TEL AVIV - InspireMD, Inc. (NASDAQ:NSPR), a medical device company, has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CGuard Prime carotid stent system. The submission, announced today, is based on data from the C-GUARDIANS clinical trial, which demonstrated a low major adverse event rate in patients treated with the device.
The C-GUARDIANS trial, which included 316 patients at 24 sites in the U.S. and Europe, reported a primary endpoint major adverse event rate of 1.95% at one year post-procedure. This rate is the lowest recorded for any carotid stent or embolic protection device pivotal trial to date. The trial's findings were initially presented in May at the Leipzig Interventional Course (LINC) 2024.
Marvin Slosman, CEO of InspireMD, expressed optimism about the PMA application's review by the FDA and the company's preparation for a potential U.S. commercial launch in the first half of 2025, should approval be granted. The company is currently setting up commercial and operational infrastructure in the U.S. to support the introduction of CGuard Prime.
The CGuard Prime system is designed to prevent stroke by treating carotid artery stenosis using the company's proprietary MicroNet® technology. InspireMD aims to establish its product as the industry standard for carotid stenting by offering superior acute results and long-term outcomes.
Investors are cautioned that forward-looking statements made by the company, including expectations about clinical trials, PMA outcomes, and product launches, involve risks and uncertainties. These include the need for additional capital, market acceptance, regulatory approvals, competition, and potential changes in market conditions.
The company's common stock is traded on the Nasdaq under the ticker symbol NSPR, and further information can be found on its website. This news is based on a press release statement from InspireMD, Inc.
In other recent news, InspireMD, a medical device company, reported a 5.4% revenue increase in the second quarter of 2024, with earnings of $1.74 million. Despite this growth, the company also experienced a 32.6% decrease in gross profit and a 48% rise in operating expenses, resulting in a net loss of $7.9 million for the quarter. These recent developments highlight the company's ongoing financial dynamics.
InspireMD is preparing for the commercial launch of its CGuard Prime in the US, anticipated in the first half of 2025. The company has completed enrollment in the CREST-2 clinical trial, and it is also investing in CAS and TCAR products and programs. The CGuard Stent System data indicates a low rate of major events, suggesting promising performance.
The company is also preparing for the C-GUARDIANS II and C-GUARDIANS III trials, expecting an increase in operating expenses next year. Despite a significant net loss this quarter, InspireMD remains optimistic about its future, particularly with the anticipated approval and launch of CGuard in the US market. The company's strategic focus on clinical trials and product development, coupled with the engagement of the medical community, suggests potential growth opportunities in the coming years.
InvestingPro Insights
As InspireMD, Inc. (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. According to InvestingPro data, InspireMD holds a market capitalization of approximately $70.02 million, reflecting investor valuation of the company's potential in the medical device market. Despite the challenges of being a non-profitable entity over the last twelve months, the company shows a notable revenue growth of 22.86% for the same period, indicating an expanding market presence.
One of the key InvestingPro Tips for NSPR highlights that the company holds more cash than debt on its balance sheet, which could provide financial flexibility as they prepare for a potential U.S. commercial launch of CGuard Prime. However, the same set of InvestingPro Tips also points out that the company is quickly burning through cash, which is a crucial consideration for investors given the capital-intensive nature of the medical device industry.
Investors should be aware that analysts do not anticipate InspireMD will be profitable this year, as reflected in the company's negative P/E ratio of -3.66. This metric suggests that investors are currently valuing the company's growth prospects rather than its current earnings. Additionally, with liquid assets that exceed short-term obligations, InspireMD appears to be in a position to manage its immediate financial responsibilities.
For those seeking more insights, there are additional InvestingPro Tips available at https://www.investing.com/pro/NSPR, which could further inform investment decisions regarding InspireMD's stock. These tips offer a deeper dive into the company's financials and market performance, providing a comprehensive view of its investment potential.
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