First Patient Enrolled in Penumbra's FORWARD Study Evaluating Mechanical Thrombectomy and Computer Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke

Rhea-AI Summary

Penumbra (NYSE:PEN) enrolled the first patient in FORWARD, an international, real‑world, prospective multi-center study evaluating mechanical thrombectomy, including computer assisted vacuum thrombectomy (CAVT) and modulated aspiration, for distal acute ischemic stroke.

The study will enroll up to 250 patients at about 40 sites and assess Penumbra’s RED reperfusion catheter portfolio, including the THUNDERBOLT CAVT platform, which has CE Mark and FDA clearance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Positive

• Initiation of FORWARD real-world multi-center study for distal ischemic stroke
• Planned enrollment of up to 250 participants at approximately 40 sites
• Study evaluates Penumbra’s RED reperfusion catheter portfolio for M2 occlusions
• Inclusion of THUNDERBOLT, first CAVT platform with modulated aspiration for stroke
• THUNDERBOLT holds both CE Mark and FDA clearance for neuro thrombectomy

Negative

• FORWARD is at an early stage with only the first patient enrolled
• Clinical outcomes for mechanical thrombectomy in distal and M2 occlusions remain unproven in this study

What This Means

Launching the FORWARD study, targeting up to 250 patients with distal acute ischemic stroke, extends...

Analysis

Launching the FORWARD study, targeting up to 250 patients with distal acute ischemic stroke, extends THUNDERBOLT’s CAVT footprint into real-world evidence. Investors may track enrollment progress and eventual outcomes against a sizeable stroke population of 11.9 million new annual cases amid modest, mixed reactions to past product news.

Key Figures

Planned enrollment: up to 250 participants Study sites: approximately 40 sites New stroke cases: 11.9 million +4 more

7 metrics

Planned enrollment up to 250 participants FORWARD distal acute ischemic stroke study

Study sites approximately 40 sites FORWARD multi-center, real-world study

New stroke cases 11.9 million Global new stroke cases in 2021

People living with stroke effects 94 million Global long-term stroke impact

Distal vessel occlusions share 25–40 percent Portion of acute ischemic strokes

M2 occlusions share 3–7% Estimated share of acute ischemic strokes

Annual M2 strokes 21,000–66,000 Estimated annual M2 occlusion strokes

Historical Context

5 past events · Latest: Jun 15 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 15	Device approval news	Positive	-0.2%	CE Mark in Europe for THUNDERBOLT CAVT stroke system following FDA clearance.
Jun 11	FDA clearance	Positive	+0.1%	U.S. FDA clearance for THUNDERBOLT CAVT platform for acute ischemic stroke.
May 06	Q1 2026 earnings	Neutral	+0.1%	Double-digit revenue growth with strong thrombectomy and embolization segments.
Apr 13	Clinical trial data	Positive	+0.5%	STORM-PE trial showed better 90-day outcomes for CAVT plus anticoagulation.
Feb 25	FY25 earnings	Neutral	-0.3%	Strong Q4 and full-year revenue growth ahead of proposed Boston Scientific deal.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent device, data, and earnings headlines have produced only modest, mixed single-day moves, even on clearly positive news.

Regulatory & Risk Context

Short Interest: 5.21%

Short Interest

5.21% of float

0% 15% 30%+

low as of 2026-06-15 Days to cover: 4.61

Reported short interest appears relatively low, suggesting limited short-squeeze dynamics and a volatility profile more likely driven by fundamentals and deal-related developments than by positioning extremes.

Key Terms

mechanical thrombectomy, computer assisted vacuum thrombectomy, acute ischemic stroke, ce mark, +1 more

5 terms

mechanical thrombectomy medical

"The study will collect safety and efficacy data on mechanical thrombectomy"

A mechanical thrombectomy is a medical procedure that removes a blood clot from a blocked blood vessel using a tiny device threaded through the blood system, like using a miniature snare or vacuum to clear a clogged pipe. It matters to investors because the procedure’s availability, success rates and device costs affect hospital spending, demand for specialized medical devices and reimbursement decisions, all of which influence the financial outlook for healthcare providers and manufacturers.

computer assisted vacuum thrombectomy medical

"including computer assisted vacuum thrombectomy (CAVT™) and modulated aspiration"

