Pounce™ Thrombectomy System First-in-Human Data Show 100 Percent Technical Success in Early Cases

Rhea-AI Summary

Surmodics, Inc. (NASDAQ: SRDX) announced the successful results of its Pounce™ Thrombectomy System in 20 First-in-Human procedures, achieving 100% technical success. The procedures, presented by Dr. Gary Ansel in London, showed that 19 of 20 patients did not require thrombolytics. The average procedure lasted 79.6 minutes, targeting a range of clot types, predominantly in the superficial femoral and popliteal arteries. This device aims to provide a non-surgical solution for peripheral artery disease, potentially revolutionizing treatment options.

Positive

• 100% technical success in 20 First-in-Human procedures.
• 19 of 20 patients avoided the use of thrombolytics.
• Average procedure time of 79.6 minutes.
• Device designed to address unmet clinical needs in treating PAD.

Negative

• None.

Thrombolytics in target lesion were not used for 19 of 20 patients treated with next-generation mechanical arterial thrombectomy device

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, announced today that its Pounce™ Thrombectomy System achieved 100 percent technical success in 20 First-in-Human (FIH) procedures. The FIH data was presented Tuesday by Dr. Gary Ansel at the Charing Cross International Symposium in London.

Technical success was defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device. Ansel, the inventor of the Pounce Thrombectomy System and a consultant for Surmodics, also revealed that 19 of the 20 procedures were able to avoid the use of thrombolytics in the target lesion. The FIH cases were performed across six U.S. medical centers, with the first use of the FDA-cleared system occurring in June 2021.

“The Pounce™ Thrombectomy System demonstrated technical success in these early clinical cases, showing an ability to quickly deal with a wide range of clot from soft to organized, including emboli in the peripheral arterial vasculature,” said Ansel. “This fully mechanical thrombectomy device has no power unit or other capital equipment requirement, making it easy to use and efficient for physicians to treat patients with complex peripheral artery disease (PAD).”

Average procedure time in the FIH cases was 79.6 minutes and the average lesion length measured 109 mm (range 5-300 mm). Clinical presentation time ranged from one hour to eight months, with 30 percent of cases involving acute on chronic clot. Chronic clot (25 percent), acute clot (25 percent) and subacute (15 percent) was also removed. Five percent of cases did not indicate clot classification. The superficial femoral artery was the most common vessel treated (50 percent) while 40 percent of the cases involved the popliteal artery.

“I appreciate the ease of use, the avoidance of thrombolytic therapy, and the ability to rapidly resolve limb ischemia,” said Dr. Bruce Gray, DO, MSVM, a physician who performed cases included in the FIH data. “These characteristics make it my go-to strategy to treat acute limb ischemia. It takes only one case to realize the profound impact the Pounce Thrombectomy System provides to patients.”

The intuitive ‘grab and go’, non-aspiration, mechanical thrombectomy solution empowers physicians to strike quickly to capture and remove clot from the peripheral vasculature without requiring external capital equipment for operation. The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

“The Pounce Thrombectomy System has the potential to revolutionize the treatment algorithm for arterial thrombectomy,” said Gary Maharaj, Surmodics CEO. “By providing peripheral interventionalists with an innovative, non-surgical tool for treating arterial thrombotic occlusions with a single session device designed to achieve an on-table result, this device will serve an important clinical need while advancing therapies for PAD.”

The Pounce Thrombectomy device is comprised of three components: a 5 Fr 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 a nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is withdrawn and removed from the body.

For more information on the Pounce Thrombectomy System, visit www.pouncesystem.com.

About Peripheral Artery Disease (PAD)

Worldwide, over 200 million people have PAD¹, a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve to 20 percent of Americans over 60 years old have PAD², which increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.³ The 5-year mortality rate after nontraumatic major amputations of the lower extremity is estimated to range from 52% to 80%.⁴

About Surmodics, Inc.

Surmodics is a leading provider of surface modification technologies for intravascular medical devices and chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated 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 technologies, along with enhanced device design, development, and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com.

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about the potential of the Pounce Thrombectomy System and the company’s 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, 2021, 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.

References:

1. Fowkes FG, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40.

2. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.

3. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web.

4. Thorud JC, Plemmons B, et al. Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review. J Foot Ankle Surg. 2016 May-June; 55(3):591-9.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220427005288/en/

Surmodics, Inc.

Tim Arens, 952-500-7000

ir@surmodics.com

Source: Surmodics, Inc.

FAQ

What were the results of Surmodics' Pounce Thrombectomy System First-in-Human procedures?

The Pounce Thrombectomy System achieved 100% technical success in 20 procedures, with 19 patients not requiring thrombolytics.

How long did the procedures using the Pounce Thrombectomy System take?

The average procedure time was 79.6 minutes.

What medical condition does the Pounce Thrombectomy System target?

It targets peripheral artery disease (PAD) by removing thrombi and emboli from the peripheral arterial vasculature.

Who presented the First-in-Human data for the Pounce Thrombectomy System?

Dr. Gary Ansel presented the data at the Charing Cross International Symposium in London.

What is the significance of the Pounce Thrombectomy System's performance?

Its performance indicates a potential revolution in the treatment algorithm for arterial thrombectomy, making it easier for physicians to treat PAD.