Vendor to begin education efforts this summerThe Food and Drug Administration this month approved ATL's premarketapproval (PMA) application for using its Ultramark 9 HDI scannerto differentiate solid breast lesions, prompting a sharp spikein the
The Food and Drug Administration this month approved ATL's premarketapproval (PMA) application for using its Ultramark 9 HDI scannerto differentiate solid breast lesions, prompting a sharp spikein the Bothell, WA, vendor's stock price. The FDA's action givesATL a free hand to promote the use of the technology in differentiatingbreast lesions.
ATL announced the PMA approval on April 12, almost two yearsafter the FDA granted the application fast-track review status(SCAN 5/18/94). In a two-year multicenter study that ATL sponsoredto support the PMA, clinical investigators found that certainsuspicious breast masses imaged with Ultramark 9 HDI scannershad structural characteristics that allowed them to be characterizedas malignant or benign without the need for biopsy (SCAN 12/27/95).ATL believes that the technique could reduce the number of breastbiopsies by 40%.
News of the PMA approval lit a fire under ATL's stock, sendingit up $5 to close at $35 a share the day of the announcement,a 17% increase. It later settled back to around $32 last week.The approval also garnered ATL considerable coverage in the consumerpress.
ATL now has the go-ahead to include claims related to differentiatingsolid breast lesions in promotional and educational materials,according to Dick Tabbutt, director of outcomes research. Tabbuttemphasized that the FDA's ruling does not affect how physicianscan practice medicine, but rather how ATL can market its products.
ATL will take a two-pronged approach in getting the word outabout the PMA, Tabbutt said. The vendor is developing self-educationmaterials for Ultramark 9 HDI sites that will allow the sitesto train themselves in using ultrasound to differentiate solidbreast masses. ATL's educational materials will include videotapesand an instructional book, in addition to a test that will allowthe sites to earn continuing medical education credits if theypass. ATL plans to begin distributing the materials in early summer.
In addition, ATL plans to sponsor courses on the technologyat major academic institutions, with one series on the East Coastand another on the West Coast. The courses should begin in latesummer or early fall.
"Our primary marketing thrust is in the area of educationand in disseminating as much information as we can to the clinicalcommunity about this application," Tabbutt said.
ATL does not plan any advertising specifically promoting itsnew-found application, although solid lesion differentiation willbe included in general women's health advertising as one of thecapabilities possible with ATL technology, according to Jane Hedberg,director of marketing communications.
"I don't think an ad would be the appropriate place to(promote the application)," Hedberg said. "It's moreof a clinical discussion or an educational discussion, not anadvertising claim."
That may come as a relief to some of ATL's competitors, whohave been warily following the company's progress in breast ultrasound.Several are worried that ATL could grab a commanding lead in thebreast ultrasound segment by heavily touting the lesion differentiationclaim.
ATL plans to expand the PMA by filing a supplement that willextend the application to its newer HDI 3000 scanner. That shouldbe filed in several weeks, Tabbutt said.
The company also hopes to gain FDA approval to promote HDIfor differentiating lesions as small as 5 mm. Its current indicationis for lesions 1 cm and larger.
For that indication, ATL hopes to use data from the multicenterclinical study, although it may also sponsor one or two additionalstudies, both to gain more clinical information and to assessthe economic impact of using ultrasound rather than biopsy todifferentiate lesions.