Surmodics Announces Commercial Release of Pounce™ XL Thrombectomy System, Enabling Rapid Non-Surgical Clot Removal in Iliac and Femoral Arteries

Rhea-AI Summary

Surmodics (SRDX) has announced the commercial release of the Pounce™ XL Thrombectomy System, expanding their thrombectomy platform for peripheral arterial clot removal. The new system is designed for larger arteries (5.5-10mm diameter), complementing existing Pounce and Pounce LP systems.

The platform features dual-basket technology that enables clot removal without requiring aspiration, thrombolytics, or capital equipment. During market release since January 2025, the system demonstrated effectiveness in removing acute and subacute clots.

Clinical data from the PROWL registry showed promising results: in 74 patients, average use time was 20.3 minutes, with 79.7% requiring no additional clot removal treatment. Only one device-related adverse event was reported. The complete Pounce platform now covers vessel diameters from 2-10mm, offering a comprehensive solution for peripheral arterial thrombectomy.

Positive

• Expanded market opportunity with new product covering larger vessel sizes (5.5-10mm)
• Strong clinical data: 79.7% of patients needed no additional treatment
• Efficient procedure time averaging 20.3 minutes
• Minimal complications with only one device-related adverse event reported
• No capital equipment required, reducing implementation costs

Negative

• clinical data with only 74 patients in the PROWL registry

Insights

Medical Device Expert

Surmodics' commercial release of the Pounce XL Thrombectomy System represents a strategically significant portfolio expansion that completes their thrombectomy platform offering. By adding this larger-vessel device (5.5-10mm diameter), Surmodics now offers a comprehensive solution spanning vessel diameters from 2-10mm throughout the peripheral vasculature.

What makes this technology noteworthy is its fully mechanical approach using proprietary dual-basket technology, enabling physicians to remove clots without capital equipment, thrombolytics, or aspiration. This creates several competitive advantages: reduced procedural complexity, minimized blood loss, and lower risk of distal embolization.

The PROWL registry data, while from a modest sample of 74 patients, demonstrates compelling efficiency metrics - average 20.3-minute use time with 79.7% of cases requiring no additional clot removal interventions. The single reported adverse event (one flow-limiting dissection) suggests a favorable safety profile.

From a market positioning perspective, this expansion essentially transforms Surmodics' offering from targeted products to a complete platform solution. The ability to address both acute and chronic clots non-surgically across vessel sizes positions them more competitively against alternative approaches requiring surgical cutdown, thrombolytics or aspiration systems.

While the financial impact isn't quantifiable from this announcement alone, the expanded addressable procedure base and enhanced competitive positioning should strengthen Surmodics' market presence in peripheral vascular intervention.

Vascular Surgeon

The commercial release of Surmodics' Pounce XL Thrombectomy System addresses a significant clinical need for large-vessel clot removal without surgical cutdown. For vessels 5.5-10mm in diameter (typical of iliac and femoral arteries), non-surgical options have traditionally presented challenges in terms of completeness of clot removal and procedural efficiency.

This system's dual-basket technology offers distinct clinical advantages. By avoiding thrombolytics, we eliminate bleeding risks and post-procedure monitoring requirements. The non-aspiration design minimizes blood loss - a crucial benefit in patients who may already be compromised. The atraumatic vessel wall interaction reported is particularly important in these larger vessels where dissection can have catastrophic consequences.

Dr. Marjan's reported case experience removing organized clot from infrarenal aorta and common iliac arteries in just three passes demonstrates the device's capability with complex clot morphology. The avoidance of surgical cutdown translates to significant patient benefits: less anesthesia requirement, reduced surgical site infection risk, and potentially shorter recovery times.

The PROWL registry data showing 79.7% of cases requiring no additional clot removal suggests excellent first-pass efficacy. The 20.3-minute average use time compares favorably to surgical thrombectomy or catheter-directed thrombolysis procedures that can extend to hours.

For clinical practice, having a complete platform spanning 2-10mm vessels with consistent technique across devices simplifies inventory and staff training while providing versatility across a wide range of anatomical presentations, from pedal to iliac vessels.

With the addition of the Pounce™ XL Thrombectomy System, indicated for use in 5.5–10 mm peripheral arteries, the fully mechanical Pounce™ Thrombectomy Platform can now remove thrombi or emboli throughout the lower and upper extremities without aspiration, thrombolysis, or capital equipment

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)-- Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the commercial release of the Pounce™ XL Thrombectomy System, the latest in a suite of Pounce Thrombectomy systems that provide rapid endovascular removal of acute or chronic clot from peripheral arteries.

Intended for removal of thrombi and emboli from peripheral arteries ranging from 5.5–10 mm in diameter, sizes typical of iliac and femoral arteries, the Pounce XL Thrombectomy System complements the Pounce and Pounce LP (Low-Profile) Thrombectomy Systems, which are intended for use in 3.5–6 mm and 2–4 mm peripheral arteries, respectively. With a combined vessel diameter range of 2–10 mm, the Pounce Thrombectomy Platform provides a standalone solution for rapid removal of peripheral arterial thrombi and emboli throughout the lower and upper extremities.

