A Medical Device Daily

Guardian Technologies International (Herndon, Virginia), innovators of threat detection technology with applications for the homeland security and healthcare markets, reported that it has partnered with Howard University Cancer Center (Washington) and the University of Southern California Image Processing and Informatics Lab (IPILAB; Los Angeles), to submit a $12 million, three-year Impact Grant to the Department of Defense (DoD) for the development of a predictive model for visualization of onset and progression of breast cancer in African-American women.

The teaming agreement is a collaboration of healthcare organizations, specialized corporate technologies and clinical information for this proposal. The team includes experienced clinical, technical and managerial personnel from all three institutions.

"Not only are we honored to be partnering with Howard and USC, we believe that this is also a major validation of our own next generation technology and its ability to potentially help millions of women suffering from breast cancer," said Michael Trudnak, CEO of Guardian Technologies International. "We look forward to this collaboration and believe that ultimately it is a sign of many more positive events to come for our shareholders."

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among women in the U.S. Mammography is a reliable and cost-effective technology, when properly conducted it has been estimated to reduce breast cancer mortality by 20%-30%. Until Guardian's signature mapping software solution, reading mammograms was difficult and prone to interpretation subjectivity and misreads.

Guardian recently announced a milestone patent filing for a vital component of the signature mapping (Medical Device Daily, June 26, 2007). Signature mapping is an advanced analysis and visualization technology that can read images from any medical imaging device to detect disease states in the brain, lungs, heart, prostate and can even visualize breast cancer in difficult to distinguish dense breast tissue.

The new grant, when completed, will create an African-American longitudinal mammography knowledge database including all screening and diagnostic mammography images, radiology and pathology reports for each normal and cancer patient; the database will be expanded from 260 to 1,300 patients which will include both normal and confirmed cancer patients.

The objective of the grant, which is expected to be bestowed by December 2007, is to save or prolong the lives of African-American women who develop breast cancer. The development of an enhanced, easy-to-use mammographic detection methodology is an additional goal and with additional large-scale testing, the technology can be moved into clinical use.

In contract news:

• Reflect Scientific (Orem, Utah), reported that Image Labs International , a wholly owned subsidiary of Reflect Scientific, has been awarded a contract to provide four more imaging and analysis systems to a U.S. military customer.

"These systems are part of our key customer program; we are excited to see the continued confidence of the U.S. military in the Image Labs technology and our dedicated development team," said Brian Smithgall, managing director, Image Labs International.

Image Labs International makes scientific equipment in the areas of automated inspection, measurement and material handling. Reflect Scientific provides scientific products for the biotechnology, pharmaceutical and medical industries.

• Dialog Medical (Atlanta), a provider of informed consent and patient education systems for hospitals and physician practices, reported a new contract for its iMedConsent application with Resurrection Health Care , an eight-hospital system serving the Chicago area.

iMedConsent includes procedure-specific consent forms for more than 2,100 medical and surgical procedures; patient education documents for thousands of diagnoses and treatments; and an extensive anatomical image gallery that allows the physician to annotate images and simplify complex topics for the patient. In addition, the application automates the completion of patient documentation ranging from HIPAA disclosures to advance directives, including the digital capture of signatures, paperless storage of signed documents and electronic notation in the patient's medical record.

Resurrection Health Care bills its family of health care services as providing advanced medical care and exceptional customer service with compassion and hope.

• Encorium Group (Wayne, Pennsylvania) said that it has recently signed two new clinical trial contracts for women's health indications. The aggregate value of the contracts is about $3 million. The trials, which represent repeat business for Encorium with a U.S. based biotechnology company, will be conducted in Europe. Encorium will provide multiple services including project management, site management and monitoring, data management, biostatistical support, and medical writing. Revenue recognition will begin during the current third quarter and continue on a proportional performance basis over the life of the contract as services are performed. Encorium is a global clinical research organization that designs and manages complex clinical trials and patient registries for the pharmaceutical, biotechnology and medical device industries.