Two FDA Decisions, Nine Days Apart
On April 7, 2026, NervGen Pharma announced that it had reached agreement with the U.S. Food and Drug Administration on the design of RESTORE, its Phase 3 registrational study of NVG-291 in chronic tetraplegia. Nine days later, on April 16, ANEUVO announced FDA clearance for the ExaStim® Stimulation System, a non-invasive spinal cord stimulation therapy for adults with chronic incomplete SCI. One is a drug moving into a registrational trial. The other is a device entering the U.S. market. Both programs have been developed with input from the SCI community, and both matter for different groups of NASCIC members.
NASCIC works with both NervGen Pharma and ANEUVO through its member network and receives updates directly from each company. NASCIC's member communications about those updates are written to be accurate and non-promotional. The full press releases are linked at the bottom of this article.
NervGen Pharma: FDA Alignment on RESTORE Phase 3 Registrational Study of NVG-291
NervGen's announcement describes the outcome of an End-of-Phase 2 meeting with the FDA. FDA alignment at this stage means the agency and the company agree on the main elements of RESTORE's design: its study population, its primary endpoint, and its statistical plan. Those are the elements the trial will need to address in order for its data, if positive, to support a future New Drug Application for NVG-291 in chronic tetraplegia.
NervGen's lead candidate, NVG-291, is a neuroreparative peptide given by subcutaneous injection. It is designed to block a signaling pathway that normally limits nerve repair after spinal cord injury. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI.
Adam Rogers, MD, President and Chief Executive Officer of NervGen, said in the company's announcement: "RESTORE's design, anchored by the strength and totality of the CONNECT SCI data, was shaped in close collaboration with the FDA, the SCI community, key opinion leaders, and advocates, to ensure the clinical data and outcomes generated reflect what matters most to the individuals it's designed to serve."
RESTORE Highlights at a Glance
- FDA alignment reached on RESTORE, a 16-week Phase 3 registrational study in chronic tetraplegia.
- Primary endpoint: change from baseline in GRASSP Quantitative Prehension at Week 12, a validated functional measure of fine-motor hand use.
- Secondary endpoints: patient and clinician ratings of change, the Spinal Cord Independence Measure, and lower-extremity spasticity (Modified Ashworth Scale).
- Blinded qualitative interviews will help contextualize what any observed improvements mean in daily life.
- Initiation on track for mid-2026, with study start-up activities already underway.
RESTORE Study Design
Based on the NervGen announcement, RESTORE is a randomized, double-blind, placebo-controlled trial of approximately 150 adult participants, running at up to 60 sites across the United States and Canada. Participants randomized to placebo will have the option to enroll in a 12-week open-label extension at the end of the main study so they can also receive NVG-291.
RESTORE Phase 3 Study Details
| Parameter | Detail |
|---|---|
| Study design | Randomized, double-blind, placebo-controlled |
| Participants | Approximately 150 adults, ages 18 to 75 |
| Population | Chronic tetraplegia (≥C7; ASIA Impairment Scale C or D), 1 to 10 years post-injury |
| Sites | Up to 60 sites across the United States and Canada |
| Dosing | Daily subcutaneous injections of NVG-291 for 12 weeks, followed by a 4-week observational period |
| Primary endpoint | Change from baseline to Week 12 in GRASSP Quantitative Prehension |
| Open-label extension | Optional 12-week extension for placebo participants |
| Planned initiation | Mid-2026 |
Source: NervGen Pharma press release, April 7, 2026.
Supporting Data from CONNECT SCI
The RESTORE design was shaped by data from the Phase 1b/2a CONNECT SCI study in chronic tetraplegia. In that earlier study, NervGen reported a mean improvement of +3.7 points on the GRASSP hand-function assessment at Week 12 among NVG-291 treated participants, compared with +0.4 points in placebo participants. That is a 3.3-point treatment difference, exceeding the 2.0-point minimally important difference. Improvement continued through Week 16 (four weeks after treatment ended), and 75% of NVG-291 treated participants reported being "much" or "very much" improved on the patient global rating of change, compared with 33% of placebo participants.
In connection with the End-of-Phase 2 meeting, NervGen also announced that it is closing enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and will unblind the available data. The company plans to use the RESTORE trial as a model for a future registrational-quality study in subacute tetraplegia.
ANEUVO: FDA Clearance for the ExaStim® Stimulation System
On April 16, 2026, ANEUVO announced that the FDA has cleared its ExaStim® Stimulation System ("ExaStim") for use in the United States. ExaStim is a portable neurostimulation system that delivers personalized transcutaneous spinal cord stimulation (electrical pulses applied to the skin, not surgically implanted) to support functional neurorehabilitation for people with paralysis from SCI. System control is managed via software on a mobile digital device.
