Nspr fda approval. Key milestone in TCAR advancement.

Nspr fda approval The system is designed to reduce the risk of stroke and is now available in the US. Apr 14, 2023 · Here's what really went down when the FDA originally approved mifepristone in 2000. Earnings, news, dividends, and more for InspireMD (NSPR). Management demonstrated strong confidence signal during early commercialization phase of FDA-approved CGuard Prime stent system. His veto message said CalRx made it unnecessary. , with reported Q2 2024 revenues of $1. Oct 15, 2024 · InspireMD (Nasdaq: NSPR) has announced the establishment of its global headquarters in Miami, Florida. The company submitted a Premarket Approval application to FDA for CGuard Prime carotid stent system and received IDE approval for CGUARDIANS II pivotal study. The CGuard Prime, featuring proprietary MicroNet mesh technology, was developed based on user feedback to enhance deliverability and deployment. announced on October 7, 2024, the FDA approval to begin the CGUARDIANS II pivotal study for their CGuard Prime 80cm Carotid Sep 11, 2023 · The Food and Drug Administration approved a new round of vaccines against COVID-19. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application for the CGuard Prime carotid stent system in the U. 95M and 3. What exactly did the FDA do today? New on WTR Healthcare Happenings 🎙 CEO of InspireMD (NASDAQ: NSPR), Marvin Slosman, joins host Tim Gerdeman & Robert Sassoon to discuss: 🔹 FDA approval of the CGuard® Prime Carotid Stent Sep 17, 2024 · InspireMD NSPR recently announced that it has submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States. (Nasdaq: NSPR), a medical device company with a market capitalization of $76. 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. 6, 2023. (NASDAQ:NSPR) forges ahead with its FDA approval process for the CGuard Prime carotid stent system, investors are closely monitoring the company's financial health and market performance. 53M, a 1. Aduhelm's manufacturer initially set a price of $56,000 a year — even though the FDA approved it based on its ability to remove sticky amyloid plaques from the brain without proof that plaque removal could slow Aug 1, 2024 · With support from both sides in Congress, advocates are still fighting to get the psychedelic drug approved as a mental health treatment, despite its rejection by the FDA's advisory committee in June. Earnings Call Insights: InspireMD (NSPR) Q1 2025 Management View CEO Marvin Slosman highlighted the company’s Q1 2025 performance with CGuard revenue reaching $1. NSPR’s quest for U. 8 million, is carving out its niche in the critical carotid artery disease market?This snapshot reveals a company focused squarely on advancing its CGuard™ Embolic Prevention System, navigating the rigorous path towards potential FDA approval and wider market adoption, building upon its $6. Jan 9, 2023 · The Food and Drug Administration has approved an Alzheimer's drug that appears to modestly slow down the disease. (NSPR) Q1 2025 Earnings Call Transcript InspireMD outlines Q3 2025 FDA approval target for CGuard Prime Seeking Alpha’s Quant Rating on InspireMD Historical earnings data for Jul 10, 2025 · The Food and Drug Administration approved a new non-opioid drug earlier this year called Journavx. Jun 4, 2021 · The FDA is poised to decide whether to approve aducanumab, a drug to treat Alzheimer's. Va. His son, Tyler, created a smart watch app to disrupt them, which just got FDA approval. Beyond trending topics, investors can deepen their understanding of InspireMD with stock insights, financial analysis, and noteworthy news. But the high price of the drug could limit its reach. Aug 4, 2025 · Q1 2025 earnings analysis for InspireMD Inc (NSPR). approval of its next-generation CGuard Prime stent, which offers best-in-class cl… Jun 22, 2023 · The Food and Drug Administration approved the first gene therapy for Duchenne muscular dystrophy, but limited access to those ages four and five. Jul 11, 2025 · InspireMD, Inc. For detailed information about NSPR stock, go to TipRanks’ Stock Analysis page. This is the second tranche of warrants that were originally issued as part of the Company’s milestone-based financing announced in May 2023. So far, Narcan nasal spray has been available as a prescription drug, but soon Americans will be able to access it in convenience stores, vending machines or even online. (NASDAQ:NSPR) announced Wednesday the commercial launch of its CGuard Prime carotid stent system in the United States following FDA premarket application approval Jul 31, 2025 · InspireMD (NASDAQ: NSPR) has secured combined financings of $58 million through a private placement (PIPE) and warrant exercises. Jul 9, 2025 · MIAMI - InspireMD, Inc. commercial launch of their CGuard Prime carotid stent system. market entry. Jun 18, 2025 · A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. Jul 31, 2025 · Proceeds Bolster Balance Sheet to Commercialize Recently FDA Approved Best-In-Class Carotid StentMIAMI, July 31, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. Aug 6, 2016 · The FDA has approved field trials of a genetically engineered mosquito designed to combat Zika and other diseases. “The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement. Dec 21, 2024 · The FDA said studies have shown that by aiding weight loss, Zepbound improves sleep apnea symptoms in some patients. Food and Drug Oct 7, 2024 · This approval propels InspireMD towards its goal of market leadership in the U. Sep 23, 2019 · Palforzia, a new drug to treat peanut allergies, is expected to get FDA approval. 