Giotto prepares ‘patient-friendly’ product for digital mammography market in U.S.

Less than two years after its establishment, Giotto USA is planning the release of a full-field digital mammography (FFDM) system. Company executives are planning strategy around a 2005 launch of the product.

The company is undaunted by the presence in the U.S. of FFDM systems developed by four competitors. Giotto's unique design will win over customers, according to Bob Rusk, president of the firm.

"We think the market will be there and that we'll be able to capture a nice percentage of it," Rusk said.

Giotto's work-in-progress Image FFDM system features a tilting circular gantry that provides an open environment for the patient and enables imaging close to the breast wall. Image is tagged by the company as an example of "patient-friendly mammography." It offers inclined positioning and "sensitive" compression of the breast to reduce patient discomfort.

The versatile digital system is designed to support standard mammography as well as prone stereotactic biopsy. It features an amorphous selenium detector outfitted to allow minimal time between exposures.

Giotto plans to submit its premarket approval application to the FDA any day, according to Rusk, who said he'd be disappointed if the Image system, which is manufactured by International Medico Scientifica (IMS) of Bologna, Italy, was not on the market by later this year.

IMS has been selling the unit for about a year in Europe, South America, and China, he said. About 20 systems have been installed.

Giotto began developing the Image FFDM about five years ago, around the time GE came to market with its Senographe, which was the first full-field digital system to receive FDA premarket approval. But being first to market can be a disadvantage, just as coming late to market can be an advantage, Rusk said.

"If you're first with a marginal product, you could actually hurt yourself," he said. "In the case of GE, they came into the market with a (19 x 23 cm) amorphous silicon system, and there are a lot of disadvantages to that."

Giotto strategists have no worries about picking up market share once the Image receives FDA approval.

"If we were worried about gaining a foothold in the marketplace, we wouldn't have started Giotto USA," he said. "Even if we just had another me-too mammography machine, I think we'd be able to take market share away on the strength of our distribution channels alone. But ours isn't another me-too system."

The system's design will benefit patients, technologists, and breast centers alike, Rusk said. He once predicted that other manufacturers would follow suit once they saw the benefits of a circular gantry system. But he has begun to hedge, acknowledging that momentum established by the companies already in the marketplace will likely keep them on track with their proprietary designs.

"There are an awful lot of people with considerable psychological and financial investment in existing systems," he said. "And there are people who have never done a mammogram, maybe never seen a mammogram done, who design products and defend their ideas."

Some companies may, however, be convinced to follow Giotto's example.

"My belief is that other people are going to ultimately see that (this design) is so positive that they will follow suit," Rusk said.