Neural Noise

ONWARD Medical FDA IDE for ARC-IM Empower BP pivotal study

4 min read

  • ONWARD Medical received FDA IDE approval to initiate the Empower BP pivotal study with the ARC-IM system.1
  • The ARC-IM system provides spinal neuromodulation for blood pressure control, adjacent to neuroprosthetics and the regulatory playbook for neuro devices.1 1

Gardner updates

  • Onward Medical submitted ARC-EX to FDA for home use and is pursuing CE mark. 2

  • ONWARD Medical received CE Mark for ARC-EX, enabling commercial launch of the spinal cord stimulation system in Europe. 3

  • ONWARD Medical demonstrated commercial traction and advanced its pipeline in the first half of 2025. 4

  • Onward Medical’s ARC-IM spinal cord stimulation system improves blood pressure control after spinal cord injury. 5

  • Onward studies highlight blood pressure regulation with spinal cord stimulation. 6

  • Onward Medical reported preliminary Q3 revenue of over EUR 1 million, a commercial milestone for the company. 7

  • ONWARD Medical announced a $58.1M private placement to fund ARC-EX and neurorehabilitation pipeline development. 8

  • The raise advances spinal cord technology and near-term execution and commercial runway for the company. 9

  • Onward Medical appointed a former Boston Scientific VP as chief commercial officer, signaling commercial scaling focus. 10

  • FDA granted 510(k) clearance expanding the ARC-EX system indication for home use in spinal cord injury care, enabling at-home spinal cord stimulation. 11

  • ONWARD Medical reported strong US adoption of ARC-EX spinal neuromodulation, signaling commercial traction and reimbursement for neurotech devices. 12

Weekly enrichment (2026-07-20)

  • The Empower BP pivotal study is registered as ClinicalTrials.gov NCT07147296; participants are randomized 2:1 into an active arm versus a control arm designed to mimic the intervention without the active component, for a 3-month blinded period before all subjects cross over to open-label active ARC-IM therapy.13
  • The primary effectiveness outcome is assessed at 3 months post-implant using the subject-reported ADFSCI (Autonomic Dysfunction Following Spinal Cord Injury) measure together with seated blood pressure assessments.13
  • Eligibility targets chronic SCI (>1 year post-injury) at neurological levels C2–T6 with injury severities AIS A–D and blood pressure instability characterized by chronic orthostatic hypotension and episodes of autonomic dysreflexia.1415
  • FDA approved the ARC-IM investigational device exemption on August 18, 2025, enabling Empower BP as ONWARD’s second global pivotal study and the first to evaluate the implantable ARC-IM System, with a planned minimum of 60 participants across approximately 20 neurorehabilitation and neurosurgical centers in the US, Canada, and Europe.14
  • The ARC-IM System consists of a purpose-designed implantable neurostimulator connected to a lead that targets the “Hemodynamic Hotspot,” a low-thoracic spinal cord region with a high density of neurons that regulate blood pressure.15
  • The first participant was enrolled and successfully implanted in Q1 2026 at Craig Hospital in Denver, Colorado, and by the Q1 2026 update ONWARD reported 12 US clinical sites activated and actively recruiting.1617
  • Supporting feasibility evidence was published concurrently in Nature and Nature Medicine on September 18, 2025, drawn from 14 participants at neurorehabilitation clinics in Switzerland, Canada, and the Netherlands, showing immediate and robust increases in blood pressure and reduced frequency and severity of hypotensive symptoms.1819
  • In those feasibility studies benefits (reduced fatigue, improved bowel management, greater tolerance of upright postures, and reduced or discontinued use of compression garments and medications) were durable for up to two years post-implant and consistent across sites, with no serious device-related adverse events reported.1819
  • ONWARD has been awarded 10 FDA Breakthrough Device Designations for its ARC Therapy platform, and notes the investigational ARC-IM System can be paired with a brain-computer interface and AI to restore thought-driven movement.16

