July 7, 2005 – PHOENIXVILLE, PA, USA Globus Medical, Inc., one of the ten largest spinal implant manufacturers in the US, announced today that it has initiated a clinical trial for it’s Secure-C™ Cervical Artificial Disc under the Investigational Device Exemption (“IDE”) recently granted to Globus by the FDA. This announcement comes the day after Dr. Mike Marzluff successfully implanted the devices in two patients in Charleston, SC. Over 15 centers across the United States have agreed to participate in this important trial. In addition to Dr. Marzluff, several leading spine surgeons are serving as clinical investigators in the trial. One of them, Dr. Scott Rushton, Clinical Assistant Professor at the University of Pennsylvania and Medical Director of the Lankenau Hospital Center for Spinal Disorders said: “We are very excited about initiating the clinical investigation of the Globus cervical artificial disc. The design of the Secure-Cä disc has significant biomechanical advantages and simplifies the insertion technique, compared to other devices. One of the long-term disadvantages of treating cervical disc disease with traditional fusion surgery is the increased risk of degenerative disease at the adjacent levels.”
David Paul, CEO and founder of Globus commented on the clinical trial saying; “The launch of the Secure-Cä Cervical Artificial Disc clinical trial is an important milestone for Globus. It is the first of several non-fusion products that Globus will be placing into clinical trials over the next year. It is also a tangible demonstration of our strategy to harness the powerful synergy of surgeons’ clinical expertise with our engineering ingenuity and capability to create products that will improve the lives of patients and grow our business.”
Globus was founded by Mr. Paul and a team of engineers in 2003, with a vision to create products that enable spine surgeons to use both fusion and non-fusion solutions to meet the needs of their patients. Today Globus is one of the fastest growing companies in the spinal device industry and is a recognized leader in the development of motion sparing technology. Since its inception, Globus has vaulted into the top 10 spine technology companies in the U.S, with over $40 million in annualized revenues. Globus’ success is a result of its extensive surgeon collaboration in product development, its innovative cutting edge technology and its unprecedented record for speed in product development from the design phase through FDA approval to market introduction. Today, Globus has a full portfolio of products to meet all of a spine surgeon’s needs and is one of the world’s leaders in the development of motion sparing technology.