STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients with Vertebral Compression Fractures

Inclusion Criteria:

1. Subject is a male or female 50 years of age or older at the time of study treatment.

2. Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if theyhave an asymptomatic, healed VCF(s) at any non-target vertebral level.

3. Each target VCF meets all of the following criteria:

4. Due to diagnosed or presumed underlying osteoporosis

5. T1 to L5 inclusively

6. Target VCF-related pain ≤ 6 months at time of study treatment

7. Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray atbaseline.

8. Each target VCF is acute or persistent (not healed), as demonstrated on imaging,including T2-weighted, STIR MRI, bone scan or bone scan with SPECT/CT, serialradiographs, or other serial imaging demonstrating acuity.

9. Focal tenderness to palpation of the spinal process of each target VCF on thephysical exam correlates with imaging.

10. Subject has failed conservative medical therapy (bed rest, observation, chiropracticcare, orthotics, opioid and non-opioid analgesics, and/or physical therapy), definedas either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks ofconservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks ofconservative care.

11. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.

12. Subject is capable of giving written informed consent to participate in the study.

13. The subject's willingness, ability, and commitment to participate in screening,treatment, and all follow-up evaluations for the full length of the study has beendocumented

Exclusion Criteria:

1. At least one of the target VCF(s) is unstable, including split or burst fracture.

2. Subject has a bleeding disorder.

3. Subject has an active infection of the spine or surgical site.

4. Subject has a bloodborne infection.

5. At least one of the target VCFs is due to underlying or suspected tumor.

6. At least one of the target VCFs is due to high-energy trauma.

7. At least one of the target VCFs is due to osteonecrosis.

8. At least one of the target VCFs has a local kyphotic angle of > 30 degrees, measuredas the angle between the superior endplate and inferior endplate at the target VCF.

9. Subject has had any prior surgical treatment at the target vertebral level oradjacent vertebral levels.

10. The pedicle(s) in the target vertebral body appears unable to safely accommodatetranspedicular access instrumentation.

11. Subject has neurologic symptoms, deficits, or radiculopathy related to the targetVCF(s).

12. Subject has spinal canal compromise causing clinical manifestations of cord, neuralforamen, or nerve root compression at the level to be treated.

13. Subject has pain, progressive weakness, or paralysis due to herniated nucleuspulposus or spinal stenosis.

14. Subject has spondylolisthesis > Grade 1 at target vertebral body(ies).

15. Subject requires daily opioid medication for pain not related to the target VCF(s).

16. Subject has severe cardiopulmonary deficiencies.

17. Subject has a Body Mass Index (BMI) > 35.

18. Subject has a history of metabolic bone disease other than osteoporosis (e.g.,Paget's disease, renal osteodystrophy, or osteomalacia).

19. Subject has a history of tuberculous spondylitis.

20. Subject has a history of invasive malignancy within the last five (5) years, otherthan non-melanoma skin cancer. Subject is not excluded if they have a history ofmalignancy over 5 years ago treated with curative intent and without clinical signsor symptoms since then.

21. Subject is on oral or parenteral immune-suppressive drugs.

22. Subject has uncontrolled diabetes mellitus.

23. Subject has severe renal insufficiency defined as an estimated glomerular filtrationrate (eGFR) < 30 mL/min.

24. Subject has a diagnosed calcium metabolism disorder.

25. Subject has known allergies to calcium-based bone void fillers.

26. Subject is pregnant or planning to become pregnant during participation in thestudy.

27. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-upschedule, progression of the fracture between screening and the procedure visit).

28. Subject is currently enrolled in another interventional clinical study.