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AAT-023 Clinical Trial Update
Issue 1, August 1, 2006

We’re on our way!

It is hard to believe that eight years have passed since we began the work which led us to this, our pivotal clinical trial for our AAT-023 product. This is indeed a very exciting time for Ash Access Technology, and we are grateful for you and your contributions to this effort.

As you know, bringing medical devices through conception, design, trials and regulatory approval is no small task. Yet when the team believes it has a product which provides a real solution to real-world problems, it can accomplish such bold goals… and our team believes just that.

Each of us in this business has a heart for the challenges ESRD patients face. In addition to the struggle to maintain a patient’s health through the disease’s complications, the issues that arise from the treatment itself add to those challenges.
Catheter-related bloodstream infections is one of the most prevalent problems for hemodialysis patients using chronic central venous catheters. We believe that AAT-023 will effectively address this problem, thereby making a significant contribution to the health and well-being of these patients we serve.

To our knowledge, ours is the first clinical trial protocol approved by the FDA to examine the safety and effectiveness of an antimicrobial/antithrombotic catheter therapy such as this. Our excitement is only increased by the feedback we have received from the National Institute of Health in its review of our grant application for this trial (see inset below).

So, now is the time. On July 17th, our first patient started treatment on the trial in Lafayette, Indiana. Bakersfield, California has brought three more in their early efforts...and now, just 396 more to go! We have worked diligently to not only design a good product, but we have worked equally hard to put together a world-class team to execute our trial. And to you, the members of that team, we say “Welcome.” You can expect us to bring the resources necessary to successfully complete this trial. We have included a roster of our trial management team on the second page of this newsletter. We need your expertise and strong support to enroll patients, execute the trial protocol and complete the appropriate data reporting. This newsletter will serve as one source of information for trial updates and enrollment status to assist you in your efforts. We’re also planning to highlight each of your research sites. Stay tuned, there will be more to follow throughout the course of the trial.

From all of us at Ash Access Technology, we are glad you’re on the team, and we look forward to working with you in the months ahead!

Robert B. Truitt
President & CEO

Stephen R. Ash
Chairman of the Board
Director of R&D

Roland K. Winger
Vice President,
Engineering & QA

A quote from the NIH review panel:

“There is no question that the use of tunneled central venous catheters will not disappear, since it provides a quick and generally reliable temporary access for dialysis… About 9% of patients develop catheter-related bacteremia per month… and nearly all will have an episode of CRBSI within 6 months.

Morbidity and mortality associated with CRBSI are significant… Development of a safe and effective antimicrobial and antithrombotic solution would represent an important advance in the management of patients on dialysis.

The application is therefore considered highly significant."

Enrollment Progress
Dr. Kopelman, Bakersfield, CA
Dr. Al-Makki, Lafayette, IN
Dr. Block, Denver, CO
Dr. Fadem, Houston, TX
Dr. Hariachar, Hudson, FL
Dr. Henriquez, Bronx, NY
Dr. Khwaja, Whittier, CA
Dr. Posner, Baltimore, MD
Dr. Rogers, Ocala, FL
Dr. Stephanz, Provo, UT

Trial Management Team:

Averion (Trial Management and Monitoring)
Rita DeVico, CCRA
Jimmy Brown, CPA
Sean Darcy, RN
Christie Morgan, CRA
Elizabeth Morrison, CRA
Holly Vidrine, RN, CRA
Steve Schmitz, MD

StatKing Consulting (Data Management)
Marla Hoelle, RN
Dennis King, PhD
Rod Lashley
Melanie Lienesch
Wendy Williams

Medical Monitors
Linda Francisco, MD
Monnie Wasse, MD, MPh

DaVita Clinical Research
Amy Young, CCRC
Deb Coffey, LPN
Lisa Korth
Lynnelle Murrell, RN, CCRP

National Institute of Clinical Research
Tarek Dessouky, MD
Joél Barra, CRC

Regulatory Affairs Associates
Steven Goldner, JD, RAC

Ash Access Technology, Inc.
Roland Winger, PE
Dan Olson

Did you know?

The AAT-023 study protocol specifies that the data required for screening patients is obtained from the patient’s regular monthly lab. It is required that patients be enrolled no more than 14 days after the labs are drawn. As most sites run all of their patients’ monthly labs at the same time, it is important to focus on what we call “The 14 Day Window.” This window makes it extremely important to consent, screen and make ready a full slate of patients in anticipation of that month’s upcoming lab draw. Once the 14 Day Window closes for that month, new enrollments must wait until the following month.

As with all trials, the quality and pace of enrollment are two critical items for success. Please let us know how we can support you in your enrollment efforts. Also, feel free to share your thoughts on how to optimize the 14 Day Window.