A computer assisted vacuum thrombectomy is a medical procedure that uses image guidance and computerized controls to steer a suction device and remove blood clots from blood vessels. Think of it as a powered vacuum with GPS that targets and extracts a clog while minimizing damage to the surrounding vessel. Investors care because adoption affects sales for device makers, hospital procedure volumes, patient outcomes, and reimbursement and can shift market demand in vascular and interventional care.

acute ischemic stroke medical

"in the management of acute ischemic stroke with distal occlusions"

A sudden interruption of blood flow to a part of the brain that causes rapid loss of movement, speech, vision or other functions — like a blocked pipe cutting water to one room of a house. It matters to investors because its frequency, available treatments, medical devices and drug approvals drive health-care spending, influence the fortunes of biotech and device makers, and can quickly change revenue and regulatory risk profiles for companies in the sector.

ce mark regulatory

"THUNDERBOLT recently received CE Mark and FDA clearance"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

fda clearance regulatory

"THUNDERBOLT recently received CE Mark and FDA clearance"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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ALAMEDA, Calif., July 7, 2026 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced the initiation of its FORWARD study, an international, real world prospective, multi-center study. The study will collect safety and efficacy data on mechanical thrombectomy, including computer assisted vacuum thrombectomy (CAVT™) and modulated aspiration, in the management of acute ischemic stroke with distal occlusions. The first patient was treated by Keith Woodward, M.D., neurointerventional radiologist at Vista Radiology in Knoxville, Tenn.  

"Distal occlusions are among the more difficult strokes to treat as medical interventions for patients in this population have historically provided limited benefit," said Nitin Goyal, M.D., co-principal investigator of FORWARD and endovascular neurologist at Semmes-Murphey Neurologic and Spine Institute in Memphis, Tenn. "FORWARD is a prospective study designed to evaluate whether that paradigm can change. Mechanical thrombectomy has an established safety profile and a strong track record in treating large vessel occlusions. With the latest advancements designed for navigating deeper into the brain, the FORWARD study aims to determine whether these same benefits can extend to distal occlusions and help pave the way for an important treatment option for a patient population that has limited choices."

FORWARD (Functional Outcomes in Real‑World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions) will enroll up to 250 participants at approximately 40 sites. The objective of the study is to evaluate Penumbra's market-leading RED reperfusion catheter portfolio, which includes THUNDERBOLT, the first CAVT platform to deliver modulated aspiration for acute ischemic stroke, to address M2 occlusions. The study will include patients treated with medical management alone and those treated with mechanical thrombectomy and medical management.

"Enrolling the first patient in FORWARD is an important milestone in understanding the true impact of mechanical thrombectomy on distal occlusions," said Alex Spiotta, M.D., co-principal investigator of FORWARD and chief of the neurosurgery department and director of neuroendovascular surgery at the Medical University of South Carolina. "We have already seen how mechanical thrombectomy can positively benefit patients with acute ischemic stroke by rapidly restoring blood flow to the brain and improve patient outcomes. The results of this study will help inform physicians on treatment selection for stroke patients with M2 occlusions, potentially supporting wider adoption of mechanical thrombectomy for this challenging condition."

Stroke remains the third leading cause of death and disability globally, with approximately 11.9 million new cases in 2021 and about 94 million people living with its long-term effects.¹ Distal vessel occlusions account for roughly 25-40 percent of acute ischemic strokes^2,3 and studies estimate M2 occlusions occur in about 3-7% of acute ischemic stroke,^4,5 or approximately 21,000-66,000 M2 strokes annually.⁶

"FORWARD will deepen the medical community's understanding of how mechanical thrombectomy, specifically our latest catheter and CAVT technology, can more effectively address the complexity of M2 stroke," said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. "Penumbra's commitment to clinical research offers more insight into how our innovations translate to real-world patient outcomes, reinforcing our mission to develop the most meaningful treatment options for challenging medical conditions."

THUNDERBOLT recently received CE Mark and FDA clearance. It introduces modulated aspiration to Penumbra's neuro thrombectomy portfolio, offering advanced CAVT technology designed to detect, fatigue, and completely ingest clot at the site of the occlusion.

About Penumbra
Penumbra, Inc., the world's leading thrombectomy company, is focused on developing the most innovative technologies for challenging medical conditions such as ischemic stroke, venous thromboembolism such as pulmonary embolism, and acute limb ischemia. Our broad portfolio, which includes computer assisted vacuum thrombectomy (CAVT), centers on removing blood clots from head-to-toe with speed, safety and simplicity. By pioneering these innovations, we support healthcare providers, hospitals and clinics in more than 100 countries, working to improve patient outcomes and quality of life. For more information, visit www.penumbrainc.com and connect on Instagram, LinkedIn and X.

