Penumbra (PEN) Announces Completion of Enrollment in STORM-PE Clinical Trial

Penumbra, Inc. (NYSE:PEN) is one of the 11 Best Mid-cap Healthcare Stocks to Buy According to Hedge Funds. The company announced the completion of enrollment in STORM-PE clinical trial. The pivotal, prospective, multi-center randomized controlled trial has enrolled 100 patients in order to evaluate computer assisted vacuum thrombectomy (CAVT) through utilising Penumbra’s Lightning Flash™ plus anticoagulation, versus anticoagulation alone, for treating acute intermediate-high risk pulmonary embolism (PE).

An operating theatre showcasing medical solutions from the company.

In the US, an estimated 900,000 cases of symptomatic PE take place annually. Pulmonary embolism could be life-threatening, with 10% – 30% of individuals dying within 1 month of diagnosis. Penumbra, Inc. (NYSE:PEN)’s Lightning Flash portfolio happens to be the most advanced mechanical thrombectomy system on the market, focused on addressing venous and pulmonary thrombus. Penumbra, Inc. (NYSE:PEN)’s gross profit for Q1 2025 came in at $215.9 million, or 66.6% of total revenue, compared to $181.1 million, or 65.0% of total revenue, for Q1 2024. This improvement in gross margin was mainly because of favorable product mix throughout the regions and productivity improvements.

Penumbra, Inc. (NYSE:PEN) increased its guidance for the U.S. Thrombectomy franchise growth to 20% – 21% YoY from 19% – 20% previously. It reiterated the guidance for gross margin expansion of a minimum of 100 bps in 2025, to over 67% for FY 2025. Baron Funds, an investment management company, released its Q1 2025 investor letter. Here is what the fund said:

“We initiated a position in Penumbra, Inc. (NYSE:PEN), a leading manufacturer of medical devices that remove blood clots from veins and arteries. Physicians use the company’s devices to treat pulmonary embolism (PE), deep vein thrombosis (DVT), acute limb ischemia, ischemic stroke, coronary disease, and other conditions. Penumbra’s devices, which are called mechanical thrombectomy devices, use computer algorithms to modulate the aspiration power depending on if a clot is detected and to control a separate valve that injects saline to reduce friction between the clot and catheter. This enables a differentiated device profile that maximizes clot removal with speed while decreasing risk of blood loss.

Penumbra serves large and underpenetrated markets. Management estimates the U.S. thrombectomy market opportunity consists of roughly 1.25 million annual procedures, including roughly 200,000 in stroke and over 1 million in PE, DVT, arterial, and coronary. The PE and DVT markets are only 10% penetrated with mechanical thrombectomy devices. Most PE patients currently receive conservative medical management with oral anticoagulation alone. Penumbra is running randomized clinical trials studying mechanical thrombectomy versus anticoagulation for PE patients. If the trials are positive, the market could shift towards greater adoption of mechanical thrombectomy. Meanwhile, Penumbra is gaining market share in PE and DVT. In stroke, the company’s new Thunderbolt device, which incorporates its computer assisted vacuum thrombectomy technology into the stroke market for the first time, could receive FDA approval and launch later this year, providing a potential catalyst for growth.”

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Disclosure: None. This article is originally published at Insider Monkey.