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

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.

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.

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.

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.