NSPR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• ● any impact of a product recall, including the current recall in the U.S. regarding the CGuard Prime 135cm Carotid Stent System, on our business, results of operations and financial conditions;

• We are a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions. Our portfolio includes two commercial products based on our proprietary CGuard carotid stent technology, designed to provide ma…

• Our first product, the CGuard Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with a MicroNet mesh sleeve as a single device for carotid artery revascularization. In January 2024, we received CE Mark recertification for CGuard EPS under the EU Medical Devi…

• Our second product, the CGuard Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh as the CGuard EPS with a differentiated deployment mechanism. CGuard Prime received premarket approval (“PMA”) by the U.S. Food and Drug Administration (“FDA”) on June 23, 2025, and is m…

• In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80 cm carotid stent system during transcarotid revascularization (“TCAR”) procedures. In the first quarter of 2026, we completed enrollment in the CGUARDIANS II pivotal study. In May 2…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• We are a medical device company focusing on the development and commercialization of products for the treatment of carotid artery disease and other vascular disease, including our proprietary CGuard™ stent platform. On June 23, 2025, CGuard Prime, our next generation carotid artery stenting (“CAS”) …

• Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the Europe…

• On September 8, 2020, we received approval from the FDA of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS was a prospective, multi…

• The primary endpoint was a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events were adjudicated by an …

• In November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure th…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Our products have and may in the future be subject to product notifications, recalls, or voluntary market withdrawals that could harm our reputation, business and financial results.

• After regulatory approval has been obtained for medical device products, the product and the manufacturer are subject to continual review, including the review of adverse events and clinical results that are reported after our products are made available to patients, and there can be no assurance th…

• The manufacturing and marketing of medical devices involves an inherent risk that our products may prove to be defective and cause a health risk even after regulatory clearances have been obtained. The FDA and similar governmental authorities in other countries have the authority to require the reca…

• In the European Economic Area, we must comply with the medical device vigilance system under Regulation (EU) 2017/745 on medical devices, or the MDR. Under this system, manufacturers are generally required to report serious incidents involving medical devices via an electronic system incorporated in…

• Any adverse event involving our products could result in other future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Adverse events have been reported to us in the past, and we cannot guarantee that they will not o…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• We have only recently transitioned to a commercial stage medical device company in the United States, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

• We only recently launched the CGuard Prime Carotid Stent System in the United States following FDA approval in June 2025. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had more experience commercializing the CGuard Prime Ca…

• CGuard Prime has been commercially launched in the United States and we have limited experience selling, marketing or distributing products in the U.S. The timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and sustain commercial success for the C…

• In July 2025, we announced the official commercial launch of CGuard Prime in the U.S. following FDA approval in June 2025, and we are currently executing on an independent commercialization plan for CGuard Prime in the U.S. As part of our plan, we have, and continue, to build out sales, marketing an…

• In October 2024, we established our global headquarters in Miami, Florida to support the U.S. commercial launch of the CGuard Prime carotid stent system. During 2024, we started the build-out of the infrastructure for commercial operations in the U.S. designed to support the commercialization of the…