Spinal Stabilization System By Matthew Leon and Katelyn Kondra LimiFlex Spinal Stabilization System By Matthew Leon and Katelyn Kondra

Simpirica Spine Established: 2006 San Carlo, CA EU: Product Distributor US: Investigational Use Ian Bennett -Ian Bennett = Founder Mechanical Engineer, Medical Device Designer, Entrepreneur Stanford BS, MS – Mechanical Engineering (1999-2004)

Lumbar Spinal Stenosis Narrowing/Compression of the Spinal Cord and associated nerves Pain and weakness US: 8 – 11 % 2.4 Million by 2021 MRI : Definitive Diagnosis Bicycle Test of Van Gelderen As the “baby boomers” age, an estimated 2.4 million Americans will be affected by LSS by 2021 Signs and Sypmtoms pain, weakness, and tingling of the legs and "radiation down the posterior part of the leg to the feet” Additional symptoms in the legs may be fatigue, heaviness, weakness, a sensation of tingling, pricking, or numbness and leg cramps, as well as bladder symptoms - Typically occurs in the aging spine of individuals beyond their fifth decade of life - MRI is the only Definitive diagnosis -The bicycle test is a simple procedure in which the patient is asked to pedal on a stationary bicycle. LSS vs. peripheral vascular disease, the patient will experience Claudication both ( decreased blood flow to Lower extremities) flexion relieves claudication if LSS

Degenerative Spondylolisthesis “Slipped Vertebral Body” L3-L4 or L4-L5 > 50 years old Females to Males (3:1) Facet Joint Aging and Flexion 3-Step diagnosis process As the facet joints age, they can become incompetent and allow too much flexion, allowing one vertebral body to slip forward on the other. 3 step diagnosis process for Medical History – primarily a review of the patient’s symptoms and what makes the symptoms better or worse. Physical Examination – the patient is examined for physical symptoms, such as range of motion, flexibility, any muscle weakness or neurological symptoms. Diagnostic Tests – if a spondylolisthesis is suspected after the medical history and physical exam, an X-ray may be done to confirm the diagnosis and/or rule out other possible causes of the patient’s symptoms. Based on the results of the X-ray, further tests may be ordered, such as an MRI scan, to gain additional insights.

Target Audience Patients who could benefit from additional stabilization 400,000 per year suffer from instability and pain with lumbar flexion Flexion: Bending forward  separation of spinous processes Most exercised component of spinal motion Problematic for those considering/undergone surgery -Most common type of spinal motion used in humans -400K Around the World -

Pre-existing Therapies Non-Surgical options Physical Therapy Immobilizing Brace NSAIDS Activity Modification Spinal Epidural Injections Surgical Options Lumbar Laminectomy Lumbar Decompression Spinal Fusion Lumbar Laminectomy – Lamina Removed Lumbar Decompression – Remove bone and soft tissue that are compressing nerves/spinal cord; screws, rods, bone grafts used to immobilize Spinal Fusion – Use bone graft to fuse two adjacent vertebrae

Limiflex Device Makeup Two dynamic spring-like titanium rods connected by two Ultra-high Molecular Weight Polyethylene (UHMWPE) straps. Attachment mechanism for the straps are integrated into the rods Loops around 2 spinous processes Fin-like projections at the back of each vertebrae No pedicle screws needed to anchor Rods attached by screws to straps which encircle process Permanent implant -Used in conjuncture with decompressions eliminates the need for stabilizing rods, screws, grafts -Non-invasive to healthy and in tact bones -No need for Fusion

Limiflex Visual http://www.youtube.com/watch?feature=player_embedded&v=2d3C4pPa4wA

Mechanism of Action Designed to resist separation via progressive tensile forces applied by straps Reduces segmental flexion and increases facet engagement Extension, rotation, lateral bending are minimally affected Device does not induce hyperextension Physiologic center of rotation of treated segments maintained -Tensile Forces (class application!!!)

Costs: Post-Op and Monetary 4-5 days in-hospital 4-6 weeks on work leave; 12 weeks for heavy lifting profession Physical therapy and Prescription medications Deep and Superficial stitches (5-10 days for removal) Post-op movement to reduce risk of thrombosis Costs and Insurance coverage are still under review due to investigational status in the United States -These Post-op regulations pertain to spinal decompression -It is thought, that limiflex will help to reduce the cost and length of rehabilitation from this decompression procedure $22 MILLION INVESTED IN THE CURRENT US TRIALS COSTS HAVE TO MAKE UP FOR IT

Device Impact Reduces pain and instability with lumbar flexion Minimally invasive treatment option Dynamic stabilization Flexion-restricting Allows for return to more active lifestyle -As compared to the spinal fusion AKA PLF -One Surgery – decompression first and then limiflex -Surgery consists of decompression followed by device implantation

Device Limitations/Complications Incision-site infection Surgical complications Not indicated for scoliosis Thrombosis Failed Back Syndrome Recurring Pain: decompression surgery does not correct underlying degenerative damage -Mention

Current Status of Device: EU Commercially available since January 2011 (CE Marked) Used in conjunction with spinal decompression treatment for stenosis Over 300 successful implants currently being studied

Current Status of Device: US Recent IDE pivotal study approved Randomized controlled study Treatment group: Decompression + LimiFlex Control group: decompression + posterolateral fusion (PLF) 24 month study Procedure -Remove bone and soft tissue that are compressing nerves/spinal cord (Compression) and the device is inserted instead of PLF -Restricts flexion

Biomechanical Testing Dr. Avinash Patwardhan of Loyola University http://www.simpirica.com/us-en/professionals/mechanism-of-action.php UCSF Loads applied by device < Loads required for spinous process fracture -Dr. Patwardhan (used cadavers) Reduced Flexional ROM Increased Facet Engagement Decreased Segmental translocation -UCSF Even when 50% of Spinous process was removed

Testing Results -Illustrates stabilization beyond pre-op condition

Limiflex: The better choice Unlike other spinal instrumentation… Bears increased loads only when spinous processes separate Doesn’t bear/transmit axial compressive loads like other instrumentation No impulse loads generated during activities like walking and running -Lets sell them on this

Sources http://www.simpirica.com/us-en/index.php http://www.spine-health.com/conditions/spondylolisthesis/degenerative-spondylolisthesis http://www.insideview.com/directory/simpirica-spine-inc http://www.wsgr.com/news/medicaldevice/pdf/simpirica.pdf http://www.aaos.org/news/aaosnow/may11/clinical10.asp