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NeoDynamics, Inc. Announces U.S. Availability of NEONAVIA, the First and Only Pulse Biopsy Technology, FDA-Cleared in Breast and Axillary Lymph Node Biopsies.

- NEONAVIA is a new, minimally invasive option designed to provide controlled needle insertion, accurate lesion targeting, and high tissue yield from technically difficult lesions as well as difficult to access pathology. - Commercial launch and introduction of NEONAVIA scheduled at 2 upcoming Conferences for Breast Surgeons and Breast Imaging Professionals. - NEONAVIA PULSE Study abstract has been accepted for electronic presentation at the 2023 SBI Breast Imaging Symposium.MATAWAN, N.J., April 27, 2023 -- NeoDynamics, Inc., a MedTech company pioneering innovative technologies to

Notice of Annual General Meeting in NeoDynamics AB (Publ)

The shareholders in NeoDynamics AB (publ), reg. no. 559014-9117 (the “Company”) are hereby convened to the annual general meeting on Tuesday 23 May 2023 at 15.00 at the Company’s premises at Lejonvägen 14, Lidingö.Right to participate Shareholders who wish to participate in the general meeting must: · be registered in the share register kept by Euroclear Sweden AB on Friday 12 May 2023 (the record date), and · notify his/her/its intention to attend the general meeting to the Company no later than Friday 19 May 2023, by mail to NeoDynamics AB (publ), Lejonvägen 14, 181 32 Lidingö,

Bulletin from Extraordinary General Meeting in NeoDynamics AB (publ)

NeoDynamics AB (publ) held an Extraordinary General Meeting today on 3 April 2023. The Extraordinary General Meeting resolved in accordance with the followingAuthorization The boards proposal to authorize the board of directors to, on one or several occasions during the period up to the next annual general meeting, increase the Company’s share capital through issues of new shares, warrants and/or convertible instruments, obtained 62% of the votes which is less than the required two thirds majority. Adoption of new Articles of Association The Extraordinary General Meeting resolved

NeoDynamics Announces Delivery of CorePulse Needles to 23 Hospitals

STOCKHOLM – April 3, 2023, NeoDynamics AB (publ) (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced that the first production run of its CorePulse needles has been shipped and is anticipated to arrive with UK and German customers this month.NeoDynamics is pleased it will now deliver CorePulse needles in April and VacuPulse needles by mid-year to the centres in Europe listed below. The following hospitals will receive deliveries in April 2023: UK

HC Andersen Capital: NeoDynamics' Management elaborates on options for long-term financing

Meet CEO Anna Eriksrud and CFO Aaron Wong who will elaborate on options to raise long-term capital to enable the commercialization of NeoNavia in the US. The event takes place Wednesday the 15th of March at 2.00 PM. Sign up here: LINK  This is a press release from HC ANDERSEN CAPITAL www.hcandersencapital.dk Disclaimer: HC Andersen Capital receives payment from NeoDynamics for a Digital IR / Corporate Visibility subscription agreement. HC ANDERSEN CAPITALClaus Thestrup, CEO

NeoDynamics granted Chinese patent for FlexiPulse needle design

STOCKHOLM – March 6, 2023, NeoDynamics AB (publ) (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced that the Company has been granted a Chinese patent for the needle design employed in the NeoNavia® FlexiPulse™ probe.The front-loaded, open-tip sampling needle is designed to enable maximum tissue yield, with minimal patient trauma. The patent is an important milestone that opens up for a future commercial launch in China and strengthens the protection of the NeoNavia biopsy system. NeoNavia

Notice of extraordinary general meeting in NeoDynamics AB (publ)

The shareholders in NeoDynamics AB (publ), corp. reg. no 559014-9117 (the “Company”) are hereby convened to an extraordinary general meeting on Monday 3 April 2023, at 15.30 at the Company’s premises on Lejonvägen 14, Lidingö, Sweden.Right to participate Shareholders who wish to participate in the general meeting must: · be registered in his/her/its own name (not nominee-registered) in the share register kept by Euroclear Sweden AB on Friday 24 March 2023 (the record date), and · notify his/her/its intention to attend the general meeting to the Company no later than Thursday 30

