A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open, Abdominal, Retroperitoneal, Pelvic and Thoracic (non-cardiac) Surgery in Pediatric Patients

Start Date14 Dec 2020

Sponsor / Collaborator-

NCT03255174 / RecruitingPhase 3

A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients

The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

Start Date20 Mar 2018

Sponsor / Collaborator

Ethicon, Inc.

NCT02553122 / WithdrawnPhase 3IIT

The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty During the Early Perioperative Period

Total knee arthroplasty is a surgical procedure that involves a significant amount of blood loss and it has always been the surgeons' goal to try to minimize blood loss. In the current study, we will investigate the effect of blood loss after total knee arthroplasty with the combination of Evicel, a fibrin sealant and Tranexamic Acid.

Start Date01 Oct 2015

Sponsor / Collaborator

Montefiore Medical Center

100 Clinical Results associated with Fibrin Sealant (Human) (Omrix)

100 Translational Medicine associated with Fibrin Sealant (Human) (Omrix)

100 Patents (Medical) associated with Fibrin Sealant (Human) (Omrix)

Literatures (Medical) associated with Fibrin Sealant (Human) (Omrix)

01 Dec 2024·European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie

A Study of Safety and Effectiveness of Evicel Fibrin Sealant as an Adjunctive Hemostat in Pediatric Surgery

Article

Author: Sharif, Khalid ; Illie, Bogdan ; Hall, Nigel J. ; Kenny, Simon ; Gabra, Hany ; Barnett, Ellie ; Flageole, Helene ; Kocharian, Richard

Introduction Data on the use of fibrin sealants to control intraoperative bleeding in children are scarce. Evicel Fibrin Sealant (Ethicon Inc., Raritan, New Jersey, United States) was found safe and effective in clinical trials of adults undergoing various surgery types. We evaluated the safety and efficacy of Evicel versus Surgicel Absorbable Hemostat (Ethicon Inc.) as adjunctive topical hemostats for mild/moderate raw-surface bleeding in pediatric surgery. Methods A phase III randomized clinical trial was designed as required by the European Medicines Agency's Evicel Pediatric Investigation Plan: 40 pediatric subjects undergoing abdominal, retroperitoneal, pelvic, or thoracic surgery were randomized to Evicel or Surgicel, to treat intraoperative mild-to-moderate bleeding. Descriptive analyses included time-to-hemostasis and rates of treatment success (4, 7, 10 minutes), intraoperative treatment failure, rebleeding, and thromboembolic events. Results Forty of 130 screened subjects aged 0.9 to 17 years were randomized 1:1 to Evicel or Surgicel. Surgeries were predominantly open abdominal procedures. The median bleeding area was 4.0 cm2 for Evicel and 1.0 cm2 for Surgicel. The median time-to-hemostasis was 4.0 minutes for both groups. The 4-, 7-, and 10-minute treatment success rates were 80.0% versus 65.0%, 100.0% versus 80.0%, and 95.0% versus 90.0%, whereas treatment failure rates were 5.0% versus 25.0%, for Evicel and Surgicel, respectively. No deaths or thrombotic events occurred. Re-bleeding occurred in 5.0% of Evicel and 10.0% of Surgicel subjects. Conclusions In accordance with adult clinical trials, this randomized study supports the safety and efficacy of Evicel for controlling mild-to-moderate surgical bleeding in a broad range of pediatric surgical procedures.

01 Nov 2024·JOURNAL OF PEDIATRIC SURGERY

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

Article

Author: Balanescu, Laura ; Slavkovic, Andjelka ; Camprubí, Sandra ; Hanna, Kim ; James, Michael K. ; Jenovari, Zoltan ; Querolt, Montse ; Gajdobranski, Djordje ; Bozzo, Jordi ; Mikickovic, Maja ; Vajda, Péter ; Kamenov, Krasimir ; Camprubí, Sandra ; Irtan, Sabine ; Querolt, Montse ; Mondou, Elsa ; Mondou, Elsa ; Kalinova, Krasimira ; Sharif, Khalid ; Ninov, Borislav ; Simeonov, Simeon ; Sretenović, Aleksandar ; Wiener, Isodoro ; Hanna, Kim

BACKGROUND:

In this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.

