Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) announced on December 18, 2025 that the U.S. Food and Drug Administration approved an expanded indication for the TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) to treat symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery.

The approval is supported by the randomized MEMBRANE trial, which showed TRUFILL n‑BCA was superior in effectiveness to standard of care and was demonstrated to be safe for cSDH. TRUFILL n‑BCA has been used in neurovascular embolization for over 25 years, with original FDA approval in 2000.

Positive

• FDA expanded indication for MMA embolization in symptomatic cSDH
• MEMBRANE RCT showed TRUFILL n‑BCA superior to standard of care
• Clinical data in MEMBRANE indicated TRUFILL n‑BCA was safe
• Product has over 25 years of neurovascular clinical use (since 2000)

Negative

• New indication is as an adjunct to surgery, not a standalone replacement
• cSDH surgical recurrence estimates remain 10%–20% after intervention

Key Figures

Recurrence rate 10%–20% Estimated recurrence after traditional surgical treatment of cSDH

Time in use Over 25 years TRUFILL n‑BCA use in neurovascular embolization

Original FDA approval year 2000 Initial U.S. approval of TRUFILL n‑BCA for AVMs

Market Reality Check

$206.37 Last Close

Volume Volume 8,423,697 is about in line with the 20-day average of 9,384,997. normal

Technical Price at 210.33 is trading above the 200-day MA of 172.01, reflecting a longer-term uptrend.

Peers on Argus

JNJ gained 0.49% while key peers were mixed: ABBV up 0.19%, but AZN, LLY, NVS, and NVO declined between -0.23% and -2.12%, pointing to a stock-specific reaction to the FDA approval.

Common Catalyst Two peers, LLY and AZN, also issued oncology-related updates today, but their mixed price moves suggest no broad sector-wide momentum.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 15	Investor conference call	Neutral	-2.3%	Q4 earnings call scheduling coincided with a notable one-day share decline.
Dec 12	FDA drug approval	Positive	+1.2%	AKEEGA approval in BRCA2-mutated mCSPC with strong Phase 3 efficacy data.
Dec 09	Phase 3 results	Positive	-0.8%	MajesTEC-3 multiple myeloma data showed major survival benefits vs standard care.
Dec 08	Conference participation	Neutral	-0.8%	Announcement of J.P. Morgan Healthcare Conference appearance linked with a small drop.
Dec 05	Phase 2b data	Positive	-0.1%	INLEXZO bladder cancer data showed strong disease-free and survival outcomes.

Pattern Detected

Across recent news, JNJ often shows muted or negative moves even on positive clinical and FDA milestones, with only one of five events showing a clearly positive, aligned reaction.

Recent Company History

Over the past few months, Johnson & Johnson reported multiple pipeline and regulatory milestones. On Dec 12, an FDA approval for AKEEGA in BRCA2-mutated mCSPC saw a +1.22% move, while strong MajesTEC-3 Phase 3 data on Dec 9 and INLEXZO Phase 2b bladder cancer results on Dec 5 were followed by modest declines. Conference and event announcements on Dec 15 and Dec 8 also coincided with negative returns, indicating investors have not consistently rewarded positive news.

Market Pulse Summary

This announcement adds an FDA-approved indication for TRUFILL n‑BCA in treating symptomatic subacute and chronic subdural hematoma via middle meningeal artery embolization. It builds on more than 25 years of neurovascular use and follows several 2025 approvals across oncology and other areas. Investors may watch real-world adoption, recurrence outcomes versus the historical 10%–20% surgical rate, and further trial readouts supporting broader neurovascular applications.

