FDA Approval Sought for Biocompatible SchurSign® Tissue Marker for Breast Cancer Diagnostics
In breast imaging, doctors mark suspicious areas with marker clips. With SchurSign®, the Hamburg-based medical technology start-up SurgMark has developed an innovative tissue marker made of the biomaterial chitosan. The start-up is now preparing to introduce their marker to the US market.
The 510(k) approval process with the FDA (Food & Drug Administration) has been underway since March 2023. SurgMark expects to receive U.S. approval for SchurSign® in Q3 2023. The market prospects for the medical device are promising for this growing segment of breast cancer diagnostics and therapy.
According to the World Health Organization (WHO), breast cancer is the most common cancer worldwide. Experts predict a 40 percent increase in the disease’s incidence by 2040. The requirements for qualified breast cancer diagnostics are high. In particular, SchurSign® improves ultrasound-assisted marking and tracking of suspicious lesions in breast tissue. The chitosan marker has immediate and permanently good visibility in all imaging modalities (mammography, ultrasound, MRI, tomosynthesis). In particular, it is designed to enable ultrasound-guided biopsy, tumor resection, and sentinel lymph node labeling. The metal-free product is painless, does not "migrate" and, thanks to the tissue-friendly biomaterial, does not cause foreign body reactions as conventional metal markers often do. In this way, SchurSign® allows minimally invasive and gentle treatment of patients as part of image diagnostics and surgery.
Clinical trials planned in North America
SurgMark is currently preparing to enter the U.S. market with SchurSign® . The number of new breast cancer cases in North America is about 330,000 cases annually with an approximately 5-fold higher number of suspected cases. SchurSign® will be reimbursable by health insurance companies as consumable and/or under the code for the breast biopsy procedures.
An expanded patent portfolio forms the basis for the development of SchurSign®. In addition, SurgMark cooperates with qualified production and distribution partners. A German medical technology and pharmaceutical manufacturer is involved in the production of the marker as well as development and production of the specific applicator. Sales will be carried out with a distribution partner already well established in North America.
As soon SchurSign® has cleared FDA, SurgMark will conduct clinical trials with the medical device in North America together with cooperation partners. Results from these clinical studies form the prerequisite for approval as a Class III medical device in the European Union and will help meet requirements under the Medical Device Regulation (MDR).