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InspireMD, Inc. (NASDAQ: NSPR), located at 800 Boylston Street, Suite 16041, Boston, Massachusetts, is a pioneering medical device company. It specializes in the development and commercialization of its proprietary MicroNet stent platform technology, which addresses complex vascular and coronary diseases. The company's flagship products include the CGuard Carotid Embolic Prevention System (CGuard EPS) and the MGuard Prime Embolic Protection System (MGuard Prime EPS).
The CGuard EPS, which integrates MicroNet technology with a self-expandable nitinol stent, is primarily used for carotid artery applications and is a significant revenue driver for the company. InspireMD operates globally, with key markets in Italy, Germany, Russia, among others.
In a recent move, InspireMD has focused on expanding its intellectual property portfolio to support its strategic direction. October 2023 saw the Centers for Medicare and Medicaid Services (CMS) expand coverage for carotid artery stenting, including asymptomatic and standard-risk patients. This development is expected to enhance the adoption of InspireMD's products.
Additionally, in the third quarter of 2023, InspireMD reported its financial results and ongoing projects. They are currently enrolling patients in a study to investigate the safety and feasibility of using CGuard EPS for treating acute ischemic stroke patients with tandem lesions. This study is expected to enroll 15 patients across three U.S. sites.
CEO Marvin Slosman emphasized the importance of this study in addressing carotid lesions in acute stroke settings, marking a crucial step in their long-term growth strategy. The company also continues its work on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE trial, anticipating key milestones in 2024 and 2025.
InspireMD's common stock is listed on the Nasdaq under the ticker symbol NSPR. For more information, visit their website at www.inspiremd.com.
InspireMD (NSPR) announced that Chief Financial Officer Craig Shore will retire after 15 years with the company. Shore will remain in his position until a successor is appointed and will assist in the transition. The announcement comes as the company anticipates potential FDA approval in the first half of 2025 for its CGuard™ Embolic Prevention Stent System.
CEO Marvin Slosman praised Shore's commitment to building the company's position as a global leader in carotid interventions. Shore expressed confidence in the company's future growth trajectory and its leadership in carotid intervention and stroke prevention. The company has initiated a search for a new CFO.
InspireMD (NSPR) has announced the enrollment of its first patient in the CGUARDIANS II clinical trial, evaluating the CGuard Prime Carotid Stent System in TCAR procedures. The study, conducted at Good Samaritan Hospital in Cincinnati, enrolled its first patient under Dr. Patrick Muck, who serves as both site principal investigator and co-lead investigator.
The CGUARDIANS II is a prospective, multi-center, single-arm pivotal study aiming to enroll a minimum of 50 evaluable patients. The trial will evaluate acute device success and technical success of CGuard Prime when used with FDA-cleared TCAR neuro-protection systems. The company is approaching potential FDA approval for CGuard Prime with a CAS indication in first half of next year, targeting a TCAR market of approximately 30,000 U.S. procedures annually.
InspireMD (NSPR) has appointed Scott R. Ward to its Board of Directors. Ward, who most recently served as CEO and President of Cardiovascular Systems until its acquisition by Abbott in April 2023, brings over 40 years of healthcare industry experience, including 30 years at Medtronic in senior leadership roles. The appointment comes as InspireMD approaches potential U.S. approval of its CGuard Prime carotid stent system. Ward's extensive operational experience in the cardiovascular space is expected to contribute to the company's strategy in advancing its carotid platform and pipeline innovations, including CAS, TCAR, and Neuro focus.
InspireMD (NSPR) reported Q3 2024 financial results, highlighting record quarterly revenue of $1.81 million, a 16.3% increase year-over-year, with 3,129 CGuard stents sold. The company submitted a Premarket Approval application to FDA for CGuard Prime carotid stent system and received IDE approval for CGUARDIANS II pivotal study. Net loss widened to $7.89 million ($0.16 per share) from $5.18 million in Q3 2023. Cash position stood at $40.4 million as of September 30, 2024. The company established new headquarters in Miami, Florida, anticipating U.S. commercial launch in H1 2025, pending approval.
InspireMD (Nasdaq: NSPR) has granted inducement awards to five new non-executive employees totaling 197,167 shares of restricted stock. The grants, made outside the company's 2021 Equity Compensation Plan, were approved by the Compensation Committee on October 24, 2024. The restricted stock will vest over three years: one-third after the first year and the remaining two-thirds in equal installments on the second and third anniversaries, contingent on continued employment.
InspireMD (NSPR), developer of the CGuard™ Embolic Prevention Stent System for Carotid Artery Disease and stroke prevention, has scheduled its Third Quarter 2024 financial results announcement for Tuesday, November 12th, 2024, before market open. The company will host a conference call and webcast at 8:30 AM EDT to discuss financial results and provide corporate updates. The call will be accessible via toll-free (1-800-225-9448) and international (1-203-518-9708) numbers, with conference ID: IMD3Q24. A webcast will be available through the company's website.
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.
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.
InspireMD (Nasdaq: NSPR) has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system. The application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which showed a primary endpoint major adverse event rate of 1.95% through twelve months post-procedure - the lowest reported for any carotid stent or embolic protection device pivotal trial to date. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. InspireMD anticipates a U.S. commercial launch in H1 2025, if approved, and is building commercial and operational infrastructure for market entry.
InspireMD (Nasdaq: NSPR) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Positive outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime carotid stent system, with a 1.95% one-year primary endpoint event rate.
2. Plans to submit a Premarket Approval (PMA) application to the FDA this quarter.
3. Raised $17.9 million in gross proceeds from Series H warrants exercise.
4. Q2 2024 CGuard EPS revenue increased by 5.4% to $1.74 million.
5. Net loss for Q2 2024 was $7.909 million, or $0.22 per share.
6. Cash, cash equivalents, and marketable securities stood at $47.2 million as of June 30, 2024.
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