MIAMI - The U.S. Food and Drug Administration (FDA) has approved InspireMD, Inc.'s (NASDAQ:NSPR) application to initiate a pivotal study of its CGuard Prime 80cm Carotid Stent System, the company announced today. The approval allows the medical device company to begin the CGUARDIANS II study, focusing on the system's use during transcarotid revascularization (TCAR) procedures, a minimally invasive method to prevent strokes.
InspireMD's CGuard Prime is designed to prevent embolic events in patients undergoing carotid artery procedures. The study will assess the stent's safety and efficacy, facilitating its potential approval for TCAR-specific applications. In February 2024, vascular surgeons Dr. Patrick Geraghty and Dr. Patrick Muck were announced as co-principal investigators for the trial, alongside a team of experts committed to the study's success.
Marvin Slosman, CEO of InspireMD, expressed the significance of the FDA's approval as a critical step in the company's mission to provide comprehensive tools for carotid disease management and stroke prevention. The trial is expected to support the company's U.S. commercial expansion and pursuit of market leadership.
InspireMD is known for its proprietary MicroNet® technology, which aims to set industry standards for carotid stenting by delivering durable, stroke-free outcomes. The company's stock is publicly traded on the Nasdaq stock market.
The press release also mentioned InspireMD's ongoing development of the next-generation TCAR Neuroprotection System, SwitchGuard NPS, which, once approved, will complement the CGuard platforms. The company's progress toward U.S. expansion and global success continues with these initiatives.
This news article is based on a press release statement from InspireMD, Inc. The information presented is intended to provide investors with key facts regarding the FDA's approval of the CGUARDIANS II study and the company's future plans in the field of carotid artery disease management and stroke prevention.
In other recent news, InspireMD, a medical device company, has seen a series of significant developments. The company reported a 5.4% revenue increase in the second quarter of 2024, earning $1.74 million. However, this was offset by a decrease in gross profit and a rise in operating expenses, resulting in a net loss of $7.9 million for the quarter.
Adding to the company's strategic moves, InspireMD has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CGuard Prime carotid stent system. This application is based on data from the C-GUARDIANS clinical trial, which showed a low major adverse event rate in patients treated with the device.
In an effort to attract top talent, InspireMD has also approved a new employee inducement plan. The 2024 Inducement Plan offers nonqualified stock options and restricted stock awards, with 2,200,000 shares of common stock reserved for issuance.
Piper Sandler has maintained an Overweight rating on InspireMD's shares, citing the strength of the U.S. pivotal trial data. These recent developments underscore the company's ongoing efforts to strengthen its position in the medical device industry.
InvestingPro Insights
As InspireMD (NASDAQ:NSPR) moves forward with its pivotal study for the CGuard Prime 80cm Carotid Stent System, investors should consider some key financial metrics and insights from InvestingPro.
Despite the positive news regarding FDA approval for the CGUARDIANS II study, InvestingPro data reveals that InspireMD's revenue for the last twelve months as of Q2 2023 was $6.57 million, with a revenue growth of 22.86% over the same period. This growth is encouraging, but it's important to note that the company is not yet profitable.
An InvestingPro Tip highlights that InspireMD is quickly burning through cash, which could be a concern for investors considering the company's ongoing research and development efforts. This cash burn rate is particularly relevant given the company's plans for U.S. commercial expansion and the pursuit of market leadership in carotid stenting.
Another InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This aligns with the company's current focus on clinical trials and product development, which often require significant investment before generating returns.
For investors interested in a more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 8 additional InvestingPro Tips available for InspireMD, providing a deeper understanding of the company's financial health and market position.
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