Gamma Medica seeks to popularize breast scintigraphy

Gamma cameras complement mammography

Nuclear medicine has not fared well on its own in women's health. That may be why Gamma Medica has taken a different tack. The Northridge, CA, company has fashioned its gamma cameras to work within existing medical practice.

Rather than serving as a freestanding medical device, Gamma Medica's pint-sized LumaGEM attaches to x-ray mammography equipment-upright diagnostic units as well as stereotactic biopsy tables. A second product, the GammaCAM/OR, couples with an articulating arm built into the operating room. With this configuration, surgeons can home in on cancer, localizing the sentinel lymph node and potentially improving patient outcomes.

The idea, according to company president Bradley E. Patt, is to bring nuclear medicine to the patient instead of the patient to nuclear medicine.

"The future of scintimammography requires specialized gamma cameras designed specifically to improve the diagnosis and localization of small lesions-cameras that can be used easily in the practice of medicine," Patt said.

A key feature of these future devices, he said, is ergonomic design. Unlike general-purpose cameras, which can be large and bulky, GammaCAM/OR and LumaGEM are compact. They can be positioned close to the breast and angled to avoid background radiation from the heart, liver, and other organs. Their tightly focused field-of-view delivers high-resolution images of areas containing suspicious lesions found on screening or diagnostic mammography that are being tracked for stereotactic biopsy or localized for surgical excision.

The LumaGEM system sells for about $150,000. It includes a mounting kit for placement of the camera on a mammography gantry, to enable partial breast compression for optimum scintimammography imaging. The GammaCAM/OR system, which includes a real-time video camera guidance system for precise localization of suspicious lesions and a complete nuclear medicine acquisition and processing station, is priced under $200,000.

Although LumaGEM, which cleared the FDA in late 2000, was focused initially on radiologists specializing in nuclear medicine, general radiologists and surgeons form the larger market, Patt said. Consequently, the company is targeting hospital radiology departments as well as freestanding mammography clinics. It hopes to sell about 20 systems during 2002.

To achieve this objective, the company is attempting to sign between 20 and 30 dealers that sell and service traditional mammography systems and related products. Each will be assigned a specific geographic area, performing both installation and routine maintenance of Gamma Medica products.

Despite obvious opportunities, Gamma Medica faces an uphill battle. Its two products are designed to fill niches that are only beginning to form, although the utility of nuclear medicine is becoming recognized. Research has documented, for example, that conventional mammography has trouble imaging dense breasts. This is not a problem, however, for scintimammography, as demonstrated at several sites, including two that use Gamma Medica products.

Los Angeles County Harbor-University of California, Los Angeles Medical Center in Torrance, CA, uses scintimammography as part of its women's healthcare program, and Gamma Medica equipment is part of the effort. The same is true at Hamot Medical Center in Erie, PA. More than 100 patients have been evaluated in studies at the two sites, and results have been encouraging for the continued use of Gamma Medica products, Patt said.

"Their use in helping to diagnose breast cancer as an adjunct to mammography is emerging," he said. "I anticipate a trend toward the use of scintimammography as a primary screening tool for dense breasts that are mammographically difficult to diagnose."