Item 3. Legal Proceedings
Item
3. Legal Proceedings
UAB
Pulsetto v. electroCore, Inc.
On
June 11, 2025, Pulsetto filed a declaratory judgment action against the Company in the United States District Court for the District
of New Jersey, captioned UAB Pulsetto v. electroCore, Inc., Civ. No. 25-10036 (D.N.J.), asserting that its non-invasive vagus
nerve stimulation product does not infringe the Company’s U.S. Patent No. 11,446,491 (the “491 Patent”).
On
July 16, 2025, the Company filed a responsive pleading, answering the complaint and asserting counterclaims, that Pulsetto’s non-invasive
vagus nerve stimulation product infringes the ‘491 Patent, as well as the Company’s U.S. Patent Nos. 8,948,873, 9,339,653,
10,874,857, 8,843,210, 9,242,092, 11,623,078, and 10,441,780, as well as claims that Pulsetto’s commercial conduct has infringed
and continues to infringe the Company’s Truvaga™ and gammaCore® trademarks, and committed acts of false advertising and
unfair competition in violation of state and federal law. On September 5, 2025, Pulsetto requested leave to file a motion to dismiss
the Company’s counterclaims for lack or jurisdiction and/or insufficient pleadings. The Company has opposed that request, which
has not yet been considered by the trial judge. On September 9, 2025, the court approved a schedule for discovery, and certain proceedings,
filings, submissions, motions, reports and conferences. The parties have exchanged initial requests for the production of documents relevant
to the dispute and have proceeded with exchanging their respective infringement and invalidity contentions, as the case may be.
The parties are still in the early stages of discovery. The parties held an in-person settlement conference with a Judge Magistrate on
March 4, 2026.
The
Company believes that Pulsetto’s claim is without merit and intends to defend vigorously against it and to pursue vigorously the
Company’s patent and non-patent counterclaims against Pulsetto. The Company expenses associated legal fees in the period they are
incurred, and in light of, among other things, the preliminary stage of the litigation, the Company is unable to determine the reasonable
probability of loss or a range of potential loss or gain or a range of potential gain. Accordingly, the Company has not established an
accrual for potential losses or gains, if any, that could result from any unfavorable or favorable outcome, and there can be no assurance
that these litigation matters will not result in substantial litigation costs and/or judgments or settlements that could adversely affect
the Company’s financial condition.
We
are subject to various claims, complaints and legal actions in the normal course of business from time to time. The Company is not aware
of any further currently pending litigation for which it believes the outcome could have a material adverse effect on its operations
or financial position. The Company generally expenses associated legal fees in the period they are incurred.
Item
4. Mine Safety Disclosures
Not
applicable.
94
PART
II