Musculoskeletal News Roundup 5-Feb-09
BY LAUREN UZDIENSKI, FEBRUARY 5, 2009
Earnings
CONMED Corp. reported 4Q:08 revenues of $179.2 million, down 5% versus 4Q:07 and beating estimates by $2.26 million. Non-GAAP diluted earnings per share were $0.34, down 23% from 4Q:07 and beating estimates by $0.05. The company reported 4Q:08 arthroscopy sales of $47.5 million, a 12% increase over 4Q:08.
M&A
Small Bone Innovations, Inc. completed the acquisition of the Scandinavian Total Ankle Replacement system (the STAR Ankle) from Link Orthopaedics. The device is not yet FDA-approved, but the company says it will be the first three-piece, mobile-bearing, non-constrained, uncemented total ankle available in the U.S. Financial terms of the transaction were not disclosed.
Product Introduction and Update
Globus Medical, Inc. introduced the PATRIOT SIGNATURE TLIF Spacer system, the newest product in its portfolio of MILDER Spine Care devices for minimally-invasive procedures. The company says the SIGNATURE system's articulating device allows the surgeon to implant it with a single instrument.
Clinical
BioSyntech, Inc. will complete enrollment on February 10 for the Canadian-European pivotal trial of BST-CarGel, its cartilage repair device. More than 70 subjects have been enrolled to date in the study, which compares the application of BST-CarGel following microfracture to microfracture alone for the treatment of cartilage defects. The study's primary endpoint is cartilage repair at twelve months, based on the quantity and quality of the repaired tissue, with secondary endpoints including safety, pain, stiffness and function.
RTI Biologics announced results of a pre-clinical study a comparing BioCleanse-sterilized meniscus to aseptically processed meniscus in a sheep model. The study, conducted at Rush University Medical Center, found that BioCleanse-treated tissue performed as well as, and offered safety benefits over, aseptic processing.
License Agreements
Artimplant and SBi have restated several license, supply and distribution pacts into one agreement covering the Artelon CMC Spacer, CMC Spacer Arthro, MTP Spacer, STT Spacer and DRU Spacer. Among the changes: the agreements have been converted to non-exclusive; minimum sales quotas are lowered and SBi's geographical territory is adjusted; the payment due to Artimplant per unit sale is significantly increased; and the agreement will run through the end of 2014.
Distribution
Centinel Spine, Inc. has merged existing STALIF TT distributors into their new distribution network, which markets and services STALIF TT and STALIF C technologies for lumbar and cervical stand-alone interbody fusion procedures.
Education
Smith & Nephew announced that they have partnered with the Orthopaedic Research and Education Foundation (OREF) to help fund graduate medical education, including fellowships and residency enhancement programs, CME and research. The press release notes that Smith & Nephew's government-appointed monitor approved the agreement and that distribution of funds and outcomes of those donations will be tracked to avoid conflicts of interest.