Key Terms

embolization medical

"TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery"

Embolization is a medical procedure that deliberately blocks a blood vessel to stop bleeding, shrink or cut off blood flow to an abnormal growth, or redirect circulation. Think of it like plugging a leaky pipe or turning off a faucet to stop water flow; doctors thread a tiny device or material through blood vessels to the target site. Investors care because embolization involves specialized devices, imaging tools and drugs whose sales, regulatory approvals and clinical outcomes can materially affect healthcare company revenues and valuation.

middle meningeal artery medical

"for embolization of the middle meningeal artery (MMA) for the treatment"

A middle meningeal artery is a key blood vessel that supplies the protective layers covering the brain; think of it as a garden hose delivering blood to the brain’s outer lining. It matters to investors because damage or disease involving this artery can drive demand for medical devices, imaging, surgical treatments and drugs, affect clinical trial risks, and influence regulatory or liability outcomes tied to neurological care.

chronic subdural hematoma medical

"for the treatment of symptomatic subacute and chronic Subdural Hematoma (cSDH)"

A chronic subdural hematoma is a slow-growing collection of old blood that gathers between the brain and its outer covering, often after a minor head bump, and gradually presses on the brain like a slowly inflating balloon. It matters to investors because it drives demand for medical procedures, devices and hospital care, influences treatment costs and reimbursement, and affects the market for drugs or technologies aimed at older patients or brain injury care.

endovascular medical

"offers a minimally invasive endovascular approach by targeting smaller brain vessels"

Endovascular describes medical procedures performed inside blood vessels using thin tubes, wires, and implantable devices guided by imaging—like repairing a broken pipe from the inside rather than opening the wall. It matters to investors because these less-invasive techniques can shorten hospital stays, lower complication rates and create demand for specialized devices and imaging equipment, so changes in adoption, regulation or reimbursement can materially affect healthcare company revenues and margins.

arteriovenous malformations medical

"supporting the treatment of patients with arteriovenous malformations (AVMs)"

Arteriovenous malformations are abnormal tangles of blood vessels where arteries connect directly to veins, bypassing the normal tiny capillaries; think of a shortcut that disrupts normal traffic flow and can cause bleeding or reduced oxygen delivery. Investors care because treatments, surgeries, imaging and long-term care create demand for medical devices, drugs and specialized services, and breakthroughs or trial results can affect healthcare costs, insurer liabilities and the fortunes of related companies.

anticoagulation therapy medical

"particularly among older adults and those on anticoagulation therapy."

Anticoagulation therapy uses medicines often called blood thinners to reduce the blood’s ability to clot, lowering the risk of strokes, heart attacks, and dangerous clots after surgery or in chronic conditions. For investors, these therapies matter because their effectiveness, safety, regulatory approvals, and insurance coverage drive demand, affect healthcare costs, and influence the financial prospects and valuation of companies that develop, manufacture, or market these drugs.

randomized controlled trial medical

"supported by findings from the MEMBRANE randomized controlled trial, which evaluated"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

standard of care medical

"demonstrated that TRUFILL n-BCA is superior in effectiveness compared to Standard of Care"

Standard of care is the accepted medical treatment or clinical approach that most qualified doctors would use for a given condition today, based on available evidence, guidelines and common practice. For investors, it acts like the baseline product customers expect: a new therapy or device must match or improve on the standard of care to win market share, gain reimbursement and limit legal or regulatory risk.

AI-generated analysis. Not financial advice.

- TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery.
- Approval builds on a trusted solution in neurovascular embolization for over 25 years.

IRVINE, Calif., Dec. 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (cSDH) as an adjunct to surgery.

cSDH is often caused by minor head trauma that leads to bleeding between the dura and arachnoid membranes, particularly among older adults and those on anticoagulation therapy. While surgical intervention is the traditional standard of care, recurrence rate estimates range between 10% to 20%.  Embolization of the MMA offers a minimally invasive endovascular approach by targeting smaller brain vessels thought to contribute to hematoma persistence and regrowth.¹

The approval is supported by findings from the MEMBRANE randomized controlled trial, which evaluated the safety and effectiveness of MMA embolization in patients with cSDH². The results of the MEMBRANE study demonstrated that TRUFILL n-BCA is superior in effectiveness compared to Standard of Care (SOC) for embolization in the MMA for the treatment of symptomatic cSDHⁱ, and importantly, TRUFILL n-BCA was demonstrated to be safe for treating cSDH².

