Device will incorporate optical, x-ray technologyLaser-based mammography imaging developers face an upward climb toward both commercialization and market acceptance, and every bit of support from the clinical community helps. One of the
Device will incorporate optical, x-ray technology
Laser-based mammography imaging developers face an upward climb toward both commercialization and market acceptance, and every bit of support from the clinical community helps. One of the technologys developers, Canadian high-tech firm Aerospace Research Technologies (ART), scored a coup this month when it formed an alliance with Massachusetts General Hospital (MGH).
Under the terms of the three-year deal, ART of Montreal and MGH of Boston will work together to develop a low-cost diagnostic device that incorporates laser-based optical technology similar to that used in ARTs screening system, SoftScan, with x-ray technology. The unit will be used to provide better lesion detection for women undergoing routine mammograms, and for other applications besides mammography in the future, according to ART.
The alliance strengthens both ART and MGH, according to Paul Bisson, president and CEO of ART.
MGH has a lot of clinical experience with using light in tissue, while we have good technical experience, Bisson said. MGH will contribute clinical expertise and staff, and well contribute funding and technology.
The deal with MGH wont derail ARTs work on SoftScan, its original laser-based mammography imaging unit, however. A noninvasive mammography imaging method, SoftScan trains a laser light source on one side of the breast, while a detector on the other side picks up the light as it is transmitted through the tissue (SCAN 6/10/98). The device uses a stationary, near-infrared light source to create 3-D images. SoftScan is now in phase II clinical trials; when it enters phase III, ART will begin to prepare data for North American regulatory approvals.
Key advantages for SoftScan are that the technology does not use x-rays and does not require compression of the breast tissue during a scan. But ART plans to use its ongoing clinical trials to show that SoftScan brings another benefit to the market: It can image dense breast tissue as well as x-ray technology.
If we claimed that SoftScan can do everything that x-ray, MRI, and ultrasound can do (for breast imaging), regulatory approval would take 10 years, Bisson said. So were starting with smaller claims, particularly that SoftScan is as good as x-ray in imaging dense breast tissue.
ART has company in its quest to develop an optical-based mammography system. Imaging Diagnostic Systems (IDSI) of Plantation, FL, has also been working on a laser-based unit (SCAN 11/22/95). IDSIs Computed Tomography Laser Mammography (CTLM) system has an integrated array of 168 detectors and a laser beam that rotates around the breast to create 3-D tomographic images with no compression of breast tissue, according to IDSI. The company has placed CTLM at a second clinical site, the University of Virginia at Charlottesville, and expects to complete its phase I clinical trials early next year. IDSI plans to meet with the FDA to discuss its premarket approval application, which it expects to submit to the agency by mid-2000.
Despite the competition, ART is confident in the direction its business is going. In fact, it plans to go public in the first half of 2000, and is considering applying for listing on the NASDAQ stock exchange. It would use funding from an initial public offering to finance its R&D efforts and clinical trials, and intends to seek partnerships with major medical imaging manufacturers.
The company hopes that its alliance with MGH will help bring its optical laser technology to market more quickly and boost its clinical credibility as well. The partners plan to seek regulatory approval for the hybrid unit within three years of their collaboration. Once the new unit receives clearance, ART will have the option to market it under conditions to be determined by ART and MGH. ART expects to sell the device to OEMs, Bisson said.