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ONWARD® Medical Reports Q1 2024 Update and Year-to-Date Highlights

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星期四, 五月 23, 2024
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EINDHOVEN, the Netherlands, May 23, 2024 (GLOBE NEWSWIRE) --  ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today provided a Q1 2024 business update.

Key Points: 
  • EINDHOVEN, the Netherlands, May 23, 2024 (GLOBE NEWSWIRE) --  ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today provided a Q1 2024 business update.
  • In May 2024, the Company announced the publication of global Up-LIFT pivotal trial results in Nature Medicine.
  • The Company was issued 13 new patents during Q1 2024, bringing its total number of issued patents year-to-date to more than 265, further strengthening its first-mover advantage.
  • ONWARD Medical will host a conference call with a live webcast today, May 23, 2024, at 2:30 pm CET / 8:30 am ET.

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

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星期四, 四月 25, 2024
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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® Announces Start of HemON NL Clinical Study

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星期四, 一月 18, 2024
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EINDHOVEN, the Netherlands, Jan. 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 the start of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands.

Key Points: 
  • EINDHOVEN, the Netherlands, Jan. 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 the start of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands.
  • The surgery was performed by neurosurgeon Erkan Kurt, MD at Radboud University Medical Center, which has a neurosurgery department affiliated with Sint Maartenskliniek.
  • Building on the Swiss HemON clinical feasibility study, HemON NL prepares the Company for expected initiation of a global pivotal trial, called Empower BP, which is designed to provide the evidence necessary to submit a pre-market approval (PMA) to the US Food and Drug Administration (FDA) and other global regulatory authorities.
  • The Company plans to enroll participants in both HemON and HemON NL as it finalizes the design of the Empower BP pivotal study.

ONWARD® Reports Q3 Business Update and Year-To-Date Highlights

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星期四, 十一月 16, 2023
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The study participant also received a wireless brain-computer interface (BCI), designed to initiate thought-driven movement when paired with ARC-IM.

Key Points: 
  • The study participant also received a wireless brain-computer interface (BCI), designed to initiate thought-driven movement when paired with ARC-IM.
  • ONWARD ARC-IM delivers targeted, programmed ARC-IM Therapy to the spinal cord to restore movement and other functions after SCI.
  • To date, ARC-IM Therapy has been applied across multiple clinical feasibility studies to restore mobility or stabilize blood pressure after SCI.
  • In September, the Company announced a partnership with Lovell Government Services (Lovell), a Service-Disabled Veteran-Owned Small Business (SDVOSB).

ONWARD Reports Q1 Business Update and Year-To-Date Highlights

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星期二, 五月 16, 2023
Blood pressure, Lead, CE, Mayo Clinic, Arm, University, European Innovation Council, CET, BCI, Hemiunu, SIX Financial Information, ARC, Neurology, American Academy, De novo, Movement, Trial of the century, EUR, BDD, Euronext, Assistant professor, Patient, Investment, Webcast, Christopher and Dana Reeve Foundation, Johnson & Johnson, Paralysis, Research, Bdd, SCI, FDA, Hand, Global marketing, Spasticity, Safety, Pharmaceutical industry, Medical device, Broadcasting, Zoom

“Our team continued to execute at a high level in Q1, achieving milestones and adding strength across our range of activities,” said Dave Marver, CEO of ONWARD.

Key Points: 
  • “Our team continued to execute at a high level in Q1, achieving milestones and adding strength across our range of activities,” said Dave Marver, CEO of ONWARD.
  • In Q1 2023, ONWARD strengthened its leadership team, appointing Erika Ross Ellison as Vice President, Global Clinical & Regulatory, and Sarah Moore as Vice President, Global Marketing.
  • ONWARD will host a conference call with a live webcast today, May 16, 2023, at 2:00 pm CET / 8:00am ET.
  • All ONWARD devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.

ONWARD Reports Third Quarter 2022 Highlights and Provides Business Update

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星期二, 十一月 8, 2022
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ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today discussed highlights from the third quarter of 2022 and provided a business update.

Key Points: 
  • ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today discussed highlights from the third quarter of 2022 and provided a business update.
  • In September 2022, ONWARD reported positive top-line results from its Up-LIFT pivotal study evaluating transcutaneous stimulation with its external ARC Therapy.
  • In October 2022, ONWARD reported topline results from the LIFT Home study, evaluating the safety and feasibility of ARC-EX Therapy when used at home.
  • In September 2022, ONWARD appointed Vivian Riefberg, a highly accomplished expert in healthcare, government, and strategy, to the Board of Directors.

ONWARD Reports First Half 2022 Financial and Operating Results

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星期二, 九月 27, 2022
Biotechnology, Health, Surgery, Medical Devices, Income, Health, European Innovation Council, Movement, High Tech Campus Eindhoven, U.S. FDA, Spinal cord, McKinsey & Company, Spinal cord injury, Hemiunu, EDT, State Administrative Expenses, News, Nature, Company, Public, SCI, Patient, Government, Investment, Business, Forward-looking statement, Technology, SME, Quality of life, CLA, General officer, University of Virginia Darden School of Business, CET, Science, ARC, Marketing, RVO, University, Webcast, Medical device, Film, Bank, Pharmaceutical industry, EU, EUR, Euronext

Total Operating Expenses increased during H1 2022 by EUR 6,3 million to EUR 16,1 million.

Key Points: 
  • Total Operating Expenses increased during H1 2022 by EUR 6,3 million to EUR 16,1 million.
  • The decrease in cash of EUR 12,6 million compared to 31 December 2021 is due to cash outflows mainly for operating activities.
  • ONWARDs management expects to continue the steady and consistent execution of its strategy in the second half of 2022 and beyond.
  • Also in the second half of 2022, the Company expects to release combined top-line data from the STIMO-HEMO and HemON studies.

ONWARD Announces First Patient Enrollment in HemON Study and First-in-Human Use of its ARCIM Implantable Neurostimulator

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星期一, 五月 9, 2022
Research, Technology, Medical Devices, Finance, Other Technology, Professional Services, Biotechnology, Health, Data Management, Science, Euronext, ARC, Nature, Company, Neurosurgery, Neurodegeneration, Safety, High Tech Campus Eindhoven, IPG, FDA, Spinal cord, SCI, CHUV, Orthostatic hypotension, Health, Quality of life, Movement, Achievement, Science, Technology, Hemiunu, CEO, Multimedia, Medical device

ONWARDs ARCIM IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator, said Dr. Jocelyne Bloch, Chief of Functional Neurosurgery at Switzerlands Lausanne University Hospital (CHUV).

Key Points: 
  • ONWARDs ARCIM IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator, said Dr. Jocelyne Bloch, Chief of Functional Neurosurgery at Switzerlands Lausanne University Hospital (CHUV).
  • Clinicians will be able to leverage these advanced capabilities to refine and deliver epidural stimulation therapies for people with spinal cord injury.
  • The first implant of our ARCIM IPG is a huge milestone for ONWARD and the SCI community, said Dave Marver, CEO of ONWARD.
  • You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.