April 07, 2016

Results presented at SBI/ACR Breast Imaging Symposium demonstrate high rates of clinical efficacy, intraoperative retrieval and surgical success rates

AUSTIN, Texas – April 7, 2016 – Cianna Medical, Inc. today announced new clinical data evaluating SAVI SCOUT® breast localization and surgical guidance system. Results demonstrating high rates of clinical efficacy, intraoperative retrieval and surgical success rates were presented in an electronic poster session at the SBI/ACR Breast Imaging Symposium, taking place from April 7-10.

SAVI SCOUT, an FDA-cleared tool for localizing and directing the removal of non-palpable breast lesions, became available in late 2015. The technology is now in use at 50 medical centers across the U.S. and has been used in approximately 1,200 patient procedures to date.

Results from the investigator-initiated trial of 154 patients demonstrated a 100 percent surgical success rate using SCOUT, with a low re-excision rate that is in line with rates reported for intraoperative ultrasound. In all cases where localization was performed and data are complete, targeted lesions and reflectors were successfully removed without any observed reflector migration.

“These data confirm previous findings demonstrating that real-time surgical guidance with SCOUT is a clinically reproducible, safe and effective technique for directing the removal of non-palpable breast lesions with no wires or radioactive materials,” said Jiyon Lee, M.D., a presenting study investigator and Assistant Professor in the Department of Radiology at NYU Langone Medical Center.

Hildegard Toth, M.D., study co-investigator and Associate Professor in the Department of Radiology at NYU Langone, added, “In our studies, SCOUT demonstrated an additional benefit of decoupling the localization and surgical procedures, which may result in improved patient scheduling and work flow.”

The study also examined clinician and patient satisfaction with SCOUT. Radiologists favorably rated the overall patient experience at 4.1 on a scale of 1-5, where 3 was seen as SCOUT having equal favorability to wire localization. Using the same scale, surgeons favorably rated ease of localization with SCOUT at 3.9 and ability to start cases earlier at 4.9. Post-procedural survey data indicated that 97 percent of patients would recommend SCOUT to other patients.

The study was conducted at 11 sites, with 17 surgeons and 24 radiologists contributing. 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, UC Irvine Health Pacific Breast Care Center, Medical Center of Plano Complete Breast Care, Morton Plant Mease Hospital, New York University Langone Medical Center, Pink Lotus Breast Center and Texas Breast Specialists.

“We are encouraged by these promising results which reinforce our ability to deliver on our commitment to developing novel approaches for breast tumor localization and treatment,” said Jill Anderson, President and CEO of Cianna Medical.  “SCOUT is a zero radiation and wire-free solution that has demonstrated potential to improve the patient and clinician experience, facilitate simplified scheduling and workflow and reduce scheduling delays when compared to wire localization.”

About SAVI SCOUT®

The FDA-cleared SCOUT system features a reflector that is placed at the tumor site up to seven days before a lumpectomy or surgical biopsy. During the procedure, the surgeon scans the breast using the SCOUT handpiece, which emits infrared light and nonradioactive electromagnetic waves to detect the location of the reflector. Real-time audible and visual indicators assist the surgeon in accurately locating the reflector, along with the target tissue. This higher level of localization precision allows the surgeon to plan a surgical approach that may result in a better cosmetic outcome.

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. 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.

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.

Media Contact:

 Danielle Lewis or Glenn Silver

LAZAR PARTNERS for Cianna Medical

dlewis@lazarpartners.com or gsilver@lazarpartners.com

212-867-1762