Lunar creates direct German base

U.S. bone densitometry firm Lunar established a German subsidiaryin July to boost sales and improve service in the vendor's largestEuropean national market. While densitometry reimbursement hasdropped dramatically in Germany over the last several years, businessopportunities remain, according to Hans-Volker Eckardt, managingdirector of Lunar GmbH of Nauheim, Germany.

"It (German reimbursement for densitometry procedures)is on a constant drift downwards," Eckardt told SCAN. "Froma level in 1988 of 300 deutsche marks per patient, (reimbursement)went down to 200, 100, 60--until today it stands at 48 d-marks."

Physicians can still operate profitably, however, by usingnewer and faster densitometers, he said. Improvements in densitometertechnology have increased the speed and economics of bone instrumentationwhile improving diagnostic quality.

Lunar will install its first Expert densitometer/imager systemin Germany later this year, Eckardt said. Expert provides a digitalx-ray imaging capability and significantly increased scan times.

Over 200 bone densitometry systems out of about 850 (not includingQCT) installed in the German market are Lunar systems, he said.Many German users, however, still operate old nuclear dual-photonand single-photon absorptiometry units. These systems are ripefor replacement both because of their slow speed and changes inreimbursement. The German government will cease paying for DPAand SPA procedures at the end of next year.

"This year we have replaced three or four old gadoliniumsystems. As the (nuclear) source runs out, doctors say they wouldrather go with a new system (than replace the source)," Eckardtsaid. "Gadolinium systems can take from 10 to 25 minutesfor a spine (scan). DPX (Lunar's first x-ray-based densitometer)took four-and-a-half minutes. Now, with Expert, they will getbetter results in less than 30 seconds."

Expert, shown as a works-in-progress at the 1992 RadiologicalSociety of North America meeting, has been under application forU.S. 510(k) market clearance from the Food and Drug Administrationsince early this year, according to Leonard S. Avecilla, directorof marketing for Lunar in Madison, WI.

The Expert system utilizes a rotating anode tube and solid-statedetectors on a C-arm, which provides what the company labels as"near-radiographic" images. Lunar expects to upgradethe system eventually to full digital radiography and CT capabilities.Images provided along with the densitometry data allow for easieridentification of structures, such as bone edges, intervertebralspaces and osteophytes in the spine, Avecilla said.

Once approved for sale in the U.S., Expert should list forabout $140,000 compared to a range of $60,000 to $90,000 for DPXunits, he said. But Lunar's largest installed base lies in Europerather than the U.S.

"It is very important for us to have a more direct presencehere in order to be closer to the large installed base,"Avecilla said. "Our direct operation in Germany is anotherstep toward better maintaining the installed base--eventuallythroughout Europe--as well as keeping our customers in the fold.We have other products that we are coming back to the installedbase with."

Other Lunar products include Expert as well as the Achillesultrasound densitometer. Lunar has also signed an agreement tosell Esaote's extremity MR imager, although only in the NorthAmerican market (see story above).

Expert should help expand Lunar's German user base. Currently,about 80% of the vendor's users are orthopedists, Eckardt said.The rest are a mixture of nuclear medicine specialists, radiologistsand endocrinologists. Providing an imaging capability with Expertmay increase interest among the radiologist segment, he said.

BRIEFLY NOTED:

• Molecular Biosystems (MBI) of San Diego received Japanesemarket approval for its cardiac ultrasound imaging agent Albunex,the company reported this week. The new drug application was filedby MBI's Japanese licensee Shionogi & Co., which plans toinitiate sales once a National Health Insurance price is establishedby the Chuikyo, Japan's Central Social Insurance Medical Council.

Shionogi has filed a price application with the Chuikyo andexpects notification within two months. MBI will initiate shipmentof Albunex to Japan upon receipt of an export license from theU.S. Food and Drug Administration. The U.S. company will receivea $5 million milestone payment from Shionogi within 30 days ofthe Japanese approval date.

The Japanese action marks the first market approval for Albunexworldwide, according to MBI chairman and CEO Kenneth J. Widder.Albunex is MBI's first in vivo diagnostic agent and, once Japanesedetails are worked out, the first ultrasound agent to reach market.MBI also has marketing agreements with Nycomed in Europe and Mallinckrodtin the U.S.

