NeoVision inks U.S. Surgical pact for ultrasound-guided breast biopsy

Cash crunch sidetracked company last year

Ultrasound developer NeoVision appears to be back in the saddleafter a cash-flow crunch last year forced the company to retoolits product development schedule. The Seattle company took advantageof the American College of Surgeons meeting in San Francisco thismonth to debut its lead product, Sonopsy, as well as a new marketingrelationship with interventional device firm U.S. Surgical.

NeoVision appeared on the medical imaging scene two years agowith Mammography Medical Fusion (MMF), a 3-D imaging device thatcombines a mammography system with an ultrasound scanner and real-timeultrasound-guided needle breast biopsy (SCAN 9/28/94). The firmhad hoped to have the product on the market by 1995, but was sidetrackedwhen it ran out of financing last year, according to presidentand CEO Peter Crosby.

NeoVision got back on its feet earlier this year thanks toa private stock placement, and in September hired Crosby, whowas chief executive of Australian ultrasound vendor Ausonics inthe late 1980s. Prior to joining NeoVision, he worked for pacemakercompany Telectronics Pacing Systems of Denver.

As part of NeoVision's new strategy, the company renamed MMFas Synopsis, and moved it further back in the product developmentpipeline due to the complexity involved in integrating mammographyand ultrasound images. The company's lead product now is Sonopsy,which was shown as a work-in-progress at the ACS meeting.

Sonopsy employs the same ultrasound scanner that is used inSynopsis, but dispenses with the mammography system. Sonopsy isdesigned for breast imaging and biopsy guidance through 3-D andreal-time ultrasound imaging. The ultrasound scanner used in bothSonopsy and Synopsis is a gray-scale system designed by NeoVision.

Patients imaged with Sonopsy are seated and lean against apadded gantry that incorporates a breast compression paddle, abiopsy gun, and an ultrasound transducer, shaped like a flat plate,on which the patient's breast rests. Like mammography systems,Sonopsy uses compression to immobilize the breast while generatingmultiple slices of ultrasound data that are reconstructed into3-D images. Sonopsy employs a 6 to 9-MHz broadband annular arraytransducer, which is better for 3-D image reconstruction thana linear array, Crosby said.

Using compression gives Sonopsy advantages over freehand ultrasound-guidedbiopsy techniques, according to Crosby.

"Because the breast is held in compression, you don'tneed to stabilize it in the same way that you do with hand-heldultrasound," he said. "Because the image generationis in multiple slices, you don't have the challenge of correlatingthe image on a screen with where your hand is pointing in space,as you do with hand-held ultrasound."

Sonopsy generates a 3-D ultrasound image that can be correlatedwith a standard x-ray mammogram. If a lesion is determined tobe suspicious, clinicians can use the system to provide real-timeultrasound guidance to place biopsy needles.

This is where U.S. Surgical comes in. The Norwalk, CT, companywill work with NeoVision to adapt its Advanced Breast Biopsy Instrumentation(ABBI) system to Sonopsy, and has sales and marketing rights forSonopsy systems that are sold with the ABBI devices.

NeoVision retains rights to sell Sonopsy systems without ABBI,and it will use a network of dealers and distributors to marketthe product. The company has received 510(k) clearance for Sonopsy,but must finalize ultrasound power measurement data before itcan begin shipping, Crosby said. NeoVision will follow its ACSdebut with an exhibit at the Radiological Society of North Americameeting, the first time the company has participated in the Chicagoconference.

NeoVision plans to emphasize the benefits of ultrasound-guidedbiopsy over x-ray-guided techniques, including digital spot mammographysystems.

"The advantages of ultrasound over x-ray is that ultrasoundis real-time, while x-ray is snapshot," Crosby said. "Evenwith the digital systems, (x-ray) is still fairly slow."