METHODS:

This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T₄ - primary endpoint), seven (T₇) and 10 (T₁₀) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.

RESULTS:

At T₄, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T₄ were undergoing soft tissue surgery. All patients achieved hemostasis by T₇. At T₁₀, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.

CONCLUSIONS:

FS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.

LEVEL OF EVIDENCE:

01 Sep 2024·CHILDS NERVOUS SYSTEM

Correction to: Safety and effectiveness of Evicel® fibrin sealant as an adjunct to sutured dural repair in children undergoing cranial neurosurgery

Author: Ilie, Bogdan ; Josan, Vivek ; Sivakumar, Gnanamurthy ; Kandasamy, Jothy ; Aquilina, Kristian ; Kocharian, Richard ; Pettorini, Benedetta ; Magdum, Shailendra ; Barnett, Ellie

News (Medical) associated with Fibrin Sealant (Human) (Omrix)

11 Jun 2022

·www.prnewswire.com

At 8.6% CAGR, Global Tissue Sealants and Tissue Adhesive Market Size & Share to Surpass USD 2.9 Billion by 2028 | Industry Trends, Growth, Value, Opportunities, Statistics, Analysis & Forecast Report by ZMR

NEW YORK, June 11, 2022 /PRNewswire/ -- As per the Zion Market Research study, The global tissue sealants and tissue adhesive market was worth around USD 1.5 billion in 2021 and is estimated to grow to about USD 2.9 billion by 2028, with a compound annual growth rate (CAGR) of approximately 8.6 percent over the forecast period. The report analyzes the tissue sealants and tissue adhesive market's drivers, restraints/challenges, and the effect they have on the demands during the projection period. In addition, the report explores emerging opportunities in the tissue sealants and tissue adhesive market. Key Industry Insights &Findings of the Tissue Sealants and Tissue Adhesive Market Reports: As per the analysis shared by our research analyst, the Tissue Sealants and Tissue Adhesive Market is expected to grow annually at a CAGR of around 8.6% (2022-2028). Through the primary research, it was established that the Cognitive and Memory Enhancer Drugs Market was valued at approximately USD 1.5Billion in 2021 and is projected to reach roughly USD 2.9 Billion by 2028. Large population and technical advancements, North America accounted for the largest share of tissue sealants and tissue adhesive. State-of-the-art medical research facilities and rising investments in healthcare infrastructure in this region, and also heightened understanding among both physicians & patients relating to therapeutic approaches, enhanced life expectancy, and a rising population will push growing demands for tissue sealants and tissue adhesives in the Asia Pacific region. Zion Market Research published the latest report titled " Tissue Sealants And Tissue Adhesive Market By Product (Natural Or Biological Sealants & Adhesives And Synthetic & Semi-Synthetic Adhesives), By Application (General Surgery, Orthopedic Surgery, Gynecology Surgery, Cardiovascular Surgery, Cosmetic Surgery, Neurosurgery, And Other Applications), By End-User (Ambulatory Surgery Centers, Specialty Clinics, And Hospitals), And By Region – Global And Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, And Forecasts 2022 – 2028 "into their research database. Tissue Sealants and Tissue Adhesive Market: Overview Sealants are materials used by surgeon to heal tissue that has been injured by a surgery or injury. Skin, internal organs, and blood vessels are among the tissues that have been damaged. Sealants are used in combination with mechanical procedures like sutures and staples to assist minimize blood loss and avoiding leaks. Tissue adhesives are liquid monomers that, when exposed to a moist surface (skin), begin an exothermic reaction, transforming into a polymer that establishes a strong tissue connection. Get a Free Sample Report with All Related Graphs & Charts (with COVID 19 Impact Analysis): Our Free Sample Report Includes: 2022 Updated Report Introduction, Overview, and In-depth industry analysis COVID-19 Pandemic Outbreak Impact Analysis Included 166 + Pages Research Report (Inclusion of Updated Research) Provide Chapter-wise guidance on Request 2022 Updated Regional Analysis with Graphical Representation of Size, Share & Trends Includes an Updated List of tables & figures Updated Report Includes Top Market Players with their Business Strategy, Sales Volume, and Revenue Analysis Zion Market Research methodology Industry Dynamics: Tissue Sealants and Tissue Adhesive Market: Growth Drivers Increase in number of orthopedic and cardiovascular procedures to foster the market. Over the forecast period, rising cardiovascular and orthopedic surgeries are expected to drive revenue growth in the global tissue sealants and tissue adhesive market. The ease of availability of novel tissue adhesives and tissue sealants among