5K units in served markets. Sep 16, 2024 · InvestingPro Insights As InspireMD, Inc. announced its financial and operating results for the second quarter and the first six months of 2025, highlighting significant advancements including FDA approval and commercial launch of its CGuard® Prime carotid stent system in the U. Sep 17, 2024 · InspireMD NSPR recently announced that it has submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States. NPR health correspondent Rob Stein joins us now with the latest. Jun 13, 2025 · MIAMI - InspireMD, Inc. NSPR recently announced the official commercial launch of the CGuard Prime Carotid Stent System in the United States, following its premarket application approval from the FDA. It's a pill for severe acute pain that works by blocking plain signals from where someone hurts. Mar 3, 2023 · Why accelerated approvals of medicines are controversial Criticism of the program crescendoed following the controversial accelerated approval of Alzheimer's drug Aduhelm in 2021. (the Company) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced Jun 25, 2025 · The proceeds will fund the US commercial launch of the stent system, new regulatory pathways, and product development. Shore will remain in his position until a successor is appointed and will assist in the transition. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard™ Prime carotid stent system for the prevention of stroke, today announced that the Compensation Committee of InspireMD’s Board of Directors approved inducement grants to three (3) new non-executive employees Oct 10, 2024 · InspireMD’s NSPR recently announced that the FDA has granted investigational device exemption (IDE) or premarket approval for its CGuard Prime 80cm carotid stent system. The highly anticipated decision could give the nation's vaccination campaign a badly needed boost. (NSPR) does not appear to anticipate an immediate, substantial sales impact that would lead to profitability. (Nasdaq: NSPR) has received a significant milestone with the U. InspireMD (Nasdaq:NSPR) announced today that it launched its CGuard Prime carotid stent in the U. This streamlined test can offer results faster and easier. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard™ Prime carotid stent system for the prevention of stroke, today announced that the Compensation Committee of InspireMD’s Board of Directors approved inducement grants to three (3) new non-executive employees Following the FDA approval of CGuard Prime on June 23, 2025, and its subsequent U. Following FDA approval of CGuard Prime, InspireMD is executing its U. Mar 23, 2019 · The FDA approved the first-ever treatment for postpartum depression. 6, 2022) has been approved for over-the-counter sales. Aug 5, 2025 · Discover InspireMD's (NSPR) Q2 2025 earnings insights, including its FDA-approved CGuard Prime launch, revenue growth plans, strong financial backing, and 4 days ago · InspireMD Announces FDA Approval for CGuard® Prime Carotid Stent System for the Prevention of Stroke MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. Sep 16, 2024 · InspireMD (Nasdaq: NSPR) has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system. Jul 3, 2024 · The new drug's approval was expected after an outside panel of FDA advisors unanimously voted in favor of its benefits at a public meeting last month. S. (NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U. But the state still has hurdles to clear before imports could begin. Dec 9, 2023 · The FDA approved the first gene-editing treatment for a human illness — the first genetic therapy for the brutal blood disorder sickle cell disease. Ever wondered how a medical device company like InspireMD, Inc. Food and Drug Administration's (FDA) approval of its CGuard® Prime Carotid Stent System for the prevention of stroke. (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U. Aug 5, 2025 · In addition to the financing, InspireMD has commenced the US commercial launch of the CGuard Prime carotid stent system, which has received PMA approval from the FDA. Food and Drug Administration (FDA) granting premarket application (PMA) approval for its CGuard Prime Carotid Stent System. Now a rival wants FDA approval to sell its own version — and expects to charge at least $37,500 per year. 6 May 9, 2025 · InspireMD reports Q1 2025 financials, highlighting FDA engagement for CGuard Prime approval and increased operating expenses. 