Changing Breast Cancer Treatment with the NeoNavia[®] Biopsy System

Following recent FDA clearance of NeoNavia, NeoDynamics announces US launch with its accompanying FlexiPulse™probe

Stockholm, Sweden, October 25, 2022 NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, announced today that it is launching the NeoNavia biopsy system configured with its FlexiPulse probe in the United States to support the diagnosis of cancer.

“The recent FDA clearance of the NeoNavia will help clinicians address the critical issues they face in diagnosing and treating breast cancer, which are the proper detection of cancerous tumors in the breast and its spread beyond”, said Anna Eriksrud, CEO of NeoDynamics. She continued, “The US breast biopsy market is expected to reach $830mm by 2025.  As we bring this much needed diagnostic product to market, there is enormous value to clinicians, patients, and all stakeholders of NeoDynamics.”

Approximately one third of breast tumors need evaluation for metastatic cancer. Many of these patients undergo surgical removal of lymph nodes in the axilla (armpit). Surgical removal of axillary lymph nodes is often associated with delayed diagnosis due to the time needed to schedule an operating room, surgeon, anesthesiologist, and nurses, the high cost of the procedure, and the side effects such as swelling in the arms or chest wall due to lymphedema.

The FlexiPulse probe is developed for biopsies in challenging locations such as the axillary lymph nodes. Guided by ultrasound and powered by pneumatic pulses that move the probe millimeter by millimeter, it allows for high precision and control during needle insertion. An open-tip probe combined with pulses ensure that the surgeon or radiologist can safely maneuver the probe to obtain a high-quality tissue sample.

NeoNavia is designed to be the optimal tool to perform both the breast and axillary biopsy during a single patient visit with one system.

The US launch of the NeoNavia biopsy system with the FlexiPulse probe is scheduled for January 2023.