"This approval reinforces the enduring value of TRUFILL n-BCA and our commitment to delivering innovative technologies that improve outcomes for patients and address complex neurovascular conditions," said Christian Cuzick, President, Worldwide Neurovascular, Johnson & Johnson MedTech.

"There is an unmet need for new treatment options for chronic subdural hematoma, particularly for patients at risk of recurrence or complications from surgery," said Dr. Chris Kellnerⁱⁱ, Director of Cerebrovascular & Intercerebral Hemorrhage programs, Mount Sinai, and investigator in the MEMBRANE trial. "The MEMBRANE study demonstrated a positive treatment effect in favor of TRUFILL over standard of care and reinforces the potential of MMA embolization to improve outcomes for patients with cSDH."

TRUFILL n-BCA has been a trusted solution in neurovascular embolization for over 25 years, supporting the treatment of patients with arteriovenous malformations (AVMs) since its original FDA approval in 2000. This expanded indication brings TRUFILL n-BCA's established performance into the treatment of cSDH, a condition where traditional surgical interventions may not always be suitable or effective for long-term control.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information, visit https://www.jnjmedtech.com/en-US/companies/cerenovus and connect on LinkedIn.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. DePuy Synthes Sales, Inc. d/b/a CERENOVUS and Medical Device Business Services, Inc. are part of Johnson & Johnson MedTech. 

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TRUFILL^TM n-BCA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

US_NEU_HEMO_410468
(c) Johnson & Johnson and its affiliates 2025

ⁱ As assessed in MEMBRANE study by the primary effectiveness endpoint of residual or re-accumulation of the cSDH (>10 mm) at 6 months (by an Independent Core Laboratory) or re-operation or surgical procedure on the cSDH within 6 months - OR 0.475 (95% CI 0.239 - 0.944) in Surgical cohort.
ⁱⁱ Dr. Chris Kellner serves as a consultant for Johnson & Johnson but was not compensated for this announcement

¹ Nouri A, Gondar R, Schaller K, Meling T (2021) Chronic Subdural Hematoma (cSDH): A review of the current state of the art. Brain Spine 1 100300.
² Siddiqui F, Al-Mufti F, Dodson V, et al. Consensus Statement on Middle Meningeal Artery Embolization in Chronic Subdural Hematoma Treatment: A Guideline from the Society of Vascular and Interventional Neurology Guidelines and Practice Standards Committee. Stroke: Vascular and Interventional Neurology. 2025;1(1):1-15. Doi:10.1161/SVIN.125.001814.

Media contact:
James Alley
Jalley1@its.jnj.com

Investor Contact:
investor-relations@its.jnj.com  

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SOURCE Johnson & Johnson MedTech

FAQ

What did Johnson & Johnson (JNJ) announce on December 18, 2025 about TRUFILL n‑BCA?

The company announced FDA approval to expand TRUFILL n‑BCA for MMA embolization to treat symptomatic subacute and chronic subdural hematoma as an adjunct to surgery.

What evidence supported the FDA approval for TRUFILL n‑BCA (JNJ)?

Approval was supported by the randomized MEMBRANE trial, which found TRUFILL n‑BCA superior to standard of care and demonstrated safety for cSDH.

Does the TRUFILL n‑BCA approval (JNJ) replace surgery for chronic subdural hematoma?

No — the approval is indicated for MMA embolization as an adjunct to surgery, not as a replacement.

How long has TRUFILL n‑BCA been used in neurovascular care prior to the 2025 approval?

TRUFILL n‑BCA has supported neurovascular embolization for over 25 years, with original FDA approval in 2000.

What is the recurrence rate cited for cSDH after surgical intervention?

The announcement cites recurrence rate estimates of approximately 10% to 20% following surgical intervention for cSDH.