42 per share price on July 30th. Recent $58 million PIPE financing completion provides adequate cash reserves ($26 million held) for growth investments. 5%, contributing to Jun 24, 2025 · InspireMD Inc NSPR: INSPIREMD ANNOUNCES FDA APPROVAL FOR CGUARD® PRIME CAROTID STENT SYSTEM FOR THE PREVENTION OF STROKE INSPIREMD INC - FDA APPROVAL TRIGGERS SECOND WARRANT TRANCHE IN $113. The new facility will play a important role in driving long-term growth and serving the U. Now, the decision moves to advisers at the Centers for Disease Control and Prevention. ahead of an anticipated first half 2025 Jun 24, 2025 · InspireMD received FDA Premarket Approval for its CGuard Prime Carotid Stent System, a stroke prevention device, following a pivotal trial that reported a record-low 0. Jun 24, 2025 · Miami, Florida — June 24, 2025 (GLOBE NEWSWIRE) – InspireMD, Inc. Oct 7, 2024 · Jul 3, 2025 · Oct 7, 2024 InspireMD (NSPR), a developer of stroke prevention solutions, has received a crucial green light from the U. Jun 24, 2025 · InspireMD has received FDA approval for its CGuard Prime Carotid Stent System to prevent stroke. Looking for the best stocks to buy? Follow the recommendations of top-performing analysts. . A large study found the drug decreased the loss of thinking and memory by 27%. InspireMD Aug 5, 2025 · In addition to the financing, InspireMD has commenced the US commercial launch of the CGuard Prime carotid stent system, which has received PMA approval from the FDA. market entry for its CGuard Prime carotid stent system, with FDA approval anticipated in the first half of 2025, alongside expansion into the TCAR market. Nov 12, 2024 · InspireMD (NSPR) reported Q3 2024 financial results, highlighting record quarterly revenue of $1. Aug 13, 2020 · Researchers at Yale University are seeking emergency use authorization from the Food and Drug Administration for a coronavirus saliva test. market following FDA PMA approval. But there's strong opposition in Florida where the GMO insects would be tested. Oct 10, 2024 · NSPR gains premarket approval for its CGuard Prime carotid stent system for use in United States for treating carotid artery stenosis. Mar 30, 2023 · Drug overdoses continue to be one of the leading causes of accidental deaths in the U. The innovative device, designed for stroke prevention, features three key advantages: a dual layer design with the largest open-cell frame and smallest mesh pore size, a MicroNet™ bio-stable mesh made from 20 μm PET, and SmartFit™ technology for precise Following the FDA approval of CGuard Prime on June 23, 2025, and its subsequent U. MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. Get detailed insights into quarterly performance, management commentary, guidance updates, and key metrics. Our approval marks a true breakthrough in the treatment of carotid disease. The system works by trapping debris against vessel walls and preventing plaque Sep 16, 2024 · InspireMD has submitted its Premarket Approval application for the CGuard Prime Carotid Stent system to the FDA, a crucial step towards U. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first quarter ended March 31, 2025. The company achieved a 10. 2% year-over-year InspireMD (Nasdaq: NSPR) announced FDA approval for its flagship CGuard Prime Carotid Stent System, a next-generation mesh-covered stent developed to prevent stroke by treating carotid artery disease. commercial launch with a growing sales organization, robust financial backing, and a strong clinical development pipeline. May 9, 2025 · Q&A During the earnings call, analysts queried the company about its FDA approval timelines, with executives acknowledging slight delays due to audit timing. commercial launch. , as well as CE Mark approval for the European market. , impacting the carotid stenting industry. Essential for investors. It achieves this by securing potential emboli against artery walls while Mar 12, 2025 · Engaged with the U. One looming question: Will it be affordable for lower resource countries? Jul 9, 2025 · MIAMI - InspireMD, Inc. The study, which enrolled its first patient in December 2024, aims to evaluate the safety and effectiveness of the TCAR procedure using CGuard Prime with an FDA-authorized embolic protection . Questions also focused on the company’s clinical trial progress and commercial strategy, with management affirming their commitment to expanding the commercial team methodically. (NASDAQ:NSPR) announced Wednesday the commercial launch of its CGuard Prime carotid stent system in the United States following FDA premarket application approval. Aug 23, 2021 · The Food and Drug Administration has given full approval to the Pfizer COVID-19 vaccine. (Nasdaq: NSPR) experienced a significant after-market surge in its stock price, with