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, US, MIAMI, LOVELL, NIJMEGEN, NEVADA, EINDHOVEN, NL, NETHERLANDS, UNITED STATES, EUROPE, CANADA

ONWARD Does Not Hold Cash Deposits at Silicon Valley Bank

Retrieved on: 
Monday, March 13, 2023
Federal Deposit Insurance Corporation, California Department of Financial Protection and Innovation, SVB, Health, Euronext, Movement, FDIC, Innovation, Silicon Valley Bank, California Department, MA, Bank

EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA, March 13, 2023 (GLOBE NEWSWIRE) -- March 13, 2023 – 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, today announced it does not hold cash deposits nor securities at Silicon Valley Bank (SVB).

Key Points: 
  • EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA, March 13, 2023 (GLOBE NEWSWIRE) -- March 13, 2023 – 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, today announced it does not hold cash deposits nor securities at Silicon Valley Bank (SVB).
  • On March 10, 2023, the California Department of Financial Protection and Innovation closed SVB and appointed the Federal Deposit Insurance Corporation (FDIC) as receiver.
  • ONWARD has no business arrangements nor known exposure to SVB.
  • All banks currently holding cash deposits and securities on behalf of ONWARD carry Moody’s Investors Service ratings of A1 / P-1 or higher on long / short-term deposits.

ONWARD Receives New FDA Breakthrough Device Designations for Bladder Control, Alleviation of Spasticity, and Blood Pressure Regulation after Spinal Cord Injury

Retrieved on: 
Thursday, February 23, 2023
Diagnosis, FDA, Patient, Euronext, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SCI, Spasticity, Movement, MA, Food, Health, Physician, Medical device

ONWARD has now been awarded a total of eight Breakthrough Device Designations, highlighting the company’s innovative approach to developing therapies for people with SCI.

Key Points: 
  • ONWARD has now been awarded a total of eight Breakthrough Device Designations, highlighting the company’s innovative approach to developing therapies for people with SCI.
  • ARC-EX is an external, non-invasive platform consisting of a stimulator and wireless programmer.
  • ONWARD is now preparing regulatory submissions for the U.S. and Europe, with the expectation that this therapy may be approved for commercialization in late 2023.
  • “Bladder control, spasticity, and blood pressure dysregulation are three of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” said Dave Marver, Chief Executive Officer of ONWARD.

ONWARD Strengthens Leadership Team with Key Appointments in Clinical & Regulatory and Marketing

Retrieved on: 
Monday, January 23, 2023
Master of Science, Marketing, Global marketing, MBA, Molecular biology, Health, Research, Assistant professor, Lee University, MA, Euronext, University, Neurosurgery, Mayo Clinic, Neurology, Head, Bachelor of Science, Advertising, Movement, SCI, Business, Johnson & Johnson, Duke University, Doctor of Philosophy, Pharmaceutical industry, Medicine, Management, Biology, Neuroscience

New VP Global Clinical & Regulatory – Erika Ross, PhD

Key Points: 
  • New VP Global Clinical & Regulatory – Erika Ross, PhD
    Erika Ross will join ONWARD as Vice President, Global Clinical & Regulatory, effective January 23, 2023.
  • In this newly created role, Erika will assume global leadership of ONWARD’s clinical and regulatory activities.
  • Erika joins ONWARD from Abbott Neuromodulation, where she was Director, Global Clinical & Applied Research.
  • I am looking forward to partnering with the clinical community to bring this game-changing therapy to market,” added Sarah Moore.

ONWARD Announces Participation at Upcoming Events

Retrieved on: 
Monday, January 16, 2023
CFO, Glassblowing

Dave Marver will give a company presentation.

Key Points: 

Dave Marver will give a company presentation.
Dave Marver or Lara Smith Weber, CFO, will give a company presentation.
Dave Marver will give a company presentation.

ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury

Retrieved on: 
Thursday, December 8, 2022
Professional Services, Health, Surgery, Finance, Managed Care, Pharmaceutical

ARC Therapy immediately improved blood pressure levels for all participants; this benefit has been sustained for the duration of the current follow-up period.

Key Points: 
  • ARC Therapy immediately improved blood pressure levels for all participants; this benefit has been sustained for the duration of the current follow-up period.
  • The results reported today with ARC Therapy are compelling and may open a new avenue to help people with spinal cord injury truly feel better, while also addressing heart health.
  • The interim outcomes reported today are from ten people with spinal cord injury who were treated at clinical centers in Canada and Switzerland.
  • Over 40% of people with spinal cord injury, or approximately 262,000 people in the U.S. and Europe2, are estimated to experience hypotension, or low blood pressure.

