Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2026 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | Commitments and Contingencies We may from time to time be involved in claims, governmental inquiries or investigations, litigation and other legal proceedings arising in the ordinary course of business, some of which may seek monetary damages, including claims for punitive damages, which may not be covered by insurance. Such matters, even if not meritorious, could result in the expenditure of significant financial and managerial resources. We evaluate all matters and record liabilities for losses from legal proceedings when we determine that it is probable that the outcome will be unfavorable and the amount, or potential range, of loss can be reasonably estimated. An adverse determination in one or more of these pending matters could have an adverse effect on our consolidated financial position, results of operations or cash flows. On November 6, 2025, the City of Pontiac Reestablished General Employees’ Retirement System, on behalf of itself and other similarly situated investors, filed a putative securities class action in the United States District Court for the District of Minnesota against the Company and certain of its executive officers, captioned City of Pontiac Reestablished General Employees’ Retirement System v. Inspire Medical Systems, Inc., et al., Case No. 0:25‑cv‑04247‑PJS‑ECW (D. Minn.) (the City of Pontiac Lawsuit). The complaint alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b‑5 promulgated thereunder, based on purportedly materially false and misleading statements made between August 6, 2024, and August 4, 2025, regarding the launch of the Company’s Inspire V neurostimulator. The complaint further alleged that when subsequent disclosures were made concerning issues with the Inspire V launch and the Company announced its third‑quarter fiscal 2025 results, the Company’s stock price declined, purportedly causing investor losses. On December 23, 2025, the plaintiff filed a Notice of Voluntary Dismissal. On December 29, 2025, the case was administratively closed without prejudice. On December 22, 2025, the Indiana Public Retirement System, on behalf of itself and other similarly situated investors, filed a putative securities class action in the United States District Court for the Southern District of New York against the Company and certain of its executive officers, captioned Indiana Public Retirement System v. Inspire Medical Systems, Inc., et al., Case No. 1:25‑cv‑10620 (S.D.N.Y.) (the Indiana PRS Lawsuit). The Indiana PRS Lawsuit arises from the same underlying subject matter as the City of Pontiac Lawsuit. It alleges the same violations of law and is based on the same or similar purportedly materially false and misleading statements made during the same class period, all of which relate to the launch of the Company’s Inspire V neurostimulator. The plaintiffs seek, among other relief, unquantified compensatory damages, together with attorneys’ fees and costs. On January 22, 2026, the Company and the individual defendants moved to transfer the case to the United States District Court for the District of Minnesota. On May 20, 2026, the United States District Court for the Southern District of New York granted the Company’s and the individual defendants’ motion to transfer. On May 28, 2026, the Indiana PRS Lawsuit was transferred to Minnesota and on May 29, 2026, the United States District Court for the District of Minnesota acknowledged receipt of the transferred case and assigned the Case Number 0:26-cv-02790. On July 30, 2026, the plaintiffs filed an amended complaint (the “Amended Complaint”), which while generally based on the same underlying subject matter as the initial complaint expands its claims and the period of the putative securities class. The Amended Complaint continues to allege the same Defendants’ violation of Section 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder relating to the launch of the Company’s Inspire V neurostimulator. It now also alleges fraud regarding the Medicare/CPT reimbursement coding and expands the period of the putative securities class to November 4, 2024 through May 4, 2026. The Company and the individual defendants intend to vigorously defend against the action. No accrual for loss has been recorded in the Company’s financial statements as of, or for the period ended, June 30, 2026 since the Company is unable to determine whether any loss ultimately will occur or to estimate the range of such loss. On January 27, 2026, a stockholder derivative lawsuit was filed in the United States District Court for the Southern District of New York, purportedly on behalf of Inspire against certain of our present and former executive officers and against all current members of the Board of Directors and Inspire (as a nominal defendant), captioned Korte v. Herbert, et al., Case No. 1:26‑cv‑680 (S.D.N.Y.) (the Korte Derivative Lawsuit). The Korte Derivative Lawsuit arises out of the same subject matter as the Indiana PRS Lawsuit described above and alleges the following claims: (1) Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder; (2) Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder; (3) Section 20(a) of the Exchange Act; (4) a common-law claim for breach of fiduciary duty; (5) common-law aiding and abetting; (6) unjust enrichment; and (7) waste of corporate assets. The Korte Derivative Lawsuit seeks unspecified damages. The Company and the individual defendants intend to vigorously defend against the action. On March 20, 2026, a stockholder derivative lawsuit was filed in the United States District Court for the Southern District of New York, purportedly on behalf of Inspire against certain of our present and former officers and against all current members of the Board of Directors and Inspire (as a nominal defendant), captioned Davis v. Herbert et al., Case No. 1:26-cv-02315 (S.D.N.Y.) (the Davis Derivative Lawsuit). The Davis Derivative Lawsuit arises out of the same subject matter as the Indiana PRS Lawsuit described above and alleges substantially the same claims as the Korte