InspireMD Announces Issuance of Key U.S. Patent Covering Its SwitchGuard™ Neuroprotection System
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The issuance of U.S. Patent No. 11,844,893 for InspireMD's SwitchGuard™ Neuroprotection System (NPS) represents a significant enhancement in the company's intellectual property portfolio. The patent covers innovative features that enable real-time visualization of blood flow during carotid artery stenting procedures, which is a critical factor for ensuring patient safety and improving outcomes. The recent CMS coverage expansion for carotid artery stenting to include a broader patient population underscores the growing importance of less invasive options in stroke prevention and carotid artery disease treatment.
In terms of market impact, this patent can potentially strengthen InspireMD's competitive position by safeguarding their unique technology and potentially leading to increased adoption rates of their systems. The upcoming submission for an Investigational Device Exemption (IDE) to the FDA is a critical step towards commercialization, which investors will closely monitor for its implications on the company's revenue growth and market share expansion.
From a financial perspective, the strategic development of the SwitchGuard™ NPS and the associated patent acquisition could contribute positively to InspireMD's valuation. The patent not only protects the company's technology but also enhances its attractiveness to potential partners or acquirers. The CGuard Prime Carotid Stent System, when coupled with the SwitchGuard™ NPS, aims to provide a comprehensive solution for carotid revascularization, which may lead to a competitive edge in the market.
Investors should note the potential for increased research and development costs associated with the IDE submission and subsequent clinical trial. However, if the FDA approves the IDE and the clinical trial yields positive results, there could be significant upside potential for the company's stock. It's important to assess the company's ability to navigate the regulatory pathway and manage the associated costs effectively.
Within the medical device industry, patents are a crucial aspect of maintaining competitive advantage and driving innovation. The patented technology of the SwitchGuard™ NPS addresses a key concern in neurovascular procedures—minimizing the risk of stroke by preventing embolic debris from reaching the brain. This aligns with industry trends favoring minimally invasive procedures that reduce recovery time and improve patient outcomes.
Looking at the broader industry context, InspireMD's advancements could stimulate further innovation in the field, prompting competitors to develop alternative or complementary technologies. The company's focus on safety and efficacy, as highlighted by the CEO, is well-aligned with regulatory and market demands for high-quality medical devices. The success of the SwitchGuard™ NPS will depend on clinical trial outcomes, regulatory approvals and the ability of InspireMD to effectively market and distribute their product in a competitive landscape.
Reflects continued focus on adding intellectual property to support the strategic direction of the Company to provide a complete solution set for the treatment of carotid artery disease and the prevention of stroke
TEL AVIV, Israel and MIAMI, Dec. 20, 2023 (GLOBE NEWSWIRE) -- InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the issuance of U.S. Patent No. 11,844,893, titled, “Shunts with Blood Flow Indicators.”
The patent covers key aspects of the company’s SwitchGuard™ Neuroprotection System (NPS) along with future features in development that are expected to enable the treating physician to visualize flow through the system. The SwitchGuard™ NPS is designed to allow the physician to reverse blood flow to the brain during a carotid artery stenting procedure, including Transcarotid Artery Revascularization (TCAR) or other neurovascular procedures. The SwitchGuard™ NPS is designed to prevent embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter housed within the SwitchGuard before returning it to the patient, to minimize blood loss during the procedure.
In October 2023, the Centers for Medicare and Medicaid Services (CMS) expanded coverage for carotid artery stenting (CAS) and TCAR to include both asymptomatic and standard risk patients at either high- or standard- risk for carotid endarterectomy (surgery). The broader availability of these less invasive options should better enable physicians to tailor treatment plans to the needs of individual patients.
Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The issuance of this patent demonstrates our continued priority to develop and build on our robust intellectual property to support our innovations, while expanding our product portfolio for optimal patient outcomes in the treatment of carotid artery disease with the utmost safety in mind. This coupled with our CGuard Prime Carotid Stent System should provide clinicians with innovation and safety during carotid revascularization procedures and minimize the risk of stroke.”
InspireMD expects to submit an Investigational Device Exemption (IDE) to the FDA in 2024, which, if approved, would allow the company to initiate a clinical trial to support the clearance of the SwitchGuard™ NPS coupled with CGuard Prime.
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 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, PMA or potential launch. 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 out 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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