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Aandeel ONWARD MEDICAL BRU:ONWD.BL, NL0015000HT4

Laatste koers (eur) Verschil Volume
5,120   -0,020   (-0,39%) Dagrange 4,980 - 5,160 61.329   Gem. (3M) 59,6K

Forum Onward Medical geopend

1.615 Posts
Pagina: «« 1 ... 68 69 70 71 72 ... 81 »» | Laatste | Omlaag ↓
  1. Renno54 24 juli 2024 20:44
    Very pleased that ONWARD Medical is one of the pioneering investments of SCI Ventures. Christopher & Dana Reeve Foundation President Maggie Goldberg does a nice job explaining the new fund's purpose and potential impact, modeled after the Cystic Fibrosis Foundation and JDRF International's T1D Fund.

    #sci
    #innovation
    #venturephilanthropy

    Bron; Dave Marver op Linkedin
  2. forum rang 5 K. Wiebes 31 juli 2024 15:04
    Tja. Ik kan nog wel verzinnen dat er nog wat nieuw nieuws uit oudere studies of uit
    lopende, nieuwe studies komt; dat ze nog nummertje zoveel "breakthrough device
    designation" kunnen krijgen of dat er nog een nieuw koersdoel van een nieuwe vol-
    ger zou kunnen komen.

    Maar of dát dan het laatste zetje richting 'n permanent hoger koersniveau zou zijn?
    Kennelijk is het wachten toch op de goedkeuring. Tot dan blijft de koers waarschijn-
    lijk op 'n paar procent boven emissieniveau plakken.

    www.thefdagroup.com/blog/2015/08/what...
  3. forum rang 5 Stork 49 31 juli 2024 15:15
    paar centjes erbij paar centjes er af: het gaat allemaal om niets. Misschien dat er kopers zijn die hopen op een plotseling bekend gemaakt bericht. Als het zover is, is het tijd genoeg om in te stappen of uit te breiden. Mijn gedacht bij dit fonds en het gezwalk vd koers de laatste weken.
  4. Renno54 6 augustus 2024 00:09
    ONWARD® Medical Reaffirms 2024 Strategic Priorities and Releases Unaudited Q2 Financial Highlights
    Gepubliceerd op 5 augustus 2024 om 23:47

    Company expects to commercialize the investigational ARC-EX® System in Q4 2024 and has commenced launch preparations

    Company preparing to initiate global pivotal trial for investigational ARC-IM® Therapy to address blood pressure instability after spinal cord injury

    Company expects to advance clinical and development activities for its unique ARC-BCI™ brain-computer interface therapy

    EINDHOVEN, the Netherlands, Aug. 05, 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 reaffirms its 2024 strategic priorities and releases its unaudited Q2 financial highlights.

    2024 Strategic Priorities

    ARC-EX commercial launch. The Company expects to launch its ARC-EX Therapy for people with SCI in the US in Q4 2024, pending FDA clearance. Accordingly, the Company has accelerated launch preparations and continues to hire and develop its field sales and service organization. More detail about its launch plans will be provided during the 1H 2024 Investor Webinar on 10 September 2024.

    ARC-EX System pricing. Based on the strength of the Up-LIFT pivotal study data published in Nature Medicine in June 2024, the Company plans to price the ARC-EX System at $40,000.
  5. Renno54 6 augustus 2024 00:13
    ARC-IM interim data publication. The Company expects a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI.

    ARC-IM pivotal study commencement. The Company prepares to launch its global pivotal study, called Empower BP, for ARC-IM Therapy to address blood pressure instability after SCI. Major associated milestones expected to occur in Q4 2024 and Q1 2025 include FDA IDE submission, FDA IDE approval, and first participant enrollment.

    ARC-BCI therapy advancement. The Company plans to advance clinical and development activities for its investigational ARC-BCI System, leveraging grant funding, previously announced FDA Breakthrough Device Designation, and acceptance into the new FDA new Total Product Life Cycle Advisory Program (TAP). Several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and CEA-Clinatec.

