CMS may pay for Charité disk
Johnson & Johnson (New Brunswick, New Jersey) said that Medicare has agreed to pay for the company's Charité artificial spinal disk to be implanted in beneficiaries under age 60, if the agency's local medical directors approve the coverage, according to The New York Times.
The agency that oversees the coverage, Centers for Medicare and Medicaid Services (CMS; Baltimore), in its final decision, reversed a national noncoverage determination for the disk, that it proposed in February, J&J said.
The Charité disk, the only such device approved by the FDA, which occurred in October 2004, is surgically inserted to replace a damaged disk between vertebrae in the spine.
Tutogen reviewing financial statements
Tutogen Medical (Alachua, Florida), a manufacturer of sterile biological implant products made from human (allograft) and animal (xenograft) tissue, reported that it is conducting a review of its previously reported financial statements for the fiscal years ended Sept. 30, 2003, 2004, and 2005, and the 2006 first fiscal quarter ended Dec. 31, 2005, as a result of an error discovered by management during its second fiscal quarter review in the accounting of actual costs associated with inventory purchased from its German subsidiary.
Management presented its findings to the company's audit committee and is continuing to examine the company's accounting for such intercompany transactions. A restatement of such financial statements is anticipated.
As a result of the company's ongoing review, it is anticipated that the release of the company's financial results for its second fiscal quarter ended March 31, 2006, will be delayed.
Based on preliminary information, as a result of the error, inventory in each of fiscal years 2003, 2004 and 2005 and the 2006 first fiscal quarter ended Dec. 31, 2005 was overstated by up to $800,000. Additionally, as a result of selling the intercompany inventory at a higher cost than actual cost, earnings for the cumulative period from Oct. 1, 2003 to Dec. 31, 2005 were understated by approximately $300,000 to $1,000,000.
Consultants say Philips leads ultrasound market
Royal Philips Electronics (Andover, Massachusetts) said that Klein Biomedical Consultants (KBC), which it describes as being “recognized as one of the world's leading authorities on the ultrasound market,” reported that in 2005 Philips Medical Systems ultrasound business unit took over the market leader position with a 26% share of the overall diagnostic ultrasound market in the U.S. Philips out-paced market revenue gains with an annual growth rate of 12%, according to KBC.
The Klein Report tracks revenues and units by market segment for all manufacturers in the U.S. ultrasound market. KBC uses public information, primary research, and interviews with manufacturers to triangulate the data.
B&L “clarifies” media reports
Bausch & Lomb (B&L; Rochester, New York) said it “wishes to clarify information” contained in media reports about the FDA's inspection of Bausch & Lomb's manufacturing plant and distribution facility in Greenville, South Carolina, that erroneously suggest that B&L withheld from FDA information the company received about Fusarium infections in Singapore.
The media reports followed FDA's release last week of its inspection's preliminary observations, one of which noted that the company “failed to notify the Agency of 35 serious injury reports of Fusarium keratitis from Singapore's Minister of Health in February 2006 relating to ReNu MoistureLoc Multipurpose Solution.”
Within days of receiving a report in February of an unusual spike of Fusarium keratitis cases among contact lens wearers in Singapore, B&L discussed those initial case reports with FDA's Office of Compliance in the Center for Devices and Radiological Health. As details of the Singapore cases were gathered, the company continued to provide updates to the FDA. On April 5, company representatives met in person with agency representatives to provide a full briefing on its Fusarium investigation activities.
After receiving guidance from FDA on its preferences for the content and form of the formal report, B&L filed the Medical Device Report on April 7.
The FDA's preliminary observations also noted that unspecified “keratitis complaints” reported to the company in July 2005 were not reported to the agency. Those six reports of noninfectious keratitis, or general eye inflammation, among contact lens wearers were not related to Fusarium infections and did not require medical treatment.
Tripos board committed to 'strategic alternatives'
Tripos (St. Louis) reported at its annual meeting of stockholders that its board had reaffirmed its commitment to exploring strategic alternatives to maximize shareholder value and enhance growth prospects for Tripos. As previously disclosed, such alternatives include, but are not limited to, a sale or merger of Tripos, going private, and separating its informatics and research businesses. Tripos does not plan to make future comments on this process unless there are material developments.
Tripos combines technology and science to deliver chemistry-research products and services for the biotechnology, pharmaceutical and other life science industries.