SAN DIEGO, Calif., March 26 /PRNewswire/ -- SpineMark CRO Management (SCROM), a wholly owned subsidiary of SpineMark Corporation, today announced the successful enrollment of a Phase II study evaluating the safety and efficacy of the LDR Spine Mobi-C(R) Cervical Disc Prosthesis through three of its sites. SpineMark CRO Management helped in contributing to the enrollment goal for the study, enrolling 95 patients during a 23-month period which includes one site that enrolled 20 patients in 86 days during the summer of 2007, an accomplishment that would normally have taken six months or more.
The Mobi-C Cervical Disc Prosthesis is an artificial disc designed to be inserted between two vertebras to preserve movement of the spine. The prosthesis could one day offer patients an alternative to spinal fusion, currently the conventional treatment for herniated or damaged discs.
The Phase II study was one of the first to utilize sites in the SpineMark CRO Management (SCROM) network, the nation's only clinical research organization dedicated to spine. It connects leading research sites to efficiently conduct clinical trials and identify innovative treatment options for patients.
"When we initiated our trial, we were looking for a partner who could help streamline the initiation process. Building relationships with the right physicians and managing trial enrollment and compliance can be a time-consuming task," said James Burrows, vice president of product commercialization at LDR Spine USA, Inc. "SpineMark CRO Management offered us valuable assistance with sites that contributed to us completing our enrollment goals."
Established in 2006, SpineMark CRO Management has a network of seven spine research sites, including the SpineMark CRO at TBI, and is currently working with over 15 sponsors on FDA clinical trial support. SpineMark estimates that fifteen to twenty sites will be in place by the end of the year. As an independent organization, SCROM is able to provide spinal device, biomaterials and pharmaceutical manufacturers with the tools necessary to service all the needs of an FDA trial under one organization.
"Because we have extensive experience in the spine industry, we understand the unique challenges faced by physicians, device companies and pharmaceutical companies that focus on spine-related ailments," said Marcy T. Rogers, M.Ed., president and CEO of SpineMark. "Participation in the LDR clinical trial is just the first of many IDE accomplishments for SCROM in the spine community. Our ultimate goal is to identify and provide patients with better treatment options that continually advance care.
In addition to individual Spine Research sites, SCROM is uniting leading spine experts to create the nation's first two regional, multidisciplinary, multisite Spine Research Organizations in Denver and Los Angeles. SpineMark SRO(TM) will provide residents with access to the most advanced spine care therapies under research today while providing an unprecedented level of support and clinical trial management experience to participating physicians and hospitals.
About SpineMark CRO Management
SpineMark CRO Management, a wholly owned subsidiary of SpineMark Corporation, is transforming the way spine research is conducted. With the world's first network of Spine Research Organizations, SpineMark CRO Management offers spinal device, biomaterials and pharmaceutical manufacturers access to a growing network of investigative research sites in the U.S. and abroad. SpineMark CRO Management also offers an array of services to help bring new innovations to the marketplace, including; regulatory guidance, product marketing, reimbursement support, payor education, and clinical trial informatics.
SpineMark CRO Management supplies a multidisciplinary, scientifically driven research environment that streamlines operational efficiency while providing intermediary oversight to ensure quality assurance for clinical trial protocols and procedures. The network of sites includes SpineMark Centers of Excellence, as well as independent credentialed research physicians.
CONTACT: Julie Johnson of WeissComm Partners, +1-451-946-3681,
jjohnson@wcpglobal.com, for SpineMark CRO Management
