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NeoDynamics has received FDA approval for the NeoNavia pulse biopsy system

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Claus Thestrup

Claus Thestrup

CEO, HCA Capital Sweden

The medTech company NeoDynamics has received approval for its innovative pulse biopsy system NeoNavia® from the US Food and Drug Administration, FDA. The US breast biopsy market is estimated to reach $830 million by 2025.

“The FDA approval for NeoNavia is a major milestone for NeoDynamics and a stamp of quality for both the product and NeoDynamics as a whole,” said Anna Eriksrud, CEO of NeoDynamics. “The US represents the potentially largest market for the product, where we now also can build on the experience gained with the system in Europe. Preparation for the launch is ongoing and we expect to begin introducing the system to clinicians and potential partners within the next few months.”

NeoDynamics intends to work with US clinics to further document the product in clinical practice to support its marketing and sales strategy. A similar strategy is being successfully implemented in Europe, demonstrating the benefits of the product while building relationships with key clinics to facilitate broad acceptance and use of the system.

NeoNavia is an innovative biopsy system that uses a patented pulse technology for controlled and precise needle insertion, which is based on research at the Karolinska Institutet. NeoDynamics’ goal is for pulse technology to become the new standard for ultrasound-guided breast biopsies. The product has CE approval in Europe, where it is in clinical use.

Disclaimer: HC Andersen Capital receives payment from NeoDynamics for a DigitalIR/Corporate Visibility agreement.