Readily deployable and simple to use, the fully mechanical Pounce Thrombectomy Platform:

• Uses proprietary dual-basket technology to remove acute or chronic peripheral arterial clot without capital equipment
• Is associated with low risk of distal embolization^1,2
• Does not require thrombolytics, optimizing single-session treatment
• Uses no aspiration for clot removal, minimizing blood loss
• Is atraumatic to vessel walls, with low risk of flow-limiting dissection^1,3

The Pounce XL Thrombectomy System has been in limited market release (LMR) since January 2025. Dr. Anna Marjan, a vascular surgeon at Allina Health Mercy Hospital in Coon Rapids, Minnesota, was among the physicians who used the Pounce XL Thrombectomy System during the product’s LMR.

“Removing organized clot from large peripheral arteries without a surgical cutdown can be very challenging,” she said. “In our first use of the Pounce XL Thrombectomy System we were able to extract a large amount of acute and subacute clot from the infrarenal aorta and common iliac arteries in a severely ischemic patient with just 3 passes of the device. Avoiding surgical cutdown reduces the need for general anesthesia and reduces risk of surgical-site infection, which benefits patients. The Pounce Thrombectomy Platform is my first-line, go-to solution for endovascular thrombectomy in peripheral arteries.”

The effectiveness and safety of the Pounce and Pounce LP Thrombectomy Systems are supported by real-world data from the PROWL registry, an open-label, retrospective, multicenter, U.S. study of the Pounce Thrombectomy Platform for the removal of emboli and thrombi in the peripheral arterial vasculature. In an interim analysis¹ of 74 patients with acute, subacute, and chronic⁴ native infrainguinal vessel limb ischemia, average Pounce Thrombectomy Platform use time was 20.3 minutes, with 79.7% of patients receiving no additional clot removal treatment of the target lesion after Pounce Thrombectomy Platform use. Device-related adverse events were limited to one report of flow-limiting dissection.³

“The addition of the Pounce XL Thrombectomy System fulfills our vision of providing a simple, effective platform for removing peripheral arterial blood clots throughout the leg,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “When minutes matter, physicians appreciate the availability of a readily deployable solution with a track record of dependable and safe results. We’re proud of the growing clinical adoption of this product and the benefits it is bringing to limb ischemia patients in need of urgent care.”

About the Pounce Thrombectomy Platform

The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy systems intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. They are intended for use in peripheral arteries 3.5–6 mm, 2–4 mm, and 5.5–10 mm in diameter, respectively.

Described as “grab-and-go” solutions, Pounce Thrombectomy Platform systems are readily deployable and simple to use. The systems are composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.

About Surmodics, Inc.

Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company’s mission is to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the Securities and Exchange Commission.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding our vision of providing a simple, effective platform for removing peripheral arterial blood clots throughout the leg, and Surmodics’ growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

1. Interim results from 74 patients with native infrainguinal vessel limb ischemia. Lyden S. Results of novel non-aspiration mechanical arterial thrombectomy device for acute and chronic lower extremity ischemia: PROWL registry study. 20th annual Leipzig Interventional Course (LINC); January 29, 2025; Leipzig, Germany.
2. No device-related distal embolization requiring surgical procedure or obstructing one of the major downstream vessels >70% (at the end of the procedure) was reported in an interim analysis of 74 patients with native infrainguinal vessel limb ischemia in the PROWL registry.
3. One device-related flow-limiting dissection was reported in an interim analysis of 74 patients with native infrainguinal vessel limb ischemia in the PROWL registry. No device-related distal embolization, perforations, or major bleeding (requiring transfusion) were reported.
4. Acute, subacute, and chronic limb ischemia were defined as time from symptom onset of ≤14 days, 15–28 days, and >28 days, respectively.

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Surmodics Investor Inquiries:

Jack Powell, Investor Relations

ir@surmodics.com

Surmodics Public Relations Inquiries:

pr@surmodics.com

Source: Surmodics, Inc.

FAQ

What are the key features of Surmodics' (SRDX) new Pounce XL Thrombectomy System?

The Pounce XL system uses dual-basket technology for 5.5-10mm arteries, requires no aspiration or thrombolytics, and operates without capital equipment.

What clinical results were reported for the Pounce Thrombectomy Platform in the PROWL registry?

The PROWL registry showed 79.7% of patients needed no additional treatment, with an average use time of 20.3 minutes and only one reported flow-limiting dissection.

What vessel sizes can Surmodics' (SRDX) complete Pounce Thrombectomy Platform treat?

The platform treats vessels from 2-10mm diameter, with Pounce LP (2-4mm), standard Pounce (3.5-6mm), and Pounce XL (5.5-10mm).

When did Surmodics (SRDX) begin the market release of Pounce XL?

The Pounce XL Thrombectomy System has been in market release since January 2025.