Last reviewed 2026-06-02 · How we verify

EVARREST™ Sealant Matrix

Ethicon, Inc. · Phase 3 active Biologic Under review

EVARREST™ Sealant Matrix is a Hemostatic sealant / Fibrin sealant Biologic drug developed by Ethicon, Inc.. It is currently in Phase 3 development for Hemostasis during general, cardiac, and vascular surgery, Control of bleeding from surgical sites where standard hemostatic measures are ineffective or impractical. Also known as: EVARREST™ Fibrin Sealant Patch.

EVARREST is a hemostatic sealant matrix that combines human thrombin and fibrinogen to form a biodegradable fibrin clot at the surgical site, promoting rapid hemostasis.

EVARREST™ Sealant Matrix is a topical hemostat used as an adjunct to hemostasis during cardiovascular surgery, and it has also been studied for its effectiveness in treating hemorrhage, soft tissue bleeding, and hepatic parenchyma bleeding. The exact mechanism of EVARREST™ is unknown, but it is classified as a fibrin sealant patch.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	EVARREST™ Sealant Matrix
Also known as	EVARREST™ Fibrin Sealant Patch
Sponsor	Ethicon, Inc.
Drug class	Hemostatic sealant / Fibrin sealant
Modality	Biologic
Therapeutic area	Surgery / Hemostasis
Phase	Phase 3

Mechanism of action

The sealant matrix works by delivering thrombin and fibrinogen directly to bleeding surfaces, where they interact to form a stable fibrin clot that adheres to tissue and controls bleeding. The fibrin matrix is gradually absorbed by the body as wound healing progresses. This topical approach provides local hemostasis without systemic absorption of the active components.

Approved indications

Hemostasis during general, cardiac, and vascular surgery
Control of bleeding from surgical sites where standard hemostatic measures are ineffective or impractical

Common side effects

Allergic reaction
Infection at surgical site
Seroma formation
Hematoma

Key clinical trials

The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study (PHASE3)
The Fibrin Pad Cardiovascular Study (PHASE2)
The Fibrin Pad CV Phase III Study (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

EVARREST™ Sealant Matrix CI brief — competitive landscape report
EVARREST™ Sealant Matrix updates RSS · CI watch RSS
Ethicon, Inc. portfolio CI

Frequently asked questions about EVARREST™ Sealant Matrix

What is EVARREST™ Sealant Matrix?

EVARREST™ Sealant Matrix is a Hemostatic sealant / Fibrin sealant drug developed by Ethicon, Inc., indicated for Hemostasis during general, cardiac, and vascular surgery, Control of bleeding from surgical sites where standard hemostatic measures are ineffective or impractical.

How does EVARREST™ Sealant Matrix work?

EVARREST is a hemostatic sealant matrix that combines human thrombin and fibrinogen to form a biodegradable fibrin clot at the surgical site, promoting rapid hemostasis.

What is EVARREST™ Sealant Matrix used for?

EVARREST™ Sealant Matrix is indicated for Hemostasis during general, cardiac, and vascular surgery, Control of bleeding from surgical sites where standard hemostatic measures are ineffective or impractical.

Who makes EVARREST™ Sealant Matrix?

EVARREST™ Sealant Matrix is developed by Ethicon, Inc. (see full Ethicon, Inc. pipeline at /company/ethicon-inc).

Is EVARREST™ Sealant Matrix also known as anything else?

EVARREST™ Sealant Matrix is also known as EVARREST™ Fibrin Sealant Patch.

What drug class is EVARREST™ Sealant Matrix in?

EVARREST™ Sealant Matrix belongs to the Hemostatic sealant / Fibrin sealant class. See all Hemostatic sealant / Fibrin sealant drugs at /class/hemostatic-sealant-fibrin-sealant.

What development phase is EVARREST™ Sealant Matrix in?

EVARREST™ Sealant Matrix is in Phase 3.

What are the side effects of EVARREST™ Sealant Matrix?

Common side effects of EVARREST™ Sealant Matrix include Allergic reaction, Infection at surgical site, Seroma formation, Hematoma.

Drug class: All Hemostatic sealant / Fibrin sealant drugs
Manufacturer: Ethicon, Inc. — full pipeline
Therapeutic area: All drugs in Surgery / Hemostasis
Indication: Drugs for Hemostasis during general, cardiac, and vascular surgery
Indication: Drugs for Control of bleeding from surgical sites where standard hemostatic measures are ineffective or impractical
Also known as: EVARREST™ Fibrin Sealant Patch

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing