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Saturday 15 November 2008
NxStage(R) Achieves Milestone with 3,000 End-Stage Renal Disease Patients Receiving Daily Home Hemodialysis TherapyPatient adoption of daily home therapy continues to grow; Positive data supports broader acceptance within ESRD community. LAWRENCE, Mass., Nov. 3 /PRNewswire-FirstCall/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced that 3,000 end-stage renal disease (ESRD) patients are now prescribed to receive therapy using its NxStage(R) System One(TM), the first truly portable home hemodialysis machine. This latest milestone represents 35% growth in patient adoption since the end of 2007. The NxStage System One is now available at hundreds of dialysis centers in markets throughout the United States."We are pleased by the continuing, annual increase in patient adoption of daily home hemodialysis (DHD) with the NxStage System One," said Jeff Burbank, President and Chief Executive Officer of NxStage Medical, Inc. "This validates our strategy to build sustained growth by working closely with patients and their care-providers in key markets while continuing to broaden nationwide access. It is exciting to see how DHD with the NxStage System One is benefiting the lives of patients. The latest significant evidence of this impact are the just-released interim results of our landmark FREEDOM study, which show that NxStage's DHD therapy significantly improves patients' health-related quality-of-life in terms of recovery time, depressive symptoms and overall health-related quality-of-life, in comparison with conventional, thrice-weekly in-center hemodialysis treatment." The NxStage System One is the first truly portable hemodialysis system cleared for home use by the FDA. Unlike traditional dialysis equipment, the System One plugs into a standard electrical outlet, requires no special infrastructure to operate and is easy to use by trained patients accompanied by their trained partners. Rather than commuting to and from a dialysis clinic three times per week for scheduled treatment sessions lasting three to four hours, patients who use the NxStage System One have the personal freedom to conduct prescribed treatments at home on their own schedule and to bring the System with them when they travel. The System One works in concert with NxStage's PureFlowTM SL dialysate preparation system, a compact, easy-to-use system that prepares high-purity dialysate from regular tap water, helping to make daily home hemodialysis even more practical and accessible to patients. The PureFlow SL eliminates the need for bagged dialysate in the home, while still allowing patients to use bagged fluids when they travel. About NxStage Medical NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of End Stage Renal Disease (ESRD) and acute kidney failure. For more information on NxStage and its products, please visit the company's website at About End-Stage Renal Disease End-stage renal disease is the permanent failure of the kidneys to filter the body's wastes. It is most commonly caused by diabetes, hypertension, or genetic disorders. In order to survive, ESRD patients must use some form of therapy to replace the function of the kidneys for the rest of their lives. Currently, over 450,000 patients in the United States suffer from ESRD, and the costs of treating ESRD patients are over $20 billion annually in the U.S. Due to increases in diabetes, hypertension, and the aging of the U.S. population, those figures are projected to double within the next 10-15 years. The most common form of kidney replacement therapy in the United States today is hemodialysis, which is used by over 350,000 patients. The great majority of these patients are treated with conventional, in-center hemodialysis, in which they must travel to a nearby dialysis center three times per week, where they are connected to dialysis machines for treatments lasting approximately three to four hours, to cleanse their blood. About Hemodialysis Today, most patients undergo hemodialysis therapy three times a week in outpatient dialysis centers. This differs significantly from the 24/7 workings of the naturally functioning kidney. Increasingly, clinicians and patients have recognized opportunities for therapy improvements with more frequent, or daily, dialysis. Hundreds of clinical papers have reported on the health and quality of life benefits of hemodialysis done more frequently. The reported benefits include reduced hypertension, reduced cardiac strain and left ventricular hypertrophy, reduced amyloid disease, and improved anemia status, appetite, and quality of life, including the ability to return to work. A summary of the literature discussing these benefits can be found on NxStage's website, Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including, but not limited to: expected growth in home daily hemodialysis and market acceptance of the NxStage System One, anticipated growth in ESRD patient numbers, the anticipated impact and results of the FREEDOM study and other factors that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2008. