, flexibility and ease of system use.

About Renal Solutions, Inc.

Renal Solutions, Inc., a medical device and health-care service company, is commercializing a revolutionary technology/service solution for the chronic and acute dialysis market and has a distinct competitive advantage as the exclusive provider of dialysis products and services utilizing sorbent-based toxin removal technology and a unique pressure controlled blood movement system.

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 Company's 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.

Source: Renal Solutions

Issuer of this News Release is solely responsible for its content.
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