This is a press release from Renal Solutions:
Renal Solutions™, Inc. Announces FDA 510(k) Clearance of the Allient® Sorbent Hemodialysis System for Chronic and Acute Hemodialysis
The Company Prepares for Home Clinical Trial
WARRENDALE, Pa., June 22, 2005 /PRNewswire via COMTEX/ – Renal Solutions, Inc., the exclusive provider of advanced sorbent hemodialysis products and services for treatment of patients with renal failure, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to begin commercialization of the Allient® Sorbent Hemodialysis System in chronic and acute hemodialysis applications. The Company further announced the approval of an Investigational Device Exemption (IDE) for the initiation of a home hemodialysis clinical trial.
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 1.5 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.
“This clearance to market represents a significant milestone for our customers, employees and investors,” said Peter M. DeComo, Chairman and CEO of Renal Solutions. “We are especially pleased with the broad label indication for use in chronic and acute hemodialysis as prescribed by a physician. We expect the inherent safety and simplicity of the system, in combination with our excellent training and support, to provide significant value to patients and clinicians in a variety of settings.”
The Investigational Device Exemption (IDE) clearance for the initiation of a home patient clinical safety trial represents the attainment of a second important milestone for the Company. This multi-center trial will be conducted in conjunction with several leading institutions in the U.S. An enrollment population of 25-35 home patients is expected under the trial design. The Company has completed agreements with several sites and expects to begin patient enrollment this summer.
“The potential for home hemodialysis is of great interest to us, because patients with kidney failure who today must travel several times per week for dialysis could benefit from an increased cumulative dialysis dose without the inconvenience of leaving home,” said Derrick L. Latos, MD, MACP, Medical Director, Wheeling Renal Care, W.V.
The Company is currently transitioning from research and development to manufacturing and expects initial product availability for both domestic and international distribution in the third quarter.
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. Using sorbent technology and a unique pressure controlled blood movement system, new flexibility is provided in the home and clinical environment.
The Allient® Sorbent Hemodialysis System requires only 6 liters of tap water. This capability eliminates the need for complex technology to create purified water as is necessary with conventional dialysis technology. The Allient System is transportable and can be used anywhere conventional power and tap water can be accessed.
Renal Solutions is a privately held company focused on providing revolutionary products and service for renal failure patients that enhance safety, expand treatment options, improve quality of life and aid in the reduction of total treatment cost. The Allient System has been cleared for sale by the FDA.
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.
SOURCE Renal Solutions, Inc.
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