end users, combined with rising disposable money, is a major driver in the global increase in such procedures. Adhesives are essential in general surgery. Natural and manufactured polymeric materials can be used to create three-dimensional networks that adhere to target tissues chemically and physically, acting as adhesives, sealants, or hemostats. Because adhesives and sealants are such an important aspect of general surgery, demand for them will rise as the number of procedures performed increases. As a result, market growth is likely to be boosted . Tissue Sealants and Tissue Adhesive Market: Restraints Less market penetration for tissue sealants and adhesives in developing countries hinders the growth. The market's growth is also likely to be hampered by the dearth of acceptance of tissue glue and bio-adhesive sealants in developing markets. This is due to a lack of knowledge about the advantages, cost-effectiveness, therapeutic application, and reliability of tissue adhesive and tissue sealants against alternative procedures or products, as well as tissue healing therapies. Directly Purchase a Copy of the Report @ Global Tissue Sealants and Tissue Adhesive Market: Opportunities Technological advancement for product launches creates numerous opportunities for market growth. Companies have been working on the development of novel tissue glue and bio-adhesive sealants to reach a variety of consumers, including toddlers, and young and elderly patients, during the last few years. Tissue sealants are currently used to protect sensitive, fragile, skin from damage, and to prevent cross-contamination & infection transmission. For innovative product launches, major companies are investing heavily in R&D activities. All such factors are likely to generate numerous opportunities for the global tissue sealants and tissue adhesive market growth during the forecast period. Global Tissue Sealants and Tissue Adhesive Market: Challenges Limitations in the development of tissue adhesive to act as a major challenge for the market growth. Despite the fact that many tissue adhesives form strong connections with tissue, they are frequently not designed for specific tissue applications. Tissue adhesives, in particular, do not biodegrade at a rate consistent with tissue repair, cause an unwanted inflammatory response upon adhesion or disintegration, fail to cohere in high-load-bearing applications, or do not match the characteristics of the underlying tissue. In the early stages of development, rigorous differentiation of target applications and greater in-depth investigation of tissue-surface features and tissue-environmental parameters are necessary. Despite the fact that the surface of the tissue and the surrounding environment change amongst tissues, the most typical technique is to utilize one type of adhesive for all conceivable tissues. This "one-size-fits-all" approach frequently results in tissue adhesive misuse, leading to inferior performance and dampening enthusiasm for potentially promising new materials. This could also lead to an incorrect cost-effectiveness analysis for specified unmet clinical requirements in the early stages of development, culminating in an exaggeration of cost in later stages of development and obstructing clinical translation. A failure to understand the physiological effects of adhesive materials after implantation is another factor for the research-to-product mismatch. All such limitations may pose challenges to market growth . Global Tissue Sealants and Tissue Adhesive Market: Segmentation The global tissue sealants and tissue adhesive market is categorized based on product, application, end-user, and region. Based on the product, the market is divided into semi-synthetic & synthetic adhesives and biological or natural sealants. The application segment consists of neurosurgery, cosmetic surgery, cardiovascular surgery, gynecology surgery, orthopedic surgery, general surgery, and other applications. The end-user segment is bifurcated into ambulatory surgery centers, specialty clinics, and hospitals. Get More Insight before [email protected]: List of Key Players inTissue Sealants and Tissue Adhesive Market: Integra LifeSciences C.R Bard Smith & Nephew Exapharma Johnson & Johnson Baxter International Inc. Tissuemed Ltd. Chemence Medical Inc. Cohera Medical Inc. Luna Innovations Incorporated Key questions answered in this report: What are the growth rate forecast and market size for Tissue Sealants and Tissue Adhesive Market? What are the key driving factors propelling the Tissue Sealants and Tissue Adhesive Market forward? What are the most important companies in the Tissue Sealants and Tissue Adhesive Market Industry? What segments does the Tissue Sealants and Tissue Adhesive Market cover? How can I receive a free copy of the Tissue Sealants and Tissue Adhesive Market