Musculoskeletal News Roundup 30-Aug-07
BY LAUREN UZDIENSKI, AUGUST 30, 2007
Earnings
Globus Medical announced 2Q:07 revenues of $30.2 million, an increase of 52% over the comparable quarter. The company attributes the revenue growth to the expansion of its sales and distribution footprint, product introductions in its fusion, MIS and biomaterials portfolio and market acceptance of the Revere™ pedicle screw system.
ORTHOsoft Inc. announced 2Q:07 revenues of $3.66 million, up 16.8% from $3.13 million in 2Q:06. Sales growth was attributed to recurring revenues, as well as direct sales of CAS systems and software applications. Net loss per share was $(0.03), unchanged from 2Q:06.
M&A
Zimmer announced plans this week to acquire ORTHOsoft Inc. in a cash transaction for CDN$1.10 (US$1.03) per share. The total purchase price, excluding the 12.4% of outstanding ORTHOsoft common stock currently held by a Zimmer subsidiary, is approximately CDN$50.0 million (US$47.04 million.) Zimmer says the transaction will be funded out of operating cash flow and is expected to be completed in 4Q:07. The company estimates the transaction to be approximately $0.01 dilutive to adjusted earnings per share in 4Q:07, $0.03 dilutive in 2008 and accretive thereafter.
Symmetry Medical entered into a definitive agreement to acquire Specialty Surgical Instruments and Ultra Containers of America, a provider of specialty surgical instruments and sterilization containers, for $15.1 million in cash on a debt-free basis, subject to certain adjustments. Symmetry Medical has also entered into a two-year agreement for a potential earn out with SSI and UCA. The acquisition is expected to close by September 30, 2007.
Regulatory
Smith & Nephew announced that the company received FDA clearance to market the JOURNEY Bi-Cruciate Stabilized Knee System, GENESIS II Total Knee System and LEGION Revision Knee System as gender-specific. Smith & Nephew described the systems as featuring an asymmetric design of the tibial baseplates, which is intended to provide an anatomically accurate fit with the proximal tibia for both male and female components. To evaluate its claims of gender specificity, the company said it analyzed the gender and sizing distribution of over 1,300 GENESIS II implants, reviewed over 300 CT scans and analyzed 200 knee replacement procedures.
Inion announced that their Hexalon™ biodegradable screw was approved for use in the shoulder, elbow, ankle, foot, hand and wrist. The product was first launched in 2002 for knee indications.
Legal
Smith & Nephew's Endoscopy Division filed a patent infringement lawsuit in a U.S. District Court against Arthrex, Inc. Smith & Nephew Endoscopy claims that Arthrex's Retrobutton infringes US Patents 5,645,588 and 5,306,301 owned by the company. The patents asserted in the claim cover Smith & Nephew’s ENDOBUTTON fixation device and similar devices and methods for attaching tissue grafts to bone during arthroscopic surgery in the knee.
Product Introduction and Update
Wright Medical launched its PRO-DENSE™ Injectable Regenerative Graft, a composite of calcium phosphate and sulfate. According to the company, in animal tests, new bone formed with PRO-DENSE was of greater density and compressive strength at 13 weeks than new bone formed with autograft. Wright Medical added that bone voids treated with PRO-DENSE formed new bone at a faster rate than autograft.
DePuy launched the Pinnacle® AltrX™ polyethylene hip bearing liner for use with the Pinnacle Acetabular Cup System. Depuy said the AltrX polyethylene showed a 92% wear reduction over conventional polyethylene liners while also demonstrating durability and oxidative resistance.
Archus Orthopedics announced the completion of the first human implants of its new TFAS-LS™ system. According to a press release, the implants mark the first ever facet joint replacement procedures done at the lumbosacral spinal level. The cases were performed in Europe by Dr. Scott Webb from the Florida Spine Institute, assisted by Dr. Radu Prejbeanu and Dr. Ioan Branea.
