MarginProbe® System U.S. Post-Approval Study

This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which
subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be
randomized to either standard of care with additional inspection ('SOC + Additional
inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).

The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at
the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It
will be used by the surgeon during lumpectomy procedures only in patients randomized to the
"Device+SOC" arm.

Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Inclusion Criteria:

- Women histologically diagnosed with carcinoma of the breast

- Women with non-palpable malignant lesions, requiring image guided localization.

- Undergoing lumpectomy (partial mastectomy) procedure

- Age 18 years or more

- Signed ICF

Exclusion Criteria:

- Multi-centric disease (histologically diagnosed cancer in two different quadrants of
the breast)

- Bilateral disease (diagnosed cancer in both breasts)

- Neo-adjuvant systemic therapy

- Previous radiation in the operated breast

- Prior surgery in the same site in the breast

- Woman histologically diagnosed by an open biopsy procedure

- Implants in the operated breast

- Pregnancy

- Lactation

- Participating in any other investigational study for either drug or device which could
influence collection of valid data under this study

- Patients for whom complete cavity shaving is planned (sites where this is the routine
practice of the investigator will also be excluded from participation in the study)