Footnotes

  1. https://news.google.com/rss/articles/CBMigwFBVV95cUxNY0ZVSWx3Ti05dFJVMmtBR2p0dEk0cXNjUHJqVFQwVGJNT0NKOFp0WlNsdmVodmZrQ01aaUZuSVRvMURnbm1RRUFSRTBzYkxhMVNVbjZjWUZOMzE1TWtlU0R5emFFZ2ZzeUVxWEs0UzFOdGNtOVp2b0NBUWZqeFoyUXpmdw?oc=5 ↩ ↩2 ↩3

  2. https://news.google.com/rss/articles/CBMib0FVX3lxTE8xdUV3b1haY1VqcTN3Q0dWUGUwcWMwMjJ4SGJnQmNTOGRldVN5V0t2RzlVSUZ3b2pyYzg0TVhKbllnOGkybUdNOXc3aWhOYW1hNmprOFc2RWszeXk1RXVDZGJ2alZ1OVVYLWhLanphZw?oc=5 ↩

  3. https://news.google.com/rss/articles/CBMihwFBVV95cUxQTjhCbGFKdmd4bXQwV1NuRF9hd0ctV0tRcndmX0pELTVUUlYxMzNrRURpcVNxMWZmY1dFYklJMUYyRlEwMkV5Y1RmemtPWnRlNHZWT04tZzVsWHQyeFN3SEtnejlySWVINFJpaWN5UWM1RTBRVzNfRlQ5YVlhZGdVblROaWZWT2c?oc=5 ↩

  4. https://news.google.com/rss/articles/CBMimAFBVV95cUxNMUprcHNtUkxJUW9oOERIR2l0dTZmM1lpMTJ3Q1VfcjlCYThlTXRxY05MZ3VwNGpUd2JhRlpvc1BONE56NXhkbHl4a3VoWEsxSGZlLTF1QnpmR0FmYXloVi1ETDFfZkFBRDdSdklwbXdtM0dWb2Q4RmVJUW1MV21sQkJ2RjNQRWctejlCQWgzM1REd3oxYVhWeg?oc=5 ↩

  5. https://news.google.com/rss/articles/CBMiogFBVV95cUxQRGRmZTdtODZ0ZTNEWjJvcDJJTElva3hrS3M5VERycHZQTXFkenNvMHp2YkFLdlBpVDAtN2Z3WV9vc2ZLa0ZBNGVReHdxblI0Qkt0aFRlSUdLeF9BVmdvZENDa1I2SFRtZlZlMHp4ZUFXTmY5emU3YmZCZm9UcXMtYjYtUDhqYVAxZDEtNEItV2VRTmNwMnpJUWU5d0dMTEE2MkE?oc=5 ↩

  6. https://news.google.com/rss/articles/CBMigAFBVV95cUxNTFE3eExyanBVSjVOR1NmdWNkbUZ2THhzRUVpb2tZV0pGMFhNUE5wdGpIVUwxeXBFTDNsSERPcmE0RjM0Q0VsMVQ4MXVKcHBmNnV4bFE0c3ktZUxkeE9wX2JjSDkwOWM4TmctMmxjekFMbkZsVU5NMlo1QWxJNDNXUQ?oc=5 ↩

  7. https://news.google.com/rss/articles/CBMilAFBVV95cUxOSTVIcEVyZWE1SDd6U0FQdV9nN1ZXaFlvVmtUU2V1ZGhuTjllWEVKTmVRZWtzQld3RmtKdXZ5am5Dc2YzeGlYS0k2MGY4eV8yQWFoY1hDaFMxQl9LMmRCTU9uanlyTlZxZnUtYzBQV1BjbXpmZFRqLTJObDBxb1ZjOWxHSnlLT3hmNGlfQnBnWUQ1SWtm?oc=5 ↩

  8. https://news.google.com/rss/articles/CBMidEFVX3lxTE1kQTdlSTlPMDhSekl1dzVaRUltUEc5U2ZURXlwNFFsZjJfNGxMeUh6OWVielRXWHMxWS1hWjlRTlFFNFdMeUNwUWJRZjFQLWNkTXEyYXlUdV82ak9HNkpfRjVFd3FsRFRJV1A0NkN5bUJ6Nl9F?oc=5 ↩

