Model to be replicated throughout cities nationally
LOS ANGELES and DENVER, April 9, 2008 /PRNewswire/ -- SpineMark CRO Management, a wholly owned subsidiary of SpineMark Corporation, is collaborating with Los Angeles- and Denver-area physicians to create the nation's first multidisciplinary, multisite Spine Research Organizations (SRO), to unite the regions' leading spine experts under one organization. The SpineMark SROs will provide patients in their respective communities with access to the most advanced spine care therapies under research today, while offering the participating physicians and hospitals an unprecedented level of support and third-party resources experienced in clinical trial management.
"Many of us have wanted to offer our patients greater treatment options, but we've been limited by the amount of infrastructure necessary to participate in large, national trials," said Dr. Robert J. Bess, an orthopedic spine surgeon and co-founder of the SpineMark SRO of Denver. "By partnering with SpineMark, we are able to provide patients with the best of all worlds -- access to community practices that can provide quality, personalized care coupled with the clinical trial opportunities of larger facilities."
The SpineMark SROs, which include surgical specialists, interventional pain specialists and conservative care physicians, will provide a seamless, integrated path of care for patients needing spine treatment. SpineMark will work with medical device and pharmaceutical companies to recruit for FDA trials, coordinate with the SRO and provide quality assurance, as well as appropriate staff infrastructure for trial protocols, policies and procedures.
"Without SpineMark's support, we would not be able to participate in clinical trials evaluating the latest minimally invasive treatments for spinal disorders and injuries," said Dr. Perry Haney, an interventional pain specialist, and cofounder of the SpineMark SRO of Denver. "This opportunity allows us to provide more advanced options to our patients in their own backyards, without having to travel to a major clinical trial facility."
"We are seeing an increased call for greater transparency in clinical research today, particularly in the spine industry. The SpineMark SRO model provides intermediary third-party oversight to ensure the highest quality monitoring, surveillance and resources can be brought to bear for patients participating in these trials," said Marcy T. Rogers, M.Ed., president and CEO of SpineMark. "This is a new model in spine care research that allows us to bring the best clinicians in spine care under one umbrella organization so that patients have the benefit of receiving cutting-edge treatments from recognized physician and healthcare provider leaders who may want to expand their capacity to participate in more FDA trials."
Los Angeles and Denver are the first of several cities nationwide that are working with SpineMark to create regional organizations dedicated to spine care, one of the leading health needs today. Nearly 80 percent of Americans will experience back pain during their lifetime. Additionally, back pain is one of the most common reasons for missed work. In fact, back pain is the second most common reason for visits to the doctor's office, outnumbered only by upper-respiratory infections.
In conjunction with the launch of the organizations, Dr. Bess and Dr. John Prall, a neurosurgeon, have commenced the organization's first clinical trial evaluating StabiliMax, a device from Applied Spine Technologies. StabiliMax is designed to provide dynamic stabilization of the spine without fusion in patients undergoing decompression surgery for the treatment of spinal stenosis.
The first sites for care in the SpineMark SRO of Denver are the Littleton Adventist Hospital, Littleton, Colo., and the Lone Tree Ambulatory Surgery Center, LoneTree, Colo. The SpineMark SRO of Los Angeles was founded by Drs. Patrick Johnson, Carl Lauryssen and Jeff Wang and includes eight key opinion leaders in all disciplines of spine care, physiatry, orthopedic surgery, neurosurgery and interventional pain.
"Specialized treatments for spine are being developed and launched at a rapid pace, and research and physician specialization in the field of spinal medicine have dramatically accelerated in the last 10 years," Rogers added. "We expect the value of our SRO model to hasten the availability of new therapies and provide infrastructure to spine specialists to support the establishment of SpineMark SROs across the United States and even globally."
For a complete list of participating physicians and centers, as well as a list of trials that are in progress, please visit http://www.SpineMarkSRO.com.
About SpineMark CRO Management
SpineMark CRO Management, a wholly owned subsidiary of SpineMark Corporation, is transforming the way spine research is conducted by building the first spine clinical research organization, which includes a network of affiliated research sites in the U.S. and abroad. SpineMark CRO Management offers spinal device, biomaterials and pharmaceutical manufacturers a full array of services including regulatory, marketing, reimbursement, payor education, project oversight, monitoring and clinical trial informatics. Through a collaborative approach, SpineMark CRO Management supplies a cross-disciplinary, scientifically driven research environment that streamlines operational efficiency and maximizes spine clinical trial research while providing intermediary oversight to ensure quality assurance for trial protocols, policies and procedures. The network of sites includes SpineMark Centers of Excellence, as well as free standing sites of credentialed research physicians.
|SOURCE SpineMark CRO Management|
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