NeoDynamics Interim Report January-September 2022

Gaining momentum in the US

Third Quarter 2022

• Revenues amounted to SEK 151 (339) thousand, of which SEK 73 (24) thousand capitalized costs and SEK 32 (300) thousand net sales, i.e., sales of finished products.
• Net loss amounted to SEK -14,629 (-13,066) thousand.
• Loss per share amounted to SEK -0.12 (-0.22).
• Cash and cash equivalents amounted to SEK 37,607 (24,710 at year-end) thousand.

First Nine Months of 2022

• Revenues amounted to SEK 462 (1,155) thousand, of which SEK 214 (785) thousand capitalized costs and SEK 135 (322) thousand net sales, i.e., sales of finished products.
• Net loss amounted to SEK -50,115 (-48,596) thousand.
• Loss per share amounted to SEK -0.53 (-0.81).
• Cash and cash equivalents amounted to SEK 37,607 (24,710 at year-end) thousand.

Significant events during the quarter

• NeoDynamics received FDA clearance for its pulse biopsy system NeoNavia® without any conditions.
• In July, NeoDynamics received ethical committee approval for a German device registry trial. The registry will be used to gather and evaluate real world data from the use of NeoNavia.
• NeoDynamics appointed Decomplix as Swiss representative. The role of the representative is to be a point of contact with authorities, keep technical documentation at hand and support with vigilance inquires.

Significant events after the end of the quarter

• A partnership with Diligent Health Solutions is announced, ensuring US hospitals, physicians, and patients get the best customer care and reimbursement support possible as part of the NeoNavia launch in the US.
• In November, Brendan Carney was hired as National Sales Director to lead commercial strategy and execution, including field sales and managed markets for the company.
• The company announced it will launch the NeoNavia biopsy system configured with its FlexiPulse probe in the United States to support the diagnosis of cancer. The launch is scheduled for January 2023.

CEO Comment

US approval paves way for growth

The hard work we put into preparing and submitting a strong file to  the US Food and Drug Administration (FDA)  for a US commercialization - paid off in the third quarter, with approval by the FDA of our innovative pulse biopsy system NeoNavia. The approval is a major milestone for NeoDynamics as it means we can now push forward quickly to begin introducing the system to a massive market. The US breast biopsy market is expected to reach $830 million by 2025. 

The company is working full speed to start introducing the NeoNavia biopsy system configured with its FlexiPulse probe to clinicians and potential partners in the US. The launch is scheduled for January 2023.

Our system helps clinicians address the critical issues they face in diagnosing and treating breast cancer. The FlexiPulse needle is unique – it gives control thanks to the pulses. It offers the possibility to go into difficult-to-reach places such as lymph nodes in the armpit where you have blood vessels and nerves, or take biopsies in breasts with implants – areas where you are prepared to pay for a new technology.

NeoDynamics is dedicated to delivering technology for precise, high-quality tissue samples to support the critical early detection of cancer.

We will leverage the deep experience gained in Europe with our Flexipulse probe as we accelerate in the US. We plan to work with clinics to further document the product in clinical use to support the marketing and sales strategy.

As part of our US ramp up, we announced after the end of the period a partnership with Diligent Health Solutions, which will support NeoDynamics’s US efforts with tasks such as managing medical information, reimbursement and coding services.

We also announced the hiring of Brendan Carney, who has more than 30 years’ experience in life science, as our national sales director in the US.

Europe

Our plan to launch in the US is supported by the hard work ongoing at leading clinics in Europe. In Europe we designed a study program to highlight the value of our biopsy technology in a clinical setting. The traction we built with independent advocates in Europe is crucial as we enter the US. We will continue to work hard in the key centers in the German-speaking regions as well as the UK, Ireland and Sweden.

The team in Europe continued to fine tune the product over the past months, and we are on track to resume production of the CorePulse and VacuPulse needles by the end of the year. Flexipulse, which will now be sold in the US, has not had any production challenges and is ready to go.  We still expect the CorePulse needle to remain in high demand in Europe, while the FlexiPulse and VacuPulse needles should garner more attention in the US.

Clinics in Europe remain very engaged in the product with dozens of clinics now using the system and many others running pilots. As always, the feedback we get from these clinics allows us to constantly ensure quality.

CEO Anna Eriksrud

The report in full is attached as a pdf file to this press release and can also be found on the company's website on the following link: https://www.neodynamics.com/en-gb/reports

This disclosure contains information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-11-2022 08:30 CET.

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 +46735 972 011 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 will soon launch in the USA. 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.