FDA Clears World’s First and Only Wire-Free Radar Breast Tumor Localization System for Long Term Implant Capabilities

ALISO VIEJO, Calif., Nov. 13, 2017 -- Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization. This technology is the first and only non-radioactive implant used in wire-free localization that can be implanted with no restrictions on the length of time the reflector can remain in the breast. 

The newly acquired FDA clearance means that physicians will no longer be constrained by a maximum implant time, allowing them the flexibility to place SCOUT to mark a biopsy or lumpectomy site. Using SCOUT, surgeons can precisely target the affected tissue using its 360˚ detection capability to pinpoint its location within ±1mm, which can mean more successful surgeries, optimized breast conservation strategies and enhanced outcomes for women.

The SCOUT FDA clearance for long term implant expands the number of women who can benefit from wire-free localization technology, creating more options for physicians and their patients. In addition, because the SCOUT reflector will not interfere with MRI studies, patients are not restricted in the types of imaging modalities they may need.

The SCOUT reflector’s 4mm body size is smaller than a grain of rice and 100% non-radioactive. The reflector is completely passive until activated by the SCOUT guide. In addition, the patient cannot feel the reflector and can continue with all activities regardless of how long it is left in the breast.

“Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families. I applaud the vision of all our physicians and health systems who are leading the way in offering a new standard of care in breast tumor localization,” said Jill Anderson, President and CEO of Cianna Medical. “SCOUT has become the most precise and broadly applicable non-wire localizing system in the industry and more than 170 leading medical centers across the United States have adopted SCOUT Radar Breast Localization and Surgical Guidance System as an alternative to placing wires on the day of surgery.”

“Our health system has made wire-free radar localization our new standard of care for breast tumor localization,” said Nina Vincoff, MD, Chief of Breast Imaging at Northwell Health. “Our patients have indicated high satisfaction with the procedure. This new FDA clearance will continue to enhance the patient experience by offering more options and flexibility for physicians to implant the reflector based on patient treatment needs.”

Northwell Health, New York State’s largest integrated health system, has collaborated with Cianna Medical to offer wire-free radar localization to patients since July 2016.

The SCOUT® radar localization system will be exhibited at the Radiological Society of North America (RSNA) in Chicago, IL, November 26–December 1, 2017. Cianna Medical booth is located in North Hall B – Booth Number 6247.

About SCOUT®

The SCOUT Breast Tumor Localization System features the first and only FDA-cleared implant used in wire-free localization that can be implanted long term, providing physicians with maximum flexibility to place the reflector for localization at any time during the continuum of care. The reflector will not interfere with MRI studies, which is critical when implants are placed long term. During the lumpectomy or surgical biopsy, the surgeon scans the breast using the SCOUT guide, which emits 50 million pulses per second, to “lock” on to the reflector’s position. The SCOUT Real-time Distance System is the only wire-free technology to offer 60mm detection range and 360° detection with ±1mm accuracy. This more advanced level of localization precision allows better surgical planning that may improve cosmetic results, as less tissue may need to be removed.

SCOUT has received significant recognition from medical societies and industry associations including, most recently, being honored as a Gold winner at the 2017 Medical Design Excellence Awards.

About Radar Technology
The SCOUT system uses highly sophisticated radar technology. Radar is used when unprecedented precision is required. Applications using radar include ground penetrating radar, automobile safety systems, flight control systems and antimissile and air-defense systems.

About Cianna Medical, Inc.
Cianna Medical is the world leader in wire-free breast localization and has been focused on breast conservation for over 10 years. Cianna Medical develops, manufactures and markets innovative medical technologies that reduce costs, improve quality and reduce the anxiety and stress breast cancer treatments place on women and their families. Cianna Medical’s world-class research, development and commercialization teams developed the world’s first non-radioactive, wire-free breast localization system and the world’s only technology that utilizes radar in tissue. Cianna Medical is focused on expanding applications that continually advance patient care. Its SCOUT and SAVI® Brachy technologies are FDA-cleared and address unmet needs in the delivery of radiation therapy, tumor localization and surgical guidance. Please visit www.ciannamedical.com for more information.

Media Contact:
Erich Sandoval
LAZAR PARTNERS for Cianna Medical
[email protected]
(917) 497-2867