electroCore, Inc. Submits 510(k) Premarket Notification to FDA Seeking Clearance of Quell® for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

The application seeks a CIPN-specific indication, for which no drugs or devices currently have FDA approval or clearance.

Rhea-AI Summary

electroCore (Nasdaq: ECOR) submitted a 510(k) notification to the FDA seeking clearance of Quell for chronic chemotherapy-induced peripheral neuropathy (CIPN).

The submission draws on 168 subjects in a randomized controlled trial and an open-label study. Neuropathic pain scores decreased approximately 40% with active treatment versus approximately 24-33% with sham treatment. A non-pre-specified analysis of subjects with moderate to severe baseline pain showed decreases of approximately 50% versus approximately 30%.

In the 142-subject randomized trial, neuropathy questionnaire scores improved 11.6% with Quell versus 8.7% with sham, meeting the preliminary study’s pre-specified statistical significance threshold of 0.2. In the open-label study, 22 completers showed 13% improvement over six weeks. Quell-related adverse events were generally infrequent, mild and self-limiting. FDA clearance remains pending.

6 points · 0 major

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.510(k) submission advances Quell toward potential clearance for chronic chemotherapy-induced peripheral neuropathy.
• Moderate pointNeuropathic pain scores decreased approximately 40% with active treatment versus approximately 24-33% with sham.
• Moderate pointRandomized trial questionnaire scores improved 11.6% with Quell versus 8.7% with sham among 142 subjects.
• Minor pointExploratory pain analysis showed approximately 50% reduction with active treatment versus approximately 30% with sham.
• Minor pointOpen-label questionnaire scores improved 13% among 22 subjects completing six weeks of treatment.
• Minor pointQuell-related adverse events were generally infrequent, mild and self-limiting.

Negative

• Moderate pointFDA review remains pending and will determine substantial equivalence to a legally marketed predicate device.
• Minor pointRandomized trial evidence evaluated preliminary efficacy using a pre-specified statistical significance threshold of 0.2.
• Minor pointModerate-to-severe baseline pain analysis was not pre-specified.
• Minor pointOpen-label evidence came from a single-site feasibility study with 22 of 26 subjects completing treatment.

News Explained

The filing asks the FDA to determine whether Quell is substantially equivalent to a legally marketed predicate for the proposed CIPN indication; clearance has not been granted, and the agency may request more information during review.

Key Figures

Subjects across supporting studies: 168 subjects Neuropathic pain score change: Approximately 40% reduction in active group vs. approximately 24–33% in sham group Pain score change in moderate-to-severe subgroup: Approximately 50% reduction in active group vs. approximately 30% in sham group +3 more

Subjects across supporting studies

168 subjects

Two clinical studies supporting the 510(k) submission

Neuropathic pain score change

Approximately 40% reduction in active group vs. approximately 24–33% in sham group

Across the studies

Pain score change in moderate-to-severe subgroup

Approximately 50% reduction in active group vs. approximately 30% in sham group

Baseline subgroup analysis that was not pre-specified

EORTC-CIPN20 score improvement

11.6% in Quell group vs. 8.7% in sham control group

142-subject randomized controlled trial

Open-label study score improvement

13%

EORTC-CIPN20 improvement among 22 subjects completing the six-week treatment period

Pre-specified statistical significance threshold

0.2

Between-group difference in the randomized controlled trial met this threshold

Key Terms

510(k), cipn, randomized controlled trial, off-label

4 terms

510(k) regulatory

"submitted a 510(k) premarket notification to the U.S. Food and Drug Administration"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

cipn medical

"chronic chemotherapy-induced peripheral neuropathy (CIPN)"

CIPN stands for chemotherapy‑induced peripheral neuropathy, a nerve damage condition caused by certain chemotherapy drugs. It typically produces symptoms such as numbness, tingling, burning pain, or weakness in the hands and feet, can be dose‑dependent, and may be temporary or long‑lasting; clinical reports and trials grade its severity using standardized neuropathy scales.

randomized controlled trial medical

"including a 142-subject randomized controlled trial"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

off-label medical

"including off-label treatments"

Off-label describes the use of an approved drug or medical device for a purpose, patient group, dose, or method that is not listed on its official regulatory label. Think of it like using a tool for a different job than the manufacturer describes: it can expand real-world demand but also raises questions about safety, reimbursement, and legal risk. Investors watch off-label use because it can boost sales quickly but may increase regulatory scrutiny, liability, or unpredictable revenue sustainability.

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Submission backed by clinical data from two clinical studies representing 168 subjects demonstrating quality of life improvements and an approximately 40% reduction in neuropathic pain scores in the active treatment group

ROCKAWAY, N.J., Oct. 28, 2026 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), (“electroCore” or the “Company”), a bioelectronic technology company, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance for its Quell® wearable neuromodulation platform (“Quell”) for the treatment of chronic chemotherapy-induced peripheral neuropathy (CIPN).

CIPN is a common and potentially persistent complication of certain neurotoxic cancer therapies that can significantly affect pain, sensation, physical function, and quality of life. There are currently no drugs or devices approved or cleared by the FDA with an indication specific to CIPN. Current management relies on therapies approved or cleared for other conditions, including off-label treatments. If cleared, Quell would be [among] the first FDA-cleared device[s] with a labeled indication specifically for chronic CIPN.