• Tomographic Technologies of Chicago last month signeda worldwide technical supply agreement for its Echo-Scan three-dimensionalultrasound image processing workstation with Vingmed, a Norwegianechocardiography subsidiary of Diasonics Ultrasound. Formal marketingcooperation followed the display of Echo-Scan with Vingmed's CFMscanner at the European Society of Cardiology conference in Nice,France, in September.

TomTec expressed an interest earlier this year in developingcooperative agreements in standard 3-D processing with establishedultrasound vendors. The firm is waiting for U.S. FDA market clearanceof its cine 3-D system for cardiac image processing, which involvesa unique vertical stepping transesophageal (TEE) probe. TomTechas a technical and marketing relationship with Interspec of Ambler,PA, for this cine 3-D system. The firm, formerly based in Munich,Germany, moved its corporate headquarters to the U.S. earlierthis year (SCAN 5/19/93 and 6/30/93).

The Vingmed agreement involved modification of CFM transducersto acquire volume image data for processing on the Echo-Scan workstation.One Vingmed external probe was fitted to a TomTec probe carriagedevice in order to permit transthoracic cardiac scanning of childrenand infants. Vingmed's multi-plane 3-D TEE probe was motorizedto allow equidistant slice acquisition necessary for 3-D processingon Echo-Scan.

• MRI manufacturer Fonar was scheduled to introduce a newimaging system, the Ultimate Quad 2000, this week. The scanneris the first of a new MRI line scheduled to begin shipment earlynext year, according to the Melville, NY, firm. The open-designedsystem will provide for MR mammography as well as full-motionorthopedic studies and MRI-directed surgery.

The Ultimate Quad 2000 is a low-cost MRI system designed tomeet health-care reform concerns in the U.S., according to Fonar.The introduction marks something of a reemergence for the independentMRI vendor, which slashed its marketing staff four years ago andceased its significant booth presence at the Radiological Societyof North America exhibition (SCAN 9/27/89). Fonar will not displayat the RSNA meeting again this year, although the firm may considera return in 1994, according to David B. Terry, secretary and treasurer.

• MRI contrast developer Advanced Magnetics of Cambridge,MA, entered into a marketing relationship with Sterling Winthroplast month. Kodak subsidiary Sterling Winthrop, a major imagingcontrast supplier, retained product license and exclusive marketingrights for Feridex, a liver cancer agent, in North America andAustralia.

Advanced Magnetics expects to file a new drug application forFeridex at the U.S. Food and Drug Administration over the nextsix months. Sterling Winthrop will file for market approval innon-U.S. markets within the licensed territory.

Feridex will be sold by Sanofi Winthrop, a marketing alliancebetween Sterling Winthrop and Elf Sanofi of France. Sterling Winthropwill pay up to $7.5 million in license fees to Advanced Magneticsbased on stipulated milestone achievements in the agreement. Inaddition, Advanced Magnetics will receive payment for supply ofthe product and a royalty on sales.

The Sterling Winthrop agreement is one of many Advanced Magneticshas signed for its MR agents. Other Advanced Magnetics' agreementsinvolve Guerbet of France, Eiken Chemical of Japan and U.S. vendorsSquibb and Mallinckrodt (SCAN 9/28/88, 10/25/89, 8/1/90 and 2/27/91).

Earlier this year, Advanced Magnetics signed a patent cross-licensingagreement with Nycomed of Oslo. The contrast developer expectsto file an NDA this month for an oral gastrointestinal agent thatwill be marketed in the U.S. by Mallinckrodt, according to AdvancedMagnetics' third-quarter report.

• Monoclonal antibody agent developer NeoRx of Seattle receiveda $3.6 million milestone payment last month from marketing andproduction partner Boehringer Ingelheim of Germany (SCAN 6/3/92and 12/16/92). The payment came in the form of a purchase of 937,500shares of NeoRx stock by BI.

Payment was made upon filing data with the FDA to demonstratethat the BI-manufactured kit for NeoRx's OncoTrac small cell lungcancer monoclonal imaging agent is the same as the product describedin NeoRx's product license application filed prior to the manufacturingagreement between the two companies.