ONWARD MEDICAL


Associated tags: Quality of life, Spinal cord, Health, FDA, Movement, Tetraplegia, Spinal cord stimulator, Science, Euronext, ARC, SCI, Medical device, Research, Pharmaceutical industry, Nature, BCI

Locations: SWITZERLAND, USA, NORTH AMERICA, MIAMI, LOVELL, NIJMEGEN, NEVADA, EINDHOVEN, NL, US, UNITED STATES, NETHERLANDS

ONWARD® Medical Reports Full Year 2023 Financial and Operating Results and Shares 2024 Highlights Year-to-Date

Retrieved on: 
Thursday, April 25, 2024
FDA, De novo, Partnership, EUR, TAP, Spinal cord, Lead, BDD, Defense, American Academy, Class, MJFF, Equity, Safety, ARC, BCI, Euronext, Research, University, Hemiunu, Global marketing, Government, SCI, Nature Medicine, Paralysis, Movement, SDVOSB, Pharmaceutical industry

The Company is developing a portfolio of ARC-IM Leads, each optimized for placement on a different area of the spinal cord.

Key Points: 
  • The Company is developing a portfolio of ARC-IM Leads, each optimized for placement on a different area of the spinal cord.
  • Also in November, ONWARD Medical research partner .NeuroRestore was awarded a $1 million grant from The Michael J.
  • In Q2, Bryan, Garnier & Co reinitiated research coverage of ONWARD Medical following the appointment of a new equity research analyst.
  • For 2023, the Company reported an operating loss of EUR 35.5M compared to EUR 32.0M in 2022.

ONWARD® Medical Announces Publication of Full Year 2023 Financial Results and Business Update Webcast

Retrieved on: 
Thursday, April 11, 2024
SCI, ARC, BCI, Euronext, Webcast, Movement, Interim, Broadcasting

EINDHOVEN, the Netherlands, April 11, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that it will publish Full Year 2023 Financial Results and host a webcast to discuss business highlights.

Key Points: 
  • EINDHOVEN, the Netherlands, April 11, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that it will publish Full Year 2023 Financial Results and host a webcast to discuss business highlights.
  • The webcast will be held on April 25, 2024, at 2:00PM CET / 08:00AM ET.
  • It will be hosted by CEO Dave Marver and Interim CFO Khaled Bahi, who will discuss highlights from 2023 and provide a business update.
  • Participants may also join by phone:
    A recording of the webcast will be available on the Company’s website following the live event.

Stifel Initiates Research Coverage of ONWARD® Medical with a Buy Rating and Target Price of EUR 12.00

Retrieved on: 
Tuesday, April 9, 2024
Buy, EUR, Target price, BCI, Target, Research, Euronext, ARC, Movement, SCI

EINDHOVEN, the Netherlands, April 09, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that Stifel, a US-based full-service investment bank, has initiated coverage of ONWARD Medical with a Buy rating and Target Price of EUR 12.00 per share.

Key Points: 
  • EINDHOVEN, the Netherlands, April 09, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that Stifel, a US-based full-service investment bank, has initiated coverage of ONWARD Medical with a Buy rating and Target Price of EUR 12.00 per share.
  • This is a premium of 140% to the closing price of EUR 5.00 on April 8, 2024.
  • The initiation report was published April 8, 2024.
  • Stifel joins four other banks whose analysts cover ONWARD Medical, all of which maintain Buy ratings and Target Prices at substantial premiums to the current share price.

ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

Retrieved on: 
Tuesday, April 2, 2024
De novo, DPT, BCI, Arm, Paralysis, Evaluation, Doctor of Philosophy, Quality of life, Euronext, BDD, Annual report, Craig Hospital, Spinal cord, Safety, ARC, Food, Marketing, FDA, SCI, NCS, Movement, Hand, Medical device

EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

Key Points: 
  • The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI.
  • Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical.
  • “We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver.
  • The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

ONWARD® Medical Publishes Closing of Accelerated Bookbuild Offering and Public Offering in France

Retrieved on: 
Monday, March 25, 2024
Offerings, Private, Brussels Stock Exchange, Euronext, DSM-IV codes, NOT, Euronext Amsterdam, Movement, SCI, Security (finance)

EINDHOVEN, the Netherlands, March 25, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today the closing of its previously announced private placement with institutional investors, certain founders, certain members of management, and certain members of the Board of Directors (the “Private Placement”) and of its separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer” and together with the Private Placement the “Offerings”).  The gross proceeds from the Offerings amount to €20 million. 

