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.

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 or moderate cognitive impairment)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.

5. Informed consent is provided by the subject or the subject's LAR.

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. Subject hospital admission is > 24 hours from the time of the index hip fracture.

2. Subject was dependent on the use of a wheelchair or was bedridden prior to the indexhip fracture.

3. Subject is currently enrolled in another clinical study.

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 one or more new fractures in addition to the index hip fracture atadmission that, in the opinion of the investigator, would further compromise patientmobility, rehabilitation, and/or recovery or subject has three or more new fracturesin addition to the index hip fracture.

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. Subject is at ASA Class IV, V, or VI.

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

11. Subject has a history of Pott's disease.

12. Subject has a history of any invasive malignancy (except nonmelanoma skin cancer),unless treated with curative intent and with no clinical signs or symptoms of themalignancy for 5 years.

13. Subject has chronic cardiac insufficiency or severe cardiovascular disease asassessed by a subject or LAR interview to be NYHA Class III or IV or has animplanted pacemaker.

14. Subject has a history of cardiovascular events (e.g. stroke, transient ischemicattack, myocardial infarction, unstable angina, pulmonary embolus, deep veinthrombosis, ventricular tachycardia, or atrial fibrillation) in the last 3 months.

15. Subject is on oral or parenteral immuno-suppressive drugs.

16. Subject has uncontrolled diabetes mellitus.

17. Subject has Hb ≤ 9 g/dL at admission.

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

19. Subject has a diagnosed and ongoing calcium metabolism disorder.

20. Subject has a Parker Mobility Score ≤ 5.

21. Subject has severe cognitive impairment as assessed by SPMSQ.

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., inability to maintain follow-up schedule, comorbidity or poor generalphysical/mental health, or drug or alcohol abuse issues).

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