InspireMD Announces Establishment of Global Headquarters in Miami, Florida to Support Anticipated U.S. Launch and Commercialization of the CGuard Prime Carotid Stent System

Rhea-AI Summary

InspireMD (Nasdaq: NSPR) has announced the establishment of its global headquarters in Miami, Florida. This strategic move is aimed at supporting the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval.

The new facility will play a important role in driving long-term growth and serving the U.S. market. InspireMD is currently building world-class commercial and operational teams, along with supporting infrastructure. The company's leadership team views South Florida as an ideal location due to its rich history of medical device innovation and access to talent.

InspireMD is actively building its marketing, training, and sales operations teams in South Florida to form the foundation of its U.S. commercial organization. The company recently submitted the final module of its Premarket Authorization (PMA) application to the FDA for the CGuard Prime carotid stent system on September 16th.

Positive

• Establishment of global headquarters in Miami, Florida to support U.S. launch
• Anticipated U.S. launch and commercialization of CGuard Prime carotid stent system in H1 2025
• Final module of Premarket Authorization (PMA) application submitted to FDA for CGuard Prime

Negative

• None.

Insights

Medical Device Analyst

The establishment of InspireMD's global headquarters in Miami marks a strategic move ahead of the potential U.S. launch of CGuard Prime. This decision demonstrates the company's commitment to building a robust infrastructure for commercialization. The South Florida location offers access to a talent pool experienced in medical device innovation, which could accelerate the company's growth.

The timing aligns with the recent PMA submission for CGuard Prime, indicating confidence in potential FDA approval. If approved in the first half of 2025, InspireMD could quickly capitalize on the U.S. market opportunity. The focus on building marketing, training and sales operations teams suggests a comprehensive approach to market penetration.

However, investors should note that FDA approval is not guaranteed and any delays could impact the planned launch timeline. The success of the U.S. commercialization will be important for InspireMD's future growth and financial performance, given the size and importance of the U.S. market in the medical device industry.

Market Strategist

InspireMD's move to establish a U.S. headquarters is a clear signal of its intent to transition from a primarily international player to a global competitor in the carotid stent market. This strategic positioning could significantly expand the company's total addressable market and potentially drive revenue growth.

The choice of Miami as a location is savvy, offering proximity to Latin American markets while tapping into a growing biotech hub. This could facilitate future expansion beyond the U.S. The company's proactive approach in building its commercial infrastructure ahead of potential FDA approval demonstrates confidence and could lead to a faster market penetration if CGuard Prime is approved.

Investors should watch for key milestones in the coming months, including the FDA's response to the PMA application and any updates on the buildout of the sales and support teams. The success of this U.S. strategy could be a significant catalyst for InspireMD's stock performance, potentially transforming it from a small-cap player to a more prominent force in the medical device sector.

MIAMI, Oct. 15, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the establishment of its global headquarters in Miami, Florida. The new facility will ideally position the Company to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, if approved.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The establishment of our new headquarters location in the U.S. represents a significant step as we prepare for potential FDA approval of CGuard Prime in the first half of next year. Together with the ongoing build-out of world class commercial and operational teams and supporting infrastructure, our new U.S.-based headquarters will be key to driving long-term growth and serving the U.S. market while creating sustained shareholder value.”

“Building our operational infrastructure in the South Florida market provides tremendous resources, as this area has a rich history of medical device innovation. This access to talent and capacity provides excellent capital to build our company as we ready for our U.S. launch,” said Peter Ligotti, General Manager of InspireMD’s U.S. Business.

Shane Gleason, Chief Commercial Officer, shared, “We’re building our marketing, training and sales operations teams in South Florida to form the foundation of a world-class US commercial organization and support our growing field sales and clinical support team. It’s an exciting time as we prepare to build on our success outside of the US and serve the demand for CGuard Prime and SwitchGuard NPS upon their highly anticipated potential approval and clearance.”

On September 16^th, InspireMD announced that the company has submitted the final module of its Premarket Authorization (PMA) application to FDA for the CGuard Prime carotid stent system.

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, 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

FAQ

When is InspireMD (NSPR) expecting to launch the CGuard Prime carotid stent system in the U.S.?

InspireMD is anticipating the U.S. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval.

Where has InspireMD (NSPR) established its new global headquarters?

InspireMD has established its new global headquarters in Miami, Florida.

When did InspireMD (NSPR) submit the final module of its PMA application for CGuard Prime?

InspireMD submitted the final module of its Premarket Authorization (PMA) application to the FDA for the CGuard Prime carotid stent system on September 16th.

Why did InspireMD (NSPR) choose Miami, Florida for its new headquarters?

InspireMD chose Miami, Florida for its new headquarters due to the area's rich history of medical device innovation and access to talent, which provides excellent resources to build the company as it prepares for its U.S. launch.