Surmodics Announces Successful Early Clinical Use of Pounce™ LP (Low Profile) Thrombectomy System, Designed to Address a Critical, Unmet Need by Facilitating Removal of Thrombi and Emboli Below the Knee

January 22, 2024 at 07:30 AM EST

Addition of a low-profile device to the Surmodics Pounce™ thrombectomy platform allows for efficient clot removal in peripheral arteries ranging from 2 mm to 4 mm, such as those found below the knee

Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced successful early clinical use of the company’s Pounce™ LP (Low Profile) Thrombectomy System. The Pounce LP Thrombectomy System, which received U.S. Food and Drug Administration (FDA) clearance in June 2023, is currently in limited market evaluation (LME), with full commercial launch planned following completion of the LME.

Surmodics’ Pounce Thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee. The Pounce LP System complements the original Pounce Thrombectomy System, introduced in 2021, which is indicated for use in vessels 3.5 mm to 6 mm in diameter.

Dr. Lucas Ferrer Cardona,* a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in Austin, was the first physician to use the Pounce LP System.

“In our first use of the device, the Pounce LP Thrombectomy System performed exceptionally well in helping our team restore blood flow to the foot for a limb-threatened patient,” he said. “Using the device, we promptly removed acute and subacute thrombus from the mid-peroneal artery below the knee with no adjunctive use of thrombolytics and no embolization. Thrombi or emboli in below-the-knee vessels have traditionally been very challenging to remove. I believe this device holds great promise in filling a major gap in our treatment algorithm.”

Dr. Elizabeth Genovese, a vascular surgeon at the Hospital of the University of Pennsylvania who has experience using the original Pounce System, is among several other satisfied early users of the Pounce LP System. She recently deployed the Pounce LP device to revascularize a patient with arterial occlusions in both the anterior tibial and peroneal arteries.

“The Pounce LP System allowed me to treat chronic thrombus in these vessels with the effectiveness I’d expect from open surgical Fogarty embolectomy while maintaining the advantages of an endovascular approach for treating underlying and distal disease,” she said. “We were able to achieve an optimal outcome in a very complex lesion, and this type of result would not have been possible without this device.”

“We’re very pleased with the successful early clinical use of the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic clots from the iliac arteries in the pelvis down to tibial vessels below the knee,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “Downstream embolization of chronic material into below-the-knee arteries during an endovascular procedure can be an interventionist’s nightmare, sometimes requiring surgical rescue. The Pounce LP System’s ability to capture and remove these unexpected emboli adds yet more value to this device for BTK revascularization.”

About the Pounce Thrombectomy Platform

The Pounce System is the first mechanical thrombectomy device designed to remove acute-to-chronic thrombi and emboli in occluded peripheral arteries without the need for capital equipment or aspiration and minimizing the use of thrombolytics. Described as a “grab-and-go” solution, the Pounce System is both readily deployable and simple to use. The System is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered 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. The Pounce Thrombectomy platform includes two different-sized devices: the original Pounce™ Thrombectomy System, indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in diameter, and the Pounce LP (Low Profile) Thrombectomy System, indicated for use in peripheral arterial vessels 2 mm to 4 mm in diameter.

In a retrospective study 3 of 44 consecutive patients treated for lower extremity limb ischemia with suspected thrombus using the original Pounce System (acute, subacute, and chronic clot), investigators achieved 83% success in effectively removing thrombus from the arterial segments in which the device was used. Adjunctive thrombolysis was used to resolve thrombus at a Pounce System treatment site in just 5.6% (2 of 44) cases.

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 what the Pounce LP Thrombectomy System is designed to address, the planned full commercial launch of the product, the promise of the product, and Surmodics’ 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 results of the limited market evaluation of the Pounce LP Thrombectomy System, adoption of the product, and 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, 2023, 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.

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* Consultant for Surmodics

Gray BH, Wheibe E, Dicks AB, Low ML, Tingen JS. Pounce Thrombectomy System to Treat Acute and Chronic Peripheral Arterial Occlusions. Ann Vasc Surg. 2023;96:104-114.