New Data Demonstrate Cianna Medical’s SAVI SCOUT® Equivalence to Radio Seed Localization for Non-Palpable Breast Lesions

Results presented during the 2017 SBI/ACR Breast Imaging Symposium

ALISO VIEJO, Calif., April 06, 2017 -- Cianna Medical, Inc. today announced new data demonstrating the proprietary SCOUT® radar localization system is clinically equivalent to radio seed localization (RSL) for surgical targeting of non-palpable breast lesions. The results were presented at the 2017 SBI/ACR Breast Imaging Symposium, taking place in Los Angeles from April 6-9.

The retrospective study evaluated 119 patients who underwent breast conserving therapy using SCOUT radar localization (n=59) or RSL (n=60), a technique that utilizes a radioactive seed to target tumors. In all cases, the average volume of resection and repeat surgery rates were equal and markers were successfully removed.

SCOUT, an FDA-cleared radar localization system, is a zero-radiation, wire-free solution for breast tumor localization. The novel technology, which is encapsulated in a device smaller than a grain of rice, has received rapid adoption at leading medical facilities across the U.S. and numerous technology awards, offers several benefits over previous localization methods, including unmatched precision to 1mm, 100 percent OR compatibility, simplified scheduling, optimal surgical planning and guidance, improved efficiencies and higher patient and physician satisfaction.

At the conclusion of the study, seven participating radiologists were surveyed about their experiences with both technologies. All radiologists agreed that there was a minimal learning curve associated with radar localization and reported that seed localization was easier than wire localization to learn and implement. The authors concluded that SCOUT is equivalent to RSL with respect to ease of device placement and subsequent removal.

“These data demonstrate that radar-based localization with SCOUT is clinically equivalent to RSL and reinforce the technology as a convenient and effective option for clinicians and patients,” said study author Thomas Frazier, M.D., medical director of the Barbara Brodsky Comprehensive Breast Center and Breast Fellowship at Main Line Health’s Bryn Mawr Hospital. “Although RSL is effective, the stringent regulatory requirements related to use of radioactive materials is cumbersome for doctors and hospital staff and becomes an expensive program to maintain. Use of SCOUT has supported improved scheduling, greater OR efficiency and an enhanced overall experience for surgeons, radiologists and patients.”

During the conference, Nina S. Vincoff, M.D., Chief of Breast Imaging at Northwell Health and Assistant Professor of Radiology at the Hofstra-Northwell School of Medicine, will present her institution’s experience with SCOUT since adopting the technology in 2016. The presentation is scheduled for Thursday, April 6 at the Westin Bonaventure Hotel and Suites from 12:30 – 1:30 p.m. PDT.

“Backed by world class research, development and commercialization teams, Cianna Medical has been exclusively focused on improving breast cancer outcomes for more than a decade and we remain deeply committed to reducing the breast cancer burden for patients and healthcare providers across the care continuum,” said Jill Anderson, President and CEO of Cianna Medical. “These data reinforce previously published studies demonstrating high clinician and patient satisfaction with SCOUT, the world’s only non-radioactive and wire-free radar breast localization solution.”

About SCOUT®
The FDA-cleared SCOUT system features a proprietary, highly sophisticated reflector that is precisely placed at the tumor site up to 30 days before a lumpectomy or surgical biopsy. During the procedure, the surgeon scans the breast using the SCOUT guide which emits 50 million pulses per second, allowing the surgeon to “lock” in on the reflector’s precise location with ± 1mm of accuracy. This higher level of localization precision allows better surgical planning that may improve cosmetic results as less tissue may need to be removed. SCOUT has an exceptional detection range of 1mm – 50mm, documented migration of <1% across multiple studies, and is OR compatible.¹

About Radar Technology
The SCOUT system uses highly sophisticated radar technology. Radar is used when unprecedented precision is required. Applications using radar include ground penetrating radar, automobile safety systems, flight control systems and antimissile and air-defense systems.

About Breast Conservation Surgery
The goal in breast-conservation surgery is to remove all detectable cancer cells. Of the estimated 174,000 women who have breast conservation surgery each year, approximately 30 percent will require repeat surgery because cancer cells are not completely removed during the first procedure. Developed more than 20 years ago, the standard preoperative technique for localizing non-palpable breast lesions is wire localization. During this procedure, a wire is inserted into the breast by a radiologist to guide the surgeon to the target tissue. The most common challenges reported with current localization techniques include scheduling and workflow, surgical planning and guidance, high re-excision rates and a sub-optimal patient experience.

About Cianna Medical, Inc.
Cianna Medical is the world leader in wire-free breast localization and has been focused on breast conservation for over 10 years. Cianna Medical develops, manufactures and markets innovative medical technologies that reduce costs, improve quality and reduce the anxiety and stress breast cancer treatments place on women and their families. Cianna Medical’s world class research, development and commercialization teams developed the world’s first non-radioactive, wire-free breast localization system and the world’s only technology that utilizes radar in tissue. Cianna Medical is focused on expanding applications that continually advance patient care. Its SCOUT and SAVI® Brachy technologies are FDA-cleared and address unmet needs in the delivery of radiation therapy, tumor localization and surgical guidance.

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1} Cox CE, Russell S, Prowler V, et al. A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision. Ann Surg Oncol. 2016;23(10):3168-74.

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