EDEN PRAIRIE, Minn. - Surmodics, Inc., a medical device company, has received FDA 510(k) clearance for its Pounce™ XL Thrombectomy System, which can remove clots from peripheral arteries ranging from 5.5 to 10 mm in diameter. This system is part of the Pounce Thrombectomy Platform, which also includes devices for smaller arteries, enhancing the company's offerings for non-surgical clot removal in the peripheral arterial vasculature.
The Pounce XL Thrombectomy System is designed to address various arteries, including iliac and femoral, and is a key addition to Surmodics' mechanical thrombectomy solutions. The platform, which includes the previously introduced Pounce Thrombectomy System for 3.5-6 mm arteries and the Pounce LP Thrombectomy System for 2-4 mm arteries, aims to provide a comprehensive mechanical thrombectomy solution for all peripheral arteries.
Gary Maharaj, President and CEO of Surmodics, stated that the FDA clearance is a significant advancement in the company's goal to offer a complete solution for peripheral arterial thrombectomy. According to Maharaj, the Pounce Thrombectomy Platform has proven effective in rapidly restoring blood flow in peripheral arteries, potentially reducing the need for follow-up procedures and intensive care unit admissions for additional thrombolytic therapy.
The Pounce Thrombectomy Platform devices are fully mechanical and designed to remove organized thrombus or embolus without thrombolytics, aspiration, or extensive equipment. The systems are composed of a delivery catheter, a basket wire, and a funnel catheter, which work together to capture and remove clots.
Surmodics plans to begin a limited market release for the Pounce XL Thrombectomy System in the first half of 2025, followed by commercialization. The company's mission is to improve disease detection and treatment through its medical device technologies.
This news is based on a press release statement from Surmodics, Inc. and has not been independently verified.
In other recent news, Surmodics Inc., a medical device company, has seen its shareholders approve a merger with BCE (NYSE:BCE) Parent, LLC, a significant development in the company's future. The merger was supported by a majority of votes, and the compensation for Surmodics' executive officers in connection with the merger was also endorsed. However, the finalization of the merger is subject to additional conditions, such as the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Simultaneously, Surmodics has agreed to a $630 million acquisition by private equity firm GTCR, which is expected to conclude in the second half of 2024. This will result in Surmodics transitioning to a privately held entity. In the wake of this news, Surmodics was downgraded from Buy to Hold by a Needham analyst, who suggested that a private equity firm is better suited for acquiring Surmodics.
Furthermore, Surmodics is currently under scrutiny by the Federal Trade Commission (FTC) regarding its planned merger with BCE Parent, LLC. The FTC has issued a "Second Request" as part of its regulatory review process, extending the waiting period for the merger. Despite this, both companies aim to finalize the transaction before February 28, 2025. These are the latest developments for Surmodics as it navigates through significant transitions.
InvestingPro Insights
As Surmodics (NASDAQ: SRDX) prepares to launch its newly FDA-cleared Pounce™ XL Thrombectomy System, investors may find value in examining the company's financial health and market position. According to InvestingPro data, Surmodics has a market capitalization of $553.27 million, reflecting its position in the medical device industry.
The company's revenue for the last twelve months as of Q3 2024 stood at $120.82 million, with a high gross profit margin of 80.84%. This strong margin suggests that Surmodics maintains efficient production costs for its medical devices, which could bode well for the commercialization of the Pounce XL Thrombectomy System.
InvestingPro Tips highlight that Surmodics "operates with a moderate level of debt" and that its "liquid assets exceed short-term obligations." These factors may provide the company with financial flexibility as it moves towards the limited market release of its new product in 2025.
It's worth noting that Surmodics has experienced a "large price uptick over the last six months," with a 39% price total return over that period. This could indicate growing investor confidence in the company's product pipeline and market potential.
However, potential investors should be aware that Surmodics was "not profitable over the last twelve months" and that "analysts do not anticipate the company will be profitable this year." These insights suggest that while the company is making strides in product development, it may take time for these innovations to translate into positive earnings.
For those interested in a deeper analysis, InvestingPro offers 8 additional tips for Surmodics, providing a more comprehensive view of the company's financial situation and market prospects.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.