Important Safety Information
Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/providers. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Please visit www.peninc.info/risk for the complete IFU Summary Statements.

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: the risk that the pending acquisition by Boston Scientific Corporation will not be completed in the expected timeframe or at all, including the risk that required regulatory approvals will not be obtained; potential adverse effects to our business during the pendency of the acquisition, such as employee departures or diversion of management's attention from our business; 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 or other assets; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; potential adverse regulatory actions; and the potential impact of any acquisitions, mergers, dispositions, joint ventures or investments we may make. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2025, which we filed on February 25, 2026. 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.

Contact
Jennifer Heth		Parinaz Farzin
Penumbra, Inc.		Merryman Communications
jheth@penumbrainc.com		parinaz@merrymancommunications.com
510-995-9791		310.600.6746

 

1. GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. Oct 2024;23(10):973-1003. doi:10.1016/s1474-4422(24)00369-7
2. Ospel JM, Nguyen TN, Jadhav AP, et al. Endovascular Treatment of Medium Vessel Occlusion Stroke. Stroke. Mar 2024;55(3):769-778. doi:10.1161/strokeaha.123.036942
3. Saver JL, Chapot R, Agid R, et al. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. Sep 2020;51(9):2872-2884. doi:10.1161/strokeaha.120.028956
4. Rai AT, Domico JR, Buseman C, et al. A population-based incidence of M2 strokes indicates potential expansion of large vessel occlusions amenable to endovascular therapy. J Neurointerv Surg. Jun 2018;10(6):510-515. doi:10.1136/neurintsurg-2017-013371
5. Duloquin G, Graber M, Garnier L, et al. Incidence of Acute Ischemic Stroke With Visible Arterial Occlusion: A Population-Based Study (Dijon Stroke Registry). Stroke. Jul 2020;51(7):2122-2130. doi:10.1161/strokeaha.120.029949
6. Rai AT, Link PS, Domico JR. Updated estimates of large and medium vessel strokes, mechanical thrombectomy trends, and future projections indicate a relative flattening of the growth curve but highlight opportunities for expanding endovascular stroke care. J Neurointerv Surg. Dec 21 2023;15(e3):e349-e355. doi:10.1136/jnis-2022-019777

 

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SOURCE Penumbra, Inc.

FAQ

What is Penumbra’s FORWARD study announced on July 7, 2026 (NYSE:PEN)?

FORWARD is a prospective, real-world, multi-center study evaluating mechanical thrombectomy, including CAVT, for distal acute ischemic stroke. According to Penumbra, it will assess safety and efficacy of treatments for patients with distal occlusions.

How many patients and sites are planned in Penumbra’s FORWARD stroke study (PEN)?

FORWARD plans to enroll up to 250 participants at approximately 40 sites. According to Penumbra, this international, real-world design aims to generate broad safety and efficacy data for distal acute ischemic stroke treatments.

Which devices are being evaluated in Penumbra’s FORWARD study for M2 occlusions?

FORWARD will evaluate Penumbra’s RED reperfusion catheter portfolio, including the THUNDERBOLT CAVT platform. According to Penumbra, THUNDERBOLT introduces modulated aspiration designed to detect, fatigue and ingest clot at the occlusion site.

What is THUNDERBOLT in Penumbra’s neuro thrombectomy portfolio (NYSE:PEN)?

THUNDERBOLT is Penumbra’s CAVT platform that delivers modulated aspiration for acute ischemic stroke. According to Penumbra, it recently received CE Mark and FDA clearance and is designed to improve clot removal at the occlusion site.

Why is Penumbra studying mechanical thrombectomy for distal and M2 stroke occlusions?

Penumbra is studying this because distal occlusions have historically seen limited benefit from existing medical interventions. According to Penumbra, FORWARD aims to determine whether mechanical thrombectomy benefits for large vessels can extend to distal and M2 occlusions.

How could Penumbra’s FORWARD study impact treatment decisions for M2 stroke patients?

FORWARD may provide data to guide treatment selection for stroke patients with M2 occlusions. According to Penumbra, results could inform wider adoption of mechanical thrombectomy if safety and efficacy are demonstrated in this challenging patient population.