Update on the FDA approval process for NeoNavia®

The MedTech company NeoDynamics filed a registration application for its novel pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA, end February. The application was filed in the form of a 510(k), which is a less -burdensome procedure than an application for a new drug.

Since then, the authority has initiated a dialogue with the company as is customary. To date, the dialogue has been smooth, and the company has been able to provide the authority with the requested information. The current assessment by analysing other companies in a similar situation, is that the practical time frame for an approval process with the authority in a 510 (k) situation, is approximately 6 months.

To prepare for an approval, NeoDynamics started a US subsidiary in March and have three senior executives focusing on the US market, Anna Forsberg as Country Manager, Matthey E. Colpoys, board member and Magnus Precht as Business Development Manager. To maintain appropriate focus and contain costs, NeoDynamics will not hire any sales executives until after NeoNavia has gained market approval. Since it is a specialist product, the number of recruits will initially be limited to only a handful.

Once the product has received market approval, NeoDynamics intends to continue to work with clinics to document the product in clinical practice to support its marketing and sales strategy

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 already has CE approval in Europe and is in clinical use in selected centers.

CEO Anna Eriksrud and CFO Aaron Wong commented on the development in the US market in an appearance on Redeye Growth Day on June 2, 2022. The interview can be accessed through the following link: https://www.neodynamics.com/en-gb/follow-us

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.


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.