Date: Thu, 18 Dec 1997 20:00:12 GMT Server: Stronghold/1.3.4 Ben-SSL/1.3 Apache/1.1.3 Content-type: text/html Content-length: 2712 Last-modified: Mon, 14 Jul 1997 05:24:38 GMT 510K acceptance

AKSYS, LTD. ANNOUNCES 510(K) FILING OF AKSYS PHD(TM) SYSTEM ACCEPTED BY FDA FOR FORMAL REVIEW

LIBERTYVILLE, Ill., July 17, 1996 -- Aksys, Ltd. (Nasdaq-NNM: AKSY) today announced that the Company has received telephone notification from the U.S. Food & Drug Administration (FDA) that the Section 510(k) premarket notification filing for the Aksys PHD(TM) Personal Hemodialysis System has been accepted for formal review. By so doing, the agency has determined that the data and documentation supplied with the submission are adequate to warrant such a review. This does not provide any assurance that 510(k) clearance will be obtained and the FDA can still request additional data, including clinical data, during the review process. "We are very pleased that the FDA has decided to accept our 510(k) application for review," stated Lawrence H.N. Kinet, Chairman and CEO of Aksys. "We look forward to further meetings with the FDA as the Aksys PHD system moves through the regulatory process." In April and in May the FDA had declined to file the Aksys application placing it on administrative hold and had requested additional data in support of the filing. Aksys responded to this request by providing a supplement and in late May, met with personnel at the agency to discuss the application resulting in the current decision to file it for review.

Aksys, Ltd. is developing hemodialysis products and services for patients suffering from kidney failure. These products and services include the Company's lead product in development, the Aksys PHD(TM) Personal Hemodialysis System designed to improve clinical outcomes of patients, reducing mortality, morbidity and the associated high cost of patient care. The PHD approach to the treatment of kidney dialysis patients is simple: more dialysis is better than less, daily treatment is better than less frequent, and the patient's home is the best location for a chronic therapy.

 

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