2019-11-21 Regulatorisch

NeoDynamics AB (publ) Third quarter Jul-Sep 2019

During the third quarter NeoDynamics developed according to plan. After the end of the quarter the new version of NeoDynamics biopsy system NeoNavia received regulatory approval in the EU and attracted great interest at the annual British radiology congress. The convertible loan was subscribed to an amount of ca SEK 15 million.

Regulatory approval! 

Third quarter 2019

  • Revenue amounted to SEK 4.581 m (3.749 m), including capitalized costs of SEK 4.469 m (3.734 m). During the quarter, the company had minor sales of materials.
  • Loss after tax amounted to SEK -4.477 m (-3.968 m).
  • Loss per share amounted to SEK -0.29 (-0.57).

Nine months 2019

  • Revenue amounted to SEK 16.329 m (15.874 m), including capitalized costs of SEK 16.214 m (15.858 m). During the quarter, the company had minor sales of materials.
  • Loss after tax amounted to SEK 12.592 m (-9.602 m).
  • Loss per share amounted to SEK-0.82 (-1.39).
  • Equity per share was SEK 4.05 (4.70).
  • The equity ratio was 75 (86) per cent.

Significant events during the second quarter

  • US Country Manager took up her position
  • Chief Compliance & Regulatory Affairs Officer recruited.
  • The EGM on September 16 resolved on a directed issue of a convertible loan.
  • Country Manager for Germany recruited.

Significant events after period-end

  •  The new version of NeoDynamics biopsy system NeoNavia received regulatory approval in the EU.
  •  NeoNavia attracted great interest at the British radiology congress in Bristol, BSBR.
  •  The convertible loan was subscribed to with SEK 14.6 million.
  •  The Company's warrant program with subscription period 5-29 November 2019 is set to end without subscription.

CEO´s comments

EU approval increases the temperature

On October 29, NeoDynamics received clearance to increase the number of products under our existing certificate to accomodate our new improved version of the biopsy system with more features and new needles.

NeoDynamics have thus obtained regulatory approval to CE-mark our products as soon as our process for verification and validation is completed and we are thereafter entitled to market the new products.

This is a fantastic piece of news that means NeoDynamics save time and resources. We can thus put all uncertainty around the regulatory issue aside and fully focus on preparing for a strong launch in prioritized markets in Europe by mid-2020.

The launch is being prepared by highly qualified Country Managers in our key markets. Already today, the system is being used and evaluated at leading cancer clinics in Germany, England and Sweden, and these clinics will act as reference hospitals when sales of the product start.

During the summer we recruited a Country Manager in the US and in Germany we added a Country Manager to the organisation, Renate Reiss. Renate is a senior person with solid experience of introducing medtech and pharmaceutical products in the market. We are convinced that she is the right woman for NeoDynamics in Germany.

The positive regulatory news means that NeoDynamics have moved closer to a registration in China. Chinese authorities require that an EU certification in order to grant go-ahead for the study program in China. An early move into China is part of our strategy and our Chinese partners are active in women's health, enabling a faster launch on this large market.

In the US, we continue to document our 510 (k) application with the US FDA (Food & Drug Administration).

In September, we strengthened the company's cash position by issuing a convertible loan of about SEK 15 million, which secured the short-term capital requirement.

In November, NeoDynamics were represented as one of the main sponsors of the annual British Breast Sonography Meeting, BSBR (British Society of Breast Radiology), gathering around 300 breast radiologists in Bristol. NeoDynamics dominated the conference with very popular Neonavia workshops where participants were offered to try out he micropulse technology using the study version of NeoNavia as well as an opportunity to see our new probes/needles. The centres trained will be among the first to use NeoNavia in a clinical setting.

In December, NeoDynamics will for the first time have meetings to show the new NeoNavia to American physicians. These meetings will take place in Chicago at the major annual radiologist meeting in the United States, RSNA, the North American Society of Radiologists.

These are just some of the activities that the company currently is undertaking to be ready for launch in the second quarter of 2020.

Clearly this is an exciting time for NeoDynamics!

Anna Eriksrud, CEO

Lidingö, 21 November 2019

Invitation to Audiocast

The report for the third quarter will be presented in an audiocast today at 10.15 (CET) by CEO Anna Eriksrud and CFO Jörgen Vrenning.To participate in the Audiocast, please use the following link:

https://financialhearings.com/event/11970

For further information about NeoDynamics, please contact:                         

Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 8 522 79 667, e-mail: anna.eriksrud@neodynamics.se, or

Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: jorgen.vrenning@neodynamics.se

This information is information that NeoDynamics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication by the contact person above on November 21 ,2019.


About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia® , in late stage development. The precision biopsy system is built on a patented micro-pulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance.  NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the micro-pulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.

About the micro-pulse technology

The patented micro-pulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micro-pulses is placed in a handheld instrument. With power from the base-unit, the driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.