2023-04-27

NeoDynamics, Inc. Announces U.S. Availability of NEONAVIA, the First and Only Pulse Biopsy Technology, FDA-Cleared in Breast and Axillary Lymph Node Biopsies.

- NEONAVIA is a new, minimally invasive option designed to provide controlled needle insertion, accurate lesion targeting, and high tissue yield from technically difficult lesions as well as difficult to access pathology. - Commercial launch and introduction of NEONAVIA scheduled at 2 upcoming Conferences for Breast Surgeons and Breast Imaging Professionals. - NEONAVIA PULSE Study abstract has been accepted for electronic presentation at the 2023 SBI Breast Imaging Symposium.

MATAWAN, N.J., April 27, 2023 -- NeoDynamics, Inc., a MedTech company pioneering innovative technologies to advance the diagnosis and care of breast cancer today announced the U.S. availability of NEONAVIA, the first and only biopsy system built on a patented pulse technology for controlled and precise needle insertion.

NEONAVIA will be commercially introduced at The American Society of Breast Surgeons (ASBrS) 24^th Annual Meeting at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts today through Sunday and the following week, at the SBI Breast Imaging Symposium, May 4-7, 2023, at the Gaylord National Resort & Convention Center in National Harbor, Maryland. ASBrS serves as the primary leadership organization for general surgeons who treat patients with breast disease and has grown to more than 3000 members in the United States and 35 countries throughout the world. SBI is the leading network of breast radiologists and medical physicists in the U.S.

The NeoDynamics commercial team will be providing hands-on workshops and demonstrations of the NEONAVIA system to demonstrate the precision and control with pulse technology as well as the FlexiPulse retractable, open-tip needle which produces up to a 299% larger sample^* than side-notch core needle systems.

“We look forward to meeting with the thought leaders and multi-stakeholders at these important venues advancing breast care through early detection, diagnosis, and treatment. Our precision pulse biopsy innovation represents a targeted approach to lesion insertion and tissue sampling, which is essential for accurate cancer diagnosis, personalized treatment plans, and patient comfort,” said Brendan Carney, National Sales Director of NeoDynamics.

NEONAVIA’s PULSE study, has been accepted for electronic presentation at the 2023 SBI Breast Imaging Symposium. The prospective, multi-center trial evaluating ultrasound-guided lymph node biopsy using NEONAVIA will be available on demand for attendees as well as included in the e-Poster Gallery, an interactive digital experience featured on the SBI Symposium website.

*Adapted from Thill et al., 2021. (p < 0.0001) Data on File. Pre-clinical study to benchmark NeoNavia needles against standard biopsy needles.

About NeoDynamics

NeoDynamics AB is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of 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 Europe and launches in USA during 2023. NeoDynamic’s shares are 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. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumor 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.

About Karolinska Institute

The Karolinska Institute is consistently ranked amongst the world's best medical schools, ranking 6th worldwide for medicine in 2021. The Nobel Assembly at the Karolinska Institute awards the Nobel Prize in Physiology or Medicine.