According to ANEUVO's announcement, ExaStim is indicated to improve hand sensation and strength in individuals aged 18 to 75 with chronic, non-progressive neurological deficits resulting from incomplete spinal cord injury, when used in conjunction with functional task practice. The FDA clearance covers both clinic and home use.
Yi-Kai Lo, CEO of ANEUVO, said in the company's announcement: "This clearance represents an important step forward for individuals living with SCI. We're providing a non-invasive solution designed for both clinic and home use, which expands access and helps patients achieve meaningful progress in their continued recovery."
ExaStim FDA Clearance Highlights
- U.S. market entry following FDA clearance announced April 16, 2026.
- Non-invasive transcutaneous spinal cord stimulation, with no surgical implant required.
- Indicated to improve hand sensation and strength in adults (ages 18 to 75) with chronic, non-progressive deficits from incomplete SCI.
- Approved for both clinic and home use, enabling flexible therapy delivery.
- Previously CE Marked in April 2025 for broad use across SCI subtypes in the European market.
How ExaStim Works
ExaStim delivers electrical pulses through surface electrodes placed on the skin to stimulate nerves along the spinal cord and dorsal roots. It is designed to be paired with functional task practice, such as practicing hand-function tasks during stimulation sessions. The company says this combination is how the therapy is intended to support neurorehabilitation outcomes.
Because ExaStim is non-invasive and portable, it can be used during clinic-based rehabilitation or at home under a clinician's direction. ANEUVO describes this as an effort to make therapy more flexible and accessible, particularly for people for whom frequent travel to a specialized clinic is not practical.
ExaStim® Stimulation System at a Glance
| Feature | Detail |
|---|---|
| Device type | Portable, non-invasive (transcutaneous) spinal cord stimulation system |
| Indicated population | Adults ages 18 to 75 with chronic, non-progressive neurological deficits from incomplete SCI |
| Intended benefit | Improvement of hand sensation and strength when used with functional task practice |
| Settings of use | Clinic and home |
| Control interface | Software on a mobile digital device |
| U.S. regulatory status | FDA clearance announced April 16, 2026 |
| European regulatory status | CE Mark certification, April 2025 (full SCI continuum of care) |
Source: ANEUVO press release, April 16, 2026.
Global Context
ExaStim previously received CE Mark certification in April 2025, becoming what ANEUVO describes as the first transcutaneous spinal stimulation therapy broadly approved in the European market for adult spinal cord injury. With the new FDA clearance, ANEUVO can now introduce ExaStim in the United States while continuing European operations, which the company notes are uninterrupted following a recent ruling by the Unified Patent Court of Appeal upholding the denial of a request for preliminary injunction related to ExaStim.
How to Read the Two Announcements Together
The two announcements describe two different kinds of progress. One is a drug moving into a Phase 3 registrational trial. The other is a non-invasive device reaching the U.S. market. Neither announcement is a cure, and neither therapy will suit every person with SCI. Each one widens the range of options that individuals, families, and clinicians can learn about and bring into conversations about care.
Following Research Is a Form of Advocacy
Keeping up with clinical trials and FDA decisions is practical self-advocacy, not just news-keeping. Paying attention to announcements like these helps members:
How to Learn More or Get Involved
Readers who want to go deeper on either announcement should start with the original press releases linked below. For current and planned clinical trials in SCI generally, ClinicalTrials.gov is a free public registry searchable by condition, location, and phase. NASCIC will publish further updates as RESTORE enrollment opens and as additional data from ANEUVO's platform become available.
If you are a NASCIC member organization or an individual who wants to see more updates like this one, please let us know what you'd like us to cover. Member feedback shapes which research developments NASCIC writes about, and how NASCIC structures its ongoing conversations with partners like NervGen and ANEUVO.
Medical Information Disclaimer
This article is for educational purposes only and summarizes publicly available company press releases dated April 7, 2026 (NervGen Pharma) and April 16, 2026 (ANEUVO). It is not medical advice and is not an endorsement of any specific therapy, device, or clinical trial. NVG-291 is an investigational therapy that has not been approved by the FDA or any other regulatory agency. Decisions about treatment or trial participation should be made in consultation with your qualified healthcare providers.
Sources
NervGen Pharma. "NervGen Pharma Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic Tetraplegia." Read the full press release. Vancouver, British Columbia, April 7, 2026.
ANEUVO. "ANEUVO Receives FDA Clearance for ExaStim®." Read the full press release. April 16, 2026.
Additional clinical trial information may be available on ClinicalTrials.gov once RESTORE enrollment opens.