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NeoDynamics receives ethical approval for German device registry

The MedTech company NeoDynamics AB (publ) has received a favorable decision by the ethical committee of the Medical Association of Hesse, to establish a device registry in Germany for its novel biopsy device NeoNavia. The registry will be used to gather and evaluate real world data from the use of NeoNavia.By establishing the registry, data from the use of NeoNavia in clinics around Germany will be proactively gathered and evaluated in a structured process. The registry differs from a classic clinical program where patients are included or excluded based on predefined criteria. “The

NeoDynamics at largest German breast cancer congress

The MedTech company NeoDynamics AB (publ) showcased its novel biopsy system NeoNavia at the 41[st] Congress of the German Society of Senology, the most important breast cancer congress in the German speaking area when it resumed after a break during the pandemic. Professor Marc Thill presented an update on the PULSE study, involving NeoNavia at the meeting.Apart from Professor Marc Thill’s presentation, NeoNavia was also referred to as a new method for axillary management by PD Dr Ines Gruber from the University Hospital Tübingen. NeoDynamics also participated in the conference, that ended

NeoDynamics announces outcome of rights issue

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE.   NeoDynamics AB (publ) (“NeoDynamics” or “the Company”) announces today that the rights issue of shares (the “Rights Issue”) has been completed. The subscription period ran from, and including, March 9, 2022, up to and including, March 23,

NeoDynamics sets up NeoDynamics USA Inc.

As part of the preparations for launching its innovative NeoNavia biopsy system in the US market, the medical technology company NeoDynamics has started a subsidiary in the USA, NeoDynamics USA Inc. The subsidiary makes it easier for NeoDynamics to recruit and hire employees, and enter into various types of agreements which will directly support the launch. Currently, NeoDynamics has Anna Forsberg operating locally in the US to lead the activities required to register the product with the US Food and Drug Administration. Business Development Manager Magnus Precht explains the investment

NeoDynamics publishes prospectus in connection with forthcoming rights issue

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR ANY OTHER MEASURE.     The Board of Directors of NeoDynamics AB (publ) ("NeoDynamics" or the "Company") has prepared a prospectus (the "Prospectus") relating to the rights issue of shares of approximately SEK 69 million (the “Rights Issue"), which was

NeoDynamics has filed for registration of NeoNavia® in the US

The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia® with the US Food and Drug Administration, FDA. The product already has CE approval in Europe and is in clinical use. “By filing for registration of NeoNavia in the US, NeoDynamics reaches an important milestone. The US is a huge potential market for NeoNavia and a US registration is also an important seal of quality for future collaborations”, says CEO Anna Eriksrud. “We expect that it will take a number of months to get the registration application approved.” The

NeoDynamics to present Q4 report on Feb 21 at 12.30

The medtech company NeoDynamics publishes its full year report on Wednesday 16 February. CEO Anna Eriksrud and CFO Aaron Wong will present the report in a webcast on Monday 21 February at 12.30. The presentation will be held in English and will be followed by a question and answer session. The event can be accessed through the following link: https://hcandersencapital643.clickmeeting.com/neodynamics-full-year-report-and-latest-development/register For further information, please contact: Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com

NeoDynamics AB (publ) full-year report 2021

NeoNavia® is gaining ground Fourth quarter October-December 2021 · Revenues amounted to SEK 930 (3,382) thousand, of which SEK 0 (2,963) thousand capitalized costs and SEK 839 (0) thousand net sales, ie sales of finished products. · Loss after tax amounted to SEK -19,134 (-11,524) thousand. · Loss per share amounted to SEK -0.32 (-0.28). · Cash and cash equivalents amounted to SEK 24,710 (73,250) thousand. Full year January-December 2021 · Revenues amounted to SEK 2,085 (18,558) thousand, of which SEK 785 (17,104) thousand capitalized costs. · Loss after tax

New data from NeoDynamics PULSE study accepted for presentation at major US breast imaging conference

NeoDynamics AB (Spotlight Stock Market: NEOD), a medtech company dedicated to advancing diagnosis and care of breast cancer, will present results from the PULSE study illustrating the benefits of the novel biopsy device NeoNavia in challenging axillary lymph nodes, at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia, taking place on May 16-19. The symposium is held to be the most important annual meeting for US breast imaging professionals. A subgroup analysis from the ethically approved German prospective multi-center study PULSE (ClinicalTrials.gov ID: NCT03975855), shows that

