Xcorporeal, Inc. Announces the XCR-6 Dialysis Platform for Self-Directed Kidney Hemodialysis
2008年11月12日 - 10:30PM
ビジネスワイヤ(英語)
Xcorporeal, Inc. (AMEX:XCR) 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: www.xcorporeal.com. 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
http://www.sec.gov.
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