SAN ANTONIO – December 11, 2015 – Cianna Medical, Inc. today announced that new data from an investigator-initiated trial evaluating the SAVI SCOUT® surgical guidance system, an FDA-cleared tool for localizing and directing the removal of non-palpable breast lesions, will be presented at San Antonio Breast Cancer Symposium (SABCS), taking place from December 8-12. An initial investigator-initiated study, entitled “A Prospective, Single Arm, Multi-Site, Clinical Evaluation of the SAVI SCOUT Surgical Guidance System for the Location of Non-Palpable Breast Lesions During Excision”, has been successfully completed. Though the study accrual has closed, data collection and analysis are ongoing with preliminary results being reported.

“We continue to be extremely encouraged by the clinical efficacy observed with SCOUT and the data suggest it is a safe and effective tool for the localization of non-palpable breast lesions and a viable alternative to wire localization,” noted Charles E. Cox, M.D., principal investigator and Professor of Surgery and McCann Foundation Endowed Professor of Breast Surgery, University of South Florida College of Medicine, Tampa, Fla. “This study demonstrates that real-time surgical guidance with SCOUT is an appropriate and accurate modality for directing the removal of non-palpable breast lesions and is reproducible in multiple clinical settings.”

Eleven sites, comprising 17 surgeons and 24 radiologists, participated in the study that enrolled over 150 patients. Participating centers include: University of South Florida Breast Health, Nashville Breast Center, Baylor Regional Medical at Plano, Cancer Centers of Colorado, Hackensack University Medical Center, The University of California Irvine Health, Morton Plant Mease Health System, New York University Langone Medical Center, Pink Lotus Breast Center, Saint Joseph Hospital, and Texas Breast Specialists.
Study results demonstrated 100 percent surgical success using SCOUT. In all cases with complete data (n=146/146), targeted lesions and reflectors were successfully removed without any observed reflector migration. Of the cases in which final pathology is available the overall re-excision rate for patients is 11.3 percent. Surgeons favorably rated ease of localization with SCOUT 4.3 on a scale of 1-5, where 3 was equal to wire localization.

“More than 93% of surgeons we interviewed have told us they need a better approach to localizing breast tumors, and SCOUT is helping address this significant unmet need,” said Jill Anderson, President and CEO of Cianna Medical. “Our investigators continue to report positive feedback from their patients and we are hearing that eliminating the need for invasive wires and wait times between radiology and surgery is helping women feel more at ease on a day already associated with high levels of stress and anxiety.”

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