EOS imaging Receives FDA Approval for spineEOS, its online 3D Planning Solution for Spine Surgery

FDA approval allows EOS to bring the first 3D surgical planning solution to the large and growing spine market in the United States

PARIS--(BUSINESS WIRE)--Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging. The FDA approval of spineEOS allows EOS to expand its presence in the large and growing U.S. spine market, in particular the complex spine and thoraco-lumbar fusion surgery markets, which include approximately 400,000 patients per year and represent more than $3 billion in orthopedic implant value¹.

The spineEOS online 3D planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients with Adolescent Idiopathic Scoliosis. It allows a surgeon to create a treatment plan to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam. The planned surgery and virtual post-correction 3D anatomy can be used to precisely plan for the 3D shape and length of the spinal implants. It can also be shared pre-operatively to engage the patient in the intended course of therapy, and is accessible in the operating room through a custom planning report.

Marie Meynadier, CEO of EOS imaging, said, “We believe that patients’ spines are complex 3D systems that need a personalized 3D planning of the intended surgery. We’re excited about the interest we’ve seen in our spineEOS planning software from surgeons inside and outside of our current installed base, as well as from our industry partners. We look forward to this next important step toward our broader goal of expanding our EOSapps planning software suite to better connect imaging to patient care.”

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Next press release: 2015 Full-year results and 2016 First-quarter sales on April 28, 2016
About EOS imaging
EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan, China, and the European Union (EC). The Group posted 2015 revenues of €21.8 million and employs 107 people including an R&D team of 39 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

¹ PiperJaffray Industry Note, January 4, 2016