Derivative Lawsuit, plus a claim for contribution under Section 21D of the Exchange Act. The Davis Derivative Lawsuit seeks unspecified damages. On April 21, 2026, counsel for Plaintiffs in the Korte and Davis Derivative Lawsuits submitted, along with all Defendants in those lawsuits, a proposed stipulation to consolidate them into one lawsuit and to stay them, among other terms. On April 29, 2026, the Court adopted the parties’ proposed stipulation, and the case remains stayed. On May 12, 2026, a stockholder derivative lawsuit was filed in the United States District Court for Minnesota, purportedly on behalf of Inspire against certain of our present and former officers and against all current members of the Board of Directors and Inspire (as a nominal defendant), captioned Ahlberg v. Herbert et al., Case No. 0:26-cv-02587 (D. Minn.) (the Ahlberg Derivative Lawsuit). The Ahlberg Derivative Lawsuit arises out of the same subject matter as the Indiana PRS Lawsuit described above and alleges substantially the same claims as the Korte and Davis Derivative Lawsuits. On June 4, 2026, counsel for Plaintiffs in the Ahlberg Derivative Lawsuit submitted a proposed stipulation to stay the Action pending resolution of the Indiana PRS Lawsuit, and on June 5, 2026, the Court entered an order granting the parties’ proposed stipulation and staying the case. The Company and the individual defendants intend to vigorously defend against the Korte, the Davis and the Ahlberg Derivative Lawsuits. On January 17, 2025, we received a civil investigative demand (CID) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act in the course of the government’s investigation concerning allegations of false claims, including false claims arising from violations of the Anti-Kickback Statute, submitted to government payors in connection with our implant. The CID requests information relating to the marketing, promotion, and reimbursement practices associated with our products. We are cooperating with the investigation. No assurance can be given as to the timing or outcome of the government’s investigation. No amount of loss has been recorded in the Company’s financial statements as of, or for the period ended, June 30, 2026 since the Company is unable to determine whether any loss ultimately will occur or to estimate the range of such loss. On November 19, 2024, a former Inspire employee, Patrick Collins, filed a civil False Claims Act qui tam lawsuit under seal in the United States District Court for the Central District of California against the Company, captioned United States ex rel. Collins v. Inspire Medical Systems, Inc., No. 2:24-cv-10001-JFW-AS (C.D. Cal.) The complaint alleges that Inspire violated the False Claims Act by improperly certifying that physicians were eligible to seek reimbursement from the Medicare program for Inspire devices, and the procedures to implant them. Relator’s complaint seeks unspecified treble damages, civil penalties, and costs and expense of the action, among other relief. On January 28, 2026, the United States, acting through the United States Attorney’s Office for the Central District of California, declined to intervene in the action, and, on January 29, 2026, the Court ordered that the case be unsealed. Notwithstanding the government's decision not to intervene, the Relator has decided to proceed with the litigation. On June 5, 2026, the Company moved to dismiss Relator’s complaint. Relator filed an amended complaint on June 26, 2026, and the Company moved to dismiss Relator’s amended complaint in its entirety on July 10, 2026. The Company intends to defend the claims in this lawsuit vigorously. On May 30, 2025, Inspire filed a lawsuit against Nyxoah SA and its subsidiary Nyxoah, Inc. (collectively Nyxoah) in the United States District Court for the District of Delaware, alleging that Nyxoah's Genio product infringes on certain of Inspire's U.S. patents related to neurostimulation therapy for obstructive sleep apnea. Inspire seeks a judgment of patent infringement and relief for such infringement, including monetary damages such as lost profits. Nyxoah has denied infringement and has asserted counterclaims seeking declaratory judgments of invalidity and non‑infringement. On December 18, 2025, Nyxoah filed three (3) petitions with the United States Patent Trial and Appeal Board (PTAB) seeking inter partes review (IPR) of the three patents asserted by Inspire in the lawsuit. On April 14, 2026, the PTAB denied institution of all three IPRs. The district court matter is ongoing. Because these matters are in their early stages, we cannot predict the outcome or estimate the range of potential loss. On September 15, 2025, Nyxoah filed a lawsuit against us in the United States District Court for the District of Delaware alleging that the Inspire IV and Inspire V devices infringe certain of Nyxoah’s patents. The lawsuit is in its early stages. The Company intends to defend the claims in this lawsuit vigorously and believes it has good and substantial defenses to them, but there is no guarantee that the Company will be successful in these efforts. No amount of loss has been recorded in the Company’s financial statements as of and for the period ended June 30, 2026 since the Company is unable to determine whether any loss ultimately will occur or to estimate the range of such loss. On December 5, 2025, Nyxoah brought suit against Inspire and its wholly-owned subsidiary, Inspire Medical Systems Europe GmbH in the Unified Patent Court, Munich Division, alleging that the Inspire IV implantable neurostimulator infringes a patent owned by Nyxoah. The lawsuit is in its early stages. The Company intends to defend the claims in this lawsuit vigorously and believes it has good and substantial defenses to them, but there is no guarantee that the Company will be successful in these efforts. No amount of loss has been recorded in the Company’s financial statements as of and for the period ended June 30, 2026 since the Company is unable to determine whether any loss ultimately will occur or to estimate the range of such loss.
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