NxStage Announces Access to Demographic and Outcomes Information for the Growing...
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NxStage Announces Access to Demographic and Outcomes Information for the
Growing U.S. Daily Home Hemodialysis Patient Population
LAWRENCE, Mass., July 23 /PRNewswire-FirstCall/ -- NxStage Medical, Inc.
(Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today
announced ongoing public access to current summary information derived from a
registry of NxStage patients with end-stage renal-disease (ESRD) who undergo
hemodialysis at home on a more frequent, or daily, basis as an alternative to
the conventional regimen of therapy received three times a week at a dialysis
center.
This unique, quantitative portrait of key characteristics of ESRD patients
who have been receiving daily home hemodialysis, which includes correlation
with survival and kidney transplant relative to that observed with
conventional hemodialysis, reflects more than a thousand patient years of
experience and more than one million treatments. This is believed to be the
largest known database of home hemodialysis patients.
Key statistics from the registry, which are available on the NxStage web
site (http://www.nxstage.com/chronic_renal_care/registry/), include the
following:
-- Survival and transplant rates are notably higher among the NxStage
patient population undergoing daily therapy vs. reported figures for
conventional, less frequent dialysis treatment. NxStage patients on home daily
hemodialysis experienced a better than 50% reduction in expected mortality
compared to the overall U.S. hemodialysis patient population. This observed
difference was statistically significant (P<0.0001).
-- Patients of varied size, age, vascular access type, and geographic
location are participating in home daily hemodialysis, indicating its broad
applicability.
-- 92% of the U.S. dialysis population resides within 60 miles of a center
offering NxStage home hemodialysis training, and nearly 80% are within 30
miles. This indicates that geographic barriers to initiating daily home
hemodialysis are being addressed.
In compiling the survival and kidney transplant analysis, NxStage captured
mortality data from 2,553 patients using the NxStage System One, from over 300
dialysis centers, totaling 1,603 patient years of experience. This data was
then compared to mortality rates reported in the United States Renal Data
System for 2007 using a Standard Mortality Ratio (SMR) methodology, adjusting
for patient age and gender.
According to Dr. Alan Hull, Chief Medical Advisor of NxStage Medical,
"With its unique leadership position in the growing home daily hemodialysis
movement, NxStage has a commitment to share data and insight gleaned from
continuing use of this therapy with patients, physicians and providers. The
information that NxStage is making available, while not derived from a
controlled study, provides a current, accurate picture of who is participating
in daily home hemodialysis and a longitudinal view of the clinical outcome
trends emerging from the growing use of this therapy. We will continue to
enhance collective knowledge about the use of daily home hemodialysis via
ongoing access to our database, which will be updated on at least a
semi-annual basis, as well as our concurrent efforts to definitively establish
long term outcomes via initiatives such as our FREEDOM Study."
The growth of NxStage therapy in the three years since its FDA clearance
for home use has led to a more than doubling of the number of patients
experiencing the potential benefits of home hemodialysis.
"NxStage was founded on our belief in the clinical benefits of daily home
hemodialysis for patients with ESRD," said Jeffrey H. Burbank, President and
Chief Executive Officer of NxStage Medical. "It is gratifying to see these
benefits experienced by our own patients. We are dedicated to improving
patient access to this important therapy, and hope that sharing this current
data with the kidney care community will help build awareness of daily home
hemodialysis, and provide patients and caregivers alike with information that
helps them make informed decisions about their care," said Mr. Burbank.
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, or
ESRD, and acute kidney failure. For more information on NxStage and its
products, please visit the Company's website at http://www.nxstage.com.
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. Examples of these forward-looking statements include statements as
to the benefits of daily home hemodialysis, expectations relating to our
ability to build upon positive clinical data relating to home daily
hemodialysis, expectations regarding our ability to update the data referenced
on a semi-annual basis, and expectations relating to improving patient and
physician awareness, and access to, home daily hemodialysis. All
forward-looking statements involve risks, uncertainties and contingencies,
many of which are beyond NxStage's control, which may cause actual results,
performance, or achievements to differ materially from anticipated results,
performance or achievements. Certain factors which may affect future operating
results are detailed in NxStage's filings with the Securities and Exchange
Commission, including the Annual Report on Form 10-Q for the three months
ended March 31, 2008. In addition, the statements in this press release
represent NxStage's expectations and beliefs as of the date of this press
release. NxStage anticipates that subsequent events and developments may cause
these expectations and beliefs to change. However, while NxStage may elect to
update these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so, whether as a result of new
information, future events, or otherwise. These forward-looking statements
should not be relied upon as representing NxStage's expectations or beliefs as
of any date subsequent to the date of this press release.
Important Additional Information
A special meeting of NxStage stockholders will be held on Thursday, July
31, 2008 to obtain stockholder approval for the second closing of a $43
million private placement in NxStage. In connection with the private
placement and required stockholder approval, NxStage filed with the SEC a
definitive proxy statement on July 8, 2008. This proxy statement was mailed to
NxStage's stockholders on or about July 9, 2008. INVESTORS AND SECURITY
HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS
FILED WITH THE SEC BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT NXSTAGE
AND THE PRIVATE PLACEMENT. Investors and security holders may obtain free
copies of these documents and other documents filed with the SEC at the SEC's
website at www.sec.gov, at NxStage's website at www.nxstage.com or by writing
to NxStage Medical, Inc., 439 S. Union St., 5th Floor, Lawrence, Massachusetts
01843, Attention: Investor Relations.
NxStage, its directors and the affiliates of its directors may be deemed
to be participants in the solicitation of proxies with respect to the private
placement. A description of the interests in NxStage of its directors,
officers and such affiliates is set forth in NxStage's proxy statement for its
2008 annual meeting of stockholders, filed with the SEC on April 29, 2008, and
is included in the definitive proxy statement relating to the private
placement and required stockholder approval filed with the SEC on July 8,
2008. These documents are available free of charge as described above.
Investor Relations Contact
Kristen Sheppard
NxStage Medical, Inc.
ir@nxstage.com
978-332-5923
Media Contact
Jane Hauser
Schwartz Communications, Inc.
nxstage@schwartz-pr.com
781-684-0770
SOURCE NxStage Medical, Inc.
Investor Relations, Kristen Sheppard of NxStage Medical, Inc.,
+1-978-332-5923, ir@nxstage.com; or Media, Jane Hauser of Schwartz
Communications, Inc. for NxStage Medical, Inc., +1-781-684-0770,
nxstage@schwartz-pr.com
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