Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

Inclusion Criteria:

1. Female aged 18 to 45 years inclusive seeking treatment for HMB.

2. Recent history (within the last 3 months) of repeat periods of HMB that adverselyaffects quality of life (Modified SAMANTA score ≥4 and comprises at least threeconsecutive days of HMB, see Appendix 2).

3. Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined byretrospective MVJ Bleeding scale score of ≥5 for prior cycle.

4. Menses frequency (24-38 days) based on subject reporting.

5. Menses regularity - shortest to longest period is ≤8 days based on subjectreporting.

6. HMB refractory to hormone therapy, hormone therapy contraindicated, or subject doesnot wish to continue hormone therapy

7. Able and willing to comply with the study protocol and agrees to the followingduring participation in the study:

8. Use an effective method of birth control until the Day 28 visit. Acceptablemethods of birth control for use in this study are abstinence and barriercontraceptives (e.g. condom)

9. No initiation of hormone use (including contraception) or any other medicalintervention for bleeding (unless clinically necessary, e.g., the subjectbecomes hemodynamically unstable)

10. Attend the follow-up exams

11. Demonstrates understanding and signs the written informed consent form

Exclusion Criteria:

1. Pregnancy and/or breast feeding within the past 3 months or planning to becomepregnant during the duration of this study.

2. Currently using intrauterine device (IUD) or has undergone removal within the last 2menstrual cycles.

3. Dysmenorrhea of a severity that, in the opinion of the investigator, precludesparticipation in the study.

4. Hemoglobin of < 8 g/dL at the time of screening.

5. Suspected or known malignancy or premalignant condition of the uterus including thecervix

6. Active pelvic infection.

7. Active sexually transmitted disease (STD) at the time of treatment (STD testing tobe performed)

8. Presence of bacteremia, sepsis, or other active systemic infection

9. Currently on anticoagulants

10. History of allergies to PEG or FD&C Blue#1 dye

11. Planning to undergo surgery or other treatments for HMB during the study period (i.e., 8 weeks post hydrogel instillation).

12. AUB-L sm with a Type 0 or 1 leiomyoma > 1 cm based on ultrasound, hysteroscopy, orMRI performed within prior 6 months.

13. AUB-P (Polyp) > 2 cm in maximum dimension based on ultrasound, hysteroscopy, or MRIperformed within prior 6 months.

14. AUB-O, Irregular menstrual cycles (cycle length variability >7 days length)

15. AUB-C (coagulopathy or bleeding disorder)

16. Any patient who is currently participating or considering participation in any otherresearch of an investigational drug or device. Does not include observationalstudies

17. Any general health, mental health, or social situation which, in the opinion of theinvestigator, could represent an increased risk for the patient or the ability ofthe patient to complete study requirements.