NeoDynamics is investigating options to raise long-term capital to enable commercialization of NeoNavia® in the US

On 16 February 2023, NeoDynamics AB (publ) (“NeoDynamics” or the “Company”) announced that the Company’s largest shareholder, Gryningskust Holding AB had provided a loan of SEK 14m to kick-start the planned launch of NeoNavia® in the US. The loan is intended to be converted into shares if the Company issues new shares in the future. The loan matures on 15 August 2023.The board of directors and management of NeoDynamics are currently exploring various options to raise long-term capital to enable commercialization and execution of the Company’s US strategy, following the FDA clearance

Interview and company presentation with questions and answers in collaboration with Uddaaktier

CEO Anna Eriksrud makes a short presentation of NeoDynamics and answers questions about the business in an interview in collaboration with Uddaaktier on Monday, February 20th at 7 p.m.The interview will be streamed live via: live.uddaaktier.com Uddaaktier will ask questions to Anna Eriksrud, but viewers will also have the chance to ask questions. The interview will be conducted in Swedish. It is also possible to watch the interview afterwards via Uddaaktier's YouTube channel: https://www.youtube.com/channel/UCgprMaNfKDJmG0Tp5pzB-Dg

NeoDynamics AB (publ) full-year report 2022

Pre-Launch Activities in the US underwayGroup consolidated accounts have been prepared for the fourth quarter, and full year, which includes the consolidation of NeoDynamics AB, NeoDynamics GmbH and NeoDynamics Inc. These are represented in the financial statements as adjusted numbers, and are the comparative figures used for last year. Fourth Quarter 2022 · Revenues amounted to SEK 130 (931) thousand, of which SEK 0 (1,039) thousand were net sales · Net loss amounted to SEK -26,857 (-19,957) thousand. · Loss per share amounted to SEK -0.22 (-0.33). · Cash and cash

NeoDynamics' largest owner secures the launch of NeoNavia in the US

NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced that the company's largest shareholder Gryningskust Holding AB is offering the company SEK 14 million in a loan that can be converted into shares in order to secure the launch of NeoNavia in the US.NeoDynamics is ready to kick-start the planned launch of the NeoNavia system to clinics and potential partners in the United States. The company's largest shareholder Gryningskust Holding AB has strong faith in NeoDynamics as a

NeoDynamics announces changes to the Board of Directors

NeoDynamics today announces that Jie Bao and Xiaojun Xu will step down from the Board of Directors as of 2023-02-14 based on a mutual agreement. They will instead focus on supporting the company and its plans for the Chinese market.The Board will subsequently consist of Ingrid Salén (Chairperson), Carina Bolin, Claes Petterson, and Matthew E. Colpoys, Jr. “I would like to thank Jie Bao and Xiaojun Xu for their valuable contributions to the Board of Directors of NeoDynamics. I am pleased that they will continue supporting our plans for the Chinese market”, said Chairperson of the Board of

NeoDynamics Partners with Uniphar for US Distribution and Logistics

NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced it is partnering with global distribution and logistics giant Uniphar Group to ensure a successful US launch of NeoNavia®, its innovative pulse biopsy system.“NeoDynamics couldn't be more pleased to be partnering with Uniphar, a proven global partner to pharma and MedTech companies.  Leveraging Uniphar’s customer service, logistics management and digital technology will allow us to aggressively hit the US market,” said Anna

HC Andersen Capital: NeoDynamics – Comissioned Equity Research – Full commercialization in the US market

