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).(23).

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

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

5. Menses regularity - shortest to longest period is ≤8 days based onsubjectparticipant reporting.

6. Actively experiencing heavy to very heavy menstrual bleeding (HMB) at the time ofthe Juveena HS treatment, i.e., MVJ score of ≥5 (treatment must be performed nolater than Day 3 of the index period).

7. HMB refractory to hormone therapy, hormone therapy contraindicated, orsubjectparticipant does not wish to continue hormone therapy.

8. The subjectparticipant is literate and clearly demonstrates an understanding of howto complete the MVJ Scale and other patient-reported outcomes.

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

10. Use an effective non-hormonal method of birth control until the Day 28 visit.Acceptable methods of birth control for use in this study are abstinence andbarrier contraceptives (e.g. condom)

11. No initiation or continuation of hormone use (including contraception) or anyother medical intervention for bleeding until after the Day 28 visit (unlessclinically necessary, e.g., the subjectparticipant becomes hemodynamicallyunstable)

12. Attends the follow-up examexams and completion of electronic diaries via asecured internet website (subject must have internet accesscompletes the MVJscale and will be trained on how to use the eDiary)other patient-reportedoutcomes per the schedule of events

13. Demonstrates understanding of the study and signs the written informed consent form.

Exclusion Criteria:

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

2. Currently using an intrauterine device (IUD) or has undergone removal within thelast 2 menstrual 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

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.