Naviscan - PET Scan Technology

How SBIR Helped Naviscan Develop Next-Generation Imaging Technology

Naviscan, Inc. developed a flagship product, the PEM Flex® PET Scanner, which uses PET technology for the breast cancer clinical application known as positron emission mammography, PEM.

The PEM Flex is about the size of a mammography unit and consists of two high-resolution detector heads mounted directly to breast immobilization paddles that optimize imaging. The close proximity of crystal detectors and limited angle tomographic reconstruction produces high-resolution images. The PEM Flex has proven imaging resolution of two millimeters, allowing physicians to visualize breast tumors about the size of a grain of rice. The scanner can detect the earliest stages of breast cancer in situ with more than 90% accuracy and sensitivity.

SBIR Impact

From 1994 to 2005, Naviscan used NCI SBIR Phase I and II funding to prototype the technology and conduct clinical and post-marketing trials.

“The SBIR program was instrumental in funding the company from an early developmental stage, which might have seemed too risky for most venture capital groups,” said Naviscan Chairman and CEO Paul Mirabella. “Naviscan’s SBIR-funded research helped us to get through the early phase of the clinical trials required for clearance from the U.S. Food and Drug Administration, which led to venture-backed funds to facilitate commercialization.”

In 2005, the company launched its first commercial product and, two years later, introduced the PEM Flex as well as the revolutionary Stereo Navigator™ PEM-guided biopsy system. Both technologies represent industry-firsts that introduce new benchmarks to the performance and accuracy of molecular imaging and modality-guided biopsy, respectively. Naviscan had revenues of just under $5 million in the first year following commercialization.

“The SBIR grant and contract processes helped to facilitate collaborations with academic sites to initiate clinical studies,” added Mirabella. “These studies were then able to generate excitement about the technology and its applications in the academic and venture capital communities.”

Naviscan Today

Thirteen years of research and development, clinical trials, and post-marketing efforts serve as a testament to the company’s unwavering vision and steadfast dedication to addressing unfulfilled needs within the women’s health community.

In 2009, Naviscan won the North American Frost & Sullivan Award for Emerging Technology of the Year. The award recognizes the company’s impressive progress in developing to market a next-generation, breast-specific PET scanner and adjunct biopsy guidance system that is set to redefine the standard of care for breast cancer patients.

Learn more on Naviscan's website.