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. Investor Relations Contact Kristen Sheppard NxStage Medical, Inc. ir©nxstage.com 978-332-5923 Media Contact Jim Weinrebe Schwartz Communications, Inc. nxstage©schwartz-pr.com 781-684-0770 SOURCE NxStage Medical, Inc. Web Site: New Machine Makes Home-Based Dialysis a Reality for Millions of Patients Worldwide  LOS ANGELES--(BUSINESS WIRE)--Xcorporeal, Inc. (AMEX:XCR - News) announced today the XCR-6 Dialysis Platform for self-directed kidney hemodialysis. The XCR-6 will be the smallest, lightest, and easiest to use dialysis machine ever conceived, using Xcorporeal’s proprietary closed loop, regenerated dialysate technology platform. The Company is currently preparing for unattended/home use clinical trials of the XCR-6 in anticipation of commercialization in the near future.The XCR-6 was developed through extensive research and represents a significant improvement compared with equipment currently utilized by patients suffering from chronic renal failure. The technology will, for the first time, allow dialysis providers to "bring the therapy to the patient" because the XCR-6 uses an extremely small amount of tap water; requires no special plumbing or water processing plants; runs on standard household electricity; is the size and weight of a small household appliance; is easy to learn and use as all tubing is integrated into a single proprietary cassette that snaps into place with one hand and retains all fluids within the disposable cassette, facilitating clean up. The Company estimates that the home hemodialysis market represents a multi-billion dollar revenue opportunity. “We are extremely excited to announce the XCR-6,” said Kelly McCrann, Chairman and Chief Executive Officer of Xcorporeal. “The XCR-6 represents the culmination of years of research and development activities in an attempt to change the lives of patients living with kidney dialysis on a daily basis. With its compact size, allowing it to fit into an airline carry-on compartment, the days of patients requiring Center visits for dialysis are numbered. Our ability to deliver a simple, robust, portable, cost-effective solution will finally remove the barriers to home-based hemodialysis services.” Unlike conventional, single pass dialysis machines that require 50 liters or more of dialysate generated by a large water purification plant, Xcorporeal’s unique approach requires only 6 liters of dialysate, generated from readily available tap water, and then recirculated in a closed loop to attain the same toxin clearance rates as conventional single pass machines. About Xcorporeal Xcorporeal, Inc. is a medical device company developing an innovative extra-corporeal platform technology to be used in devices to replace the function of various human organs. The platform leads to three initial products: a Portable Artificial Kidney (PAK) for hospital based Renal Replacement Therapy, the XCR-6 for home hemodialysis, and a Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis. For the hospital market, Xcorporeal is developing a portable, multi-functional renal replacement device that will offer cost-effective therapy for those patients suffering from Acute Renal Failure, which causes a rapid decline in kidney function. In the U.S., the disease affects more than 200,000 patients annually with a mortality rate approaching 50%, according to a study published in the Clinical Journal of American Society of Nephrology in 2006. The Company has completed a functional prototype of the product, which is currently undergoing bench testing, and anticipates submitting 510(k) filings, for the device and attendant disposable components, with the Food and Drug Administration (FDA) during 2009. The Company also plans to commercialize the XCR-6, a home hemodialysis device, for the chronic End Stage Renal Disease (ESRD) market, comprised of patients in whom the kidneys have ceased to function. The Company’s devices are intended to combine the best attributes of currently marketed home hemodialysis machines to offer patients convenient, durable and truly portable treatments at home. The Company believes its devices will provide a cost-effective alternative to current home treatment modalities, due to their ability to offer hemodialysis without the need for large quantities of dialysate fluid or purified water. The Company has also completed a functional prototype of the XCR-6, which is currently undergoing bench testing, and anticipates submitting a 510(k) with the FDA during 2010. The Company’s WAK is also a device for the chronic treatment of ESRD. The Company has successfully demonstrated a prototype system that weighs less than 6 kg., is battery operated, and can be worn by an ambulatory patient. This miniature, wearable device is intended to enable continuous (up to 24 hours × 7 days per week) renal replacement therapy at home. Increasing dialysis time has previously been shown to reduce morbidity and improve quality of life of ESRD patients. The WAK has been featured in articles written by the Los Angeles Times, The Lancet, Kidney International, and various other medical periodicals. Additional Company information may be found on the Internet at: Forward-Looking Statements Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, the risk that our technology may not be effective, uncertainty as to the outcome of arbitration and legal proceedings, intense competition and substantial regulation in the medical device industry; and additional risks factors as discussed in the reports filed by the Company with the Securities and Exchange Commission, which are available on its website at MULTIMEDIA AVAILABLE Contact: Investor Relations: Xcorporeal, Inc. Robert Weinstein Chief Financial Officer 310-923-9968 IR©xcorporeal.com or Public Relations: Dan Klores Communications Tim Sullivan 212-981-5234 tim_sullivan©dkcnews.com (Source: Yahoo Finance) Are Phosphate Binders Any Better? "Take a look at this video blog on what Jeffrey S. Berns, MD, from the Hospital of the University of Pennsylvania has to say about Phosphate binders." Slowing kidney disease Davita Shows you How to Reduce Potassium from Potatoes
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