sample report and company profiles? Report Scope: Free Brochure: Recent Developments: In January 2020, Polyganics, a medical technology business that develops, manufactures, and sells bioresorbable medical devices, revealed that LIQOSEAL®, its effortless and unique dural sealant patch, has received CE certification and will be available in Europe immediately. In December 2019, Johnson & Johnson Medical Devices Companies announced that Ethicon has released VISTASEAL Fibrin Sealant (Human) to assist surgeons minimize bleeding during surgery. VISTASEAL Fibrin Sealant (Human) is made up of fibrinogen and thrombin, which are both clotting proteins present in human plasma. It creates a fast, adherent, and permanent clot after placed on the bleeding site and has been shown to maintain hemostasis (blood stoppage) in high-risk patients. Regional Dominance: North America is the leader in the global market. Among the regions, North America is estimated to lead the global tissue sealants and tissue adhesive market during the forecast period. Because of its large population and technical advancements, North America accounted for the largest share of tissue sealants and tissue adhesive. However, the market for tissue sealants and tissue adhesives is expected to expand significantly in Asia Pacific countries. Factors such as state-of-the-art medical research facilities and rising investments in healthcare infrastructure in this region, and also heightened understanding among both physicians & patients relating therapeutic approaches, enhanced life expectancy, and a rising population will push growing demands for tissue sealants and tissue adhesives in Asia Pacific region. Global Tissue Sealants and Tissue Adhesive Market is segmented as follows: Tissue Sealants and Tissue Adhesive Market:ByProduct Outlook(2022-2028) Natural or Biological Sealants and Adhesives Synthetic and Semi-Synthetic Adhesives Tissue Sealants and Tissue Adhesive Market: By ApplicationOutlook (2022-2028) General Surgery Orthopedic Surgery Gynecology Surgery Cardiovascular Surgery Cosmetic Surgery Neurosurgery Other Applications Tissue Sealants and Tissue Adhesive Market: By End-user Outlook (2022-2028) Hospitals Specialty Clinics Ambulatory Surgery Centers Tissue Sealants and Tissue Adhesive Market:By Region Outlook(2022-2028) North America The U.S. Canada Europe France The UK Spain Germany Italy Rest of Europe Asia Pacific China Japan India South Korea Southeast Asia Rest of Asia Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa GCC South Africa Rest of Middle East & Africa Browse Other Related Research Reports from Zion Market Research Orthopedic Navigation Systems Market - Global Industry Analysis : The global Orthopedic Navigation Systems market accrued earnings worth approximately 2.1(USD Billion) in 2020 and is predicted to gain revenue of about 7.3 (USD Billion) by 2028, is set to record a CAGR of nearly 14.7% over the period from 2021 to 2028. Intravenous Infusion Pumps Market - Global Industry Analysis : The global Intravenous Infusion Pumps market accrued earnings worth approximately 4.7 (USD Billion) in 2020 and is predicted to gain revenue of about 8.9 (USD Billion) by 2028, is set to record a CAGR of nearly 8.1% over the period from 2021 to 2028. Disposable Hospital Gowns Market - Global Industry Analysis : The global Disposable Hospital Gowns market accrued earnings worth approximately 2.02 (USD Billion) in 2020 and is predicted to gain revenue of about 5.72 (USD Billion) by 2028, is set to record a CAGR of nearly 13.8% over the period from 2021 to 2028. Browse through Zion Market Research's coverage of the Global Medical Device Industry Follow Us on: LinkedIn | Twitter | Facebook About Us Zion Market Research is an obligated company. We create futuristic, cutting-edge, informative reports ranging from industry reports, and company reports to country report. We provide our clients not only with market statistics unveiled by avowed private publishers and public organizations but also with vogue and newest industry reports along with pre-eminent and niche company profiles. Our database of market research reports comprises a wide variety of reports from cardinal industries. Our database is been updated constantly in order to fulfill our clients with prompt and direct online access to our database. Keeping in mind the client's needs, we have included expert insights on global industries, products, and market trends in this database. Last but not the least, we make it our duty to ensure the success of clients connected to us—after all—if you do well, a little of the light shines on us . Contact Us: Zion Market Research 244 Fifth Avenue, Suite N202 New York, 10001, United States Tel: +49-322 210 92714 USA/Canada Toll Free No.1-855-465-4651 Email: [email protected] Website: Blog - Logo: SOURCE Zion Market Research

