SentiMag® Intraoperative Comparison in Breast Cancer

This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag®
and SiennaXP® magnetic sentinel node localization system with the standard of care
(radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in
patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed
to provide powered evidence that the lymph node detection rate of the SentiMag® and
SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

Inclusion Criteria:

- Subjects with a diagnosis of primary breast cancer or subjects with pure ductal
carcinoma in situ (DCIS).

- Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy
procedure being a part of the surgical plan.

- Subjects aged 18 years or more at the time of consent.

- Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of
Grade 0 - 2.

- Subject has a clinical negative node status (i.e. T0-3, N0, M0).

Exclusion Criteria:

- The subject is pregnant or lactating.

- The subject has clinical or radiological evidence of metastatic cancer including
palpably abnormal or enlarged lymph nodes.

- The subject has a known hypersensitivity to Isosulfan Blue Dye.

- The subject has participated in another investigational drug study within 30 days of
scheduled surgery.

- Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c)
lymphatic function that is impaired in the surgeon's judgment.

- Subject has had preoperative radiation therapy to the affected breast or axilla.

- Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.

- Subject has intolerance or hypersensitivity to iron or dextran compounds or to
SiennaXP.

- Subject has an iron overload disease.

- Subject has pacemaker or other implantable device in the chest wall.