TFAS™ Total Facet Arthroplasty System™
(Sponsored clinical trial listing)

Introduction
Spinal stenosis is a progressive degenerative condition, typically first manifesting in the 5th or 6th decade of life, marked by a predominance of painful leg symptoms, including burning, tingling, numbness and weakness. It occurs when the articulating spinal joints, called “the facets”, become arthritic and no longer provide necessary stability to the spine. As with any joint in the body, the arthritic facets often become inflamed and osteophytic (produce bony spurs), resulting in irritation and impingement of nearby nerves leading to clinical symptoms. As the disease progresses, symptoms escalate, and the ability to walk and carry out basic activities of daily living becomes increasingly difficult due to clinical symptoms. While patients are treated with conservative therapy during the early phases of the disease, many patients ultimately require surgical removal of the arthritic spinal elements and placement of spinal instrumentation to achieve spinal stability and symptom relief.

The Total Facet Arthroplasty System™ (TFAS™) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS™ replaces the diseased facets (and lamina, if necessary, to attain adequate decompression) following surgical removal. TFAS™ offers the surgeon new options for treating spinal stenosis, enabling a more comprehensive decompression via complete removal of the facets. TFAS™ also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion and restoration of stability and sagittal balance to the spine. TFAS™ eliminates the need for painful bone graft harvest from the patient’s hip, typically required with fusion procedures.

The Total Facet Arthroplasty System™ is a new device currently limited by United States law to investigational use within the U.S. The TFAS™ clinical trial is a multi-center, prospective, randomized controlled clinical trial comparing the safety and effectiveness of the TFAS™ to spinal fusion surgery in the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Objective
The objective of this clinical investigation is to demonstrate the safety and effectiveness of the Total Facet Arthroplasty System™ (TFAS™) for the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Overview
Approximately 20 investigative sites will enroll patients satisfying the inclusion/exclusion criteria into the TFAS™ clinical trial. At a high level, the study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.

Study participants will be placed into one of two groups: 1) treatment with the investigational artificial facet replacement device (TFAS™) or 2) treatment with posterior instrumented fusion, considered the current standard of care for stenosis patients and likely the treatment that would be carried out on these patients, regardless of their participation in the trial. Patient enrollment in the trial will be randomized such that two thirds will receive the TFAS™ and one third will receive the standard instrumented fusion treatment.

Study sponsor
Archus Orthopedics, Inc. is a medical device developer focused on pioneering novel solutions for diseases requiring complete removal and replacement of the facets of the lumbar spine. Visit www.archususa.com for more information about the company and the Total Facet Arthroplasty System™ (TFAS™).

Status
Patients are currently being enrolled and treated at Phase One investigative sites. Archus Orthopedics is currently recruiting clinical investigators for Phase Two of the trial.

Inclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients must have the following conditions and meet the following inclusion criteria to be enrolled in this trial:

• Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with radiographic confirmation of any one of the following by CT, MRI, plain film or myelography:
• Evidence of thecal sac and/or cauda equina compression;
• Evidence of nerve root impingement by either osseous or non-osseous elements;
• Evidence of hypertrophic facets with encroachment into the central canal or lateral recess.
• No greater than Grade I degenerative spondylolisthesis at the index level;
• Intermittent neurogenic claudication, indicated by the presence of persistent leg symptoms, marked by posterior or anterior thigh or calf discomfort, pain, numbness, parasthesia, weakness, tiredness or heaviness, buttock or lower back symptoms including pain, numbness, burning or tingling, that is aggravated by walking and/or standing and is relieved only after resting in a flexed lumbar spine position;
• Skeletally mature male or female between the ages of 50 and 85 years of age inclusive;
• Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression (Note: Up to three contiguous levels of decompression is allowed, however, only one level is eligible for instrumentation with the TFAS™ system or control);
• Willing and able to sign the Informed Consent document;
• Experienced symptoms of intermittent neurogenic claudication and/or functional deficit for a minimum duration of six months; and
• Failed to respond to non-operative treatment modalities for a minimum duration of six months.

Exclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients meeting one or more of the following criteria shall be excluded from the trial:

• Male or female less than 50 or greater than 85 years old;
• Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level;
• More than 3 vertebral levels of degenerative spinal stenosis requiring decompression;
• More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation;
• Not willing or able to sign the Informed Consent document;
• Not available for long term follow-up and interval visits;
• Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine;
• Two or more previous surgeries to the lumbar spine at the same level to be implanted (definition of surgery includes: discectomy, laminectomy, laminotomy, rhizotomy);
• Is being treated with other devices for the same disorder (e.g. pain control devices);
• Active systemic infection or infection at the operating site;
• Has endocrine or metabolic disorders known to affect osteogenesis;
• Is currently taking medications that are known to affect osteogenesis;
• Unable to undergo autologous grafting procedure due to insufficient bone stock;
• Osteoporosis or osteopenia with DEXA -T score less than -2.5, absolute density of less than 0.9 gm/cc per a previous diagnosis (within last 2 years) or is at significant risk for these conditions due to predisposing factors per the surgeon’s judgment;
• Known sensitivity to device materials (i.e. titanium alloy, cobalt, chromium, molybdenum, barium sulfate or polymethylmethacrylate bone cement);
• Has an immunosuppressive disorder;
• Has a medical condition that may interfere with clinical evaluations (active malignancy, unstable cardiac disease, advanced emphysema or Alzheimer’s disease);
• Is a prisoner;
• Is obese defined by a patient body mass index greater than 40 (weight in pounds multiplied by 703/height in inches squared);
• Investigator determines that procedure is technically not feasible;
• Has significant scoliosis (Cobb >25°);
• Is mentally incompetent;
• Has current or recent history (within last 2 years) of substance abuse (alcoholism and/or narcotic addiction); or
• Is pregnant or planning to become pregnant within the proposed three year investigation.

Participating sites and contact information
Sites that are currently participating are located in the following cities and states:

• Clearwater, Florida
• Denver, Colorado
• Baltimore, Maryland
• Plano, Texas
• Los Angeles, California

Additional sites will be added to this list as they begin enrollment.

To learn more about Archus Orthopedics, please access our website at www.archususa.com.

Spine Patients
To determine if you may be a potential candidate for the TFAS™ clinical trial, please access our website at www.archususa.com and click on “Clinical Trial” and “Am I a Candidate?” If you are a spine patient who has been diagnosed with moderate to severe lumbar spinal stenosis, you feel that you may meet the study criteria and you live within 50 miles of the cities listed above, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.

Physicians
If you are a spine surgeon who treats patients meeting the inclusion/exclusion criteria and may be interested in participating as a clinical investigator in the TFAS™ clinical study, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.

TFAS™ Total Facet Arthroplasty System™
(Sponsored clinical trial listing)

Introduction
Spinal stenosis is a progressive degenerative condition, typically first manifesting in the 5th or 6th decade of life, marked by a predominance of painful leg symptoms, including burning, tingling, numbness and weakness. It occurs when the articulating spinal joints, called “the facets”, become arthritic and no longer provide necessary stability to the spine. As with any joint in the body, the arthritic facets often become inflamed and osteophytic (produce bony spurs), resulting in irritation and impingement of nearby nerves leading to clinical symptoms. As the disease progresses, symptoms escalate, and the ability to walk and carry out basic activities of daily living becomes increasingly difficult due to clinical symptoms. While patients are treated with conservative therapy during the early phases of the disease, many patients ultimately require surgical removal of the arthritic spinal elements and placement of spinal instrumentation to achieve spinal stability and symptom relief.

