Musculoskeletal News Roundup 5-June-08
BY ARMELLE WIART, JUNE 6, 2008
Earnings
Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the first quarter of 2008 was $0.50 per diluted share, a 52% increase over the $0.33 earned in the first quarter of 2007, and 22% higher than analysts' consensus, largely due to currency gains. Full year guidance for revenues and adjusted earnings per share remains unchanged however the company has updated quarterly guidance for the remaining three quarters of the year to maintain its full year revenue and earnings per share guidance in light of first quarter actual results.
Funding
OrthoData Inc. has raised $1.1 million in Series A funding, enough to carry the company through its first phase of clinical trials and transform its prototype into a marketable design. The device, a small sensor placed on an implanted metal rod, can monitor the progress of spinal fusion surgeries by measuring the strain being put on the rod and could thus help eliminate unnecessary exploratory surgeries. According to OrthoData, the first phase of clinical trials is expected to begin in November and should be complete by February or March 2009.
Product Introduction & Update
CompuMed, Inc. announced an agreement with Osteometer MediTech, Inc., a subsidiary of OSI Systems, Inc., that will add Osteometer MediTech’s peripheral dual energy x-ray absorptiometry (pDXA) bone densitometry systems to the products offered by CompuMed to measure bone mineral density (BMD), including CompuMed’s OsteoGram and Digital OsteoGram systems. CompuMed also announced the launch of its OsteoCare initiative, a clinical network which will give primary care physicians and other healthcare providers access to a suite of BMD solutions that do not require a dedicated facility or specialized staff. According to CompuMed, OsteoCare's low acquisition and operating costs will help diagnose osteoporosis in patients before it manifests itself by a fracture.
DePuy Spine, Inc., announced the worldwide launch of the Confidence Spinal Cement System, a novel treatment for vertebral compression fractures, during SpineWeek last week in Geneva. The Confidence System consists of a proprietary hydraulic-based delivery system that provides precise placement of a specially formulated PMMA bone cement directly into vertebral bodies to stabilize fractures and to potentially reduce pain. According to Depuy, the cement has a very short mixing time, has a doughlike consistency which is easy to handle, and stays
at a constant high viscosity for nine minutes, allowing for optimal working time.
BioMedical Enterprises, Inc. announced the launch of the OSSAnchor Grip, a nitinol implant designed to secure soft tissue to bone. The Grip, the first in the family of OSSAnchor nitinol soft tissue implants, has aggressive barbs on the legs for bone adhesion and teeth on the underside of the implant for grasping of soft tissue. A national launch will take place at the American Orthopaedic Foot and Ankle Society summer meeting in Denver, Colorado being held June 25-28.
joimax has developed 360 degree TESSYS Spinal Stenosis System, an instrumentation for the treatment of spinal canal stenosis which enables surgeons to remove the osteophytes narrowing the spinal canal under direct endoscopic view through the vertebral foramen. The instrumentation requires only local anesthesia and a small incision, enabling the patient to leave the hospital a few hours after surgery. joimax also announced the launch of iLESSYS - interLaminar Endoscopic Surgical System, which enables a fully dorsal endoscopic access to the lamina and to the spinal canal. Both systems are based on the TESSYS - Transforaminal Endoscopic Surgical System, a lumbar disc herniations removal method.
License Agreements
Orthofix announced that it has entered into a 10-year exclusive license agreement with Texas Scottish Rite Hospital for Children (TSRHC) extending their current collaboration which provides the TRUE/LOK External Fixation System to the global orthopedic market. TRUE/LOK is a versatile, lightweight system designed to correct limb deformities, treat bone fractures and lengthen limbs using a simple frame. The arrangement also provides for TSRHC and Orthofix to collaborate in the development and marketing of future versions of the TRUE/LOK system.
Regulatory
Mazor Surgical Technologies announced that it has obtained FDA approval to extend the application of the company's SpineAssist imaging and robotic device for assisting in spinal surgical procedures for the cervical, in addition to thoracic and lumbar regions. SpineAssist is a miniature robotic guidance system designed for treatments of spinal compression fractures and other vertebral surgical issues.
Distribution
Alphatec Spine announced its sales launch in Europe with its first binding sales order. It expects to have the products shipped by the end of the month.
