December 11, 2015
- Eleven clinical sites announce preliminary results in investigator-initiated study to expand procedural experience using FDA-cleared non-radioactive, real-time guidance technology
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 more than 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), 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 and removal 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.”
About SAVI SCOUT®
SCOUT is an FDA-cleared medical device that utilizes passive non-radioactive electromagnetic wave technology to provide real-time guidance during excisional breast procedures by using a reflector that can be placed in the target tissue up to seven days prior to surgery. During the procedure, the surgeon uses the SCOUT handpiece that emits infrared light and electromagnetic waves, to locate the reflector and plan the incision. Aided by audible and visual feedback provided by the console, the surgeon is able to remove the reflector and the target tissue with a high degree of precision.
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 (WL). With 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.
Radioactive seed localization (RSL) was developed as an alternative to wire localization. Despite some proven advantages, the adoption of RSL has been impacted by considerable regulatory requirements and precautions for the safe handling of radioactive materials.
About Cianna Medical, Inc.
Cianna Medical develops, manufactures and markets innovative medical technologies that reduce costs, improve quality, and reduce the burden breast cancer treatment places on women and their families. Its SAVI® technologies are FDA-cleared and address unmet needs in the delivery of radiation therapy, tumor localization and surgical guidance.
For more information, call 866-920-9444 or visit www.ciannamedical.com
Danielle Lewis or Glenn Silver
LAZAR PARTNERS for Cianna Medical