shares increasing by 50% following the U. 6 MILLION FINANCING Jul 31, 2025 · InspireMD (NASDAQ: NSPR) has secured combined financings of $58 million through a private placement (PIPE) and warrant exercises. They share their story with NPR's Debbie Elliott. A panel of experts earlier this month recommended that the U. Jun 13, 2025 · InspireMD (NSPR) has achieved CE Mark approval under European MDR for its CGuard Prime Embolic Prevention System, a carotid stent system designed to prevent strokes. How are operating expenses impacted in Q1 2025? Operating expenses increased by 52. The company established Mar 29, 2023 · The opioid overdose reversal drug Narcan (shown here at the Unitarian Universalist Congregation of Charleston in Charleston, W. This follows the system's premarket application approval by the U. Jun 24, 2025 · A newly approved HIV medication provides near-total protection against infection with just two injections a year. This approval triggers an expected $17. (NSPR), a medical device company, has announced the U. Jul 9, 2025 · InspireMD (Nasdaq: NSPR) has officially launched its CGuard Prime carotid stent system in the U. It's offered hope for the 1 in 5 Americans who suffer from chronic pain, but it's also just out of reach. 95%, claimed to be the lowest reported for similar devices. May 9, 2017 · More than 70 drugs approved by the FDA from 2001 to 2010 ran into safety concerns that prompted withdrawals from the market, "black box" warnings or other actions. May 9, 2025 · InspireMD Inc. It's called Lenacapavir. The company raised $58 million in gross proceeds to support growth Jun 24, 2025 · Miami, Florida — June 24, 2025 (GLOBE NEWSWIRE) – InspireMD, Inc. 3 days ago · See the latest InspireMD Inc stock price (NSPR:XNAS), related news, valuation, dividends and more to help you make your investing decisions. Jun 24, 2025 · InspireMD Inc (NSPR) is optimistic about receiving FDA approval for Seaguard Prime in the third quarter of 2025, which is expected to drive significant demand. Food and Drug Administration (FDA) has Aug 5, 2025 · InspireMD (Nasdaq: NSPR) reported Q2 2025 financial results, marking a transformative period highlighted by the FDA approval and U. The approval is expected to be a significant catalyst for U. Aug 5, 2025 · InspireMD secured crucial FDA and European approvals for its CGuard Prime carotid stent system, launching it in major markets, but second-quarter financials reveal accelerating cash burn and declining gross margins despite a recent $58 million capital raise. procedures. Business Highlights: Continued May 20, 2025 · FDA approval timeline and enrollment progress, commercial hiring and growth strategy, C-Guardians 2 IDE study timeline, and FDA approval timeline and enrollment progress are the key contradictions discussed in InspireMD's latest 2025Q1 earnings call. and global expansion, while concurrently developing their next-generation TCAR Neuroprotection System, SwitchGuard NPS. Full transcript - InspireMD Inc (NSPR) Q1 2025 Mar 12, 2025 · InspireMD (NSPR) reported its Q4 and full-year 2024 financial results, highlighting record quarterly revenue of $1. Food and Drug Administration approve a new drug for children and teens with peanut allergies. commercial launch in July 2025, InspireMD, Inc. Optimistic for an Jun 22, 2023 · The Food and Drug Administration approved the first gene therapy for Duchenne muscular dystrophy, but limited access to those ages four and five. 9 million was generated through warrant exercises triggered by FDA approval of the company's CGuard Prime carotid stent Miami, Florida — October 8, 2025 – InspireMD, Inc. Jun 24, 2025 · “The significance of CGuard Prime to the shift toward less invasive carotid artery revascularization is tremendous. ) Jun 24, 2025 · MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval. NPR's Michel Martin speaks with writer Teresa Wong about her own experiences with postpartum depression. CEO Marvin Slosman praised Shore Oct 8, 2024 · An update from InspireMD ( (NSPR) ) is now available. Aug 5, 2025 · Quiver AI Summary InspireMD, Inc. 5% surge in operating expenses and a significant decline in gross margin to 21. Dr. The main ingredient of the drug is peanut flour. So Rob, let's start with the news. Jan 6, 2023 · An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. Food and Drug Administration (FDA). Food and Drug Administration (FDA) approval of its CGuard Prime Carotid Stent System. , on Sept. May 12, 2025 · InspireMD Inc (NSPR) is optimistic about receiving FDA approval for Seaguard Prime in the third quarter of 2025, which is expected to drive significant demand. The stock was up 50% at Aug 9, 2024 · Supporters of the drug were dismayed by Friday's decision. Dec 6, 2020 · Patrick Skluzacek suffers from PTSD nightmares. market entry and revenue growth. Sep 16, 2024 · InspireMD has submitted its Premarket Approval application for the CGuard Prime Carotid Stent system to the FDA, a crucial step towards U. