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Pressemeddelelse

NeoDynamics (“NeoDynamics” or the “Company”) provides a status update on the US market launch

NeoDynamics

NeoDynamics CEO Anna Eriksrud gives an interview with Redeye, providing a status update on the commercialisation and development on the American market. Link to the interview below:

NeoDynamics - Redeye interview Sep 21, 2023
 
In October 2022, NeoDynamics received FDA approval for its NeoNavia® pulse biopsy system, after which commercialization efforts in the US market have begun. The company has built a specialized sales organization in the US and received its first order from a prominent university hospital in August 2023. The company follows the previously communicated plan with a launch on the US market in the second half of 2023, and is currently in discussions with a number of potential customers regarding NeoNavia®. An important part of the sales process is to conduct workshops with nurses and other end users in the environment where the product will be used. During the current quarter, workshops have been conducted at a number of prominent hospitals, and the feedback received from these has been very positive. In particular, the following advantages are highlighted:

  • Time efficiency - limited or no preparation time before biopsy, a so-called "press and go" solution
  • Ease of visually following the needle via ultrasound when performing the biopsy 
  • Potential to avoid sending patients to surgery 
  • Avoiding a part of the stereotactic imaging, meaning that the clinic can keep the patient 

As previously communicated, revenue from additional orders in the US market is expected to contribute to the reported figures in the fourth quarter. The company assesses that the big job of getting into the hospital has largely been done, which also shortens the decision-making process for new potential customers. 
 
The company assesses the chances as good that during the next 12-month period it will be possible to achieve cost coverage for the variable costs in the USA. 
 
"The fact that we are now going out in the USA is something that resonates very positively in the field of medical technology and that in itself is an important signal for discussions with others who may also be interested in our biopsy instrument." - comments Anna Eriksrud.

For further information, please contact:
Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com
Aaron Wong, CFO NeoDynamics AB, phone +46790 101 714 or e-mail aaron.wong@neodynamics.com

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.

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NeoDynamics (“NeoDynamics” or the “Company”) provides a status update on the US market launch

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