On Tuesday, InspireMD Inc . (NASDAQ:NSPR), a medical device company, achieved a significant step forward in its regulatory journey. Piper Sandler maintained an Overweight rating and a price target of $4.50 on the company's shares following the announcement that InspireMD has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CGuard Prime carotid stent system.
The submission, which took place on Monday, is a pivotal event for InspireMD as it seeks to enter the U.S. market. The company aims to commercialize the CGuard Prime system in the first half of 2025, aligning with the timelines previously communicated by management. The strength of the U.S. pivotal trial data (C-Guardians) presented earlier this year supports a low risk of FDA approval, according to the firm's analysis.
Piper Sandler's commentary highlighted the importance of this milestone, which puts InspireMD on a clear path to commercialization in the U.S. The firm anticipates that InspireMD will now intensify efforts to establish its U.S. commercial sales organization in preparation for the product launch.
The firm also pointed to the potential for significant value creation for InspireMD over the next 12 to 24 months. This period is expected to be marked by the company reaching various regulatory milestones and initiating commercial operations in the U.S. marketplace, which could have a positive impact on the company's valuation. The reiterated Overweight rating and price target reflect Piper Sandler's positive outlook on InspireMD's prospects.
In other recent news, medical device company InspireMD has submitted a Premarket Approval application to the U.S. Food and Drug Administration for its CGuard Prime carotid stent system.
The 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. The company also reported a 5.4% revenue increase in the second quarter of 2024, with earnings of $1.74 million. However, InspireMD also experienced a decrease in gross profit and a rise in operating expenses, leading to a net loss of $7.9 million for the quarter.
The company is preparing for the commercial launch of its CGuard Prime in the US, anticipated in the first half of 2025. Despite the significant net loss this quarter, InspireMD remains optimistic, especially with the anticipated approval and launch of CGuard in the US market.
InvestingPro Insights
As InspireMD Inc. (NASDAQ:NSPR) progresses on its journey towards commercialization of the CGuard Prime system in the U.S., the company's financial health and market performance are key factors for investors to monitor. According to InvestingPro data, InspireMD currently holds a market capitalization of approximately $69.15 million. Despite the company's revenue growing by 22.86% over the last twelve months as of Q2 2024, it has been facing challenges with a negative operating income margin of -412.99% and an EBITDA decline of -41.22% in the same period.
InvestingPro Tips suggest that while InspireMD has more cash than debt on its balance sheet and its liquid assets exceed short-term obligations, the company is quickly burning through its cash reserves. Analysts do not expect InspireMD to be profitable this year, and the net income is anticipated to drop. These financial insights are particularly relevant as the company prepares to expand its operations and may impact its ability to sustain the commercialization efforts without additional financing.
For investors considering InspireMD's potential, it's worth noting that the company's price has underperformed over the last decade, and it does not offer a dividend to shareholders. However, with a fair value estimate of $2.58 by InvestingPro, slightly below the previous close price of $2.69, there might be cautious optimism surrounding the company's valuation. For a deeper dive into InspireMD's financial health and future prospects, additional InvestingPro Tips are available, offering investors a comprehensive tool for making informed decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.