Flagship Antimicrobial / Antithrombotic Therapy To Be Evaluated In DaVita Dialysis Clinics
FOR IMMEDIATE RELEASE, February 16, 2006 7:57 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 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 Centers for Disease Control, 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. (www.ashaccess.com) 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, biomed financing, NIH grants