Hey, y’all, how’s this for cool?! New press release just out. I couldn’t find a photo. (We’ll have to see if these folks will sponsor our site when their machine gets closer to market. :-))
Xcorporeal, Inc. Announces the XCR-6 Dialysis Platform for Self-Directed Kidney Hemodialysis
New Machine Makes Home-Based Dialysis a Reality for Millions of Patients Worldwide
Last update: 8:30 a.m. EST Nov. 12, 2008
LOS ANGELES, Nov 12, 2008 (BUSINESS WIRE) – Xcorporeal, Inc. (XCR:0.32, +0.02, +6.7%) 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.
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
– 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 A- 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: http://www.xcorporeal.com.
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 http://www.sec.gov.
SOURCE: Xcorporeal, Inc.
Chief Financial Officer
Dan Klores Communications