NeoDynamics appoints Aaron Wong as CFO

The medtech company NeoDynamics AB has appointed Aaron Wong as CFO. Aaron Wong most recently comes from a similar position at the medtech company ADDvise Group AB listed on Nasdaq First North. He will assume the new position on February 1, 2022. Aaron Wong has extensive experience from the industry, financial markets and transactions, which fits in well with the development phase that NeoDynamics is entering. He has previously worked in financial roles at Johnson & Johnson and Informa Group, among others. Aaron Wong holds a BA in Accounting & Finance from De Montford University in

NeoDynamics presents Q3 report

The medtech company NeoDynamics publishes its interim report for the period January - September 2021 on Wednesday, November 17 at 08.30. A webcast presentation of the report will be held at 12.00 on the same day where CEO Anna Eriksrud presents the report. The presentation will be held in English and will be followed by a question and answer session. Registration for the event via the following link: https://hcandersencapital643.clickmeeting.com/neodynamics-presentation-of-q3-quarterly-results/register For further information, please contact: Anna Eriksrud, CEO NeoDynamics AB,

NeoDynamics presents first results from PULSE study

NeoDynamics AB (Spotlight Stock Market: NEOD), a med-tech company dedicated to advancing diagnosis and care of breast cancer, presents first results from the PULSE study, an ethically approved German prospective multi-center study (ClinicalTrials.gov ID: NCT03975855) to document the performance of the NeoNavia biopsy device in the axillary lymph nodes at the prestigious British Society of Breast Radiology (BSBR) Annual Scientific Meeting 2021, November 7th – 9th. Data from 115 procedures across seven German hospitals show that the device is well suited for use in the axillary lymph nodes,

NeoDynamics starts subsidiary in Germany

NeoDynamics has started a subsidiary in Germany, NeoDynamics GmbH to grow in this important market for the company’s innovative biopsy system NeoNavia. NeoDynamics has initiated the launch of NeoNavia in Germany and nearby German-speaking countries. The company has received initial orders and dialogues have been established with leading centers. Operations are led by Country Manager Renate Reiss, who will also be responsible for recruiting additional sales staff. “NeoNavia has been well received in Germany and neighboring countries. Now that the pandemic restrictions are easing, we

NeoDynamics confirms four orders for NeoNavia

NeoDynamics has received orders from four high profile clinics in Germany and Switzerland for its novel biopsy system NeoNavia. This positive development shows that clinics are advancing to the next level in evaluating the system and progressing towards incorporating it into their clinical practice. “I am delighted that the launch of NeoNavia is progressing well despite the limitations the pandemic continues to place on our introduction of the system to clinics in the German speaking part of Europe. Physicians appreciate how easy the system is to handle and are enthusiastic about the

NeoDynamics demonstrates NeoNavia live at congresses

NeoDynamics has demonstrated its novel biopsy system NeoNavia at two scientific congresses in Austria and Switzerland in September. The system was very well received by physicians participating in the congresses that marked a return towards a more normal market environment. “We are excited to finally demonstrate our novel biopsy system NeoNavia to a broader audience at these two congresses, as is customary when introducing a new product in the market. The team has engaged with practitioners from a wide range of clinics and has received very positive feedback on our novel system,” says

Interim report Jan-June 2021

Clinics build experienceSecond Quarter 2021 · Revenue amounted to SEK 411 (6,263) thousand, of which SEK 383 (5,787) thousand were capitalized costs. · Loss after tax amounted to SEK-18,263 (-5,516) thousand. · Loss per share SEK -0.30 (-0.18). · Cash and cash 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 costs. · Cash flow from operating activities amounted to SEK -23,999 (-13,107) thousand. · Profit after tax amounted to SEK -35,519 (-12,

Matthew E. Colpoys, Jr. nominated to the Board of Directors

NeoDynamics Nomination Committee proposes Matt Colpoys as a new member of the Board. Matt Colpoys is an American with broad experience from the healthcare sector where he worked with orphan drugs and precision medicine. Today, Matt leverages his experience as a consultant for biotech and medical device companies, specializing in business development and commercialization. “With Matt, we bring in strong expertise from the US, which is a key market for NeoDynamics. He has contributed to a number of successful launches and deals in the sector. I look forward to welcoming him to the board,”

NeoDynamics presents preclinical results today

Dr. Stefan Paepke presents an abstract on preclinical results with NeoDynamics’ innovative biopsy system NeoNavia at the St Gallen International Breast Cancer Conference 2021, which begins in Vienna today. The results show that tissue samples taken with all of NeoNavia’s three needle types provide significantly larger tissue samples than what today’s gold standard technologies achieve. The weight of the tissue samples taken with NeoNavia’s needles was 299 percent higher with the FlexiPulse needle than with today’s gold standard, 37 percent higher with CorePulse and 12 percent higher with

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