Musculoskeletal News Roundup 21-Aug-08
BY LAUREN UZDIENSKI, AUGUST 21, 2008
Earnings
Kensey Nash reported FQ4:08 revenues of $22.0, representing a 29% increase over FQ4:07 and beating estimates by $1.0 million. Biomaterials were up 37% to $13.3 million, which was attributed to strong growth in the orthopedic and cardiovascular product lines. Orthopedic sales were up 39% to $8.4 million, which the company attributed to growth in sports medicine and spine sales. Adjusted diluted earnings per share for FQ4:08 was $0.35, beating estimates by $0.03 and representing an increase of 218% over FQ4:07.
Medtronic reported FQ1:09 sales of $3.71 billion, up 19% over FQ1:08 and in line with estimates. Non-GAAP net earnings were $813.0 million, or $0.72 per diluted share, beating estimates by $0.03 and representing an increase of 14%. The spinal division reported $859.0 million in sales, an increase of 33% over the year-ago period. Kyphon contributed $161 million in revenue. Excluding Kyphon, revenue increased 8%, with 16% sales growth in Biologics.
Funding
Spineology received $1.5 million in financing from Minneapolis-based venture capital firm Affinity Capital Management. This announcement follows a $7.5 million private placement announced last month. The July press release said funds would be used for "additional commercialization, product development and clinical research efforts."
Regulatory
Arthrocare faces delisting from the NASDAQ for failing to file its 10-Q for 3Q:08 in a timely fashion. The company is appealing this determination.
Mazor Surgical received FDA market clearance for the C-InSight System. The system converts 2D x-rays into 3D images for use in the OR. The company says the product will be available for sale in early 2009.
VG Innovations received CE Mark approval for the VerteLoc Minimally Invasive Spine Stabilization System, an implant that "utilizes a rectangular shape and opposing stabilizers to limit facet motion."
X-Spine received an FDA warning letter following the company's alleged failure to correct quality problems, document complaint assessment and establish quality requirements for suppliers.
Product Introduction & Update
ETEX launched Equivabone, a bone graft substitute consisting of a proprietary combination of DBM and ETEX's nanocrystalline calcium phosphate. The product is is indicated for use in filling bone voids or defects of the skeletal system (including extremities, pelvis and spine) that are not intrinsic to the stability of the bone structure.
Legal
A judge in Florida federal court ruled in favor of Endotec in a suit where the FDA claimed the company had illegally distributed its mobile-bearing ankle system. The court found that Endotec's ankle device was custom-made, and therefore not subject to FDA regulation.
Medtronic is suing NuVasive for patent infringement, according to a complaint filed in a San Diego federal court. At issue are 12 patents and several products which NuVasive CEO Alex Lukianov says have been on the market "for several years."
Stryker filed a lawsuit against the U.S. Department of Health and Human Services and the U.S. Justice Department over "oppressive" and "overly broad" subpoenas relating to a False Claims Act investigation. The company says the subpoenas were designed to "harass and harm" them.
Reimbursement
The Department of Health and Human Services has proposed replacing the existing ICD-9 code system with ICD-10 codes by October of 2011. The new codes will better reflect current treatments and procedures, in addition to offering more detailed codes; ICD-9 is limited to 17,000 codes, whereas ICD-10 has room for 155,000.
Clinical
Globus Medical, Inc. announced that the first FLEXUS Interspinous Spacers have been implanted under an IDE led by Dr. Donald Johnson II and Dr. Rhett Murray. The prospective, randomized study will enroll 340 people and is seeking to prove equivalence with the X-Stop over the two-year study period.
