Neurologically based medical device offers new therapeutic approach for phantom limb pain

CHARLOTTE, N.C., Jan. 26, 2026 /PRNewswire-PRWeb/ -- Axolo Health, a surgeon-founded medical software company, today announced that its Targeted Brain Rehabilitation (TBR) platform has been registered with the U.S. Food and Drug Administration as a Class II Software as a Medical Device.

Developed by Dr. Glenn Gaston and Dr. Bryan Loeffler at the OrthoCarolina Reconstructive Center for Lost Limbs, TBR was created to address phantom limb pain, a condition that affects up to 80 percent of amputees. Phantom limb pain is commonly managed through approaches that often focus on symptom relief rather than addressing underlying neurological disruption following amputation.

Axolo Health's approach is based on the view that when pain originates in the brain, treatment should begin there. Targeted Brain Rehabilitation applies established neurological rehabilitation principles, including laterality recognition, motor imagery and mirror therapy, within a structured, immersive framework designed to retrain disrupted neural pathways.

Delivered through FDA-registered Class II medical software, TBR uses hands-free, gaze-controlled virtual reality to support consistent and repeatable therapy delivery in real-world clinical settings. The regulated platform is designed to support clinicians and integrate into existing care pathways.

"Phantom limb pain is a neurological condition caused by disrupted brain pathways after amputation, yet many existing approaches focus on managing symptoms rather than addressing that disruption," said Loeffler, co-founder of Axolo Health. "Targeted Brain Rehabilitation was designed to address phantom limb pain at its source, using established neurorehabilitation principles delivered through regulated medical software that clinicians can trust and integrate into real-world care."

FDA registration allows Axolo Health to deliver its neurologically grounded therapy through regulated medical software designed for consistent use in real-world clinical settings, supporting clinician trust, integration into care pathways, and responsible expansion beyond a single center of excellence.

For many patients, persistent phantom limb pain can interfere with prosthetic use, sleep and daily function. By focusing on neurological retraining rather than short-term symptom management, Axolo Health aims to support meaningful improvements in quality of life over time.

"In caring for amputees, it became clear that persistent phantom limb pain reflects a disruption in how the brain maps and interprets the missing limb," said Gaston, co-founder of Axolo Health. "Rather than layering temporary symptom controls, we focused on neurological retraining using established rehabilitation principles, delivered in a structured way that clinicians can apply consistently as part of long-term care."

Regulatory Information

Targeted Brain Rehabilitation is delivered through TBR, an FDA-registered Class II Software as a Medical Device.

• FDA registration number: Establishment: 3042026071. Owner: 10094253
• Product code: QKC
• Regulation number: 21 CFR 890.5360
• Device listing owner: AxoloHealth
• Date of registration: December 21, 2025
• Intended use: The Targeted Brain Rehabilitation (TBR) Treatment System is a prescription use immersive reality system intended to provide cognitive behavioral and physical therapy.

Availability

• Commercial status: Currently available
• Care setting: In-clinic

To learn more about Axolo Health and the TBR therapy, please visit www.axolohealth.com.

About Axolo Health

Axolo Health is a surgeon-founded medical software company delivering Targeted Brain Rehabilitation (TBR), a structured, neurologically grounded therapy designed to relieve symptoms of Phantom Limb Pain at its source. Developed by world-class surgeons at the OrthoCarolina Reconstructive Center for Lost Limbs, Axolo Health was born from decades of hands-on amputee care and clinical research addressing one of the most persistent challenges in rehabilitation medicine.

TBR is delivered through FDA-registered Class II Software as a Medical Device (SaMD) and uses immersive, hands-free virtual reality to retrain disrupted neural pathways following amputation. By combining established rehabilitation principles, including laterality recognition, motor imagery, and mirror therapy, within a regulated software platform, Axolo Health enables consistent, repeatable delivery of neurological rehabilitation in real-world clinical settings.

Designed to support clinicians and responsibly expand access to care, Axolo Health is working to establish a new standard of care for phantom limb pain, improving quality of life, and restoring possibility for people living with limb loss. Learn more at www.axolohealth.com.

Media Contact

Mae Young, Axolo Health, 1 704-218-9362, media@ascentcomms.com, axolohealth.com

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SOURCE Axolo Health