    Q2 Unaudited Financial Highlights

    The net cash balance on June 30, 2024 was EUR 32.1 million.
    Company plans to publish its Half Year 2024 financial statements and host an investor webinar focused on commercial launch plans for the ARC-EX System on September 10, 2024.
    “We are preparing to launch the ARC-EX System in Q4 in the US. The strength of the Up-LIFT pivotal trial data published in Nature Medicine supports a system price of $40,000,” said Dave Marver, CEO of ONWARD Medical. “In addition to this important first commercial launch, the coming quarters promise many significant milestones and developments, including major publications, study initiations, and clinical advancements.”
  6. Renno54 6 augustus 2024 00:14
    To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

    *All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

    About ONWARD Medical

    ONWARD® Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of scientific discovery, preclinical, and clinical research conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy™, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA).

    ONWARD ARC Therapy is targeted, programmed spinal cord stimulation designed to be delivered by the Company’s external ARC-EX® or implantable ARC-IM® platforms. ARC Therapy can also be delivered by the Company’s ARC-BCI™ platform, which pairs the ARC-IM System with brain-computer interface (BCI) technology to restore movement after SCI with thought-driven control.
  7. Renno54 6 augustus 2024 00:19
    Use of non-invasive ARC-EX Therapy significantly improved upper limb function after SCI in the global pivotal Up-LIFT trial, with results published by Nature Medicine in May 2024. The Company has submitted its regulatory application to the FDA for clearance of the ARC-EX System in the US and is preparing for regulatory submission in Europe. In parallel, the Company is conducting clinical studies with its ARC-IM Therapy, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing clinical studies focus on using ARC-IM Therapy to address mobility after SCI and gait challenges in Parkinson’s disease as well as using the ARC-BCI platform to restore thought-driven movement of both upper and lower limbs after SCI.

    Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Brussels and Amsterdam (ticker: ONWD).

    For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

    For Media Inquiries:
    Aditi Roy, VP Communications
    media@onwd.com

    For Investor Inquiries:
    Amori Fraser, Finance Director
    investors@onwd.com
  8. forum rang 10 voda 6 augustus 2024 10:09
    Nog ruim 32 miljoen euro in kas Onward Medical
    06-aug-2024 10:02

    Strategische prioriteiten voor 2024 bevestigd.

    (ABM FN) Onward Medical heeft de strategische prioriteiten voor 2024 bevestigd. Dat bleek uit een persbericht van het medtechbedrijf met noteringen in Amsterdam en Brussel.

    Verder is Onward van plan om op 10 september een update te geven over de eerste jaarhelft.

    Die dag zal ook een bijeenkomst voor beleggers worden georganiseerd met focus op de lanceringsplannen voor het ARC-EX-systeem.

    Het bedrijf verwacht het systeem in het vierde kwartaal van 2024 op de markt te brengen. Dit in afwachting van goedkeuring door de FDA.

    Inmiddels zijn de voorbereidingen voor de lancering wel al begonnen.

    Onward is van plan om het ARC-EX-systeem een prijs van 40.000 dollar te geven.

    Onward bereidt zich daarnaast ook voor op het starten van een wereldwijd onderzoek naar bloeddrukinstabiliteit na een dwarslaesie. En de onderzoeken met de ARC-BCI braincomputer zullen voortgezet worden.

    Op 30 juni had Onward nog 32,1 miljoen euro in kas.

    Door: ABM Financial News.

    pers@abmfn.be

    Redactie: +32(0)78 486 481
  9. forum rang 5 K. Wiebes 6 augustus 2024 12:12
    ir.onwd.com/financial-information
    ir.onwd.com/news-events

    Unaudited of niet: de datum van vandaag had op de site gemoeten. En 10 September,
    bij de 'upcoming events" óók.
    Over hun kennelijk onvermogen om 'n fatsoenlijk werkende mailinglist op te zetten héb ik
    al 'n keer geklaagd; maar ik ga hierover tóch weer 'n mailtje sturen. Met die gebrekkige
    info-voorziening trekken ze niét meer beleggers over de streep: daar moeten ze dan maar
    'n paar euro voor vrij maken.