The 510(k) submission is supported by clinical evidence from two studies involving a total of 168 subjects, including a 142-subject randomized controlled trial and a 26-subject open-label study. Across the studies, treatment with Quell was associated with improvements in CIPN-related symptoms and quality-of-life measures. In the active treatment group, neuropathic pain scores decreased by approximately 40%, compared with approximately 24-33% in the sham group. In an analysis that was not pre-specified of subjects with moderate to severe pain at baseline, neuropathic pain scores decreased by approximately 50% in the active group compared with approximately 30% in the sham group.

The EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-item scale) is a validated patient-reported outcome measure used to assess the severity of peripheral neuropathy symptoms in cancer patients receiving neurotoxic chemotherapy. In the 142-subject randomized controlled trial, subjects treated with Quell demonstrated an 11.6% improvement in EORTC-CIPN20 scores compared with an 8.7% improvement in the sham control group. The between-group difference met the study’s pre-specified statistical significance threshold of 0.2, which was selected because the proof-of-concept study was designed to evaluate preliminary efficacy. In the 26-subject single-site, open-label feasibility study, the 22 subjects who completed the six-week treatment period demonstrated a 13% improvement in EORTC-CIPN20 scores. Across the clinical program, Quell-related adverse events were generally infrequent, mild and self-limiting.

“Chemotherapy-induced peripheral neuropathy can persist long after cancer treatment has ended and can have a profound impact on patients’ daily lives,” said Peter S. Staats, M.D., MBA, Chief Medical Officer of electroCore. “The clinical evidence supporting this submission is particularly encouraging because it includes data from a randomized controlled trial shows encouraging improvements in symptoms that matter to patients, including neuropathic pain and quality of life. Following our interactions with the FDA, we have determined to pursue the 510(k) pathway for this indication. Submitting our 510(k) is an important step toward potentially bringing patients and clinicians a non-pharmacologic treatment option for this difficult-to-treat condition, and we look forward to continuing to work closely with the Agency during its review.”

The submission builds upon clinical data generated with the Quell platform and represents an opportunity for electroCore to expand its neuromodulation portfolio into oncology supportive care. Because the studies supporting the submission have already been completed, the Company has been able to advance the program to this regulatory milestone while leveraging its existing technology platform, clinical evidence, and organizational infrastructure.

A 510(k) premarket notification is intended to demonstrate that a device is substantially equivalent to a legally marketed predicate device. FDA review of the submission will determine whether Quell is substantially equivalent to a legally marketed predicate device for the proposed indication. Submission of a 510(k) does not guarantee that FDA will clear the device, and FDA may request additional information during its review.

About Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-induced peripheral neuropathy is a frequent adverse effect of several commonly used cancer therapies and may include pain, numbness, tingling, sensory abnormalities, and impaired function. For some patients, symptoms persist for months or years after completion of chemotherapy and can substantially affect quality of life. Despite its clinical burden, treatment options remain limited. There are currently no therapies approved or cleared by the FDA with a labeled indication specifically for CIPN, and patients are commonly treated with therapies approved or cleared for other conditions.

About Quell®

Quell is a wearable neuromodulation platform designed to deliver non-invasive neurostimulation for the treatment of chronic neurological symptoms. The platform is designed for convenient use outside the clinical setting and builds upon electroCore’s broader expertise in bioelectronic medicine and non-invasive neuromodulation. Quell is not cleared by the FDA for the treatment of CIPN.

About electroCore, Inc.
electroCore, Inc. is a bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company’s two leading prescription products, gammaCore® non-invasive vagus nerve stimulation (nVNS) and Quell® neurostimulator, treat chronic pain syndromes through non-invasive neuromodulation technology. Additionally, the company commercializes its handheld, and personal use Truvaga™ and TAC-STIM™ nVNS products utilizing bioelectronic technologies to promote general wellness and human performance.

For more information, visit www.electrocore.com.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about the FDA's review of the Company's 510(k) premarket notification for Quell for the treatment of CIPN, the timing and outcome of that review, and the anticipated commercialization of Quell for CIPN, the Company’s future business strategies, growth opportunities, prospects, product development, and market expansion, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” and other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the preliminary nature of the clinical evidence, which was generated using a proof-of-concept study design, the possibility that the FDA may determine that Quell is not substantially equivalent to a predicate device, which could require the Company to pursue a De Novo classification request or other regulatory pathway, or may clear Quell for a narrower indication than requested, the possibility that the FDA may request additional clinical data or information, which could delay or prevent clearance, the ability to use strategic partnerships to provide more accessibility to those looking to purchase our consumer devices, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize its products, electroCore’s results of operations and financial performance, inflation and currency fluctuations, and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates, competition from existing therapies, including drugs and devices approved or cleared for other indications that are used to manage CIPN symptoms, which physicians and payors may continue to prefer, and which may limit market acceptance of, or reimbursement for, Quell for CIPN if cleared, and overall economic and market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Contact:
ECOR Investor Relations
(973) 302-9253
investors@electrocore.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Has electroCore received FDA clearance for Quell to treat chronic CIPN?

No clearance has been announced; electroCore has submitted a 510(k) notification seeking clearance for chronic CIPN. FDA review will determine whether Quell is substantially equivalent to a legally marketed predicate device for the proposed indication.

What pain reductions supported electroCore’s Quell CIPN submission?

Neuropathic pain scores decreased by approximately 40% in the active treatment group versus approximately 24-33% in the sham group. A non-pre-specified analysis of subjects with moderate to severe baseline pain showed decreases of approximately 50% with active treatment versus approximately 30% with sham.