InspireMD Reports 13% Revenue Growth to $7.0 Million, Faces Increased Net Loss

InspireMD, Inc. reported a revenue increase of 13% for the fiscal year ending December 31, 2024, totaling $7.0 million, compared to $6.2 million in the previous year. This growth was primarily driven by increased sales in Europe and Asia, which saw respective increases of $772,000 and $141,000. However, the company also experienced a net loss of $32.0 million, a significant rise from the $19.9 million loss reported in 2023, largely attributed to a 70.8% increase in research and development expenses, which reached $13.6 million. The gross profit margin decreased to 21.5% from 29.1% due to rising costs of goods sold, which increased by $1.1 million.

In terms of strategic developments, InspireMD has made significant strides in its clinical trials and product offerings. The company completed enrollment for its pivotal C-GUARDIANS trial in June 2023, which evaluated the safety and efficacy of its CGuard Carotid Stent System. Positive results were announced in November 2023, showing a major adverse event rate of 0.95% at 30 days post-procedure. The company plans to submit a premarket approval application to the FDA for the CGuard Prime stent system in September 2024, with potential approval expected in the first half of 2025. Additionally, InspireMD has initiated the CGUARDIANS II study for its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization procedures.

Operationally, InspireMD has expanded its workforce to support its growth strategy, with a total of 86 employees as of December 31, 2024. The company has also established its global headquarters in Miami, Florida, to facilitate the anticipated U.S. launch of the CGuard Prime system. The Centers for Medicare and Medicaid Services (CMS) recently expanded coverage for carotid artery stenting procedures, which is expected to significantly increase the addressable market for InspireMD's products.

Looking ahead, InspireMD faces challenges related to its financial health, as it reported an accumulated deficit of $254 million and negative cash flows from operations. The company is actively seeking additional capital to support its commercialization efforts and operational expansion. Despite the positive clinical trial results, there remains uncertainty regarding the market acceptance of its products and the ability to secure adequate reimbursement from third-party payors. The company’s future success will depend on its ability to navigate these challenges while continuing to innovate and expand its product offerings in the competitive medical device market.