Musculoskeletal News Roundup 25-Aug-11
BY LAUREN UZDIENSKI, AUGUST 25, 2011
Earnings
Corin reported 1H:11 sales of GBP 22.1 million, down 1% over the year ago period. Among segments, hip sales increased by 13%; knee sales declined by 21% and "other" sales, including the LARS ligament and the Zenith mobile-bearing ankle, declined by 9%. Growth rates exclude the effects of currency. The company reported a loss per share of GBP 0.56, which compares to earnings per share of GBP 0.56 in 1H:10.
Medtronic reported F1Q:12 revenues of $4.1 billion, up 2% over the year ago period and beating estimates by $100.0 million. Spine sales declined by 3% to $825 million compared to F1Q:11, with core spinal down 5% and biologics, including Osteotech, up by 2%. Growth rates exclude the effects of currency. Adjusted net earnings for F1Q:12 declined 3% to $845 million, or and $0.79 per share. EPS were in line with estimates.
M&A
Ceremed announced that their Ostene hemostat, including all branding and manufacturing rights, has been sold to Baxter for an undisclosed amount.
Reguatory
DePuy received 510(k) clearance for the TRUMATCH Personalized Solutions for use with the company's SIGMA Fixed-Bearing Knee System. TRUMATCH is a surgical instrumentation and computer software system "designed to aid in knee implant positioning and procedure efficiency." The company says TRUMATCH decreases OR time by an average of 35 minutes, requires less instrumentation and eliminates up to nine surgical steps compared to total knee replacement performed without the devices.
Ellipse Technologies received FDA clearance of their PRECICE Limb Lengthening device. The system allows for an internal implant to be adjusted via non-invasive methods from outside the body.
Zyga Technology announced that the FDA cleared expanded indications for its SImmetry Sacroiliac Joint Fusion System including sacroiliac joint disruptions and degenerative sacroiliitis.
Product Introduction and Update
Mesoblast announced that the first procedure in a phase II study evaluating the use of its proprietary adult Mesenchymal Precursor Cell (MPC) product to treat lower back pain has been completed. The company reported that the outpatient procedure lasted less than 20 minutes, with the patient fully awake and under light sedation. The human study follows preclinical data showing that a single injection of MPCs into severely damaged intervertebral discs resulted in "significant reversal of the degenerative process, regrowth of disc cartilage and sustained normalization of disc pathology, anatomy and function for at least six months."
VG Innovations launched the VerteLoc v2.0 Spine Stabilization System, which features "refined" implant and instrumentation design. The VerteLoc is indicated for spinal posterior element stabilization in patients with facet osteoarthritis and spinal stenosis and "allows for earlier intervention in the continuum of spine care" compared to traditional fusion.
Intellectual Property
SANUWAVE received U.S. patent 7,985,189 entitled "Method For Using Acoustic Shock Waves in the Treatment of Medical Conditions," which covers the treatment of a variety of orthopedic conditions with acoustic shock wave applications. The acoustic shock waves are intended to stimulate growth factors and increase new blood vessel formation to promote or accelerate the body's natural healing processes.
Spinal Restoration received a Notice of Allowance from the U.S. Patent and Trademark Office for claims concerning the delivery device and method of use of the Biostat System for the treatment of discogenic low back pain. The Biostat System consists of BIOSTAT BIOLOGX Fibrin Sealant, a human-derived biologic tissue sealant and the Biostat Delivery Device, a delivery system to apply the material to an intervertebral disc.
Clinical
Zyga Technology enrolled the first European patients in its GLYDER Facet Resurfacing System Clinical Study. This is a prospective, multi-center study.
