Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that it has received Institutional Review Board (IRB) approval for its new multicenter study of its SiLOTM SI Fusion System, which is intended for use on patients who require sacroiliac joint fusion surgery.
The system implants a bone allograft into the SI joint to stabilize and fuse the joint.
The IRB is an FDA-registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The SiLO registry will be conducted at up to 11 investigative sites in the United States and is anticipated that data from up to 60 subjects will be entered into the registry.
Trent Northcutt, Aurora Spine President, CEO and co-founder stated, “In the past few months, Aurora has been conducting advanced training sessions and cadaver labs that introduced leading neurosurgical, orthopedic, and pain management physicians to the SiLOTM SI Fusion System. With many procedures already completed, the SiLO system has been safe and effective in an outpatient setting. The IRB approval allows Aurora to launch a multicenter, prospective clinical study to investigate the efficacy of the SiLO device managing low back pain and improving quality of life in patients suffering from SI Joint pain.”
“This registry aims to provide interventional pain physicians in the United States with clinical data that supports the safety and effectiveness of the SiLO sacroiliac fixation technique. I am excited to be part of the study and to train others so that we can continue to advance therapies that relieve pain and restore function,” said Jack Diep, M.D., a Pain Medicine Specialist in Lake Havasu City, AZ. Dr. Diep has adopted this therapy with his patients as a minimally invasive alternative approach. Dr. Diep stated, “The launch of this registry will give the ability to produce published clinical outcomes utilizing a minimally invasive option to treat sacroiliac pathology.”
“SiLO carries features within the implant design and instrumentation that leads to a congruent fit of the graft within the sacroiliac joint allowing proven biomechanical stability with a single graft approach to posterior fixation,” said Steven Falowski, M.D., Director of Functional Neurosurgery at Argires-Marotti Neurosurgical Associates of Lancaster, PA . “The IRB approval to start the registry will now allow Aurora to obtain real world clinical evidence in its patients to demonstrate the efficacy and utility of this truly minimally invasive approach.”
“SiLO is an efficient posterior approach procedure which results in quicker post-op recovery times and better patient outcomes,” said Dr. Michael Stoffman, a Neurosurgeon at University at Buffalo Neurosurgery. “The SiLO study is an important milestone for the physician community as we are committed to helping patients experiencing chronic SI Joint pain by advancing the benefits of the SiLO procedure through vigorous clinical research.”
“The SiLO Registry will provide valuable clinical data regarding the safety and effectiveness of the SiLO system and its minimally invasive approach,” said Anish S. Patel, MD, MBA, managing partner at National Spine & Pain Centers. “The IRB approval for Aurora Spine’s study is a key step in gathering clinical evidence of the benefits of the SiLO system and its treatment of sacroiliac pain and better patient outcomes.”
The primary outcomes for this analysis will be change in patients’ self-reported pain, quality of life, and disability over time. Pain, quality of life, and disability will be assessed using the Visual Analog Scale in both the numerical and facial scales, the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), and the Oswestry Disability Index (ODI).