The Total Facet Arthroplasty System™ (TFAS™) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS™ replaces the diseased facets (and lamina, if necessary, to attain adequate decompression) following surgical removal. TFAS™ offers the surgeon new options for treating spinal stenosis, enabling a more comprehensive decompression via complete removal of the facets. TFAS™ also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion and restoration of stability and sagittal balance to the spine. TFAS™ eliminates the need for painful bone graft harvest from the patient’s hip, typically required with fusion procedures.

The Total Facet Arthroplasty System™ is a new device currently limited by United States law to investigational use within the U.S. The TFAS™ clinical trial is a multi-center, prospective, randomized controlled clinical trial comparing the safety and effectiveness of the TFAS™ to spinal fusion surgery in the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Objective
The objective of this clinical investigation is to demonstrate the safety and effectiveness of the Total Facet Arthroplasty System™ (TFAS™) for the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Overview
Approximately 20 investigative sites will enroll patients satisfying the inclusion/exclusion criteria into the TFAS™ clinical trial. At a high level, the study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.

Study participants will be placed into one of two groups: 1) treatment with the investigational artificial facet replacement device (TFAS™) or 2) treatment with posterior instrumented fusion, considered the current standard of care for stenosis patients and likely the treatment that would be carried out on these patients, regardless of their participation in the trial. Patient enrollment in the trial will be randomized such that two thirds will receive the TFAS™ and one third will receive the standard instrumented fusion treatment.

Study sponsor
Archus Orthopedics, Inc. is a medical device developer focused on pioneering novel solutions for diseases requiring complete removal and replacement of the facets of the lumbar spine. Visit www.archususa.com for more information about the company and the Total Facet Arthroplasty System™ (TFAS™).

Status
Patients are currently being enrolled and treated at Phase One investigative sites. Archus Orthopedics is currently recruiting clinical investigators for Phase Two of the trial.

Inclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients must have the following conditions and meet the following inclusion criteria to be enrolled in this trial:

• Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with radiographic confirmation of any one of the following by CT, MRI, plain film or myelography:
• Evidence of thecal sac and/or cauda equina compression;
• Evidence of nerve root impingement by either osseous or non-osseous elements;
• Evidence of hypertrophic facets with encroachment into the central canal or lateral recess.
• No greater than Grade I degenerative spondylolisthesis at the index level;
• Intermittent neurogenic claudication, indicated by the presence of persistent leg symptoms, marked by posterior or anterior thigh or calf discomfort, pain, numbness, parasthesia, weakness, tiredness or heaviness, buttock or lower back symptoms including pain, numbness, burning or tingling, that is aggravated by walking and/or standing and is relieved only after resting in a flexed lumbar spine position;
• Skeletally mature male or female between the ages of 50 and 85 years of age inclusive;
• Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression (Note: Up to three contiguous levels of decompression is allowed, however, only one level is eligible for instrumentation with the TFAS™ system or control);
• Willing and able to sign the Informed Consent document;
• Experienced symptoms of intermittent neurogenic claudication and/or functional deficit for a minimum duration of six months; and
• Failed to respond to non-operative treatment modalities for a minimum duration of six months.

Exclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients meeting one or more of the following criteria shall be excluded from the trial:

