Penumbra Enrolls First Patient for Study on Coronary Vessels

Penumbra, Inc. PEN recently announced enrollment of the first patient into its CHEETAH study. The multi-center U.S. study aims to assess safety and performance of the Indigo System with CAT RX Aspiration Catheter in coronary vessels. The company’s Aspiration Catheter was launched in 2018 as part of the Indigo Aspiration System.

Per management, the study is expected to inform researchers of the potential outcome after the removal of clot on patients with high thrombus burden. The company has been working on addressing the limitation of traditional manual aspiration for the coronaries by increasing experience in neuro thrombectomy and subsequently developing the Indigo System CAT RX device.

With the successful completion of the study, the company aims to solidify its position in the global endovascular interventions and percutaneous coronary intervention (“PCI”) market.

 

Few Words About Indigo System

The Indigo System was introduced in 2014 and was designed to remove clot from arteries and veins in the peripheral vasculature. It uses the company’s ENGIN aspiration source to perform its role of addressing thrombus in vessels of various sizes.

The Indigo CAT RX Aspiration Catheters and Indigo Separator 4, which are parts of the broader Indigo System, are aimed at the removal of fresh and soft emboli, and thrombi from vessels in the coronary and peripheral vasculature system.

Significance of the Study

The Indigo System CAT RX device uses mechanical power aspiration to remove thrombus in the coronaries. The post-market prospective CHEETAH study is expected to enroll around 400 patients with coronary thrombus for PCI at various centers.

The primary endpoint of the study is the composition of cardiovascular (CV) death, recurrent myocardial infarction (MI), cardiogenic shock or new or worsening New York Heart Association (NYHA) Class IV heart failure within 30 days. The secondary goal is to include the final TIMI flow grade, final TIMI thrombus grade and safety assessments after six months.

The company believes that the CHEETAH study is the stepping stone to make coronary mechanical thrombectomy the standard treatment for patients with high thrombus burden.

Industry Prospects

Per a report by Market Research Future, the global PCI market is expected to see a CAGR of 7.1%, reaching $15,205.4 million by 2023. The key factors driving the market are the rising occurrence of cardiac diseases, increasing preferences for minimally invasive procedures and growing elderly population, which is more susceptible to these diseases.

Given the huge potential in this market, the enrollment for the study has come at the right time.

Recent Developments

Of late, the company has made certain developments in its cardiovascular care.

Penumbra commercially launched its latest technology — the Penumbra JET 7 Reperfusion Catheter with XTRA FLEX technology — in July this year. The system is supposed to be used with the ENGINE platform of the integrated Penumbra System (which is an aspiration-based mechanical thrombectomy system) that will help clinicians to remove thrombus in patients with acute ischemic stroke.

Price Performance

The company’s shares have gained 4.2% in the past year against the industry’s decline of 2.6%. However, the S&P 500 index rose 5.4% during the same period.

Zacks Rank & Key Picks

Currently, Penumbra carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the broader medical space are Conatus Pharmaceuticals Inc CNAT, GW Pharmaceuticals PLC GWPH and Stryker Corporation SYK.

Conatus, currently sporting a Zacks Rank #1 (Strong Buy), has projected third-quarter 2019 earnings growth rate at 30.8%. You can see the complete list of today’s Zacks #1 Rank stocks here.

GW Pharmaceuticals estimates third-quarter earnings growth rate to be 70.2%. It currently carries a Zacks Rank #2 (Buy).

Stryker, with a Zacks Rank #2, has projected third-quarter earnings growth rate of 12.4%.

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