April 30, 2015
Seven clinical sites announce participation in second investigator-initiated study to expand procedural experience using FDA-cleared non-radioactive, real-time guidance technology
ORLANDO, FL – April 30, 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 the American Society of Breast Surgeons (ASBrS) 16th Annual Meeting, taking place from April 29 to May 3, 2015. An initial investigator-initiated study, entitled “Pilot Study of a New Non-Radioactive Surgical Guidance Technology to Localize Non-Palpable Breast Lesions,” has been successfully completed. The Company also provided an update on its second investigator-initiated study, which currently includes seven active sites and has a goal of enrolling 150 patients in the next few months.
“We are extremely encouraged by the clinical efficacy observed with SAVI SCOUT to date and are excited by the enthusiasm within the medical community to adopt this potentially transformative breast tumor localization technology into widespread clinical practice,” 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. “We expect the clinical evaluation study, currently enrolling patients across the country, will provide further validation of SAVI SCOUT and the outcomes will underscore its benefits to patients and healthcare providers.”
Seven additional sites have committed to participating in a second study (“SAVI SCOUT Clinical Evaluation Study”) that will enroll 150 patients. Participating centers include: The University of California, Irvine Health; University of South Florida Breast Health; Nashville Breast Center; Morton Plant Mease Health System; Pink Lotus Breast Center; Saint Joseph Hospital and New York University Langone Medical Center.
“I believe SAVI SCOUT will allow us to safely and effectively refine the process of breast conservation surgery while increasing patient satisfaction. We’re seeing breast surgery come into the modern era using new, better technology,” said Freya R. Schnabel, M.D., Director of Breast Surgery, Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center. “This refined technology allows us to localize lesions in a really direct way with feedback to the surgeon in the operating room. It also relieves the scheduling burden and allows operating rooms to schedule lumpectomy or excisional biopsy procedures early in the morning. This flexibility may improve OR efficiencies and allow for significant cost savings while enhancing the ability to accurately pinpoint non-palpable breast lesions and direct our surgery accordingly.”
Results of the first pilot study, which included 50 patients, demonstrated 100 percent surgical success using SAVI SCOUT. In all cases (n=50/50), targeted lesions and reflectors were successfully removed. Forty one patients underwent lumpectomy and nine patients underwent excisional biopsy. Final pathology reports showed 93 percent of lumpectomy patients (n=38/41) had clear margins. Three patients were recommended for re-excision, comparable to reported rates for radio seed localization and intraoperative ultrasound (IOUS). During the study, no reflector migration occurred.
Following the study, participating surgeons rated ease of lesion localization and removal with SAVI SCOUT 9.4 and 9.7 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.
“In our ongoing discussions with surgeons, radiologists and hospital administrators, one of the chief benefits of SAVI SCOUT is the additional scheduling flexibility introduced by the uncoupling of operating room and radiology scheduling, contributing to a simplified workflow that eliminates challenges caused by multiple same-day procedures in different departments,” said Jill Anderson, President and CEO of Cianna Medical. “Our investigators are reporting 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.”
As part of the ASBrS Annual Meeting, Dr. Cox will also be presenting his clinical experience with SAVI SCOUT at a symposium entitled “Moving Beyond Wires: A Non-Radioactive Solution for Tumor Localization,” on May 2 from 6:15 – 7:45 a.m.
Dr. Cox also contributed to a white paper with the same title, co-authored with Pat Whitworth, M.D., Director, Nashville Breast Center, Nashville Tenn., and Kate Maguire, President, Motivation Mechanics, Philadelphia, Pa., that was recently published on the Oncology-Central website, available for download by accessing: https://oncology-central.com/content/article/beyond-wires-overcoming-the-challenges-of-breast-tumor-localization. The authors conclude that SAVI SCOUT offers several benefits over current localization methods including non-radioactive technology, simplified scheduling, optimal surgical planning and guidance, and enhanced patient satisfaction.
About SAVI SCOUT®
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.
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