2022-09-08 Regulatory

NeoDynamics received FDA clearance for pulse biopsy system NeoNavia®

Stockholm, Sweden September 8, 2022 - The MedTech company NeoDynamics has today 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 successfully being executed on in Europe, demonstrating the benefits of the product while forging relationships with important clinics to facilitate a broad acceptance and uptake of the system.

NeoNavia is an innovative biopsy system that uses a patented pulse technology for controlled and accurate needle insertion, which is based on research at Karolinska Institutet. NeoDynamics’ goal is for the 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.

For further information, please contact:

Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com

CFO Aaron Wong, phone +46 735 972 011 or e-mail aaron.wong@neodynamics.com

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company’s first product NeoNavia®, a new innovative pulse biopsy system for ultrasound guided tissue sampling, is currently being introduced to the market. The biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. NeoNavia is evaluated for breast cancer diagnosis at leading clinics in UK, Germany, and Sweden. The pulse biopsy system has been used for tissue sampling in breast and axilla in over 500 patients. NeoDynamic´s share is listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB.

About NeoNavia

NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling. It consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumour whilst enabling high-quality tissue samples from both breasts and lymph nodes. The pulse biopsy system NeoNavia is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.

This information is information that NeoDynamics AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 8,  2022 at 20.30 CEST.