A Clinical Study Evaluating the Safety and Effectiveness of VIA Disc NP in Subjects With Symptomatic Disc Degeneration

Inclusion Criteria:

• Age 22 to 85 years old

• Diagnosis of early to moderate degenerative disc disease (DDD), Modified PfirrmannGrade 3-7

• Chronic axial midline low-back pain with or without referred non-radicular leg painfor at least 6 months prior to screening; unresponsive to at least 3 months ofconservative care

• Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS

• ODI score of ≥ 40 to ≤ 80

• Positive sustained hip flexion test as confirmed with the Neurologic Exam indicatingpositive provocation with sustained hip flexion at the time of screening

• Demonstrated intolerance to sitting for more than 30 minutes at a time based onself-report or assessed by a qualified healthcare professional at the screeningvisit

• Able to give voluntary, written informed consent to participate and have signed anInformed Consent Form specific to this study

• Willing and able to comply with all study procedures and availability for theduration of the study with a life expectancy of > 2 years

Exclusion Criteria:

• Contraindications to the proposed sedation/anesthetic protocol

• Involvement of more than two lumbar discs

• 3 or more discs with a Modified Pfirrmann grade of 3 or greater

• Disc height of less than 4mm for any disc between L1-S1

• Fracture of the lumbar spine, previous lumbar spine surgery or previous surgicaltreatment of the target disc

• History of sacroiliac (SI) joint pain/injections during the past 1 month or SI jointfusion within the past six months

• Received chemonucleolysis or percutaneous treatment of the affected disc prior tothe study

• History of lumbar epidural steroid injections within 4 weeks prior to studytreatment

• Received any lumbar intradiscal treatment injection or procedure (e.g., injection ofmethylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty) orany nerve ablation procedures at the same or adjacent level (e.g., Basivertebralnerve ablation, dorsal ramus or sinuvertebral nerve ablations); discography andanesthetic discography may be performed but must be done at least 2 weeks or moreprior to the VIA Disc NP procedure

• History of lumbar facet joint steroid injections within 4 weeks of procedure

• History of lumbar radiofrequency ablation within 8 weeks of procedure

• Received prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc

• Evidence of dynamic instability on lumbar flexion-extension radiographs

• Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or otherundifferentiated spondyloarthropathy, or Type III Modic changes around the targetdisc

• Clinical suspicion of a full thickness annular tear at the target disc or otherabnormal disc morphology

• Clinical suspicion of facet pain as primary pain generator

• A systemic condition or disease not stabilized or judged by the Investigator to beincompatible with participation in the study (e.g. current systemic infection,uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history ofmyocardial infarction, uncontrolled diabetes (>7.0% HbA1C), etc.)

• Received VIA Disc NP previously.

• Deemed unsuitable for clinical study participation by the Investigator

• Evidence of substance abuse (including marijuana); note: subjects using prescribedextended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3months prior to screening and subjects on long-acting opioids may be given option towean off opiates before enrollment; subjects on short-acting opiates (e.g.,hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitoredafter the treatment

• Opioid use of more than 90 MME/day

• Currently receiving treatment with radiation, chemotherapy, immunosuppression, orchronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd isallowed, as well as inhalation steroids for asthma)

• Metal or ceramic implants in the lumbar spine region

• Non-MRI compatible devices and active implantable devices such as spinal cordstimulators, intrathecal pumps, etc.

• Compensated injuries or ongoing litigation regarding back pain/injury, or financialor other incentives to remain impaired

• Any mental instability, bipolar disorders, post-traumatic stress disorder (PTSD) oruncontrolled anxiety/depression and/or require new or changed anti-depressants oranti-psychotic medications within 3 months of enrollment

• Diagnosis of any traumatic neurological disorders

• Women who are pregnant or breastfeeding at the time of enrollment and/or plan tobecome 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 ofcontraception (as determined by the Investigator)

• Received any experimental drug or device used within 30 days prior to the screeningvisit or during the course of the clinical trial.

• Other persistent pain/nerve issues including, for example, radiculopathy, leg pain,cauda equine syndrome, etc.