A Medical Device Daily

ZumaTek (Durham, North Carolina), a breast imaging company, reported it received a Small Business Innovative Research (SBIR) Phase 1 grant award from the National Cancer Institute of the National Institutes of Health (NIH) to continue research on the development of dedicated imaging technologies for enhanced 3-D lesion detection.

The awarded project for $100,000 (grant number 1R43CA125924-01A1), which will focus on solving challenges related to imaging the full breast, chest wall, and axillae, was funded for a twelve-month period and could potentially lead to additional funding from an SBIR Phase II award to take the technology closer to commercialization.

“The SBIR Phase I grant money will allow us to focus on the pioneering work that was started at Duke University [also Durham],” said Dr. Randolph McKinley, CEO and the grant’s principal investigator. “ZumaTek was formed to commercialize the successful work on these next generation, patient-friendly and information rich scanners so we can get the technology in the hands of the medical community and greatly aid both in the detection of early cancers and the diagnosis and monitoring of disease.”

Currently, the mammogram is the most widely used tool for breast cancer screening with a market size of $1.5 billion worldwide. ZumaTek’s technology, dubbed mammotomography, has a number of significant advantages over a mammogram, according to the company. It could replace the mammogram as the primary screening tool for breast cancer detection, and also be used as the primary diagnostic tool in breast cancer patient management.

“We can detect subtle changes in breast cells before a lump can be felt by hand or seen with X-ray mammography,” said Dr. Martin Tornai, Zumatek co-founder and associate professor in the Departments of Radiology and Biomedical Engineering at Duke University Medical Center. “Earlier detection is meant to enable doctors to more successfully treat breast cancer before it has formed a tumor or spread to lymph nodes. This is a major advancement that could save lives and improve overall quality of life.”

ZumaTek’s technology is designed to improve a radiologist’s ability to detect certain cancers by providing several views of the breast from many different angles and reconstructing the image into a 3-D volume set. This enables the detection of tumors that are otherwise hidden by overlapping anatomical structures. The technology may also be used in conjunction with certain treatments to improve delivery and monitoring of therapeutics.

In contract news:

The Encorium Group (Wayne, Pennsylvania) a company that designs, develops, and manages complex clinical trials and patient registries for pharmaceutical, biotechnology and medical device companies, reported the awarding of new business contracts with an aggregate value of about $4 million.

These contracts are for developmental support of new clinical trials and various changes-of-scope for existing studies. The predominant therapeutic areas included in these contract awards are oncology, cardiovascular diseases, and biologics/vaccines. Services to be provided are varied and include project management, field monitoring, data management, statistics, medical writing, and quality assurance.