rewrite this title and make it good for SEOSurmodics reports high success in limb ischemia study By Investing.com

EDEN PRAIRIE, Minn. – Surmodics, Inc. (NASDAQ:SRDX), a provider of medical device and in vitro diagnostic technologies, has released early results from a subset of its PROWL registry study, showing significant procedural success in patients with limb ischemia. The findings were presented at the 36th Annual TCT Symposium in Washington, D.C.

The subset analysis focused on 60 patients with acute, subacute, or chronic limb ischemia symptoms. The study reported a 96.8% rate of procedural flow restoration using the Pounce™ Thrombectomy System, a non-surgical device for removing emboli and thrombi in peripheral arterial vasculature. The procedural success rate, defined as the restoration of pulsatile flow with or without adjunctive treatment, reached 90.0%. Additionally, 81.7% of subjects did not require further thromboemboli removal treatment within 30 days post-use.

The Pounce Thrombectomy Platform consists of FDA-cleared mechanical devices designed to remove organized thrombus or embolus without the need for thrombolytics or aspiration. The platform includes systems suitable for peripheral arteries of various diameters, with the Pounce XL Thrombectomy System pending commercial release.

This early data suggests the Pounce Thrombectomy System may serve as an effective standalone solution for acute-to-chronic clot removal in real-world clinical settings. The study also highlighted the system’s safety, with only one device-related adverse event reported.

Surmodics’ Pounce Thrombectomy Platform is part of the company’s broader strategy to develop and commercialize medical devices that address unmet clinical needs. While the results are promising, they are part of an ongoing registry expected to enroll up to 500 patients across up to 30 sites.

The company’s mission is to improve disease detection and treatment, and it is headquartered in Eden Prairie, Minnesota. Further information can be found on Surmodics’ website, though it is not part of this press release or any SEC filings.

The information presented is based on a press release statement and the full results of the PROWL registry study are awaited to determine the long-term efficacy and safety of the Pounce Thrombectomy System.

In other recent news, Surmodics, Inc., a medical device company, has received FDA 510(k) clearance for its expanded Pounce™ XL Thrombectomy System, enhancing its offerings for non-surgical clot removal in the peripheral arterial vasculature. The company plans to begin a limited market release for the system in the first half of 2025. In other developments, Surmodics shareholders have approved a merger with BCE (NYSE:) Parent, LLC, a move that is subject to additional conditions such as the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Furthermore, Surmodics has agreed to a $630 million acquisition by private equity firm GTCR, which is expected to conclude in the second half of 2024. Following this announcement, Surmodics was downgraded from Buy to Hold by a Needham analyst. Additionally, the Federal Trade Commission (FTC) has issued a “Second Request” extending the waiting period for the merger with BCE Parent, LLC. 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

Surmodics’ promising early results from the PROWL registry study align with the company’s focus on innovative medical device technologies. However, investors should consider both the potential and challenges facing the company.

According to InvestingPro data, Surmodics has a market capitalization of $537.3 million, reflecting its position in the medical device sector. 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%, indicating strong pricing power for its products like the Pounce Thrombectomy System.

Despite these positive indicators, InvestingPro Tips reveal that Surmodics was not profitable over the last twelve months, with analysts not anticipating profitability this year. This aligns with the reported operating income of -$7.48 million for the same period. The company’s focus on research and development for products like the Pounce Thrombectomy System may be contributing to these short-term financial pressures.

On a more positive note, an InvestingPro Tip highlights that Surmodics operates with a moderate level of debt, which could provide financial flexibility as it continues to develop and commercialize its medical device portfolio. Additionally, the company has seen a large price uptick over the last six months, with a 46.01% total return, suggesting investor optimism about its future prospects, possibly influenced by developments like the PROWL study results.

For investors seeking a comprehensive analysis, InvestingPro offers 6 additional tips for Surmodics, providing a deeper understanding of the company’s financial health and market position.

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