Key Points: 
  • OTHER RESTRICTIONS ARE APPLICABLE.
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • As of today, the new shares issued pursuant to the Offerings are admitted to listing and trading on Euronext Brussels and Euronext Amsterdam.
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

ONWARD® Medical Publishes Prospectus for Listing of New Shares

Retrieved on: 
Thursday, March 21, 2024
EUR, Offerings, AFM, Euronext, Prospectus, DSM-IV codes, Market, NOT, Movement, SCI

EINDHOVEN, the Netherlands, March 21, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today that it has published a prospectus for the admission to listing of 4,444,444 ordinary shares in the Company’s share capital, with a nominal value of EUR 0.12 each, issued through a private placement with institutional investors, certain founders and certain members of management, and certain members of the Board of Directors (the “Private Placement”) and in a separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer”), for which pricing and allocation have occurred prior to trading on March 21, 2024 (the “Offerings”). In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today. The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today.
  • The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information .
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

ONWARD® Medical Successfully Raises €20 Million in a Capital Increase by Way of an Accelerated Bookbuild Offering and by Way of a Public Offering in France

Retrieved on: 
Thursday, March 21, 2024
Offerings, Public, Private, Brussels Stock Exchange, KBC, Euronext, DSM-IV codes, CSO, Euronext Amsterdam, NOT, SCI, Movement, Hand, Security (finance)

PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • “We are delighted to announce the successful capital raise of €20 million, including a fully subscribed upsize option despite challenging market conditions,” said Dave Marver, CEO of ONWARD Medical.
  • Existing shareholders participated in the deal with an aggregate of 333,333 shares and 333,333 shares respectively allocated to INKEF Capital and EQT Life Sciences.
  • Following the Offerings, INKEF Capital and EQT Life Sciences will respectively hold 11.5% and 11.2% of the Company’s share capital.

ONWARD® Medical Launches Capital Increase by Way of an Accelerated Bookbuild Offering and of a Public Offering in France for an Indicative Amount of EUR 15 Million, with an Up to EUR 5 Million Upsize Option

Retrieved on: 
Wednesday, March 20, 2024
Brussels Stock Exchange, SCI, Public, Private, KBC, VWAP, ARC, Hand, Acceleration, Regulation, DSM-IV codes, CSO, Movement, EUR, Private placement, BCI, Offerings, Public offering, Equity carve-out, Euronext, Issue, Euronext Amsterdam, Security (finance)

The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.

Key Points: 
  • The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.
  • The New Shares will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights.
  • “It is the Company’s intention to raise gross proceeds of indicatively EUR 15 million from the Offerings, with an up to EUR 5 million upsize option.
  • A separate announcement will be made shortly regarding the Public Offer in France via the PrimaryBid platform and its terms.

ONWARD® Medical Launches Capital Increase by Way of an Accelerated Bookbuild Offering and of a Public Offering in France for an Indicative Amount of EUR 15 Million, with an Up to EUR 5 Million Upsize Option

Retrieved on: 
Wednesday, March 20, 2024
Failure, Economy, Brussels Stock Exchange, Exercise, Patient, Risk, European, Intellectual property, Marketing, SCI, Annual, Public, Private, KBC, AFM, Prospectus, Royal Victorian Order, VWAP, ARC, Hand, Acceleration, Part, Research, Classification, Enrollment, Certification, DSM-IV codes, CSO, FDA, Movement, Engineering, EUR, Private placement, BCI, Offerings, Public offering, Market, Issue, Euronext Amsterdam, Probability, Security (finance)

The Issue Price will be determined by the accelerated book-building initiated with institutional investors.

Key Points: 
  • The Issue Price will be determined by the accelerated book-building initiated with institutional investors.
  • The Public Offering will not extent to retail investors located outside of France.
  • The New Shares will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights.
  • It is the Company’s intention to raise gross proceeds of approximately €15.0 million from the Offerings, with an up to €5 million upsize option.

ONWARD® Medical Successfully Completes Benchmark Testing on Path to Commercialize ARC-EX® System

Retrieved on: 
Monday, March 18, 2024
BCI, Paralysis, Euronext, ARC, Movement, SCI, Medical device

  EINDHOVEN, the Netherlands, March 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces receipt of a positive report from a leading US-based medical equipment testing laboratory confirming its investigational ARC-EX System conforms to prevailing electrical standards, a requirement for commercial launch.  

Key Points: 
  • Last year, the Company announced its decision to update the ARC-EX printed circuit board assembly.
  • With the positive testing report, the Company moves closer to meeting regulatory obligations for market launch.
  • The ONWARD ARC-EX System is designed to improve upper extremity movement after paralysis caused by spinal cord injury.
  • “The positive tests are an important milestone on our path to commercialize the external, non-invasive ARC-EX System in the US later this year,” said ONWARD Medical CEO Dave Marver.