Read the analysis here . NeoDynamic's ultrasound-guided biopsy technology NeoNavia® addresses an unmet need in the diagnosis of breast cancer, the most prevalent female cancer type. The breast cancer diagnostic market is expected to be a USD 1.7bn market worldwide by 2025. Following an FDA approval of NeoNavia®, the primary value driver and focus for NeoDynamics is successful commercialization in the US market, where NeoDynamics is launching NeoNavia® with the FlexiPulse® during 2023. As a needle ultrasound-

NeoDynamics appoints Matthew Colpoys, to lead US operations

NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced the appointment of current board member Matt Colpoys as head of the company’s US subsidiary. Colpoys will remain on the board and will report to CEO Anna Eriksrud.“Matt is an experienced executive with an extensive background in new product launches, commercialization and corporate finance. He has also guided international companies in US launch efforts in the past – a perfect fit for NeoDynamics as we move quickly to

NeoDynamics Interim Report January-September 2022

Gaining momentum in the USThird 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

NeoDynamics gears up for US launch by partnering with Diligent

NeoDynamics announced today it is partnering with Diligent Health Solutions who will support the company for the upcoming launch of its novel pulse biopsy system NeoNavia.“Now that we have clearance from the US Food and Drug Administration, we are ready to move quickly to start introducing the NeoNavia system to clinicians and potential partners in the US,” said Anna Eriksrud, CEO of NeoDynamics. “Teaming up with Diligent to start our sales effort is a key milestone for the company. The US breast biopsy market is expected to reach $830 million by 2025 so this is an exciting moment for the

NeoDynamics hires National Sales Director for the launch of its NeoNavia® Biopsy System

NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced it hired Brendan Carney as National Sales Director. He will lead commercial strategy and execution, including field sales and managed markets for the company.Mr. Carney has more than 20 years of experience including Genentech and Pharmacia, leading teams and product launches in oncology, infectious diseases, endocrinology, and medical devices.  He has most recently served as Sr. Director, Market Access for Syneos Health where

Changing Breast Cancer Treatment with the NeoNavia[®] Biopsy System

Following recent FDA clearance of NeoNavia, NeoDynamics announces US launch with its accompanying FlexiPulse™probeStockholm, Sweden, October 25, 2022 NeoDynamics AB (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, announced today that it is launching the NeoNavia biopsy system configured with its FlexiPulse probe in the United States to support the diagnosis of cancer. “The recent FDA clearance of the NeoNavia will help clinicians address the critical issues they face in diagnosing and treating breast

HC Andersen Capital: FDA approval of NeoNavia Q&A session with NeoDynamics, CEO Anna Eriksrud, and CFO Aaron Wong

HC Andersen Capital hosted a Q&A session with the management from NeoDynamics, CEO Anna Eriksrud, and CFO Aaron Wong. NeoDynamics recently received FDA approval for the promising NeoNavia™ pulse biopsy system in the US.Get a short update on the NeoNavia system, targeting the biopsy market with focus on breast cancer and how NeoDynamics will approach the US market. The company already has a strong management/organization in place in the US and is ready to launch the product with full commercialization in 2023. The CEO Anna Eriksrud updates you on why they got the approval so fast, and CFO

NeoDynamics appoints Decomplix as Swiss representative

The MedTech company NeoDynamics has appointed Decomplix as representative in Switzerland, to facilitate and ensure that its novel biopsy system NeoNavia meets all legal requirements in the local market.Since late May 2022, Switzerland requires all foreign manufacturers that places medical devices on the Swiss market to appoint a Swiss Authorized 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. “Switzerland is set to be an important market for NeoDynamics, since it is a

NeoDynamics received FDA clearance for pulse biopsy system NeoNavia®

Stockholm, Sweden September 8, 2022 - The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia® from the US Food and Drug Administration, FDA. The US breast biopsy market is estimated to reach $830 million by 2025. “The FDA approval for NeoNavia is a major milestone for NeoDynamics and a stamp of quality for both the product and NeoDynamics as a whole,” said Anna Eriksrud, CEO of NeoDynamics. “The US represents the potentially largest market for the product, where we now also can build on the experience gained with the system in

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