Model-Based RSA Software receives FDA clearance
March 12, 2014

Nova Scotia – March 10, 2014 – Halifax Biomedical Inc. (HBI), a Nova Scotia based company specializing in precision assessment of spine and joint-replacement micro-instability, is pleased to announce that their image processing software has received FDA clearance.

Model-based RSA (MBRSA) Software has been developed and maintained by HBI partner RSAcore of the Department of Orthopaedics at Leiden University Medical Center (LUMC). “Our strong and longstanding partnership with Leiden University Medical Center has enabled us to complete the final regulatory step in our transition from clinical research use of our technology to everyday clinical use,” says Chad Munro, Chief Executive Officer for HBI.

MBRSA Software is an analytical software package for evaluation of orthopaedic implant fixation and bone segment motion. MBRSA is the first of its kind and measures the in-vivo 3D position and/or relative motion of metal implants, markers beads, and/or bone segments in 3D from calibrated stereo x-ray images. When interpreted by trained physicians these measurements may be useful to derive conclusions for critical patient treatment decisions.

“This FDA clearance will enable HBI to provide image processing services for two key clinical issues: deciding whether to intervene to stabilize a Total Knee Replacement due to implant fixation concerns and deciding whether sufficient spine instability is present to justify spine fusion surgery,” said Chad Munro, Chief Executive Officer for HBI.

“The FDA clearance of this analytical software is not only a major milestone for HBI but also for the orthopaedic community as we shift toward broad clinical use in the United States. The HALIFAX program now includes FDA clearance for Halifax intra-operative bone markers, Halifax SR imaging systems, and now, SR image processing services” said Crystal Jones, VP Operations for HBI.

“This approval represents an important step forward in independent and quantitative assessment of orthopedic patients” said Bart Kaptein, MSc, PhD and Professor Rob Nelissen, MD, PhD of the Department of Orthopaedics at LUMC. “MBRSA is a leading edge analysis platform, we are proud of the many years of intense research and development at LUMC to create this orthopedic research tool”.

Halifax Biomedical Inc
Halifax Biomedical Inc. (HBI) is an evidence based Orthopaedic Clinical Measurements company headquartered in Nova Scotia, Canada with a US office located in Cambridge, MA.

HBI is a world leading provider of micro-instability assessment services using very precise proprietary Stereo Radiography (SR) imaging technology (HALIFAX exams).

HBI focuses on two clinical problems; detection of implant loosening for total hip and knee replacements, and quantification of instability of the spinal column in patients with chronic low back pain.

Products provided by HBI to support HALIFAX exams include surgical bead inserters, bead sets, SOR imaging equipment, and centralized image processing services. The centralized processing of joint replacement images is performed by HBI’s image analysis experts using Model-based RSA software developed by HBI’s partner RSAcore of the Leiden, The Netherlands, University Medical Center.

For more information, please visit www.halifaxbiomedical.com, or contact:

John Simon, COO
Email: john.simon@halifaxbiomedical.com
Office: (902) 945-2771
Fax: (902) 945-2324

Mailing Address:
Halifax Biomedical Inc.
1 Broadway, 14th Floor
Cambridge, MA 02142 USA

About Leiden University Medical Center (LUMC)
As a center of medical innovations, the Leiden University Medical Center (LUMC) strives towards an (inter)nationally recognized leading role in the improvement of quality of health care. Core business of the LUMC are patient care, research, education and training. LUMC plays a leading role in the international radiostereometry community. The LUMC is part of the Dutch Federation of University Medical Centers (NFU). The NFU is a collaboration of the 8 University Medical Centers of the Netherlands.

For more information, please visit: www.lumc.nl

Contact information of the Leiden University Medical Center (LUMC), the Netherlands, directorate Communication, telephone +31 71 526 8005, e-mail: communicatie@lumc.nl