Company sees niche in superficial scanningDevelopers of ultrasound breast imaging systems may have another player in their midst if Longport of Swarthmore, PA, has its way. The firm expects to apply for 510(k) clearance this month for a
Company sees niche in superficial scanning
Developers of ultrasound breast imaging systems may have another player in their midst if Longport of Swarthmore, PA, has its way. The firm expects to apply for 510(k) clearance this month for a high-frequency ultrasound device, Longport Digital Scanner (LDS), which will be targeted at what Longport believes is an untapped market niche: monitoring treatment of pathologies that are best imaged with detailed scans of surface areas.
The portable, digital LDS scanner functions at 20 MHz, capturing and reproducing images of soft tissue down to 2 cm. The unit can produce images with axial resolution of 65 microns and lateral resolution of 200 microns, according to Bonita Weyrauch, Longport's clinical trial coordinator. The images are stored in a laptop computer and can be e-mailed off-site for interpretation.
The company has developed LDS with specific applications in mind, particularly wound management, identification of potential pressure ulcers, and detection of metastasizing cancer in patients diagnosed with malignant melanoma. But Longport would also like to expand the device's applications to the rehabilitation of patients with known breast pathologies, such as women who have already had lumpectomies, mastectomies, or reconstructive surgery.
Longport was established in 1993 by Jim McGonigle, the company's president and CEO, for the purpose of marketing wound-care products. The company opened its own wound healing center in its first year of operation, but when the facility became financially infeasible, the company shifted its focus to providing consulting and management services to other wound centers in existing healthcare facilities.
In 1995, Dr. Mary Dyson of Guy's Hospital, United Medical Dental Schools in London, U.K., contacted Longport in hopes of establishing an alliance to develop LDS. Longport and UMDS entered into an agreement in which UMDS gave Longport exclusive marketing rights in North America, and in September 1997 Longport acquired the patent for the technology.
Longport hopes LDS will enable physicians to assess the status of a wound without having to cut the patient or use an invasive probe. LDS includes software that measures the depth and width of a wound in millimeters and creates a fractal signature for a particular wound or lesion that identifies its characteristics so that physicians can better track its response to treatment. Longport expects to receive clearance for the scanner this spring and will rent the unit primarily to private physician offices and outpatient centers.
The firm believes that LDS is the first ultrasound device to image the skin, and its portability and real-time imaging capabilities are strong selling points.
"With LDS, physicians can scan immediately and make an interpretation of the data in real-time. This is a digital system-everything runs off a laptop and is processed by e-mail files-so it's true telemedicine," Weyrauch said.
The company also believes that the system would be useful for breast applications, particularly for patients with known breast pathology. LDS could help physicians track patients' progress after reconstructive surgery, mastectomies, or lumpectomies and could also help doctors catch lymphodema before it develops.
Last month, Longport signed an agreement with physical therapy company Mammosource of Marlton, NJ, to explore the commercial viability of LDS in breast pathology applications. Using LDS units placed in its facilities, Mammosource will gather clinical data, sending the information to its own interpretation centers for processing. If LDS proves itself in the breast imaging arena, Longport expects to establish a joint venture with Mammosource in which Mammosource would have exclusive North American marketing rights to the system as a breast pathology scanning unit.