09 Jun 2022

·www.prnewswire.com

Global Surgical Sealants and Adhesives Market (2022 to 2030) - Size, Share & Trends Analysis Report

DUBLIN, June 9, 2022 /PRNewswire/ -- The "Surgical Sealants and Adhesives Market Size, Share & Trends Analysis Report by Type (Natural or Biological, Synthetic & Semi-synthetic), by Application (General Surgery, Cardiovascular), by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering. The global surgical sealants and adhesives market size is expected to reach USD 5.4 billion by 2030. It is expected to expand at a CAGR of 11.4% from 2022 to 2030. Proper closure of injured tissues post-operation is a major step to restore tissue's structure and function. Postoperative leakages occur in 3% to 15% of cases and are considered serious complications. They are responsible for one-third of postoperative deaths in patients. Surgical sealants and adhesives are designed to improve patient outcomes by reducing the prospect of postsurgical complications, such as leakages, thus resulting in improved patient outcomes through the prevention of leakage and a decrease in length of stay and mortality rates. The rapid advancements in sealants and adhesives are major impact rendering drivers, and their usage in modern surgery to reduce anastomotic leakage has risen significantly. Surgical adhesive is expected to replace traditional surgical sealing agents such as sutures, wires, and staples. These are time taking, can result in further tissue trauma, and are hard to use in some surgical locations. Surgical sealants overcome these issues and create immediate and proper sealing, compared to sutures and staples. The factors contributing to the growth of the market are the rising demand for surgical services worldwide and increasing concerns to reduce postoperative wound infections. Surgical procedures are increasing worldwide, with the WHO estimations projecting surgeries to account for approximately 235 million per year globally. Surgical Sealants and Adhesives Market Report Highlights North America held the largest revenue share in 2021 owing to the growing demand for high-quality healthcare in the region. Asia Pacific is expected to observe lucrative growth over the forecast period due to the transformation of healthcare delivery systems into advanced value-based healthcare practices to establish a sustainable health system. In the natural and biological adhesives and sealants type segment, the fibrin sealants segment accounted for the largest revenue share in 2021. In the synthetic and semi-synthetic adhesives and sealants type segment, the cyanoacrylates segment is expected to register the fastest growth rate in the forecast period owing to its fast-drying properties, strong mechanical strength, and ease of adhesion. Market participants combine a blend of both large public companies and more specialized small companies. These companies focus on only one segment or product. An example of such companies is Cohera Medical, Inc. Key Topics Covered: Chapter 1. Methodology and Scope Chapter 2. Executive Summary Chapter 3. Surgical Sealants and Adhesives Market Variables, Trends & Scope 3.1. Market Segmentation & Scopes 3.2. Surgical Sealants and Adhesives: Market Dynamics 3.2.1. Market driver analysis 3.2.2. Market restraint analysis 3.3. Key Opportunities Prioritized 3.4. Surgical Sealants and Adhesives-SWOT Analysis, by Factor (Political & legal, economic and technological) 3.5. Industry Analysis-Porter's 3.6. Surgical Sealants and Adhesives Market: Market Position Analysis, 2015 Chapter 4. Surgical Sealants and