February 26, 2015
Preliminary study results of Cianna Medical’s non-radioactive, real-time guidance technology presented during the 32nd Annual Miami Breast Cancer Conference®
MIAMI – February 26, 2015 – Cianna Medical, Inc. today announced that recent data from an investigator-initiated trial on the SAVI SCOUT® surgical guidance system, an exciting new tool for localizing and directing the removal of non-palpable breast lesions, will be presented at the 32nd Annual Miami Breast Cancer Conference®, taking place from February 26 to March 1, 2015.
SAVI 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 SAVI 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.
“The SAVI SCOUT surgical guidance system confers several advantages over the current medical standards to identify non-palpable breast lesions. In addition to the uncomfortable wait times that patients have traditionally faced between the localization procedure and the surgery, standard techniques often don’t allow us to spare as much healthy tissue as we might want,” said 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. “Additionally, using SAVI SCOUT eliminates the need for invasive wires to be implanted into the breast, a procedure which has been shown to increase patient anxiety and discomfort.”
The study, entitled “A Multi-Site, In Vivo Pilot Study of a Real-Time Surgical Guidance System for the Location of a Non-Palpable Breast Lesion During Excision,” completed enrollment of 50 patients at the University of South Florida College of Medicine and the Nashville Breast Center.
Preliminary results of the study, which included 49 patients, demonstrated 100 percent surgical success using SAVI SCOUT. In all cases (n=49/49), targeted lesions and reflectors were successfully removed. Forty patients underwent lumpectomy and nine patients underwent excisional biopsy. Final pathology reports showed 93 percent of lumpectomy patients (n=37/40) had clear margins. Four patients were recommended for re-excision. During the study, no adverse events or reflector migration occurred.
In a follow-up study evaluation, surgeons rated ease of lesion localization and removal with SAVI SCOUT 9.1 and 9.5 respectively, on a scale of 1-10 where a score of 5 was equivalent to wire location (WL), less than 5 was worse than WL and greater than 5 was better than WL.
“The SAVI SCOUT system offers practice-changing advantages for lumpectomy procedures, plus the potential to improve surgical outcomes,” said Pat Whitworth, M.D., Director, Nashville Breast Center, Nashville, Tenn. “Breast surgeons have looked forward to this technology for decades. Precise, real-time intra-operative guidance serves the two primary goals of breast conservation surgery: completely remove the cancer while minimizing the removal of healthy tissue. For breast surgeons the system is easy to implement with the additional bonus that the reflector can be placed at any time up to a week before the procedure, making life easier for both surgeon and patient.”
As part of the Miami Beast Cancer Conference, Dr. Whitworth will also be presenting about the clinical experience with SAVI SCOUT at a symposium entitled “Moving Beyond Wires: A Non-Radioactive Solution for Tumor Localization,” on February 27 from 12:45 – 2:00 p.m.
“In a recent market research study, 93 percent of surveyed breast surgeons expressed a need for better options for breast tumor localization and we believe that SAVI SCOUT is helping address this significant gap in clinical care,” said Jill Anderson, CEO, Cianna Medical. “We are excited to be building on the patient-centric heritage established by SAVI brachytherapy, and advancing access to technologies that improve breast conservation therapy. We look forward to making SAVI SCOUT broadly available to physicians and their patients later this spring.”
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, Inc. is a medical device company whose mission is to improve quality of life and reduce the burden breast cancer treatment places on women and their families. Led by an experienced management team with a rich history in women’s health and oncology services, Cianna Medical is committed to developing and bringing innovative new medical technologies to healthcare professionals and patients.
The company manufactures and markets the SAVI breast brachytherapy applicator, a device that allows for precise sculpting of a radiation dose after lumpectomy surgery. To date, more than 20,000 women have been treated with the SAVI brachytherapy applicator.
In 2014, Cianna Medical expanded its family of products to include the SAVI SCOUT surgical guidance system, a novel technology that uses real-time audible and visual indicators to give surgeons a precise way to target tissue for removal during lumpectomy and excisional biopsy procedures.
For more information, call (toll-free) 866-920-9444 or visit www.ciannamedical.com