Inclusion Criteria:

- Women, age between 18 and 50 years

- Ethnicity has a match with the intended profile for the site

- Weight < 140kg or 310lbs

- Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating
Hormone (FSH) level < 40 IU/L

- Willing and able to attend all study visits

- Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline
Hematin (AH) method

- Willing and able to use reliable contraception methods

- Uterine size < 24 weeks

- Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial
Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of
Uncertain Significance (ASCUS) subtypes of cervical tissue

- MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid
volume can be treated.

- Fibroids selected for treatment meeting the following criteria (further extrapolated
in the protocol):

1. Total planned ablation volume of all fibroids should not exceed 250 ml and

2. No more than 5 fibroids should be planned for ablation and

3. Dominant fibroid (diameter) is greater than or equal to 3 cm and

4. Completely non-enhancing fibroids should not be treated as the identification of
treated volume becomes ambiguous

- Patient's self-assessment indicates that she has had episodes of heavy menstrual
bleeding in the past 6 months.

- Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml

Exclusion Criteria:

- Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease,
significant adenomyosis)

- Desire for future pregnancy

- Significant systemic disease even if controlled

- Positive pregnancy test

- Hematocrit < 25%

- Extensive scarring along anterior lower abdominal wall (>50% of area)

- Surgical clips in the potential path of the HIFU beam

- MRI contraindicated

- MRI contrast agent contraindicated (including renal insufficiency)

- Calcifications around or throughout uterine tissues that may affect treatment

- Communication barrier

- Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2
contrast obtained using the Philips MR-HIFU MR protocol) fibroids

- Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements
are not feasible)

- Menses lasting > 7 days or intermenstrual bleeding (patient can be included if there
is endometrial biopsy within 6 months to exclude malignancy)

- Patient is currently on hormonal medication for fibroids or has a hormonal medication
history as described below:

1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or

2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement
or

3. Depo Provera or equivalent: less than 6 months prior to MBL measurement