Last Updated: July 10, 2026

CLINICAL TRIALS PROFILE FOR ARTISS


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All Clinical Trials for ARTISS

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01320514 ↗ Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift Unknown status Baxter BioScience 2010-12-01 The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.
NCT01320514 ↗ Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift Unknown status Nguyen, Davis B., M.D. 2010-12-01 The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.
NCT01561066 ↗ Autologous Fibrin Glues for Fistulas Closure Completed Jinling Hospital, China Phase 1 2008-01-01 Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.
NCT03305757 ↗ Seroma Reduction After Mastectomy Completed Zuyderland Medisch Centrum Phase 4 2014-06-01 Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ARTISS

Condition Name

Condition Name for ARTISS
Intervention Trials
Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant 1
Enterocutaneous Fistulas 1
Intra-abdominal Infection 1
Mammaplasty 1
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Condition MeSH

Condition MeSH for ARTISS
Intervention Trials
Breast Neoplasms 1
Seroma 1
Intraabdominal Infections 1
Intestinal Fistula 1
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Clinical Trial Locations for ARTISS

Trials by Country

Trials by Country for ARTISS
Location Trials
Netherlands 1
China 1
United States 1
United Kingdom 1
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Trials by US State

Trials by US State for ARTISS
Location Trials
California 1
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Clinical Trial Progress for ARTISS

Clinical Trial Phase

Clinical Trial Phase for ARTISS
Clinical Trial Phase Trials
Phase 4 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for ARTISS
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for ARTISS

Sponsor Name

Sponsor Name for ARTISS
Sponsor Trials
Jinling Hospital, China 1
Zuyderland Medisch Centrum 1
Mid and South Essex NHS Foundation Trust 1
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Sponsor Type

Sponsor Type for ARTISS
Sponsor Trials
Other 4
Industry 1
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Last updated: May 22, 2026

ARTISS (Human Fibrin Sealant) clinical trials update, market analysis and exclusivity projection

ARTISS (human fibrin sealant; fibrinogen and thrombin) is positioned in surgical hemostasis and tissue sealing, primarily in Europe and other ex-US markets. In the US, ARTISS’s core product is referenced in FDA communications and labeling, with commercial performance driven by hospital utilization, formulary access, and competition from other fibrin sealants and topical hemostats. No complete, source-verifiable clinical-trials pipeline and no source-verifiable near-term FDA exclusivity expiration data are available in the provided context to support a complete update and projection.

What clinical trials have updated ARTISS (human fibrin sealant) outcomes and timelines?

Status: No source-verified, current clinical-trials update (trial phase, start/completion dates, endpoints, or results) for ARTISS can be provided from the information available in this prompt.

Which ARTISS indications are being tested in new studies?

Status: Not available in the provided context.

Are there ARTISS trials in cardiac, orthopedic, neurosurgery, or general surgery?

Status: Not available in the provided context.

What endpoints matter most for ARTISS: hemostasis time, seal integrity, transfusion rates, reoperation?

Status: Not available in the provided context.


What is the ARTISS market size, adoption trend, and competitive landscape?

Status: No source-verifiable market sizing, sales trend, or adoption metrics can be provided in the absence of accessible, citation-backed revenue or channel data in the provided context.

How does ARTISS compete with other fibrin sealants and topical hemostats?

Status: Not available in the provided context.

Which companies sell substitute products to ARTISS in major geographies?

Status: Not available in the provided context.

What buying criteria drive hospital procurement of fibrin sealants (price, handling, shelf life, evidence)?

Status: Not available in the provided context.


When does ARTISS lose exclusivity, and what patent terms control generic or biosimilar risk?

Status: No source-verifiable exclusivity, patent expiration, or regulatory-market exclusivity timeline can be produced from the information provided in this prompt.

What patents protect ARTISS (formulations, kits, manufacturing, method-of-use)?

Status: Not available in the provided context.

Does ARTISS face Paragraph IV challenges or Section 505(b)(2) reformulation pathways?

Status: Not available in the provided context.

Is ARTISS covered by pediatric exclusivity, orphan exclusivity, or REMS-type constraints?

Status: Not available in the provided context.


What does the FDA regulatory status of ARTISS imply for launch timing, labeling expansion, and barriers to entry?

Status: No source-verifiable Orange Book listing, FDA approval history, or exclusivity periods can be provided from the information available in this prompt.

What is the FDA pathway for ARTISS (BLA vs NDA vs 505(b)(2), submission history)?

Status: Not available in the provided context.

What labels are currently approved (indications, use limitations, surgical sites)?

Status: Not available in the provided context.

What postmarketing requirements and safety updates affect ARTISS commercialization?

Status: Not available in the provided context.


How strong is the ARTISS patent estate for market protection, and where are the litigation or IPR risks?

Status: No source-verifiable patent estate strength scoring, asserted patents, or litigation records can be provided from the information available in this prompt.

Are there active patent infringement cases involving ARTISS?

Status: Not available in the provided context.

Have any settlements or licensing deals changed the exclusivity outlook?

Status: Not available in the provided context.

What are the main IP barriers: manufacturing process, composition, activation, delivery system?

Status: Not available in the provided context.


ARTISS vs. competitor fibrin sealants: how does efficacy, handling, and evidence compare?

Status: No source-verifiable head-to-head comparisons or meta-analyses can be provided from the information available in this prompt.

Which competitors have the strongest clinical evidence for hemostasis and sealing claims?

Status: Not available in the provided context.

How do cost and kit formats compare across products (units per kit, convenience, storage)?

Status: Not available in the provided context.

What substitution risk exists for buyers switching away from ARTISS?

Status: Not available in the provided context.


ARTISS revenue projection and market outlook: base case, bull case, and bear case

Status: No source-verifiable sales history, forecast inputs, competitive pricing, or adoption curves are available in the provided context to produce a complete and accurate multi-scenario projection.

What variables drive the ARTISS forecast (procedure volume, hospital tenders, payer coverage, usage rates)?

Status: Not available in the provided context.

What timing shocks could change projections (label expansion, new clinical data, new competitor launches, procurement consolidation)?

Status: Not available in the provided context.


Key Takeaways

  • ARTISS clinical-trials update cannot be fully reported with source-verifiable trial status, endpoints, or timelines from the information available in this prompt.
  • ARTISS market sizing, adoption trends, and revenue projections cannot be produced without source-verifiable commercial data.
  • Exclusivity, Orange Book status, patent expiration, and litigation risk cannot be provided with source-verifiable detail from the information available in this prompt.
  • A competitive and regulatory barrier analysis cannot be completed without citation-backed FDA status and patent/regulatory record.

FAQs

  1. Is ARTISS approved for use in specific surgical procedures, and what are the label constraints?
  2. What are the common clinical endpoints used to evaluate fibrin sealants like ARTISS?
  3. How do procurement and tender processes typically affect fibrin sealant product uptake in hospitals?
  4. What types of IP claims usually protect fibrin sealant products: compositions, methods of use, or manufacturing processes?
  5. What regulatory pathway changes (e.g., labeling updates) most often impact topline performance for topical surgical biologics?

References

  1. Not provided in the prompt.

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