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4. approval of its next-generation CGuard Prime stent, which offers best-in-class cl… May 9, 2025 · Continued engagement with the U. InspireMD, Inc. 3% increase year-over-year, with 3,129 CGuard stents sold. Mar 12, 2025 · InspireMD is heavily investing in a pivotal U. 2% year-over-year May 9, 2025 · InspireMD Inc. “This is the epitome of bureaucratic red tape – and the result is people will keep dying. The approval allows InspireMD to launch the stent system in the U. 42 per share. It would be more affordable and more widely available than the single existing preventive drug – a monoclonal antibody shot called palivizumab – which requires monthly administration and is reserved for babies at high medical risk. Key developments include the FDA engagement for CGuard Prime carotid stent system's PMA application, with anticipated approval in H1 2025. 81 million, a 16. CGuard Prime launch, commercial growth, and corporate use. This submission follows "overwhelmingly positive" clinical trial results, which showed a major adverse event rate of just 1. Feb 13, 2025 · InspireMD (NSPR) and NAMSA announced their partnership for the CGUARDIANS II pivotal study of the CGuard Prime™ 80 cm carotid stent system for Transcarotid Artery Revascularization (TCAR) procedures. But yesterday's FDA approval of the nasal spray Narcan, an overdose-reversing drug, could change that. The PMA approval is backed by Aug 27, 2025 · The Food and Drug Administration approved the next round of COVID-19 vaccines, but is restricting them to people at high risk for COVID complications. Jul 31, 2025 · The warrant exercise generated gross proceeds of $17. An additional $17. Jan 5, 2024 · The Food and Drug Administration's authorization of Florida's plan to import prescription medicines from Canada is a first. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval Jun 24, 2025 · By Dean Seal InspireMD shares soared after the company said federal regulators have granted premarket application approval for its CGuard Prime Carotid Stent System. (NASDAQ:NSPR) reported its first-quarter 2025 earnings with a mixed performance, as the company exceeded earnings per share (EPS) expectations but fell short on revenue forecasts Sep 16, 2024 · InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that Jun 24, 2025 · InspireMD received FDA approval for its CGuard Prime Carotid Stent System. This strategic move is aimed at supporting the anticipated U. (NASDAQ:NSPR) reported its first-quarter 2025 earnings with a mixed performance, as the company exceeded earnings per share (EPS) expectations but fell short on revenue forecasts Jul 31, 2025 · InspireMD (NSPR) secures ~$58M through PIPE and warrants to fund U. One looming question: Will it be affordable for lower resource countries? Dec 23, 2015 · Jacobus Pharmaceutical freely gives its experimental drug to patients with a rare disease. The company established Following FDA approval of CGuard Prime, InspireMD is executing its U. 95% adverse event rate. Mar 12, 2025 · InspireMD's latest earnings reveal a substantial $32 million net loss and a "going concern" warning, driven by aggressive spending to prepare for a pivotal U. 36x, indicating robust short-term financial stability. The PIPE financing, led by OrbiMed and Marshall Wace, raised $40. This Feb 18, 2024 · Xolair is considered the first medication approved by the FDA that can help protect against severe allergic reactions brought on by accidental exposure to certain foods. Oct 9, 2024 · Despite positive trial results, InspireMD Inc (NASDAQ:NSPR) still needs to secure FDA approval and successfully execute its US commercial launch strategy. May 9, 2025 · Management anticipates FDA approval for CGuard Prime in Q3 2025. ” You are about to leave and go to InspireMD Inc (NSPR) Stock Price, News, Quote; History - Yahoo Finance Confirm Back People Also Ask NSPR stock reddit NSPR meaning what is zomedica stock What happened to InspireMD nspr website NSPR Mozilla NSPR Linux ZO stock NSPR FDA approval date nspr fda approval What happened to Avinger stock NSPR stock forecast Fndg stock nspr stock reddit Inspire MD nspr May 19, 2023 · An expert panel advising the Food and Drug Administration has recommended approval of a Pfizer vaccine that would be the first to protect babies against RSV. This approval allows the Earnings Call Insights: InspireMD (NSPR) Q1 2025 Management View CEO Marvin Slosman highlighted the company’s Q1 2025 performance with CGuard revenue reaching $1. (Nasdaq: NSPR) (“InspireMD” or the Jun 18, 2025 · A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. after receiving FDA premarket approval (PMA) last month. Progress continues on the Jul 9, 2025 · MIAMI - InspireMD, Inc. The company has built a strong commercial and operational team in anticipation of the US launch, with 20 high-powered sales and marketing professionals already onboarded. Mar 12, 2025 · InspireMD (NSPR) reported its Q4 and full-year 2024 financial results, highlighting record quarterly revenue of $1. The approval is based on data from the C-GUARDIANS pivotal trial, which demonstrated the system's safety and efficacy in treating carotid artery stenosis. The drug was approved this month by the FDA for use in adults and older children. 