SurgMark: FDA 510(k) Clearance for SchurSign Tissue Marker

Next steps towards entering the US Market for the MedTech Start-up from Hamburg

In January SurgMark GmbH announced that the U.S. Food & Drug Administration (FDA) has issued a 510(k) premarket notification for its SchurSign® Tissue Marker. The soft, biomaterial based implant for tissue marking offers promising prospects for a new standard in breast cancer diagnostics and care.

Together with its partners, SurgMark is now preparing to conduct clinical studies in North America and Europe and is building its distribution network. (Picture: Gorodenkoff/Adobe Stock)

The 510(k) clearance of SchurSign® by the FDA is a significant step towards an effective and gentle option in breast cancer diagnostics and care that will soon be available to patients in the US. SurgMark's tissue marker shows consistently good visibility in all breast imaging modalities, especially in ultrasound. The product is based on chitosan, a naturally occurring polysaccharide. This biomaterial is tissue-friendly and flexible and causes significantly less foreign body reactions than conventional metal markers often do. Christine König, PhD, CEO of SurgMark, shares her excitement: "We believe our device will improve the quality of life for women in the US and soon around the world by providing them with a non-metallic product which, when in the body, is soft, therefore causing less pain or discomfort. Most importantly, SchurSign® is easily visible by ultrasound and MRI. FDA clearance really marks a very significant milestone in our corporate development. It catapults us onto a new trajectory of our mission to improve breast cancer diagnostics and treatment for women around the world."

Next steps towards entering the US Market

With the clearance of the FDA’s 510(k) process SurgMark is accelerating the availability of SchurSign® to patients in the US. Together with its partners, the company is now preparing to conduct clinical studies in North America and Europe and is building its distribution network. Alpo Medizintechnik GmbH, a German contract manufacturer and SurgMark’s strategic partner, is the manufacturer of the marker and is involved in development and manufacture of a newly designed and more ergonomic inserter for SchurSign®.

In North America, the number of new cases of breast cancer is about 330,000 annually and rising, with an approximately 5-fold higher number of suspected cases. SchurSign® will be reimbursable through health insurance companies under the codes for breast biopsy procedures.

The results of clinical trials with SchurSign® in North America and Europe form the prerequisite for approval as a Class III medical device in the European Union and will serve to meet requirements under the new Medical Device Regulation (MDR).

Source: SurgMark, 23.012024