Xcorporeal Announces Filing of Form 10-K and 2008 Operational Highlights
March 31 2009 - 4:30PM
Business Wire
Xcorporeal, Inc. (NYSE Amex:XCR) announced today that it has
filed its Form 10-K with the Securities and Exchange Commission for
the fiscal year ended December 31, 2008. The Company also announced
operational highlights for 2008.
As a result of the Company�s current financial condition
reflected in its financial statements included in the 10-K, the
Company�s auditors expressed substantial doubt about Xcorporeal�s
ability to continue as a going concern. In the view of the
Company�s management, the Company�s ability to continue as a going
concern is substantially dependent on the successful execution of
many of the actions referred to below, on the timeline contemplated
by its plans and the Company�s ability to obtain additional
financing.
Some of the operational highlights for 2008 include:
- Announcement of new prototype.
The Company launched the XCR-6 Dialysis Platform for self-directed
kidney hemodialysis. The XCR-6 is anticipated to be the smallest,
lightest, and easiest to use dialysis machine, using Xcorporeal's
proprietary closed loop, regenerated dialysate technology platform.
The Company is preparing for unattended/home use clinical trials of
the XCR-6 in anticipation of future commercialization. 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 Company
estimates that the home hemodialysis market represents a
multi-billion dollar revenue opportunity.
- Appointment of a new Chairman
and Chief Executive Officer. The Company named Kelly McCrann to
each position. Mr. McCrann is a senior healthcare executive with
extensive experience in board governance, strategic leadership,
profit and loss management and strategic transactions. He was
recently Senior Vice President of DaVita Inc. (NYSE: DVA), a
leading provider of kidney care services in the United States,
where he was responsible for all home-based renal replacement
therapies for the United States' second largest kidney dialysis
provider.
�We believe the recent cost reduction activities we completed
will allow the Company additional time to complete one or more
strategic transactions with potential partners,� said Mr. McCrann.
�We have significantly reduced our cash utilization, and in
addition to the preliminary discussions we have held with potential
strategic partners, we are focusing our efforts in commercializing
our Portable Artificial Kidney (PAK), which represents the device
that is most cost-effective and furthest along in development.�
On March 13, 2009, the Company announced a cost reduction
program under which it terminated the employment of 19 employees,
or approximately 73%. The layoffs and other efforts focused on
streamlining our operations through a series of initiatives
designed to reduce annual expenses by approximately $3.5 million to
a current operating burn rate of approximately $200,000 per month.
In conjunction with these efforts, the Company announced that it
was focusing its development activities on the PAK, and was
exploring various strategic alternatives, which may include the
license of certain intellectual property rights as a means to
further develop its technologies, among other possible transactions
and alternatives.
About Xcorporeal, Inc.
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 functional prototypes of
subsystems, which are currently undergoing bench testing.
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 demonstration prototype of the XCR-6.
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 in periodicals worldwide such as the Los Angeles Times, Le
Figaro, Frankfurter Algemeiner and Corriere dela Sera. Scientific
papers discussing the WAK have been published in several peer
reviewed journals, including The Lancet and Kidney
International.
Additional Company information may be found on its website 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,
the risk that we may not have sufficient financial resources to
adequately finance the development activities described in the
press release, uncertainty as to the outcome of arbitration and
legal proceedings, intense competition and substantial regulation
in the medical device industry, and additional risk 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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