Adhesives: Type Estimates & Trend Analysis 4.1. Surgical Sealants and Adhesives Market: Type Movement Analysis 4.1.1. Natural or biological adhesives and sealants 4.1.1.1. Natural or biological adhesives and sealants market, 2018-2030 (USD Million) 4.1.1.1.1. Fibrin Sealants 4.1.1.1.1.1. Fibrin sealants market, 2018-2030 (USD Million) 4.1.1.1.2. Collagen Based Adhesives 4.1.1.1.2.1. Collagen based adhesives market, 2018-2030 (USD Million) 4.1.1.1.3. Gelatin Based Adhesives 4.1.1.1.3.1. Gelatin based adhesives market, 2018-2030 (USD Million) 4.1.2. Synthetic and Semi-synthetic Adhesives and Sealants 4.1.2.1. Synthetic and semi-synthetic adhesives and sealants market, 2018-2030 (USD Million) 4.1.2.1.1. Cyanoacrylates 4.1.2.1.1.1. Cyanoacrylates market, 2018-2030 (USD Million) 4.1.2.1.2. Polymeric Hydrogels 4.1.2.1.2.1. Polymeric hydrogels market, 2018-2030 (USD Million) 4.1.2.1.3. Urethane Based Adhesives 4.1.2.1.3.1. Urethane based adhesives market, 2018-2030 (USD Million) Chapter 5. Surgical Sealants and Adhesives: Application Estimates & Trend Analysis 5.1. Surgical Sealants and Adhesives Market: Application Movement Analysis 5.1.1. Central nervous system 5.1.1.1. Central nervous system market, 2018-2030 (USD Million) 5.1.2. Cardiovascular 5.1.2.1. Cardiovascular market, 2018-2030 (USD Million) 5.1.3. General surgery 5.1.3.1. General surgery market, 2018-2030 (USD Million) 5.1.4. Orthopedic 5.1.4.1. Orthopedic market, 2018-2030 (USD Million) 5.1.5. Pulmonary 5.1.5.1. Pulmonary market, 2018-2030 (USD Million) 5.1.6. Urology 5.1.6.1. Urology market, 2018-2030 (USD Million) 5.1.7. Ophthalmology 5.1.7.1. Ophthalmology market, 2018-2030 (USD Million) 5.1.8. Others 5.1.8.1. Others market, 2018-2030 (USD Million) Chapter 6. Surgical Sealants and Adhesives: Regional Estimates & Trend Analysis, by Type and Application Chapter 7. Competitive Landscape 7.1. Company Profiles 7.1.1. Baxter International, Inc. 7.1.1.1. Company overview 7.1.1.2. Financial performance 7.1.1.3. Product benchmarking 7.1.1.4. Strategic initiatives 7.1.2. CryoLife, Inc. 7.1.2.1. Company overview 7.1.2.2. Financial performance 7.1.2.3. Product benchmarking 7.1.2.4. Strategic initiatives 7.1.3. C.R. Bard, Inc. 7.1.3.1. Company overview 7.1.3.2. Financial performance 7.1.3.3. Product benchmarking 7.1.3.4. Strategic initiatives 7.1.4. Medtronic PLC 7.1.4.1. Company overview 7.1.4.2. Financial performance 7.1.4.3. Product benchmarking 7.1.4.4. Strategic initiatives 7.1.5. B. Braun Melsungen AG 7.1.5.1. Company overview 7.1.5.2. Financial performance 7.1.5.3. Product benchmarking 7.1.5.4. Strategic initiatives 7.1.6. Cohera Medical, Inc. 7.1.6.1. Company overview 7.1.6.2. Financial performance 7.1.6.3. Product benchmarking 7.1.6.4. Strategic initiatives 7.1.7. Ethicon, Inc. 7.1.7.1. Company overview 7.1.7.2. Financial performance 7.1.7.3. Product benchmarking 7.1.7.4. Strategic initiatives 7.1.8. Mallinckrodt PLC 7.1.8.1. Company overview 7.1.8.2. Financial performance 7.1.8.3. Product benchmarking 7.1.8.4. Strategic initiatives 7.1.9. Cardinal Health 7.1.9.1. Company overview 7.1.9.2. Financial performance 7.1.9.3. Product benchmarking 7.1.9.4. Strategic initiatives 7.1.10. Integra LifeSciences Holdings Corporation 7.1.10.1. Company overview 7.1.10.2. Financial performance 7.1.10.3. Product benchmarking 7.1.10.4. Strategic initiatives For more information about this report visit ? Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets

08 Apr 2008

·www.biospace.com

Haemacure Corporation Announces Details of its Annual General and Special Meeting of Shareholders

