Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

Inclusion Criteria:

• Age 22 to 85 years old

• Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7

• Chronic axial midline low-back pain in the absence of lower extremitymotor/sensory/reflex changes with or without referred non-radicular leg pain for atleast 6 months prior to screening; unresponsive to at least 3 months of conservativecare

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

• ODI score of ≥ 40 to ≤ 80

• Positive sustained hip flexion test

• Demonstrated intolerance to sitting

• 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 as evidenced by 3 or more discs withModified Pfirrmann grade of 3 or greater

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

• Symptomatic vertebral compression fracture

• Previous surgical treatment of the lumbar spine

• History of sacroiliac (SI) joint fusion within the past six months

• Received lumbar epidural or intradiscal steroid injection, lumbar facet jointsteroid injection, lumbar radiofrequency ablation, provocative or anestheticdiscography, SI joint pain injection, injection of methylene blue, dextrose,glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0procedure

• Received intraosseous radiofrequency nerve ablation procedure at the same oradjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)

• Received prior intradiscal stem cell/progenitor cell therapy or other biologicalintervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0procedure

• Evidence of dynamic instability on lumbar flexion-extension radiographs (>3 mm)

• Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or otherundifferentiated spondyloarthropathy, or Type III Modic changes adjacent to thetarget disc

• Radiographic evidence 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, recenthistory of myocardial 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, orinhalation steroids for asthma is allowed)

• Metal or ceramic implants in the lumbar spine region

• Contraindications to MRI, including non-MRI compatible devices and activeimplantable devices such as spinal cord stimulators, intrathecal pumps, etc.

• Involved in ongoing or closed (within 6 months of screening visit) litigationrelated to their back pain condition

• Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stressdisorder (PTSD) or uncontrolled anxiety/depression and/or require new or changedanti-depressants or anti-psychotic medications within 3 months of enrollment

• Diagnosis of any traumatic neurological disorders that may impact the study as perthe judgement of the Investigator

• 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 to treat the same condition used within 6months prior to the screening visit or during the course of the clinical trial

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