InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
Rhea-AI Summary
InspireMD (Nasdaq: NSPR) has received FDA approval for its Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System for transcarotid revascularization (TCAR) procedures. This approval marks a significant milestone in the company's mission to provide comprehensive tools for carotid stent procedures.
The study aims to facilitate approval for using CGuard Prime in an optimized TCAR version and indication. InspireMD is also developing the SwitchGuard NPS, a next-generation TCAR Neuroprotection System. These initiatives are part of the company's strategy to enter the U.S. market and achieve global success in stroke prevention and carotid disease management.
Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as co-principal investigators for the CGUARDIANS II study.
Positive
- FDA approval of IDE Application for CGUARDIANS II pivotal study
- Potential expansion into the U.S. market upon approval
- Development of comprehensive next-generation TCAR Neuroprotection System (SwitchGuard NPS)
Negative
- None.
Insights
The FDA's approval of InspireMD's Investigational Device Exemption (IDE) for CGUARDIANS II represents a significant regulatory milestone in the company's US approval pathway. This approval allows InspireMD to legally conduct their pivotal clinical study for the CGuard Prime 80cm Carotid Stent System specifically during transcarotid revascularization (TCAR) procedures.
In the medical device regulatory process, securing IDE approval is a crucial gating step that validates both the device's preliminary safety profile and the company's clinical trial design. However, investors should understand this represents an early-to-middle stage in the overall approval journey. Typically, pivotal studies like CGUARDIANS II require 1-3 years for enrollment and follow-up, with subsequent FDA review adding another 6-12 months before potential commercialization.
The recruitment of Drs. Geraghty and Muck as lead investigators adds credibility to the trial, as both are respected vascular surgeons with significant procedural experience. Their involvement should support quality site selection and investigator training, potentially enhancing trial execution.
What's particularly strategic about this development is InspireMD's dual approach: optimizing their existing CGuard Prime for TCAR procedures while simultaneously developing their SwitchGuard Neuroprotection System. This comprehensive strategy targets both transfemoral carotid stenting and TCAR approaches, positioning the company to address the full spectrum of physician preferences in carotid revascularization.
This IDE approval positions InspireMD to evaluate their technology in the rapidly growing TCAR procedure market, which has become increasingly important in stroke prevention. TCAR procedures represent a significant advancement in carotid revascularization by using flow reversal to protect the brain during stent placement, reducing procedural stroke risk compared to traditional approaches.
The carotid intervention market represents approximately 140,000 procedures annually in the US alone, with TCAR growing from virtually zero to roughly
From a clinical perspective, expanding their CGuard Prime system's indications to include TCAR would significantly broaden InspireMD's addressable market. Their CGuard technology features a MicroNet mesh designed to trap and exclude embolic debris, which complements the embolic protection mechanism of TCAR procedures.
The parallel development of CGuard Prime for TCAR and the SwitchGuard Neuroprotection System demonstrates strategic awareness of procedural evolution in carotid interventions. Vascular surgeons and interventionalists increasingly favor techniques with lowest periprocedural stroke risk, making this dual-path approach clinically sound.
While this IDE approval doesn't guarantee clinical success or ultimate FDA approval, it does show InspireMD is executing on their regulatory strategy and making measurable progress toward their goal of US market entry in the carotid intervention space.
MIAMI, Oct. 07, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.
In February 2024, InspireMD announced that Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have agreed to act as lead investigators for the trial.
Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized TCAR version and indication.”
“In parallel, we continue to advance development of our comprehensive next generation TCAR Neuroprotection System, SwitchGuard NPS. Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial’s success,” Mr. Slosman concluded.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, the C-GUARDIANS II trial, including the timing of its commencement, as well as the timing and outcome of any subsequent results, potential FDA approval, or potential launch or commercialization in the U.S. or elsewhere. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently; actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
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