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SenoRx was co-founded by breast care physicians who recognized an unmet need to improve patient outcomes for each of the steps associated with the diagnosis and treatment of breast cancer. Years of experience working with breast cancer patients demonstrated that traditional technologies sometimes resulted in discordant findings, false negatives or even positive margins, all of which required patients to undergo additional costly procedures.

For each of the steps: Biopsy, Marking, Fixation, Detection and Excision, the physicians sought to develop technologies that would provide more accurate and consistent clinical results. In a relatively short period of time, SenoRx has introduced an array of minimally invasive products that have been clinically proven to enhance patient outcomes. These are some of the SenoRx technological advancements:

Step	Clinical Issues	Technology Advancements
Biopsy	Targeting Accuracy — Dense breast tissue and/or solid lesions can interfere with obtaining biopsy samples. Spring-loaded devices have been reported to bounce off dense lesions into normal tissue resulting in discordant findings.	The patented Tri-Concave™ trocar tip technology significantly enhances the penetration capability of both the EnCor® and SenoCor 360® biopsy devices. A radiofrequency cutting tip – incorporated in the SenoCor 360 biopsy product – utilizes a thin electrosurgical wire that easily penetrates the toughest tissue.
	Sampling Accuracy – Lesions can be in difficult-to-biopsy locations such as close to the chest wall or the surface of the skin. They can also be concentrated or diffuse.	EnCor enables the physician to pre-select the exact sample pattern that is best suited for the clinical situation. Once selected, EnCor automatically excises tissue and then precisely rotates to the next sampling position until the biopsy is complete. The excised tissue is automatically transferred from inside the breast through the device and out into a collection chamber.
	Sample Quality – Small or insufficient samples can lead to discordant findings requiring re-biopsy or referral for surgical biopsy.	For tough dense lesions EnCor offers a dense mode setting which enables longer vacuum dwell time and slower cutter speed to enhance sample quality. SenoCor 360 introduced the 360° virtual sample chamber. Samples are harvested from a full 360° circumference inside the mass, ensuring definitive diagnosis.
Marking	Ultrasound Visibility – Traditional markers are visible with x-ray imaging requiring the needle localization procedure to be performed prior to surgery in the radiology department. As a result, patients can experience vasovagal reactions and run the risk of the wire being dislocated away from the lesion following breast decompression.	SenoRx pioneered the concept of an ultrasound visible marking system. Ultrasound visible markers serve as a surrogate for the lesion, enabling surgeons to perform needle localizations in the operating room, eliminating vasovagal reactions. Furthermore, it has been demonstrated in a large 45 surgeon, 432 patient, registry trial that use of Gel Mark® Markers resulted in clear margins in 90% of the cases. (“Surgical Benefits Conveyed by Biopsy Site Marking System Using Ultrasound Localization”, American Society of Breast Surgeons, 2005)
Fixation	Positive Margins – Traditional localization wires provide no external perimeter around the lesion to help guide surgeons in their effort to remove all of the diseased tissue. As a result, re-excision rates, as reported in the literature, range from 30% to 50%.	Anchor Guide® incorporates 12 fixation wires that are deployed to form a 3cm sphere around the lesion. Surgeons can palpate the wires and then precisely excise tissue surrounding the wires to yield clear margins. In a prospective, randomized, multicenter trial, Anchor Guide yielded 90% clear margins compared to 70% for the control group. (“A prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a new lesion localization device”. The American Journal of Surgery 184 (2002) 318-321 Scientific Paper)
Detection	Sentinel Node Detection – Gamma detection probes must balance two competing tasks. First they must be sensitive enough to detect the general location of the sentinel node through the surface of the skin, and second they must have excellent spatial resolution to be able to discern one lymph node from the one right next to it.	Gamma Finder® provides the optimum balance between sensitivity and spatial resolution. Gamma Finders 11mm tip is able to scan for gamma rays from the skin surface. Once inside, it can detect between two lymph nodes 14mm apart. Gamma Finder is also the first cordless, battery operated gamma detection system with a built in display on the probe. The surgeon can correlate the beeping sounds with a direct visual count on the end of the probe while in the sterile field.
Excision	Irregular shaped cavities – Effective brachytherapy treatment requires a smooth symmetrical shaped cavity to ensure full contact with the brachytherapy balloon. Traditional scalpels or Bovie knives cannot always achieve this desired effect.	SenoRx developed SenoPulse™ technology which is used to power the Shape Select® radiofrequency scalpel. Shape Select consists of a long cutting wire that can be molded or shaped to create symmetrical, curvilinear cuts around the lesion.
Treatment	Cancer Cell Recurrence - Following lumpectomy treatment for breast cancer there is a risk of cancer cells remaining in tissues near the lumpectomy cavity. The current standard of care for treatment of breast cancer following lumpectomy is whole breast radiation. This requires the patient to return to the radiology suite daily for a period of five to eight weeks.	New and exciting alternatives to whole breast radiation treatment have emerged in the area of accelerated partial breast irradiation (APBI). Short term targeted radiation therapy alternatives include multi-catheter brachytherapy, conformal beam targeted radiation and balloon brachytherapy. SenoRx received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Multi-Lumen Radiation Balloon Applicator for Brachytherapy. The radiation balloon uses vacuum to remove excess fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order to deliver precise radiation dosing through multiple seed lumens. Certain patients who are candidates for balloon therapy are currently excluded because of the location of their lesion. Our multi-lumen approach addresses this problem.

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