LINCOLNSHIRE, Ill., Oct. 5 /PRNewswire-FirstCall/ -- Aksys(R), Ltd. , a pioneer in innovative dialysis systems, today announced the on-time delivery of the first integrated prototype of its next-generation personal hemodialysis system, known as G-2. The G-2 system is expected to replicate the impressive safety record, ease-of-use, and demonstrated clinical benefits of Aksys' current PHD(R) System while providing best-in-class reliability, minimal installation costs and low manufacturing costs. The prototype was delivered on schedule, meeting an internal milestone.
Howard J. Lewin, Aksys' President and Chief Executive Officer, commented, "We are pleased to have reached this critical milestone on schedule. The delivery of this prototype that incorporates patented technologies from both Aksys and DEKA represents an important step in the joint R&D program. Based on our current timeline, we anticipate the commercial launch of our G-2 system in the first half of 2009."
In November 2005, Aksys announced a program agreement with Dean Kamen's company, DEKA, to develop the G-2 system with the goal of developing the best- in-class at-home dialysis system for people suffering from end-stage renal disease (ESRD).
Dean Kamen, President of DEKA, stated, "The current prototype integrates all the sub-systems of the G-2 system, including dialysate pumping system, ultrafiltration, chemical mixing, and blood handling. The integrated prototype gives us the opportunity to test the appropriate software and the system's functioning with blood samples. We are very excited and look forward to continued success in the R&D collaboration with Aksys."
For more than 20 years, DEKA Research & Development Corporation, founded and led by Dean Kamen, has been successfully creating and integrating state- of-the-art technologies to develop and commercialize advanced FDA-approved medical devices, DEKA has worked with industry leading companies to introduce new technologies that help transform people's lives. DEKA's team of engineering professionals is dedicated to creating solutions that meet critical needs through the innovative application of advanced technologies.
Aksys, Ltd., designs, develops, and markets innovative hemodialysis products and services for patients suffering from kidney failure. The Company's next-generation system, known as the G-2 system, is being designed to leverage the safety record, ease-of-use, and clinical benefits provided by the original PHD System, while significantly improving reliability and lowering costs. Patients with ESRD who dialyze at home benefit from improved quality of life, reduced mortality, and morbidity while reducing the associated high cost of in-hospital or in-clinic patient care. Further information is available on Aksys' website: http://www.aksys.com .
This press release contains forward-looking statements that involve a number of risks and uncertainties. Our actual results could differ materially from the results identified or implied in any forward-looking statement. These statements include, without limitation, statements regarding the expected capabilities and benefits of the Company's G-2 system, statements regarding the expected margins and service costs of the Company's G-2 system, statements regarding the anticipated commercial launch date of the G-2 system, and other statements containing words such as "expects" and words of similar import or statements of management's opinion. These forward-looking statements reflect our views as of the date they were made with respect to future events and financial performance but are subject to many uncertainties and factors that may cause our actual results to be materially different from any future results expressed or implied by such forward-looking statements. Any of these risks could make it difficult for us to produce the G-2 system on satisfactory commercial terms, if at all, and could adversely affect the price of our common stock and our business, financial condition and results of operations. We believe factors that could cause such a difference include, but are not limited to, the following: (i) our ability to obtain sufficient capital on acceptable terms to run our business; (ii) risks and uncertainties relating to our ability to satisfy the continued listing requirements of the Nasdaq Capital Market; (iii) risks relating to our ability to comply with regulatory clearances and approvals required to manufacture, market, and sell the current PHD system and the G-2 system, and the potential adverse impact on our company of failing to maintain or obtain any such clearances and approvals; (iv) uncertainty about the acceptance of the G-2 system by both potential users and purchasers, including without limitation, patients, clinics and other health care providers; (v) risks related to uncertain unit pricing and product cost, which may not be at levels that permit us to be profitable; (vi) risks related to quality control issues and consistency of service applicable to both systems; (vii) market, regulatory reimbursement and competitive conditions; (viii) risks related to the failure to meet additional development and manufacturing milestones for the G-2 system on a timely basis, including, without limitation, manufacturing and servicing cost reduction efforts; (ix) potential errors, design flaws or other problems with the G-2 system; (x) changes in QSR requirements; (xi) risks related to our ability to protect our intellectual property rights, operate without infringing the proprietary rights of others and develop additional patentable technology; and (xii) other factors detailed in our filings with the SEC, including our recent filings on Forms 10-K, 10-Q and 8-K. We do not undertake to publicly update or revise our forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.