NSPR

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 6, 2024

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

InspireMD to Report Fourth Quarter and Full-Year 2023 Financial Results and Provide Corporate Business Update on Wednesday, March 6th

Retrieved on: 
Wednesday, February 28, 2024

TEL AVIV, Israel and MIAMI, Feb. 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report fourth quarter and full-year 2023 financial results on Wednesday, March 6th, 2024, before the financial markets open.

Key Points: 
  • -Conference call and webcast to be held at 8:30 a.m. EST-
    TEL AVIV, Israel and MIAMI, Feb. 28, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report fourth quarter and full-year 2023 financial results on Wednesday, March 6th, 2024, before the financial markets open.
  • Management will host a conference call and webcast with the investment community at 8:30 am (EST) that same day to review financial results and provide an update on corporate developments.

InspireMD Appoints Principal Investigators for C-GUARDIANS II Clinical Trial of the SwitchGuard™ Neuroprotection System

Retrieved on: 
Monday, February 12, 2024

TEL AVIV, Israel and MIAMI, Feb. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that the Company has appointed principal investigators (PIs) for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System (NPS).

Key Points: 
  • TEL AVIV, Israel and MIAMI, Feb. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that the Company has appointed principal investigators (PIs) for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System (NPS).
  • Additionally, William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas Jefferson University in Philadelphia, PA, will act as an advisor to the Company.
  • Marvin Slosman, chief executive officer of InspireMD, stated, “As the only company with a mission to develop solutions that support both CAS and TCAR carotid revascularization procedures with a best-in-class implant, we consider initiation of the C-GUARDIANS II clinical trial of our SwitchGuard™ Neuroprotection System as a very significant upcoming milestone for our company.
  • Geraghty and Muck, both recognized leaders in the field of vascular surgery, have agreed to lead the execution of this important trial, planned to start later this year.

InspireMD Receives CE Mark Recertification Under EU’s New Medical Device Regulation (MDR) Regulatory Framework

Retrieved on: 
Wednesday, January 31, 2024

TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework.

Key Points: 
  • TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework.
  • MDR replaced the previous MDD framework, which had governed the approval and marketing of medical devices in the EU until May of 2021.
  • Marvin Slosman, chief executive officer of InspireMD, stated, “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines, and priorities during this process.
  • We continue to aggressively work toward multiple value creating milestones, including the potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025,” Mr. Slosman concluded.

InspireMD Announces Appointment of Medical Technology Executive Pete Ligotti as Executive Vice President and General Manager of North America

Retrieved on: 
Wednesday, January 3, 2024

TEL AVIV, Israel and MIAMI, Jan. 03, 2024 (GLOBE NEWSWIRE) -- InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America. Mr. Ligotti brings more than 30 years of general management and commercial leadership experience to the InspireMD team.

Key Points: 
  • TEL AVIV, Israel and MIAMI, Jan. 03, 2024 (GLOBE NEWSWIRE) -- InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America.
  • Mr. Ligotti brings more than 30 years of general management and commercial leadership experience to the InspireMD team.
  • Before that, he served as Vice President of Global Commercial Strategy at Smith+Nephew, and, prior to that, in various roles of increasing responsibility at Integra LifeSciences, culminating with Senior Vice President and General Manager - Extremity Orthopedics.
  • In connection with the appointment of Mr. Ligotti as Executive Vice President and General Manager of North America, InspireMD has granted Mr. Ligotti 138,460 shares of restricted stock and stock options to purchase 46,150 shares of InspireMD’s common stock.

InspireMD Announces Issuance of Key U.S. Patent Covering Its SwitchGuard™ Neuroprotection System

Retrieved on: 
Wednesday, December 20, 2023

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.

Key Points: 
  • 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 broader availability of these less invasive options should better enable physicians to tailor treatment plans to the needs of individual patients.

InspireMD Announces Strategic Agreement with Jacobs Institute to Execute Early Feasibility Study of CGuard EPS for the Treatment of Acute Stroke Patients with Tandem Lesions

Retrieved on: 
Monday, November 27, 2023

As a result, there are currently no FDA approved stents for this specific indication.

Key Points: 
  • As a result, there are currently no FDA approved stents for this specific indication.
  • Retrospective analyses from large centers across the globe have suggested the safety and efficacy of stenting in conjunction with intracranial thrombectomy.
  • I am also excited that this brings the carotid disease as it pertains to neurointerventionalists to the forefront.
  • The EFS is expected to enroll 15 patients across three U.S. trial sites and explore the safety and feasibility of using the CGuard EPS carotid stent, with its unique MicroNet™ mesh covering, to treat acute ischemic stroke patients with tandem lesions.

Hunter Shkolnik, Partner, NSPR Law Services, Appointed Executive Committee for the Self-Funded Payer Track Insulin Pricing Litigation Case No. 2:23-md-03080 (BRM)(RLS) MDL No. 3080

Retrieved on: 
Wednesday, December 20, 2023

Hunter Shkolnik , a Partner in NSPR Law Services — widely considered one of the country’s leading personal injury attorneys — has been appointed to the Executive Committee for the Self -Funded Payer Track Insulin Pricing Litigation Case No.

Key Points: 
  • Hunter Shkolnik , a Partner in NSPR Law Services — widely considered one of the country’s leading personal injury attorneys — has been appointed to the Executive Committee for the Self -Funded Payer Track Insulin Pricing Litigation Case No.
  • 2:23-md-03080 (BRM)(RLS) MDL No.
  • 3080, currently in the N.J. courts under the jurisdiction of Judge Brian R. Martinotti and Judge Rukhsana l. Singh.
  • In that role, he will collaborate with a selection of peers on the management of the litigation and leadership structures for Plaintiffs spanning self-funded payers or self-funded payer groups, including local governments and subdivisions (including county, borough, municipality, city, town, township, parish, local public authority, special district, intrastate district, council of governments, and agencies or instrumentalities of multi-regional or intra-state or local government); unions; schools and educational institutions; for-profit and non-profit organizations; and other similar self-funded payers who pay for prescription drugs provided to members of their health plan with prescription drug coverage.

InspireMD Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023

TEL AVIV, Israel and MIAMI, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial results and business updates for the third quarter ended September 30, 2023.

Key Points: 
  • Generated CGuard revenue for the third quarter 2023 of $1,556,072, an 8.8 % increase over the same period in 2022.
  • Sold 2,734 CGuard EPS stent systems in the third quarter of 2023, as compared to 2,624 in the third quarter of 2022, an increase of 4.2 %.
  • Total financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter of 2022.
  • Management will host a conference call today, Monday, November 6th, at 8:30 AM ET, to review financial results and provide an update on corporate developments.

InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23

Retrieved on: 
Wednesday, November 1, 2023

The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.

Key Points: 
  • The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.
  • From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.
  • Stenting with the C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, from procedure through 30 days follow-up.
  • We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularizations from ‘surgery first’ to an endovascular ‘stent first’ approach.