MONTREAL, April 7 /PRNewswire-FirstCall/ - Haemacure Corporation , a Montreal-based specialty bio-therapeutics company, will hold its Annual General and Special Meeting of Shareholders on Wednesday, April 9, 2008 at 4 p.m. at The National Club, 303 Bay Street, Toronto, Ontario. Presentation Mr. Joseph Galli, Chairman and Chief Executive Officer of Haemacure, will report on accomplishments of 2007 and provide an outlook for 2008 and beyond, including a report on Haemacure's clinical programs for its two proprietary, human product candidates, a fibrin sealant and an active, topical hemostatic agent (thrombin). Live Webcast For those who are unable to attend in person, Haemacure will simultaneously host a live webcast of the presentation with slides, at About Haemacure Haemacure Corporation is a specialty biotherapeutics company developing high-value human plasma-derived protein products for commercialization. Haemacure's research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical hemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first quarter of 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant. Follow-on development will focus on surgical hemostats, adhesion prevention, regenerative medecine, drug delivery and combinations with biomaterials. Haemacure has identified eleven additional specialty proteins and enzymes in one if its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX. Forward-looking Statements Certain of the statements contained in this news release are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the biotech industry, changes in the regulatory environment in the jurisdictions in which Haemacure does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. Haemacure disclaims any intention or obligation to update these statements. CONTACT: Haemacure Corporation: Joseph Galli, Chairman and CEO, (514) 990-7074, jgalli@haemacure.ca; Diane Roch, Director, Communications and Investor Relations, (514) 282-3350 ext. 27, Mobile: (514) 952-3350, droch@haemacure.ca;