• Male or female less than 50 or greater than 85 years old;
• Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level;
• More than 3 vertebral levels of degenerative spinal stenosis requiring decompression;
• More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation;
• Not willing or able to sign the Informed Consent document;
• Not available for long term follow-up and interval visits;
• Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine;
• Two or more previous surgeries to the lumbar spine at the same level to be implanted (definition of surgery includes: discectomy, laminectomy, laminotomy, rhizotomy);
• Is being treated with other devices for the same disorder (e.g. pain control devices);
• Active systemic infection or infection at the operating site;
• Has endocrine or metabolic disorders known to affect osteogenesis;
• Is currently taking medications that are known to affect osteogenesis;
• Unable to undergo autologous grafting procedure due to insufficient bone stock;
• Osteoporosis or osteopenia with DEXA -T score less than -2.5, absolute density of less than 0.9 gm/cc per a previous diagnosis (within last 2 years) or is at significant risk for these conditions due to predisposing factors per the surgeon’s judgment;
• Known sensitivity to device materials (i.e. titanium alloy, cobalt, chromium, molybdenum, barium sulfate or polymethylmethacrylate bone cement);
• Has an immunosuppressive disorder;
• Has a medical condition that may interfere with clinical evaluations (active malignancy, unstable cardiac disease, advanced emphysema or Alzheimer’s disease);
• Is a prisoner;
• Is obese defined by a patient body mass index greater than 40 (weight in pounds multiplied by 703/height in inches squared);
• Investigator determines that procedure is technically not feasible;
• Has significant scoliosis (Cobb >25°);
• Is mentally incompetent;
• Has current or recent history (within last 2 years) of substance abuse (alcoholism and/or narcotic addiction); or
• Is pregnant or planning to become pregnant within the proposed three year investigation.

Participating sites and contact information
Sites that are currently participating are located in the following cities and states:

• Clearwater, Florida
• Denver, Colorado
• Baltimore, Maryland
• Plano, Texas
• Los Angeles, California

Additional sites will be added to this list as they begin enrollment.

To learn more about Archus Orthopedics, please access our website at www.archususa.com.

Spine Patients
To determine if you may be a potential candidate for the TFAS™ clinical trial, please access our website at www.archususa.com and click on “Clinical Trial” and “Am I a Candidate?” If you are a spine patient who has been diagnosed with moderate to severe lumbar spinal stenosis, you feel that you may meet the study criteria and you live within 50 miles of the cities listed above, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.

Physicians
If you are a spine surgeon who treats patients meeting the inclusion/exclusion criteria and may be interested in participating as a clinical investigator in the TFAS™ clinical study, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.

The Total Facet Arthroplasty System™ is a new device currently limited by United States law to investigational use within the U.S. The TFAS™ clinical trial is a multi-center, prospective, randomized controlled clinical trial comparing the safety and effectiveness of the TFAS™ to spinal fusion surgery in the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Objective
The objective of this clinical investigation is to demonstrate the safety and effectiveness of the Total Facet Arthroplasty System™ (TFAS™) for the treatment of moderate to severe degenerative lumbar spinal stenosis.

Study Overview
Approximately 20 investigative sites will enroll patients satisfying the inclusion/exclusion criteria into the TFAS™ clinical trial. At a high level, the study is designed for patients with moderate to severe lumbar spinal stenosis requiring neural decompression with facetectomy at L3-L4 or L4-L5 at a single level to treat central or lateral stenosis, Grade I degenerative spondylolisthesis with objective evidence of neurologic impairment, and degenerative disease of the facets, with or without instability.

Study participants will be placed into one of two groups: 1) treatment with the investigational artificial facet replacement device (TFAS™) or 2) treatment with posterior instrumented fusion, considered the current standard of care for stenosis patients and likely the treatment that would be carried out on these patients, regardless of their participation in the trial. Patient enrollment in the trial will be randomized such that two thirds will receive the TFAS™ and one third will receive the standard instrumented fusion treatment.

Study sponsor
Archus Orthopedics, Inc. is a medical device developer focused on pioneering novel solutions for diseases requiring complete removal and replacement of the facets of the lumbar spine. Visit www.archususa.com for more information about the company and the Total Facet Arthroplasty System™ (TFAS™).

Status
Patients are currently being enrolled and treated at Phase One investigative sites. Archus Orthopedics is currently recruiting clinical investigators for Phase Two of the trial.

Inclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients must have the following conditions and meet the following inclusion criteria to be enrolled in this trial:

• Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5, with radiographic confirmation of any one of the following by CT, MRI, plain film or myelography:
• Evidence of thecal sac and/or cauda equina compression;
• Evidence of nerve root impingement by either osseous or non-osseous elements;
• Evidence of hypertrophic facets with encroachment into the central canal or lateral recess.
• No greater than Grade I degenerative spondylolisthesis at the index level;
• Intermittent neurogenic claudication, indicated by the presence of persistent leg symptoms, marked by posterior or anterior thigh or calf discomfort, pain, numbness, parasthesia, weakness, tiredness or heaviness, buttock or lower back symptoms including pain, numbness, burning or tingling, that is aggravated by walking and/or standing and is relieved only after resting in a flexed lumbar spine position;
• Skeletally mature male or female between the ages of 50 and 85 years of age inclusive;
• Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression (Note: Up to three contiguous levels of decompression is allowed, however, only one level is eligible for instrumentation with the TFAS™ system or control);
• Willing and able to sign the Informed Consent document;
• Experienced symptoms of intermittent neurogenic claudication and/or functional deficit for a minimum duration of six months; and
• Failed to respond to non-operative treatment modalities for a minimum duration of six months.

Exclusion criteria for the Total Facet Arthroplasty System™ U.S. IDE Clinical Trial
Patients meeting one or more of the following criteria shall be excluded from the trial:

• Male or female less than 50 or greater than 85 years old;
• Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level;
• More than 3 vertebral levels of degenerative spinal stenosis requiring decompression;
• More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation;
• Not willing or able to sign the Informed Consent document;
• Not available for long term follow-up and interval visits;
• Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine;
• Two or more previous surgeries to the lumbar spine at the same level to be implanted (definition of surgery includes: discectomy, laminectomy, laminotomy, rhizotomy);
• Is being treated with other devices for the same disorder (e.g. pain control devices);
• Active systemic infection or infection at the operating site;
• Has endocrine or metabolic disorders known to affect osteogenesis;
• Is currently taking medications that are known to affect osteogenesis;
• Unable to undergo autologous grafting procedure due to insufficient bone stock;
• Osteoporosis or osteopenia with DEXA -T score less than -2.5, absolute density of less than 0.9 gm/cc per a previous diagnosis (within last 2 years) or is at significant risk for these conditions due to predisposing factors per the surgeon’s judgment;
• Known sensitivity to device materials (i.e. titanium alloy, cobalt, chromium, molybdenum, barium sulfate or polymethylmethacrylate bone cement);
• Has an immunosuppressive disorder;
• Has a medical condition that may interfere with clinical evaluations (active malignancy, unstable cardiac disease, advanced emphysema or Alzheimer’s disease);
• Is a prisoner;
• Is obese defined by a patient body mass index greater than 40 (weight in pounds multiplied by 703/height in inches squared);
• Investigator determines that procedure is technically not feasible;
• Has significant scoliosis (Cobb >25°);
• Is mentally incompetent;
• Has current or recent history (within last 2 years) of substance abuse (alcoholism and/or narcotic addiction); or
• Is pregnant or planning to become pregnant within the proposed three year investigation.

Participating sites and contact information
Sites that are currently participating are located in the following cities and states:

• Clearwater, Florida
• Denver, Colorado
• Baltimore, Maryland
• Plano, Texas
• Los Angeles, California

Additional sites will be added to this list as they begin enrollment.

To learn more about Archus Orthopedics, please access our website at www.archususa.com.

Spine Patients
To determine if you may be a potential candidate for the TFAS™ clinical trial, please access our website at www.archususa.com and click on “Clinical Trial” and “Am I a Candidate?” If you are a spine patient who has been diagnosed with moderate to severe lumbar spinal stenosis, you feel that you may meet the study criteria and you live within 50 miles of the cities listed above, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.

Physicians
If you are a spine surgeon who treats patients meeting the inclusion/exclusion criteria and may be interested in participating as a clinical investigator in the TFAS™ clinical study, please contact us by sending an email to clinicaltrialdept@archususa.com. Please include your name, address and contact information, including an email address where you can be reached.