EDAP suspends U.S. marketing

February 13, 1991

EDAP International has suspended its U.S. marketing effort asit awaits Food and Drug Administration approval for renal andbiliary application of its lithotripter, according to AllisonDolphin, director of regulatory affairs for EDAP in the U.S. Robert

EDAP International has suspended its U.S. marketing effort asit awaits Food and Drug Administration approval for renal andbiliary application of its lithotripter, according to AllisonDolphin, director of regulatory affairs for EDAP in the U.S.

Robert Reeders, former general manager for EDAP's U.S. organization,has left the firm and no replacement has been hired. Olivier Missosse,president of the French company, officially heads up the U.S.operation as well, she said.

EDAP has moved its U.S. headquarters to: Five Sunny Knoll Terrace,Lexington, MA 02173 (phone: 617/674-2030). The firm will maintainits regulatory effort and service of lithotripters at clinicalsites. EDAP recently sent a revised premarket approval submissionto the FDA for renal applications, she said.

"The decision has been made that we will not make anymarketing efforts until we obtain PMA approval for the kidney,"Dolphin told SCAN. "Meanwhile, EDAP continues to maintaina strong position internationally. They have also put a lot ofeffort into research and development of new products."

BRIEFLY NOTED:

  • Imlogix of St. Louis has signed an OEM supply agreementwith Genesys, a Maitland, FL, picture archiving and communicationsintegrator and IBM business partner. Genesys uses the IBM RS/6000workstation as the host computer for its ROI PAC system.

Imlogix will supply more than 100 image display stations forthe ROI PACS, which will be used in stand-alone and multiscreenviewing configurations. The high-resolution displays will be offeredin 1000 x 1000-, 2000 x 2000- and 2000 x 3000-pixel configurations.

Genesys also integrates a Kodak optical disk storage systemand a Du Pont film digitizer in its PACS offering.

  • Schering has signed a development, manufacturing and marketingagreement with Liposome Company of Princeton, NJ, aimed at commercializationof the smaller company's proprietary liposome technology as anonionic radiographic contrast agent. The giant German drug companywill pay Liposome a licensing fee, milestone payments and a royaltyon worldwide sales. If the agent reaches market, the smaller firmhopes to earn $15 million, plus royalties.

The agent will be targeted at computed tomography scanningof liver metastases. Initial studies indicate that the liposomeagent remains in the liver much longer than existing CT contrastagents, according to the U.S. company.

"They (Schering) are the world leader in developing andmarketing imaging contrast agents. They are the only company witha contrast agent field force that markets its products throughits own affiliates in all major pharmaceutical markets of theworld," said Charles A. Baker, chairman and CEO of Liposome.The firm estimates a potential worldwide market for improved CTliver imaging agents of as much as $700 million per year.

  • Diminishing European sales of it x-ray bone densitometerspushed Hologic into the red in its first quarter (end-December)of fiscal 1991. The firm had a loss of $78,000 during the period,compared to net income of $481,221 in the first quarter of 1990.Revenues decreased 1% for the quarter, from $3.92 million in 1990to $3.86 million this year (see graph).

Hologic said increased R&D expenditures for its QDR-2000multi-beam densitometer also contributed to the loss. This unitis being tested at Hologic's facility in Waltham, MA. The companyhopes to begin shipments to outside beta sites shortly.

  • AFP Imaging's sales sagged over the summer, but appearto be on the way back up, the company said. AFP, which sells imagingproducts to the graphic arts and printing markets as well as themedical field, had a loss of $244,000 in its second quarter (end-December)of fiscal 1991. This was down from a net income of $317,000 inthe same period of 1990. Revenues declined by 23% for the quarter,from $12.7 million in 1990 to $9.7 million this year.

Despite the poor financial performance compared to last year,AFP's second quarter loss was two-thirds less than its first quarterloss and revenues increased by about $1 million from the firstto second quarters, the company said.