FDA Clears Biospace med's New 3D X-Ray Orthopedic Imaging System, 'sterEOS', Enabling Routine Weight-Bearing and 3D Examination of the Spine at Ultra-Low Radiation Dose : "The sterEOS platform, with its FDA-cleared 3D capability, is not only designed to dramatically reduce radiation doses for both children and adults but also makes possible the first weight-bearing 3D x-ray images for better surgical planning." Jean-Charles LeHuec, M.D., Ph.D. Bordeaux Spine Center, Pellegrin University Hospital

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Biospace med announced today that it has received 510(k) clearance from the FDA (Food and Drug Administration) to market the Company’s EOS x-ray imager along with its new image workstation, sterEOS, which enables 3D skeletal reconstruction.

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Role of Balance, Posture and 3D Imaging in Spine Surgery

EOS is particularly well-suited for clinical indications such as spine pathologies and hip and knee arthropathies, where a weight-bearing assessment is necessary to ensure optimal treatment. EOS can capture head-to-toe images of patients in a standing, weight-bearing position with a dramatic reduction in radiation dosage—up to 10 times less than a conventional x-ray and up to 1000 times less than a CT (Computed Tomography) scan. Additionally, the new sterEOS 3D reconstruction and measurement workstation is designed to reduce surgical planning time and help establish the most effective course of treatment.

"The 3D capability of EOS will be integral to the successful surgical planning of orthopedic spine procedures and, ultimately, will also be useful for hip and knee replacement surgeries," said Jean-Charles LeHuec, M.D., Ph.D, Bordeaux Spine Center, Pellegrin University Hospital, Bordeaux, France. "EOS is especially helpful in any situation where patients want to limit their exposure to radiation, and also in situations where long-length, weight-bearing images are needed. The full-length, weight-bearing imaging capabilities of EOS are able to provide physicians with a global assessment of balance and posture and now, with 3D, an assessment of the relative positioning of each vertebra, thereby enabling better preoperative assessment."

Currently, the only possibility for 3D planning for orthopedic surgery is a CT (Computed Tomography) scan, which is not reflective of a weight-bearing, functional position of the spine. Using diagnostic images made in the supine (lying down) position leads to significant changes in relative position of the bones and joints to one another, and ultimately changes the clinical parameters and measurements that are made for preoperative planning purposes, making them potentially inexact.

"We believe that our ultra-low-dose EOS 3D x-ray imager may become the standard of care for indications such as spine surgery and hip and knee replacement, as well as all orthopedic therapies that require a true weight-bearing assessment in order to ensure optimal treatment," added Marie Meynadier, Ph.D., chief executive officer of Biospace med. "We expect the EOS low dose, 3D capability to become a new paradigm for safely and effectively imaging the spine, and we are looking forward to launching our new 3D capability at the upcoming NASS meeting."

About Biospace med's Educational Dinner Symposium at NASS

During the upcoming NASS (North American Spine Society) meeting, Biospace med will sponsor an educational dinner symposium on Wednesday, Oct. 15, from 6:30-8:00 p.m., at the Intercontinental Toronto Centre (Haliburton Room), 225 Front Street West. The educational symposium — "Role of Balance, Posture and 3D Imaging in Spine Surgery" — will feature presentations by four surgeons: Jean-Charles LeHuec, M.D., Ph.D., and Keyvan Mazda, M.D., from France; and Matt Gornet, M.D., and Gordon Donald, M.D., from the U.S. Attendance is strictly limited. To register for this educational dinner symposium, please contact Gisela Bryant at 678-564-5400, or gbryant@biospacemed.com.

About the sterEOS 3D Workstation

sterEOS creates, from two simultaneously captured planar images, a 3D image of the adult spine. The company has also developed additional software* to address pediatric spine and a lower extremity package for hip and knee assessment. The workstation software is designed to enable measurements within 3D space, which eliminates errors made from projected planar x-ray images.

*sterEOS 3D is currently commercially available in Europe and Canada for spine and is cleared in the US for adult spine, patients over 16 years of age.

About Biospace med

Biospace med was founded on a unique partnership between Nobel Prize-winning physicist Georges Charpak and a team of biomedical engineers, orthopedic surgeons and radiologists who have developed a complete orthopedic imaging solution. The Company's lead product, EOS ultra-low-dose 2D/3D x-ray imager, allows full-body imaging of patients in a weight-bearing position that enables global assessment of balance and posture. The Company has corporate headquarters in Atlanta and Paris, an office in Montreal, and is targeting a $2 billion orthopedic imaging marketplace. Learn more at http://www.biospacemed.com.

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Ronald Traha
Biospace Med
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