in

Interim report Jan-June 2021: NeoDynamics

STOCKHOLM, Aug. 19, 2021 /PRNewswire/ —

Second Quarter 2021

  • Income amounted to SEK 411 (6,263) thousand, of which SEK 383 (5,787) thousand have been capitalized prices.
  • Loss after tax amounted to SEK-18,263 (-5,516) thousand.
  • Loss per share SEK -0.30 (-0.18).
  • Money and money equivalents amounted to SEK 48,339 (7,177) thousand.

First half of 2021           

  • Revenues amounted to SEK 816 (12,531) thousand, of which SEK 762 (12,090) thousand capitalized prices.
  • Money circulate from working actions amounted to SEK -23,999 (-13,107) thousand.
  • Revenue after tax amounted to SEK -35,519 (-12,751) thousand.
  • Earnings per share amounted to SEK -0.59 (-0.53).
  • The fairness ratio was 95 (94) p.c.

Important occasions throughout the quarter           

  • NeoDynamics offered a scientific summary on the annual surgical procedure convention ABS, Affiliation of Breast Surgeons, in Birmingham, which describes how the corporate’s FlexiPulse needle surpasses customary biopsy in preclinical fashions by virtually 300 p.c by way of quantity.
  • The Annual Common Assembly re-elected the Board members Carina Bolin, Claes Pettersson, Ingrid Salén, Jie Bao and Xiao-Jun Xu, and appointed Matthey E. Colpoys Jr. as a brand new Board member.
  • At mid-year, about 30 clinics with radiology groups in Sweden, the United Kingdom, Germany and different German-speaking nations in Europe had had workshops with the biopsy system NeoNavia.

Important occasions after period-end           

  • Hermann-Josef-Hospital in Erkelenz, a college hospital throughout the College of Aachen, grew to become the primary German hospital to order NeoNavia.

CEO remark

Clinics construct expertise

We proceed to introduce the biopsy system NeoNavia in clinics in our markets in Europe. The pandemic has made conventional and efficient launch strategies inconceivable, which suggests introducing the product to docs at congresses and commerce festivals, in parallel with constructing expertise via workshops and thereby reaching out extra rapidly. As an alternative, NeoDynamics has been compelled to depend on particular person hospital conferences with workshops the place docs are given the chance to check the product and prepare in how it’s used.

The problem with this process throughout the spring has been to get permission to be on the clinic. On a couple of events, smaller workshops have been held exterior the hospitals. As soon as these workshops are accomplished, a majority of clinics wish to use the product in common operation for 2-3 months to see the way it matches in and let the entire staff of the hospital’s radiologists, or as in Germany gynecologists, get used to dealing with NeoNavia in medical on a regular basis life. In dialogue with the clinic, the hospital’s buying division is concerned in designing a quote and qualifying NeoDynamics as a provider. Solely then can NeoDynamics anticipate an order for the product. The method takes time and  varies between clinics. By mid-year, the staff had performed about 30 workshops.

First in Germany to position an order was the respected breast middle at Hermann-Josef-Hospital in Erkelenz, Germany, which belongs to the College Hospital of Aachen, which participated within the PULSE examine and which additionally serves as a reference middle. We anticipate to recruit extra reference facilities in numerous nations to pave the way in which for almost all of the clinics which have tried the product to additionally undertake the know-how and submit orders throughout the latter a part of 2021.

The staff continues to rearrange workshops with specialists and within the autumn, a number of conferences as soon as once more welcome individuals to take part bodily. The primary convention we plan to attend on web site is the Schweizerische Gesellschaft fur Senology, which will likely be held in Basel on September 8-9 to be adopted by two additional congresses in September and October for the German-speaking a part of the nation. A really constructive signal which signifies that we in Europe are progressively starting to return to a extra regular market scenario.

Publications create curiosity

 One other vital technique to current NeoNavia to physicians is to current peer reviewed abstracts from our medical program via varied varieties of scientific conferences. Getting an summary chosen for presentation is a measure of the scientific degree we maintain in our examine program – and naturally a technique to make NeoNavia identified.

Throughout the second quarter, NeoNavia was uncovered on this manner on the prestigious annual British Breast Surgical procedure Congress, ABS. NeoDynamics continues the work of documenting the product via its medical program and extra scientific abstracts are anticipated this yr. The work in fact facilitates the dialogue with docs, concurrently additionally it is part of creating curiosity in NeoNavia amongst potential companions. 

United States the following main milestone

In the US, work continues on compiling the registration software to have the ability to submit it to the US Meals and Drug Administration FDA within the fall. We now have a dialogue with the authority, which additionally communicates that their response instances are longer than regular because of a big a part of the authority’s sources being redirected to issues associated to Covid-19. With a well-prepared software, nonetheless, the necessity for interplay with the authority after the file has been submitted decreases. The staff’s ambition is to realize an software of top quality via underhand dialogue with the FDA. A registration of the product within the USA is a crucial milestone for each NeoDynamics and NeoNavia because it is a crucial stamp of high quality that additionally opens up a big new market. It’s also anticipated to result in a considerably extra concrete curiosity from potential companions.

Throughout the quarter, NeoDynamics strengthened its experience within the vital US market via the election of Matt Colpoys to the Board. Matt provides useful information about each the market and potential companions. The items are thus starting to return into place for NeoDynamics to have the ability to add the USA as a market.

I look ahead to a continued eventful 2021.

CEO Anna Eriksrud

For additional data, please contact

Anna Eriksrud, telephone +46 (0)708 444 966, e-mail [email protected]

This data was dropped at you by Cision http://news.cision.com

https://news.cision.com/neodynamics/r/interim-report-jan-june-2021,c3399329

The next information can be found for obtain:

SOURCE NeoDynamics