Spineology Clinical Outcomes Trial: An IDE Investigation

This regulated prospective, multi-center, Institutional Review Board (IRB) approved
single-arm performance goal clinical investigation will be conducted at a maximum of 15
centers with no more than 102 subjects being enrolled and treated.

It is anticipated that enrollment will be compete within 24 months. Subjects will be
actively evaluated to 24-months postoperative and depending on enrollment duration, may be
remotely assessed through self-administered surveys at 36- and 48-months.

The primary endpoint, assessed at 24-months postoperative, is a composite score that
includes pain, function, fusion and safety assessments.

Inclusion Criteria:

- Skeletally mature;

- Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2
and S1;

- Minimum low back VAS pain score of 40mm;

- Minimum ODI score of 40;

- Received at least 6-months of conservative care; and

- Willing and able to comply with protocol evaluations and provide informed consent.

Exclusion Criteria:

- Previous fusion or total disc replacement at the index level;

- Greater than Grade I spondylolisthesis;

- Has symptomatic multi-level lumbar DDD;

- Active systemic infection or infection at the local surgical site;

- Active or suspected malignancy;

- Body Mass Index of greater than or equal to 40;

- Significant metabolic bone disease;

- Taking medication known to interfere with bone healing;

- Has a current substance abuse disorder;

- Has a somatoform, dissociative, eating or psychotic disorder;

- Waddell Signs of inorganic behavior;

- Current tobacco user;

- Is a prisoner;

- If female, pregnant or contemplating pregnancy during follow-up period; or

- Enrolled in a concurrent clinical investigation that may confound the findings of the
current investigation