100 Deals associated with Fibrin Sealant (Human) (Omrix)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Blood Coagulation Disorders	EU	OMRIX biopharmaceuticals NV	05 Oct 2008
Blood Coagulation Disorders	IS	OMRIX biopharmaceuticals NV	05 Oct 2008
Blood Coagulation Disorders	LI	OMRIX biopharmaceuticals NV	05 Oct 2008
Blood Coagulation Disorders	NO	OMRIX biopharmaceuticals NV	05 Oct 2008
Hemorrhage	US	Omrix Biopharmaceuticals Ltd.	21 Mar 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cerebrospinal Fluid Leak	Phase 3	GB	Ethicon, Inc.	01 Oct 2014
Oral Hemorrhage	Phase 3	BE	Ethicon, Inc.	01 Aug 2014
Oral Hemorrhage	Phase 3	CA	Ethicon, Inc.	01 Aug 2014
Oral Hemorrhage	Phase 3	GB	Ethicon, Inc.	01 Aug 2014
Cardiovascular Diseases	Phase 3	US	Ethicon, Inc.	01 Jan 2014
Cardiovascular Diseases	Phase 3	JP	Ethicon, Inc.	01 Jan 2014
Cardiovascular Diseases	Phase 3	AU	Ethicon, Inc.	01 Jan 2014
Cardiovascular Diseases	Phase 3	BE	Ethicon, Inc.	01 Jan 2014
Cardiovascular Diseases	Phase 3	GB	Ethicon, Inc.	01 Jan 2014
Cerebral Hemorrhage	Phase 3	US	Ethicon, Inc.	01 Oct 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EUCTR2013-003558-26-GB \| NCT02309645 (Pubmed) Manual	Phase 3	Cerebrospinal Fluid Leak	40	Evicel® fibrin sealant	ulkacyeizq(iinnqbbplx) = ctirqegkjx rnpphtkfaw (wcayzdgvsf )	Positive	10 May 2024
				Sutures	ulkacyeizq(iinnqbbplx) = fztsfwmhtr rnpphtkfaw (wcayzdgvsf )
NCT02227992 (CTgov)	Phase 3	Hemorrhage	40	Fibrinogen+EVARREST+Thrombin (EVARREST Sealant Matrix)	hdusdlaqcd(buuyogunai) = itwveakiog svcvfcsgue (joubjmvnqb, aexuxycino - ehtdkpqjsh) View more	-	08 Sep 2023
				oxidized regenerated cellulose (SURGICEL Absorbable Hemostat (Control))	hdusdlaqcd(buuyogunai) = agzfgeejsm svcvfcsgue (joubjmvnqb, tjgokiwnur - drusahmcwe) View more
NCT02227706 (CTgov)	Phase 3	Hemorrhage \| Oral Hemorrhage	40	EVICEL (EVICEL®)	aklpbesfzh(rikruzyszn) = dmbuvjyaxu mmdzvdabcl (pagfzidivg, tlskrahawz - aruqkdxlov) View more	-	31 Aug 2020
				SURGICEL (SURGICEL®)	aklpbesfzh(rikruzyszn) = ucdadzkyft mmdzvdabcl (pagfzidivg, aklnrvgmer - bgnbbushyl) View more
NCT01226914 (CTgov)	Not Applicable	Postoperative Complications \| Goiter \| Thyroid Cancer	55	EVICEL (EVICEL)	xtkwuelmsg(zpxorykmfn) = bevflhfclm yohvpmfghm (udrpzkelvf, ouboxclypv - vcvuiknbjp) View more	-	05 Feb 2019
				EVICEL (Placebo)	xtkwuelmsg(zpxorykmfn) = quofechvbb yohvpmfghm (udrpzkelvf, cbospglnmd - ckbawtzvqr) View more
NCT02457546 (CTgov)	Phase 3	Cerebrospinal Fluid Leak	234	EVICEL (Evicel)	cdkirenaav(yastuurqvb) = ozhqhykvlh jesqcvyimi (gzncedwqwd, xkfzrfvuuc - afzjiktknh) View more	-	04 Dec 2018
				rilysine (DuraSeal)	cdkirenaav(yastuurqvb) = tpifkbrpym jesqcvyimi (gzncedwqwd, aovoacyeni - uzpfdqueeu) View more
NCT02034799 (CTgov)	Phase 4	Meningioma	256	Standard of Care (SoC) (Standard of Care (SoC))	beibowpamr(sxwbujvixf) = gufpsqkhgb uutrviojlb (fmzeuhdnho, spqlezbuau - btgrdawznk) View more	-	26 Feb 2018
				Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	beibowpamr(sxwbujvixf) = bsenvotrak uutrviojlb (fmzeuhdnho, gpbkanqxma - xuvvzpzxsp) View more
NCT02040428 (CTgov)	Phase 3	Cardiovascular Diseases	156	Fibrin Sealant Patch (EVARREST Fibrin Sealant Patch)	cinaugiqha(xmfrnqcvwx) = jnfmlpfzhq hocezcyygh (rcmzraogsa, qjzexjcyty - dcqpuxhvbs) View more	-	15 Aug 2017
				TachoSil+thrombin (TachoSil)	cinaugiqha(xmfrnqcvwx) = vfssjbsdal hocezcyygh (rcmzraogsa, nllpmenpvv - ktbtykkddz) View more
NCT02094885 (CTgov)	Phase 4	Hemorrhage	252	Bioseal Fibrin Sealant (Bioseal Fibrin Sealant)	vxajnvtyey(etkgejauep) = afqbnyinxd iidwqffzkq (vmuzhcfdnb, hcesxcpokm - oyipocuaup) View more	-	12 Sep 2016
				Manual Compression (Manual Compression)	vxajnvtyey(etkgejauep) = ukmdpvsdhl iidwqffzkq (vmuzhcfdnb, pxqnutkwvv - tviclcrpnv) View more
NCT01993888 (CTgov)	Phase 3	Cerebral Hemorrhage \| Hemorrhage	102	Standard of Care (SoC)	goeujdnoxp(dujxppognn) = arhddbyxby ydogwvkahz (ldzxhmjhlp, lxehjpbsty - rbholgmzme) View more	-	11 Jul 2016
ARVO2013	Not Applicable	Pterygium	96	Evicel	vegfrwaojv(mcgevjeuij) = yjqkzngfxu llseulvvaa (ylzxpzmjln ) View more	Positive	01 Jun 2013
				Tisseel	vegfrwaojv(mcgevjeuij) = luwsgypmwd llseulvvaa (ylzxpzmjln ) View more

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