ALAMEDA, Calif. – January 17, 2018 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced key events at the upcoming International Stroke Conference 2018 meeting (ISC 2018) to be held January 24-26 at the Los Angeles Convention Center. These events include results from two new clinical studies evaluating the company’s aspiration thrombectomy system for ischemic stroke revascularization.
The results of the independent, prospective, randomized controlled COMPASS Trial (A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach) will be presented by J. Mocco, M.D., M.S., Ichan School of Medicine at Mount Sinai, New York. The multi-center COMPASS Trial compared mechanical thrombectomy with the ADAPT (A Direct Aspiration First Pass Technique) approach to stent retrievers in patients presenting with acute ischemic stroke (AIS) within six hours of symptom onset. The COMPASS Trial planned to enroll approximately 270 patients at up to 20 centers. The presentation is scheduled for Thursday, January 25 from 11-11:12 a.m. PT.
In addition, results of the company-sponsored PROMISE Study (Reperfusion with ADAPT Technique using ACE™68 and ACE64 is Safe and Effective in Large Vessel Occlusions of the Anterior Circulation) will be presented by Peter Schramm, M.D., Universitätsklinikum Schleswig-Holstein, Lübeck, Germany. The PROMISE Study was a prospective, single-arm multi-center study that enrolled 204 patients across 20 European centers using ADAPT with the Penumbra System® as frontline treatment. The presentation is scheduled for Wednesday, January 24 from 6:30-7 p.m. PT.
Attendees will also have the opportunity to learn more about the company’s portfolio of products, including the Penumbra System, Penumbra SMART COIL® System and Artemis™ Neuro Evacuation Device, at Penumbra booth #521 in the Science and Technology Hall.
About COMPASS Trial
The COMPASS Trial: A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach is an independent, prospective, randomized trial that compared mechanical thrombectomy with the ADAPT (A Direct Aspiration First Pass Technique) approach to stent retrievers in patients presenting with acute ischemic stroke (AIS) within six hours of symptom onset. The primary objective of the trial was to show that AIS patients, with appropriate image selection, treated with the ADAPT approach within 6 hours of symptom onset do not have inferior clinical outcomes to those treated with a first-line stent retriever with 90-day global disability assessed via the modified Rankin Scale score (mRS) analyzed using success criteria as mRS 0 to 2. The study planned to enroll 270 patients at up to 20 centers in the U.S., and was funded by the company through a research grant. (Clinicaltrials.gov Identifier: NCT02466893)
About Penumbra’s Neuro Products
Penumbra has a growing portfolio of products for use in a range of neuro procedures:
· The Penumbra System® is a fully integrated system designed specifically for mechanical thrombectomy by aspiration that first received 510(k) clearance by the U.S. Food & Drug Administration in December 2007. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive “vacuum” inside the artery to remove stroke-causing blood clots from the brain safely and effectively. It is intended for use in the revascularization of patients with AIS secondary to intracranial large vessel occlusion. The latest generation of the Penumbra System features the ACE™ Reperfusion Catheters, Hi-Flow Aspiration Tubing, the 3D Revascularization Device™ and Pump MAX™ aspiration pump and accessories. Launched in 2016, the ACE68 Reperfusion Catheter offers outstanding trackability and enables even greater aspiration power for clot removal through its large .068” lumen. Launched in 2017, the 3D Revascularization Device is a next generation stroke device, designed and optimized for aspiration with ACE Reperfusion Catheters.
· Penumbra’s neuro embolization systems are designed to meet the unique challenges of aneurysm coiling, vessel sacrifice and other neurovascular malformations. The Penumbra SMART COIL® is a 10-size, detachable, platinum embolization coil system specifically engineered to offer smooth, controlled coil delivery using the latest innovations in coil design and material science. The Penumbra Coil 400™ is a large-volume, detachable, platinum coil system engineered to offer four times the volume of a 10-size coil to efficiently embolize large aneurysms and other large, complex lesions.
· Artemis™ Neuro Evacuation Device is specifically designed for the controlled evacuation of fluids and tissues from the ventricular system and cerebrum. Artemis is Penumbra’s second generation device, following the introduction of the Apollo System in 2014. Artemis is a minimally invasive surgical tool that utilizes Pump MAX for powerful and controlled hematoma evacuation.
Important Safety Information
Additional information about Penumbra’s products can be located on Penumbra’s website at http://www.penumbrainc.com/healthcare-professionals. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.
About Penumbra
Penumbra, Inc., headquartered in Alameda, Calif., is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra P logo, Penumbra System, ACE, 3D Revascularization Device, MAX, Penumbra SMART COIL, Penumbra Coil 400, and Artemis are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com.
Forward-Looking Statements
Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2016. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.
# # #
Source: Penumbra, Inc.
