IUB SEAD RED (Revolutionary Endometrial Ablation Device Study)

Inclusion Criteria:

1. Female subject age 40 to 50 years, inclusive
2. Suffering from the symptom of heavy menstrual bleeding (HMB) from benign causes withno definable organic cause and are candidates for endometrial ablation or surgicaltreatment.
3. PBAC score of >150 - an average of 2 consecutive screening scores prior to studytreatment
4. Are thought to be ovulatory with cyclic predictable onset of menses with a cyclelength of 24-38 days.
5. Have either a normal appearing endometrial cavity as assessed by hysteroscopyperformed within 90 days of study treatment, or one that is distorted by a FIGO Type 2submucous leiomyoma ≤3 cm in mean diameter.
6. Have endometrial sampling with normal histology within 6 months of the studyprocedure.
7. Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L).FSH level measurement will be repeated in case of a borderline result
8. Screening hemoglobin levels >9.0 g/dL
9. Uterine sound measurement of 6.5-12 cm (external os to internal fundus)
10. Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
11. women whose sexual activity places them at risk for pregnancy must agree to use aneffective, non-hormonal, non-intrauterine method of contraception throughout thecourse of the study. For this study, acceptable effective methods of contraception areconsidered to be those listed below:

• Barrier method, i.e., (a) condom (male or female) with spermicide or (b)diaphragm with spermicide or
• Vasectomy (partner), or
• Abstinence, if in line with the preferred and usual lifestyle of the subject [where abstinence is defined as refraining from heterosexual intercourse]

12. Subject is able to understand and sign a written informed consent form
13. Subject is willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures
14. The subject demonstrates an understanding of how to record menstrual blood loss usinga menstrual pictogram

Exclusion Criteria:

1. Pregnant women or those who desire to conceive at any time in the future
2. An endometrial cavity with any of the following: congenital malformation of (egseptate uterus), endometrial polyp >8 mm in largest dimension, FIGO Type 0 or 1leiomyomas of any diameter or Type 2 leiomyomas > 3 cm in mean diameter; intrauterineadhesions/ synechiae that distort the endometrial cavity sufficient to impairdeployment of the SEAD device.
3. Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural abdominal (laparoscopic or laparotomic) or hysteroscopic myomectomyand/or metroplasty during last 3 months prior to screening, classical Cesareansection, or endometrial ablation
4. Have an abnormal endometrial biopsy that suggests either anovulation or a risk for thedevelopment of endometrial cancer (i.e., benign hyperplasia, endometrial hyperplasiawith atypia, endometrial intraepithelial neoplasia, endometrial cancer)
5. Have a documented clinical history of titanium allergy or hypersensitivity to anycomponent of IUB™SEAD™.
6. Suffers from active endometritis, active pelvic inflammatory disease (PID) or activesexually transmitted disease (STD)
7. Suffers from active infection of the genitals, vagina, cervix, or uterus
8. Presence of bacteremia, sepsis, or other active systemic infection
9. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
10. Known clotting defects or bleeding disorders
11. Currently using anticoagulant treatment
12. Subjects with abnormal Papanicolaou (Pap) test or atypical squamous cells ofundetermined significance (ASCUS) with positive high-risk human papilloma virus (HPV)test result within the appropriate screen timeframe, and prior to SEAD™ treatment.Alternatively, a colposcopy performed prior to SEAD™ treatment, that showed evidenceof dysplasia requiring treatment. In case treatment was performed > 6 months prior toenrollment and follow-up was done with no evidence of disease by clinical evaluation,the subject is eligible.
13. Suffers from clinically significant adenomyosis indicated by subject complaints orimaging
14. Presence of an implantable contraceptive device, unless subject agrees to have thedevice removed immediately on screening, and prior to PBLAC assessment
15. Post-partum ≤ 6-months
16. Currently participating in or considering participation in a research study of aninvestigational drug or device that would begin during the course of thisinvestigational study
17. Any general health or mental, or other situation or condition which, in the opinion ofthe Investigator, could present an increased risk for the subject or impact thesubject's ability to comply with protocol requirements.
18. Has a polyp that was not removed before day of treatment