Published: February 16, 2006
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
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.
Keywords: DaVita, DaVita Clinical Research, dialysis, FDA clinical trial,
catheters, CRBSI, ESRD, Indiana, IEDC, biotech, biomed, medical device
companies, biomedical financing, NIH grants
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