    Dát kwijt zijnde: ze lijken goed op schema te liggen; en uit m'n blote hoofd was de prijs
    eerst $30.000 i.p.v. die $40.000 nu.
  10. forum rang 4 Anna91 6 augustus 2024 12:29
    quote:

    K. Wiebes schreef op 6 augustus 2024 12:12:

    ir.onwd.com/financial-information
    ir.onwd.com/news-events

    Unaudited of niet: de datum van vandaag had op de site gemoeten. En 10 September,
    bij de 'upcoming events" óók.
    Over hun kennelijk onvermogen om 'n fatsoenlijk werkende mailinglist op te zetten héb ik
    al 'n keer geklaagd; maar ik ga hierover tóch weer 'n mailtje sturen. Met die gebrekkige
    info-voorziening trekken ze niét meer beleggers over de streep: daar moeten ze dan maar
    'n paar euro voor vrij maken.

    Dát kwijt zijnde: ze lijken goed op schema te liggen; en uit m'n blote hoofd was de prijs
    eerst $30.000 i.p.v. die $40.000 nu.
    Dat laatste dacht ik ook! Die 40.000 is hoger dan voorheen.

    En inderdaad. Ontvang nooit hun mailtjes ondanks geregistreerd staan.
  11. forum rang 5 K. Wiebes 6 augustus 2024 15:50
    Dear Ms. Fraser,

    Is it possible that Onward spends somewhat more time and money to professionalise
    the IR-part of its site?

    1. The mailinglist (still) does not work. The only messages I (and others) get are the stock-
    notifications. In those I am actually not interested, but I can not cancel them.

    2. The update of today should have been announced on the financial calendar.

    3. The 10th of September should be on the “upcoming events”.

    Such inadequacies are nót a nice business card for (potential) investors.

    Looking forward to receiving your eventual replay, I wil place this mail and your even-
    tual replay on the Onward-forum of investment site IEX.nl.

    Kind regards,

    K. Wiebes
    Shareholder

    www.iex.nl/Forum/Topic/1389142/Onward...
  12. biobert 6 augustus 2024 22:50
    quote:

    K. Wiebes schreef op 6 augustus 2024 15:50:

    Dear Ms. Fraser,

    Is it possible that Onward spends somewhat more time and money to professionalise
    the IR-part of its site?

    1. The mailinglist (still) does not work. The only messages I (and others) get are the stock-
    notifications. In those I am actually not interested, but I can not cancel them.

    2. The update of today should have been announced on the financial calendar.

    3. The 10th of September should be on the “upcoming events”.

    Such inadequacies are nót a nice business card for (potential) investors.

    Looking forward to receiving your eventual replay, I wil place this mail and your even-
    tual replay on the Onward-forum of investment site IEX.nl.

    Kind regards,

    K. Wiebes
    Shareholder

    www.iex.nl/Forum/Topic/1389142/Onward...
    Een uitstekend verzoek want ik vind dit alles ook behoorlijk storend. Ik krijg wel rgelmatig een mail door van de ceo die dan schrijft hoe geweldig ze bezig zijn en dat zonder feiten.
  13. Renno54 12 augustus 2024 21:50
    Welliswaar een herhaling van nieuws maar dat kan geen kwaad, komt van LinkedIn.

    This week, we reaffirmed our 2024 strategic priorities, and we have an exciting 2H ahead! Our top priority remains preparing for commercialization, and we look forward to bringing the investigational ARC-EX® System to the Spinal Cord Injury (SCI) Community in the US later this year.*

    Here’s more detail:

    ?? ARC-EX® commercial launch. We intend to launch our ARC-EX Therapy for people with SCI in the US in Q4 2024, pending Food and Drug Administration (FDA) clearance.

    ?? ARC-IM® interim data publication. We expect a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI.

    ?? ARC-IM pivotal study commencement.?We are preparing to launch our global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after SCI, pending FDA Investigational Device Exemption approval.

    ?? ARC-BCI™ Therapy advancement. Clinical and development activities for our investigational ARC-BCI System continue and several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and CEA-Leti.

    Here are our unaudited Q2 2024 financial highlights:

    ? We plan to publish our Half Year 2024 financial statements on September 10, 2024.

    ? The net cash balance on June 30, 2024, was EUR 32.1 million.

    To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit www.ONWD.com.

    *All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
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