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OFFICIAL RELEASE
Ash
Access Technology, Inc. Partners with DaVita Clinical Research
to Conduct Pivotal FDA Clinical Trial
Flagship Antimicrobial / Antithrombotic Therapy To Be Evaluated
In DaVita Dialysis Clinics
Thursday, February 16, 2006
8:12 AM EST - - - (Lafayette, Indiana) - Ash Access Technology, Inc., a privately-held
biomedical and medical device company in Lafayette, Indiana, announced
today that it has established an agreement with DaVita Clinical
Research (a subsidiary of DaVita Inc.) to conduct the pivotal Food & Drug
Administration clinical trial for its flagship antimicrobial/antithrombotic
therapy in select dialysis clinics across the United States.
This announcement leverages the recent flow of investment into the
company. Ash Access completed a $6 million Series B round of funding
in January 2006 and received a $2.7 million National Institutes of
Health Fast-Track Phase I/Phase II Small Business Innovation Research
(SBIR) grant to partially fund the clinical trial in August 2005.
The company has also been notified of a $100,000 Phase I SBIR matching
grant from the 21st Century Research and Technology Fund managed
by the Indiana Economic Development Corporation, who provided tax
incentives for Indiana investors participating in the recent Series
B round of funding.
“Collectively, with the DaVita agreement in place, these funding
milestones represent significant forward momentum in our aggressive
path to market,” commented Bob Truitt, President and CEO of
Ash Access Technology, Inc. “We are very excited about the
partnership with DaVita Clinical Research. DaVita is a world class
organization and we are committed to working with partners that will
add great strategic value. DaVita provides dialysis services to over
94,000 U.S. patients suffering from end stage renal disease (ESRD)
and we believe their expertise will help us optimize every aspect
of this FDA clinical trial.”
The trial will consist of 10 study sites, eight of which are associated
with DaVita Inc., and two independent clinics in Bakersfield, CA,
and Lafayette, IN. The trial is a multi-centered study evaluating
the efficacy and safety of Ash Access Technology's antimicrobial
/ antithrombotic therapy for the prevention of catheter-related blood
stream infections (CRBSI).
"CRBSI poses a significant challenge to dialysis patients and
providers. It is a relatively common problem that is difficult and
costly to treat once diagnosed, and is associated with a high rate
of mortality. The Ash Access investigational product, a non-antibiotic
therapy designed to reduce the incidence of CRBSI, may demonstrate
an improvement in the associated morbidity and establish an important
new therapy," said Geoffrey A. Block, M.D., a Principal Investigator
in the Ash Access Technology trial and Director of the Division of
Clinical Research at Denver Nephrologists, PC.
According to the United States Centers for
Disease Control (CDC), the magnitude of CRBSI in the U.S is significant
with an estimated 200,000 to 400,000 episodes annually. Studies
have also shown that mortality rates associated with CRBSI range
from 12 – 25% while
annual healthcare costs associated with treating these infections
may exceed $2 billion.
“Our antimicrobial / antithrombotic therapy has tremendous
potential to prevent life-threatening catheter-related bloodstream
infections and complications. It is an exciting technology that has
demonstrated a high degree of efficacy in preclinical trials against
known antibiotic resistant strains of bacteria, including Staphylococcus
aureus and Staphylococcus epidermidis. Our partnership with DaVita
Clinical Research gives us access to a broad network of experienced
investigators, resources and services,” said Dr. Stephen Ash,
Chairman and Director, Research and Development.
Ash Access Technology, Inc. is a privately-held
company founded to develop antimicrobial and vascular access technologies,
devices and methodologies to combat the deadly and expensive problem
of catheter-related bloodstream infections, with an emphasis on prevention.
Dr. Stephen R. Ash, Chairman and Director, Research and Development,
is a practicing Nephrologist with the Arnett Clinic in Lafayette,
Indiana, and is a world-recognized researcher and patent holder in
extracorporeal devices, sorbent chemistry, and vascular and peritoneal
access devices. Ash Access Technology is located in Lafayette, Indiana
in the INOK Business Center.
This press release contains forward-looking statements, which if
not based on historical facts, involve risks and uncertainties. Our
actual results may differ materially from the results or events stated
in the forward-looking statements, including, but not limited to,
certain events not within the Company's control. |