RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Inclusion Criteria:

1. Subject is a postmenopausal female at least 1-year post menses and at least 65 yearsof age and less than 92 years of age.

2. Subject presents with a low-energy index fragility hip fracture in one hip and willundergo surgical repair of the fractured hip.

3. Subject has at least one of the following additional risk factors for a secondaryhip fracture (as determined by subject or legally authorized representative (LAR)interview or medical record review):

• Documented falls assessment indicating subject is at moderate or high risk offalls

• Falls history (2 or more falls in the previous 12 months)

• History of vertigo, dizziness, or postural hypotension

• Documented T-score < -2.5 at the hip

• Taking more than 3 daily prescription medications

• Visual impairment as confirmed by one of the following:

• Subject reports difficulty seeing

• Lack of depth perception or vision loss in one eye

• Macular degeneration

• Cataracts

• Prior non-hip fragility fracture

• Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined bySPMSQ ≤ to 4) or delirium

• Parkinson's disease stage 3 or 4

• 10-year hip fracture probability >15% using the FRAX® Fracture Risk AssessmentTool of the clinical site country

4. Subject is expected to be ambulatory after the hip fracture repair procedure. "Ambulatory" is defined as a patient's ability to ambulate beyond simple transferswith or without assistive devices.

5. Informed consent is provided by the subject or the subject's LAR. Use of an LAR toobtain patient consent requires that the patient must understand and be able toparticipate in post operative restrictions and requirements.

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

Exclusion Criteria:

1. Criterion omitted

2. Criterion omitted

3. Subject is currently enrolled in another interventional clinical study affecting thetarget hip.

4. Subject has a history of hip surgery or previous hip fracture on the targetunfractured hip contralateral to the index hip fracture.

5. Subject has new fractures in addition to the index hip fracture at admission that,in the opinion of the investigator, would further compromise patient mobility,rehabilitation, or recovery.

6. Subject has an infection at the LOEP intended treatment site or has non-intact skinor acute traumatic injuries with open wounds close to the area of intended LOEPtreatment.

7. Subject has a progressive increase in undiagnosed pain in the target hipcontralateral to the index fractured hip over the previous 3 months that in theopinion of the Investigator may suggest underlying bone or joint pathology on theunfractured side.

8. Subject has radiological evidence of gross bony or joint pathology of the hip,including signs predictive of atypical femoral fractures (e.g. cortical beaking), orhas been diagnosed and/or treated for atypical femoral fractures.

9. Criterion omitted

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

11. Criterion omitted

12. Subject has active cancer

13. Criterion omitted

14. Criterion omitted

15. Criterion omitted

16. Criterion omitted

17. Criterion omitted

18. Subject has end stage renal insufficiency defined as an estimated glomerularfiltration rate (eGFR) < 15 mL/min.

19. Criterion omitted

20. Criterion omitted

21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 orhigher.

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

23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subjectwould not be a good candidate to undergo an ELECTIVE orthopedic surgical proceduresuch as a total hip arthroplasty in her current medical, physiological condition.

24. Subject fails pre-operative or intraoperative eligibility criteria as specified insection 7.4.2. of the clinical investigation plan.