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PHT's LogPad System Selected By Asthmatx to Collect Endpoint Data in Pivotal Asthma Trial; Innovative Market-Leading eDiary Solution Features Automated Eligibility Requirement Criteria Calculations

Posted on: Tuesday, 6 September 2005, 15:01 CDT

PHT Corporation, the leading provider of electronic patient reported outcome (ePRO) solutions used in over 170 trials worldwide, announced today that Asthmatx, Inc. has chosen PHT's market-leading LogPad System to collect endpoint data in a pivotal Asthma Intervention Research (AIR 2) trial. The pivotal study will investigate the safety and effectiveness of a novel device-based procedure in subjects with severe asthma who are symptomatic despite being managed with conventional therapy. Both wireless and analog LogPads, using hand-held Palm(TM)devices, will be provided to subjects in five countries incorporating multiple daily diaries in four languages.

"We selected PHT primarily because of its experience with respiratory trials and the ease-of-use of its LogPad System," said Narinder Shargill, Ph.D., Vice President of Clinical Affairs at Asthmatx. "Because this is a pivotal trial, it is imperative that we work with an ePRO provider with knowledge of the respiratory and standardized questionnaires in our trial. We also appreciated that PHT was able to demonstrate the flexibility, willingness and expertise needed to meet our dynamic trial requirements with an innovative solution."

One such innovation is the ability for the LogPad to provide automated eligibility requirement criteria in order to facilitate subject inclusion/exclusion decisions for sites. The LogPad also automates other calculations critical to the study's endpoints, and generates immediate subject and site alerts in order to encourage subject diary compliance and enhance trial management efficiencies.

"The LogPad provides tremendous tangible benefits to clinical trials of all phases," said Phil Lee, President and CEO of PHT Corporation. "The high quality of timestamped eSource data and the simple, intuitive user interface of the LogPad are especially important for respiratory trials where frequent assessments are critical to supporting efficacy. Subjects need an easy way to record their symptoms and sponsors need to know that the diary data entered by patients is timely and accurate."

The pivotal trial will deploy later this year on Palm's new Tungsten E2 and TREO wireless devices.

About Asthmatx, Inc.

Asthmatx, Inc. is focused on developing technology to help patients with asthma breathe easier. Asthmatx designs, develops and manufactures medical devices for the treatment of asthma, a condition that affects over 20 million people in the United States. Asthmatx has developed the Alair(R) System, which consists of a single-use treatment catheter that is attached to a controller that delivers radiofrequency energy to airway walls during a bronchoscopic procedure known as Bronchial Thermoplasty(TM). The Alair System provides a novel investigational treatment approach to asthma that applies controlled heat to the airway wall to reduce the amount of airway smooth muscle and restrict its ability to narrow the airway. Asthmatx is currently conducting a pivotal study to establish the safety and efficacy of the Alair System for the treatment of asthma (www.AIR2Trial.com).

CAUTION: The Alair System is an Investigational device. It is limited by Federal (United States) law to investigational use. To be used by Qualified Investigators only.

About PHT Corporation

PHT Corporation is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in over 170 trials worldwide. More than 65 biopharmaceutical and medical device companies, including 13 of the top 15 drug development firms in the world, rely on PHT's innovative and comprehensive ePRO solutions for their Phase I-IV clinical studies. PHT's integrated Product Suite enables successful clinical trials by improving data quality, reducing data variance, and providing real-time access to the data collected. FDA and other regulatory authorities have approved new drug applications that include endpoint data collected using PHT's Product Suite. PHT's experience includes more than 75,000 subjects at 9,000 clinical sites in 61 languages and 59 countries around the globe. PHT is headquartered in Charlestown, MA, and Geneva, Switzerland. To learn why more biopharmaceutical and medical device companies choose to rely on PHT over any other ePRO provider, please visit www.phtcorp.com.

LogPad and PHT are registered trademarks of PHT Corporation. Palm is a trademark of Palm, Inc. (C)PHT Corporation.

Source: Business Wire

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