Innovative 3D-Printed Surgical Guide for Breast Conserving Surgery

Anymedi Solution announced March 18 that "patient-customized surgical guide that leads to excision plan for breast conserving surgery (hereinafter referred to as Surgical Guide for Breast Conserving Surgery)" was selected as the "innovative medical technology" by the National Evidence-Based Healthcare Collaborating Agency (NECA) under the Ministry of Health and Welfare.

The "Surgical Guide for Breast Conserving Surgery," which was studied and developed by Anymedi Solution and Asan Medical Center, is a medical device that analyzes medical images of breast cancer patients in 3D, produces tumor removal surgical guides through 3D printing, and helps with breast cancer surgery.

According to Anymedi Solution, the guide for breast conserving operation is expected to lead to safe surgery and reduce recurrence by combining 3D technology to assist in conserving breasts as much as possible—being a great help in delicate surgeries—and effectively delivering the data of suspected areas of remaining tumors that cannot be detected with ultrasound or MRI in patients who had chemotherapy to the operating room.

This surgical guide is the country’s first to be selected as the innovative medical device in the 3D printing medical device area. Anymedi Solution was already selected 2019 as the Ministry of Health and Welfare’s “new medical device” for the first time among medical equipment using 3D printing in recognition of its safety and validity of the technology as the “congenital heart disease surgical simulation using patient-personalized 3D printed model.”

The innovative medical technology evaluation system was introduced in March last year when the Ministry of Health and Welfare announced and implemented a revision to the "Rules on Assessment of New Medical Technology," mainly targeting advanced and innovative technologies such as artificial intelligence, robots, 3D printing, virtual/enhanced reality, precision medical, and renewable medical.

The breast-conserving surgical guide's acknowledgment of innovative medical technology was conducted through the Ministry of Trade, Industry and Energy's "3D Printing Medical Device Industrial Technology Demonstration Project." Organized by Anymedi Solution, together with Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, and Severance Hospital, valid reports have been acquired through multicenter clinical trials, and the Foundation for Industry Cooperation of University of Ulsan and Korea Conformity Laboratories jointly participated in technology development.

In addition to this acknowledgment of the innovative medical technology, Anymedi Solution already obtained the U.S. FDA and European CE certification July 2020 and is preparing for a clinical application letter from Victorian Breast and Oncology Care, Australia.

CEO of Anymedi Solution, Kim Gook-bae said, "The reason why we were able to be acknowledged as the 'innovative medical technology' was because we achieved what used to be impossible to do with existing tumor screening methods. It is very meaningful that we can directly display tumor areas on the breasts including the past tumor areas, that cannot be seen through ultrasound or MRI."