Musculoskeletal News Roundup 18-Mar-10
BY LAUREN UZDIENSKI, MARCH 18, 2010
Earnings
Anika Therapeutics reported 4Q:09 revenues of $9.9 million, up 18% over 4Q:08 and missing estimates by $1.0 million. The company attributed the revenue increase partially to an increase in ORTHOVISC sales. Adjusted net income for the quarter was $2.0 million, or $0.17 per diluted share, up 85% over the year-ago period.
ArthroCare reported 4Q:09 revenues of $92.5 million, up 15% over the year-ago period and beating estimates by $10.1 million. The company noted that sales increased in both the sports medicine and ENT businesses. Net income of $7.1 million, or $0.21 per diluted share, beat estimates by $0.29 and improved from a net loss of $28.7 million in 4Q:08.
M&A
Alphatec Holdings, Inc. announced that at a special meeting of stockholders held on March 16, 2010, its stockholders approved the issuance of 24,000,000 shares of the Company's common stock in connection with the acquisition of Scient'x Groupe SAS. Approximately 78% of the shares of the company's common stock that were eligible to vote on the matter were voted. Of the shares that were voted, over 99% voted in favor of the transaction. The company expects the closing of the transaction to be completed prior to the end of the first quarter.
Funding
Non Linear Technologies raised $8.8 million in a round led by Accelmed and Peregrine Ventures. Funds will support the development of minimally-invasive spinal devices, including a fusion system.
Spinal Restoration, which is currently conducting a study on the Biostat System for discogenic pain, raised $20 million from four unnamed investors.
Product Introduction and Update
CareFusion launched the AVAmax Vertebral Balloon for use during kyphoplasty.
Integra Spine commenced the full commercial launch of the Paramount Pedicle Screw System, which follows a nationwide training effort. The Paramount system offers an MIS option whereby pedicle screws can be placed through a percutaneous tube.
Integra Surgical introduced the Ruggles Bayonet Curettes, which the company says offer an offset handle that allows a surgeon to "see the operative field more clearly," as well as a new version of the LumbarTrak retractor system, which has undergone changes to the frame and is "designed to help surgeons establish prompt and lasting exposure during their lumbar spine procedures."
Intellectual Property
AlloSource received its first patent for a propriety tissue cleaning and disinfecting process called RICA, which applies ultrasonics and cleaning solutions to tissue inside a fully-automated, closed, rotating canister.
Bone Biologics received a U.S. patent covering the surgical application of the NELL 1 protein (UCB-1), which is involved in the formation of cartilage.
Clinical
Magellan Spine Technologies completed enrollment in a 20-patient study to evaluate the Magellan DART (Disc Annular Repair Technology) System for annular repair following lumbar discectomy. The company noted that following the procedure, patients reported a "significant improvement" in pain scores, and radiographic and MR images confirmed that there were no recurrent disc herniations or evidence of disc height loss in the first year of follow-up.
Spinal Restoration has started enrollment on a phase III study of the Biostat System, which consists of a fibrin sealant applied to an intervertebral disc for the treatment of low back pain. According to the company, the 15-center study is "one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted."
Vertos Medical released data on its 75-patient study of the mild device for the treatment of lumbar spinal stenosis. At six weeks, mild patients "[experienced] statistically and clinically significant improvement in both pain and functional ability," with 67% of patients reporting a minimum two-point improvement on the VAS scale and an average improvement of 17.9 points on the ODI scale. Additionally, there were no reported patient complications associated with the device.
In 1,494 patients who underwent vertebroplasty, average VAS scores dropped "significantly" from 8.2 to an average of 1.1 following treatment, and average ODI scores dropped from 68.7 to 18.5. These results were presented this week at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Florida.
Appointments
TranS1 named Dwayne Montgomery Vice President of Sales. Prior to joining the company, Mr. Montgomery held the role of Vice President of Sales at ConMed Linvatec and has also held positions at Smith & Nephew and Guidant.
