DST-XL is Second in Adjustable Dual-head Line The adjustable dual-head gamma camera segment has been lucrativefor Sopha Medical Systems. The Columbia, MD, company rode thesuccess of its variable-angle Sophycamera DST to improved
The adjustable dual-head gamma camera segment has been lucrativefor Sopha Medical Systems. The Columbia, MD, company rode thesuccess of its variable-angle Sophycamera DST to improved financialperformance last year (SCAN 3/16/94).
Despite DST's success, Sopha has seen a few sales slip awaybecause DST's smaller field-of-view is not optimal for whole-bodyimaging. Sopha is planning to rectify the situation at this month'sSociety of Nuclear Medicine meeting by introducing a second gammacamera in the DST line.
Sophycamera DST-XL features two larger variable-angle detectorheads for whole-body and large-organ imaging, according to presidentColin McNaught. The larger detectors should assuage cliniciansconcerned about Sophycamera's ability to image large areas ofinterest.
"The new camera will fill out the product line and enableus to compete more effectively (in facilities) where the percentageof whole-body or large-organ studies is higher compared to cardiology,"McNaught said. "There have been instances where potentialcustomers were not willing to purchase a camera that had a field-of-viewless than the large field-of-view jumbo detectors that are onthe market today."
The field-of-view of Sophycamera DST-XL's detector heads is21.2 x 15.75 inches, compared to 11.8 x 15.75 inches on the DST.DST-XL has all the functionality of DST, such as automatic contouring;indeed, it was developed at the same time as DST, according toMcNaught.
The adjustability of DST-XL's detector heads enables cliniciansto use its 90-degree configuration to conduct spine SPECT imagingwith one 90-degree tomographic acquisition.
DST-XL has Food and Drug Administration clearance and Sophawill begin shipping in quantity in the fourth quarter. The companywill sell the camera for $40,000 to $50,000 more than a SophycameraDST, McNaught said.
Sopha also plans to unveil several changes to its corporateidentity at the SNM conference to leave no doubt that the companyhas put its troubled past behind it. Sopha will debut a new exhibitbooth at the meeting, as well as a new corporate logo that includesthe name of CEA-Industrie, the for-profit division of the Frenchatomic energy agency that owns 86% of Sopha.
Throughout last year, Sopha was bedeviled by rumors hintingthat CEA-I was selling the gamma camera developer. The new logoindicates that CEA-I intends to maintain its interest in the company,McNaught said.
"This new look and new logo are a statement to the marketplaceof the strength that we have with the new owner and that owner'semphasis on technology," McNaught said.
In what is perhaps a sign of CEA-I's commitment to Sopha, theagency last month approved a capital increase of $13 million toSopha. The funds will be used to maintain Sopha's level of investmentin R&D and technology, McNaught said.
Immunomedics MoAb agent "not approvable" The Food andDrug Administration dealt a blow to monoclonal antibody developerImmunomedics last week. The agency told the Morris Plains, NJ,company that its product license application for ImmuRAID-CEAis "not approvable" at present.
Immunomedics filed the PLA in 1991 for ImmuRAID-CEA, a colorectalcancer imaging agent (SCAN 7/31/91). ImmuRAID-CEA is one of severalagents in the Immunomedics pipeline, including breast and lungcancer imaging products that are in clinical trials.
Immunomedics did not indicate the FDA's reasons for issuingthe letter. The company did say, however, that it intended towork with the agency to clarify the issues raised in the letter.
"We will continue to work cooperatively with the FDA andthe company remains confident that the product will ultimatelybe licensed by the FDA," said Carl Pinsky, vice presidentof medical affairs.
Shares of Immunomedics on the Nasdaq stock exchange plummetedafter the FDA's action was disclosed. The company's stock fell36%, from $5.50 a share to $3.50.