InspireMD, Inc. (NSPR) SEC Filings, Mar-May 2026

InspireMD filed an 8-K detailing a mix of product setback and regulatory progress. The company has initiated a voluntary U.S. recall of its CGuard Prime 135 cm carotid stent delivery system after controlled-launch experience showed technical success in procedures did not meet performance expectations. The CGuard stent implant itself is not included in the recall and continues in use.

Management highlighted strong demand, citing Q1 2026 global year-over-year unit sales growth of 53% and 34% quarter-over-quarter U.S. unit sales growth, but is withdrawing its prior full-year 2026 revenue guidance due to the temporary pause in U.S. commercialization while it awaits anticipated FDA approval of the original CGuard delivery system in the third quarter of 2026. InspireMD also expects FDA approval of the CGuard Prime 80 cm system for TCAR procedures in the second half of 2026 and is pursuing design improvements to the 135 cm system, with FDA approval anticipated in the first half of 2027.

Separately, the FDA has approved an Investigational Device Exemption for the CGUARDIANS III pivotal study of the SwitchGuard neuro protection system for use with the CGuard Prime 80 cm stent platform in TCAR procedures, supporting plans for a potential U.S. commercial launch of SwitchGuard in 2027 and expanding access to a TCAR market estimated at approximately 35,000 procedures annually in the United States.

InspireMD, Inc. executive Marvin Slosman filed a Schedule 13D reporting beneficial ownership of 2,556,760 shares of InspireMD common stock, representing 5.18% of the outstanding shares. This stake reflects his role as Chief Executive Officer and director.

The holdings include 16,722 common shares, multiple tranches of restricted stock units that are currently exercisable or become exercisable within 60 days, and 696,005 shares issuable upon exercise of stock options that are currently exercisable or become exercisable within 60 days. Only 10,330 shares were purchased for cash in a July 2025 private placement for $24,998.60; the remainder were granted as equity compensation.

Based on company information, InspireMD had 46,838,962 shares outstanding as of the date referenced. Slosman states he has no present plans for corporate actions such as mergers or control changes, and he reports no transactions in InspireMD shares in the prior 60 days, while reserving the right to buy or sell securities in the future.

InspireMD, Inc. has called its 2026 Annual Meeting of Stockholders for June 3, 2026 at its Tel Aviv offices. Stockholders will vote on re-electing three Class 3 directors, including CEO Marvin Slosman, and on several key corporate matters.

The agenda includes amending the certificate of incorporation to increase authorized common shares from 150,000,000 to 250,000,000, ratifying Kesselman & Kesselman (PwC network) as independent auditor for 2026, and approving a potential adjournment to solicit additional proxies if needed. Holders of InspireMD common stock at the April 10, 2026 record date, when 46,892,979 shares were outstanding, are entitled to vote, either in person or by proxy, with detailed instructions provided for registered and street-name holders.

InspireMD, Inc. is soliciting stockholder votes at its annual meeting to be held June 3, 2026, to elect three Class 3 directors and to approve an amendment to increase authorized common stock from 150,000,000 shares to 250,000,000.

The board also asks ratification of Kesselman & Kesselman as auditor and approval of an adjournment proposal. The record date for voting was April 10, 2026, and shares outstanding were 46,892,979 as of April 10, 2026.

InspireMD, Inc. entered a new Equity Distribution Agreement with BTIG, LLC allowing it to sell, from time to time at its option, up to $75,000,000 of common shares in an at-the-market offering under its existing Form S-3 registration.

BTIG will act as sales agent and may receive a commission of up to 3.0% of gross proceeds. InspireMD currently plans to use any net proceeds for operations, including research and development, sales and marketing, working capital and other general corporate purposes. On the same date, the company terminated its prior at-the-market equity distribution agreement with Piper Sandler, under which 1,361,519 shares had been sold, and incurred no termination penalties.

InspireMD, Inc. is offering up to $75,000,000 of common stock for sale from time to time under an Equity Distribution Agreement with BTIG, LLC acting as sales agent.

The shares will be sold as an “at the market offering” (Rule 415(a)(4)) and may be sold directly on Nasdaq or by other lawful methods. The prospectus supplement illustrates up to 90,702,092 shares assuming aggregate sales of $75,000,000 at an assumed price of $1.59 per share. Shares outstanding were 43,532,281 as of December 31, 2025. BTIG’s commission is up to 3.0% of gross proceeds. Net proceeds are intended for operations, including research and development, sales and marketing, working capital and general corporate purposes.

InspireMD, Inc. is a medical device company focused on treating carotid artery disease using its proprietary MicroNet mesh–based CGuard stent platform. The company now sells CGuard EPS in over 30 countries and, after FDA premarket approval of CGuard Prime on June 23, 2025, began U.S. commercialization through a direct sales force.

The 10-K highlights strong clinical data from multiple trials, including the C-GUARDIANS pivotal study, showing low rates of stroke, myocardial infarction, and restenosis, and an estimated addressable market of about $1.3 billion and total available market of about $9.3 billion. Strategy centers on a “stent-first” approach, expanding TCAR and acute stroke indications, and growing U.S. and international presence.

Key risks include a history of recurring losses and negative operating cash flows, substantial doubt about the company’s ability to continue as a going concern, the need to raise additional capital, intense competition from large device makers, reliance on a single manufacturing facility, and ongoing regulatory and reimbursement uncertainties, including maintaining Nasdaq listing compliance.

InspireMD reported strong 2025 revenue growth but widening losses as it invests in its U.S. launch. Total revenue rose to $9.0 million in 2025, up 28% from $7.0 million in 2024, with fourth quarter revenue of $3.1 million increasing 62% year over year.

Gross margin improved as higher‑margin U.S. sales grew, with Q4 gross profit reaching $1.2 million, or 37.5% of revenue, versus 24.1% a year earlier. However, full‑year operating expenses climbed to $52.3 million from $35.0 million, reflecting expanded U.S. commercial headcount and infrastructure.

Net loss widened to $48.8 million in 2025, compared with $32.0 million in 2024, even as cash and marketable securities increased to $54.2 million as of December 31, 2025 from $34.6 million a year earlier. For 2026, management expects revenue of $13 million to $15 million, implying approximately 45% to 65% growth over 2025.