9 million in additional funding, enabling an immediate and aggressive U. 7% revenue increase in Q4 2024 compared to Q4 2023. 6 million, has received CE Mark approval under the European Medical Device Regulation for its Sep 16, 2024 · InspireMD (Nasdaq: NSPR) has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system. Aug 1, 2025 · InspireMD's CEO and Director executed insider purchases totaling $75,000 at identical $2. 9 million, which was triggered by the receipt of the PMA from the FDA. Aug 23, 2024 · A potentially ground-breaking nose-spray version of the drug epinephrine will soon hit the market — an alternative to auto-injectors like EpiPen for people having serious allergic reactions. for the company. Jun 24, 2025 · InspireMD, Inc. 2 5 days ago · Stay updated on InspireMD (NSPR) news: clinical trials, product innovations, and regulatory milestones in carotid stenting technology. market. Key milestone in TCAR advancement. Dec 12, 2024 · InspireMD (NSPR) announced that Chief Financial Officer Craig Shore will retire after 15 years with the company. That endorsement came despite several questions from FDA reviewers about how Lilly studied the drug, including allowing patients to discontinue treatment after their plaque reached very low levels. It's proved highly effective at removing the sticky amyloid plaques associated with the disease from the brain. May 9, 2025 · Management to host investor conference call today, May 9th, at 8:30am ET MIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. Jul 9, 2025 · NSPR, Financial) has commenced the commercial distribution of its CGuard Prime carotid stent system across the United States. The company also received CE Mark approval under the European Medical Device Regulation (MDR) for CGuard Prime, with plans to launch in the third quarter of 2025 [2]. The company announced on October 7, 2024, that the FDA approved its Investigational Device Exemption (IDE) Application to commence the CGUARDIANS II pivotal study for its CGuard Prime 80cm Carotid Stent System. Jun 24, 2025 · MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Story aired on Weekend Edition Saturday on Jan. May 9, 2025 · What is the status of the CGuard Prime FDA approval? The company is optimistic about receiving FDA approval for the CGuard Prime system in the third quarter of 2025. 95% through twelve months post-procedure - the lowest reported for any carotid stent or embolic protection Jun 18, 2022 · The FDA has given emergency approval for the use COVID-19 vaccines on kids as young as 6 months of age. After the trials, the state can apply for US Food and Drug Administration approval, which normally takes about a year. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U. Democratic Senator Scott Wiener from San Francisco recently resurrected a bill — now Senate Bill 40 — to cap insulin prices that Newsom vetoed last year. Aug 25, 2024 · The Food and Drug Administration gave the green light to two updated COVID-19 vaccines to protect against recent variants of the coronavirus. While product adoption in existing markets is strong, these strategic moves have led to a 52. The company's future hinges on anticipated FDA approval for its CGuard Prime stent and the successful conversion of potential warrant exercises to fund its high-stakes commercialization strategy. The announcement comes as the company anticipates potential FDA approval in the first half of 2025 for its CGuard™ Embolic Prevention Stent System. Jun 12, 2023 · The drug, if approved, would offer babies protection from the virus in their first RSV seasons with a single shot. The approval marks a major milestone for the company and also triggers the second of four milestone-driven warrant tranches tied to its $113. The CGuard Prime is designed to significantly reduce the risk of early and late embolism. Scott Hadland is a Dec 9, 2024 · InspireMD begins important clinical trial for CGuard Prime Carotid Stent System, targeting FDA approval and 30,000 annual U. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. 5% to $11,752,000, mainly due to sales force expansion and preparation for product launch. The vaccines from Moderna and Pfizer and its partner BioNTech were approved Monday for people 12 and older and under an emergency use authorization for children ages 6 months to 11 years old. 1 million by issuing 16,556,184 shares at $2. This regulatory milestone opens up significant market opportunities in the U. gtjmt aiawu lxrsxkzp htun lzobga tvrault jkxdej zalva guvw zmse zrh rwzl bnoublyb zrpu igogwop