ONWARD Awarded European Innovation Council Grant to Further Develop Brain-Computer Interface Technology; Company also Wins First Place in 2022 Brain-Computer Interface Awards

Retrieved on: 
Monday, November 21, 2022
Medical Devices, Health, Other Health, Research, Science, Biotechnology, University of California, San Francisco, EUR, CHUV, Euronext, Partnership, Materials Research Science and Engineering Centers, In the First Place, International, SCI, Interface (computing), Stanford University, Swiss Federal Institute of Aquatic Science and Technology, Loss of Sensation, Science, EIC, Quality of life, Spinal cord injury, Hyperreflexia, U.S. FDA, Pathfinder, EPFL, Swiss Federal Institute of Technology, Research, Spinal cord, Paralysis, Nature, Incontinence, Paraplegia, ARC, Record, European Innovation Council, Tetraplegia, Lausanne University Hospital, University, BCI, Movement, Infection, Hope, Health, NEMO, Brain–computer interface, Medical device, Pharmaceutical industry

Separately, ONWARD announced that it was the First Place Winner of the 2022 Brain-Computer Interface (BCI) Award .

Key Points: 
  • Separately, ONWARD announced that it was the First Place Winner of the 2022 Brain-Computer Interface (BCI) Award .
  • The award was granted to ONWARD and several research partners for their submission, Walking naturally after spinal cord injury using a brain-spine interface.
  • ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries.
  • You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

ONWARD’s Research Partner .NeuroRestore Publishes Groundbreaking Paper Identifying Neurons that Restore Walking after Paralysis

Retrieved on: 
Thursday, November 10, 2022
Health, Medical Devices, Neurology, Health Technology, Research, Science, Biotechnology, Quality of life, ARC, Forward-looking statement, Health, Partnership, Research, CHUV, Technology, Swiss Federal Institute of Technology, Spinal cord, Neuron, Science, Leg, Spinal cord injury, Lausanne University Hospital, Muscle, SCI, Movement, Company, Program, Walking, Materials Research Science and Engineering Centers, Euronext, Hyperreflexia, EPFL, CEO, U.S. FDA, Swiss Federal Institute of Aquatic Science and Technology, Paralysis, Medical device, Trapping, Nature

The findings published yesterday continue to build our strong knowledge base in spinal cord stimulation to help people with paralysis.

Key Points: 
  • The findings published yesterday continue to build our strong knowledge base in spinal cord stimulation to help people with paralysis.
  • ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries.
  • ONWARDs work builds on more than a decade of basic science and preclinical research conducted at the worlds leading neuroscience laboratories.
  • You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

ONWARD Reports Third Quarter 2022 Highlights and Provides Business Update

Retrieved on: 
Tuesday, November 8, 2022
Medical Devices, Health, FDA, Research, Science, Biotechnology, ARC, Company, Program, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Health, Spinal cord, EUR, Quality of life, U.S. FDA, Government, Director, CHUV, Swiss Federal Institute of Aquatic Science and Technology, Arm, Forward-looking statement, Partnership, SIX Financial Information, Webcast, Lausanne University Hospital, FDA, Nature, Public, EPFL, McKinsey & Company, Science, Spinal cord injury, Safety, Technology, CEO, SCI, Food, Movement, Diagnosis, Physician, Swiss Federal Institute of Technology, CET, Patient, Board, Neurogenic bladder dysfunction, Euronext, NIH, Investment, Hemiunu, Marketing, Hyperreflexia, Medical device, Pharmaceutical industry, Tutoring, Risk management, EU, Zoom

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 Schedules Webcast to Provide Third Quarter Business Update and Announces Participation at Upcoming Conferences

Retrieved on: 
Thursday, October 27, 2022
Software, Finance, Hardware, Health, Medical Devices, Health Technology, Professional Services, Technology, Science, Spinal cord injury, Swiss Federal Institute of Aquatic Science and Technology, CET, Nature, U.S. FDA, Movement, Swiss Federal Institute of Technology, Technology, Quality of life, Company, Partnership, Spinal cord, EPFL, Lausanne University Hospital, ARC, Health, CHUV, Medical device, Risk management

Lara Smith Weber will give a company presentation and be available for questions together with Markus Rieger, Field Clinical Specialist.

Key Points: 
  • Lara Smith Weber will give a company presentation and be available for questions together with Markus Rieger, Field Clinical Specialist.
  • ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries.
  • ONWARDs work builds on more than a decade of basic science and preclinical research conducted at the worlds leading neuroscience laboratories.
  • You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

ONWARD Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home

Retrieved on: 
Wednesday, October 5, 2022
Research, Medical Devices, Finance, Professional Services, Other Health, Biotechnology, Physical Therapy, General Health, Health, Science, Quality of life, Incontinence, Euronext, Movement, Spinal cord, PT, Infection, Science, U.S. FDA, Patient, Loss of Sensation, High Tech Campus Eindhoven, NCS, Technology, University, Company, SCI, Health, CEO, Nature, Afghanistan Research and Evaluation Unit, DPT, Safety, Evaluation, Spinal cord injury, Forward-looking statement, University of Minnesota, ARC, Paralysis, University of Washington Department of Bioengineering, Pharmaceutical industry, Risk management, Medical device, Research, Shepherd Center

ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with spinal cord injury (SCI) and other movement disabilities.

Key Points: 
  • ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with spinal cord injury (SCI) and other movement disabilities.
  • The main objective of the study is to evaluate the safety and feasibility of ARC-EX Therapy when used at home.
  • The absence of any device-related adverse events confirmed the favorable safety results observed during the Up-LIFT Study when ARC-EX Therapy was used in clinics.
  • Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S. and Europe alone.