ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs

Key Inclusion Criteria:

• Age 22 to 85 years old
• Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
• Chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
• Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
• Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
• Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
• ODI score of ≥ 40 to ≤ 80 at the time of Screening

Key Exclusion Criteria:

• Contraindication to MRI for any reason
• Contraindications to the proposed sedation/anesthetic protocol
• Symptomatic involvement of more than two lumbar discs
• Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s)
• Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
• Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
• Clinical suspicion of facet pain as primary pain generator
• Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study. Pregnancy is confirmed by:

• A positive pregnancy test during the screening visit
• Self-reported pregnancy
• Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)