  9. https://news.google.com/rss/articles/CBMiigFBVV95cUxOM2VxUjlpUUhPRGhxRTRUSExLTUN2ejhkeTJ5Y0l2R1JiN0lJcjVfNy1NeHJtMDNTNS1XVGVlTUs1ZEh6VHMwc0o0a0hpV3BiejBUcm9qNU9zNzJjUktlcnliRHNDWm4zYXJlOXNLdk84enRBeTNRci1sVTNUWUM0bWRIMmdmSVo0RGc?oc=5 ↩

  10. https://news.google.com/rss/articles/CBMigAFBVV95cUxPc0IxOXFxTFRhT01fUmoybzVjYVpCUDNLYWlUQ1ZLdFhhSUtUTm5GVmdZNUxSSDdpazlQVzFET2J2d3E2X2dBckg3R1RzSUhEUDZzcEtNcWlDdTc0YmdDanJCTFhoeUhVbVQ5T09kdkstSEt6dVY1d05Pa1N2bDhRUA?oc=5 ↩

  11. https://news.google.com/rss/articles/CBMi9gFBVV95cUxPaHZ5OVJGR2VoTVRyYWpMUkI1aGhLMVF4YmwtdW0xdHdPQUVzTFRyY0c1NmFyWkNHZHl6d1Q0aTVhRDRnMHJGWnVLQkpFaENmOXZVXzNhdmozUTZqdkxObmdsLVRYbFhVdzAxQ0J0Vm1PeGRKYkxqQWpZM0dXa2hBaDdMY3dDUzVueE1fYWFsTDRIQnF6UjI2YmdLemFlUFUySHliYWZRMERRNnhNM1EyNU5jMS1zVFp4VnFfSVVEMW5rNDFlMUNFV2lCRER2NTJETHBPdzFOMXRjZVpwQmFCZVdDaUJBT1RDVXFFSmt5VzNINUJIekE?oc=5 ↩

  12. https://news.google.com/rss/articles/CBMimgJBVV95cUxQZ2RGWUwxc0pNdVNiczNCUVRWckxTNVFpYV9TeExuOWxPb2M0X0pEX1lQVGE5N2FDT0h5YXI0cllMZkljRk5pMzNSeDNFclg0bVNfcWc3aU5WV1RYbkJEdGk0bElaeGFjUGNweDRRUzBPckFwX0xDbzZ5WDRtWlZKY2R1X0hzM2JyVUlFNE8zSmZ6YjJZMnhtdzJOVy1CT2hmeG9nUFFGeWgzZGV0bDlxSHIxa2s4a2FFN1hKdGdEUmhrMUtjbGtUY2haYjBmemJHYVdrWHVqSlc5NTRhaXVHNGdTMmVYVHhJRzFfTjloMEo5ZmdRNGhYb20yQXN4ejhoTW9tQXNjc3h0ZlF2WjVRN1lDVGdfbGFsVlE?oc=5 ↩

  13. https://ichgcp.net/clinical-trials-registry/NCT07147296 ↩ ↩2

  14. https://www.globenewswire.com/news-release/2025/08/18/3135202/0/en/ONWARD-Medical-Receives-FDA-IDE-Approval-to-Initiate-the-Empower-BP-Pivotal-Study-with-the-ARC-IM-System.html ↩ ↩2

  15. https://www.onwd.com/empower-bp/ ↩ ↩2

  16. https://ir.onwd.com/static-files/0a8c6ce4-3d2e-4e63-92d1-2230e0b3bc65 ↩ ↩2

  17. https://ir.onwd.com/static-files/b67fd924-b270-4f8a-9db3-4263ccc815ca ↩

  18. https://www.massdevice.com/onward-studies-blood-pressure-regulation-arc-im/ ↩ ↩2

  19. https://www.globenewswire.com/de/news-release/2025/09/18/3152152/0/en/Concurrent-Publications-in-Nature-and-Nature-Medicine-Highlight-Advances-in-Blood-Pressure-Regulation-after-Spinal-Cord-Injury-Using-ONWARD-ARC-IM-Therapy.html ↩ ↩2

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