With help from NCI’s Small Business Innovative Research (SBIR) office providing phase I and II funding, Naviscan, Inc., based in San Diego, CA, was able to turn a hunch into a prototype of the company’s flagship product PEM Flex® PET Scanner. From 1994 to 2005, Naviscan used SBIR funding to take its product through the stages of prototype building, clinical trials, and definitive post-marketing trials. Naviscan received FDA clearance in July of 2003, and distributed many of its first units strictly for post-marketing studies and patient/customer acceptance testing. During this period of time, SBIR funding and venture-backed investment kept Naviscan in business. In April of 2007, Naviscan introduced its first commercial unit and had revenues of just under $5 million during that fiscal year. Revenues for FY 2008 are projected to be multiples beyond that of 2007.
"The SBIR program was instrumental in funding the company from an early developmental stage which might have seemed a bit too risky for most venture capital groups,” said Naviscan’s chairman and CEO, Paul Mirabella. “Naviscan’s SBIR-funded research helped us to get through the early phase of the clinical trials required for FDA-clearance, which was opportunistically parlayed into venture-backed funds to facilitate commercialization."
Naviscan’s PEM Flex Scanner utilizes PET technology for the breast cancer clinical application known as positron emission mammography, PEM. The PEM Flex scanner is similar to the size of a mammography unit, and consists of two high-resolution detector heads, mounted directly to breast immobilization paddles, that are positioned to optimize imaging of the breast. The close proximity of crystal detectors and limited angle tomographic reconstruction produces the high resolution images. The PEM Flex has proven imaging resolution of 2.0 millimeters, allowing physicians to visualize breast tumors about the size of a grain of rice. The scanner’s imaging capability enables detection of the earliest stages of breast cancer (in situ) and tumors less than two millimeters in size with very high accuracy and sensitivity (93 percent). This cannot be achieved by any other modality and may be important for early detection and treatment.
“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, Inc. wins the 2009 North American Frost & Sullivan Award for Emerging Technology of the Year
Frost & Sullivan, the Growth Partnership Company, presented Naviscan, Inc. with the 2009 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. Naviscan is the sole company to commercially offer a dedicated PEM scanner.
With help from NCI’s Small Business Innovative Research (SBIR) office providing phase I and II funding, Naviscan launched its first commercial product in 2005 and swiftly introduced in 2007 the Naviscan PET scanner—a second-generation PEM scanner—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. 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.