Tag Archives: fibrin

Hemostat products and companies

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Hemostats have been used for over a hundred years to prevent bleeding in the surgical situation. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers, such as Johnson & Johnson, which now sells Surgicel (an oxidized regenerated cellulose hemostat), Instat (a freeze-dried collagen product), and Spongostan/Surgifoam (a freeze-dried gelatin hemostat). For stopping bleeding, modern hemostats go far beyond simple gauze.

Almost all hemostatic agents work in conjunction with or in addition to the body’s own blood clotting activity. These agents generally work by physically obstructing the outflow of blood in the wound, accelerating clotting reactions, and providing a matrix for increased platelet interactions, resulting in faster and stronger fibrin clot formation that can bind to and seal vascular injuries. However, the effective hemostatic action of these products depends heavily on the patient having a capable and intact coagulation function. This may not be the case if the patient has received, for example, a synthetic colloid fluid in the field to prevent shock, which results in hemodilution, or if the patient is hypothermic or in hypovolemic shock. If there is pre-existing coagulation deficiency, then many of these hemostats will not work. There is a need for a hemostatic agent that can function effectively in the absence of the patient’s coagulation function. One of the products that function well in these situations is the fibrinogen-based dressing.

Fibrin sealants can also act as hemostatic agents, so there is in effect some overlap between the ‘Fibrin and Other Sealants’ and the ‘Hemostats’ categories. However, at upwards of $600 per use, fibrin sealants are rather too expensive to use as hemostats. There are over 40 active companies market and/or developing hemostat products and many of them have multiple types of hemostats based on the constituent active ingredients.  Below is illustrated the number of active hemostat companies based on the product types they are pursuing or selling.

Source: MedMarket Diligence, LLC, Report #S190.

Posted via email from medmarket’s posterous

Opportunities for med/surg sealants, glues, hemostats driven by type of clinical benefit, competition

Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • Important and enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved clinical outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and perceived benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.


Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures, staples, mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

The report's complete description, table of contents, and list of exhibits is at link.  The report is available for purchase and immediate download at link.

Opportunities for surgical sealants, glues and hemostatic agents

See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

In the field of surgical sealants, glues, wound closure and anti-adhesion, the most significant opportunity for products is the area of high strength glues.  Currently, there is no standout biologically or chemically based product that has the performance necessary to displace the very large and established market for traditional wound closure — sutures, staples and clips.  Fibrin-based surgical sealants, glues, hemostats and other products are at best adjuncts to traditional wound closure, providing a complementary role of helping to seal wounds or hasten the healing process.  The real opportunity of fibrin or other surgical sealants and glues lies in their ability to provide the tensile strength of sutures with rapid hemostasis and tissue adhesion and with no toxicity or other biocompatibility effects beyond what sutures might produce. Secondly, such future sealant/glue products must also be able to achieve this performance at lower cost and/or improved outcomes.

So, this is no small challenge.

Having said this, there are quite a number of companies active in the development of these products and it is eminently reasonable that the companies involved will be making significant inroads to this challenge over the coming decade.

Even at existing levels of performance, biological and other sealants/glues/hemostats are progressively gaining caseload and market share from traditional wound management products.  The forecast below, which illustrates shares for the market in 2009, imputes a modest level of penetration of traditional products.  Any significant advance in improved tensile strength, with reduced toxicity, of emerging sealants/glues/hemostats would result in the market growth rate eclipsing the modest 11.5% CAGR in the data below.

Source: MedMarket Diligence, LLC; Report #S180.

High Strength Medical and Surgical Glues

See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

Cyanoacrylate products are the main form of high-strength surgical glue that is approved for human clinical use in the worldwide market. A number of new materials are under development for internal use in particular, but these represent new chemical entities and their commercialization is likely to be delayed by regulatory requirements.  While sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years, this will only occur after some technical challenges are overcome. For example, cyanoacrylate glues used for external skin closure are approximately five times less strong than sutures, and cyanoacrylates produce cytotoxic compounds as part of the curing process when used for securing torn or excised tissue. This has delayed the development and clinical evaluation of these potentially useful materials for internal surgical procedures. However, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.

Given the current size of the global market for high strength glues (at over $700 million) and the potential for this market to expand as products overcome the challenges of strength and toxicity, a respectable number of competitors compete in this space and many are working on further developing cyanoacrylate-based and other high strength adhesives (including fibrin-based and other “bio-glues”) to not only garner greater share of the existing market but to also erode the market for sutures and other mechanical wound closure products (e.g., clips and staples).

Source: MedMarket Diligence Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015.”

Ethicon (J&J), Covidien and B. Braun (Aesculap) hold the major positions in the market for high strength medical and surgical adhesives, but their positions are at risk, and will continue to be at risk, as long as the unmet need exists for stronger, more compatible glues.  Some of the many products on the market and in development in the area of high strength glues include SurgiSeal, DermaSeal, FloraGuard, LiquiBand, SkinLink, Histoacryl, Gluetiss, Autologous biological glue, Chemence USP Class VI adhesives, TissueGlu, Indermil, Glubran2, Glubran Tiss, GluSeal, GluSite, PeriAcryl, GluShield, Dermabond, InteguSeal, Epiglu, Surgical Tissue Sealants (STS) and others.

Sutureless Vascular Anastomosis and Other Applications of Sealants and Glues

(Note: This was posted initially in August 2011. The data in the table is drawn from the 2012 updated, published report #S190.)

In light of the recent development in which Stanford researchers invented a method for a sutureless attachment of blood vessels (i.e., vascular anastomosis) using a surgical glue (Dermabond), it is worth highlighting that the applications of surgical sealants and glues in medical/surgical applications are remarkably numerous, with a potential already begun to be realized in reshaping many medical and surgical procedures.

Below is an excerpt of the clinical applications by major field for surgical sealants and glues (drawn from Report #S190):

Surgical FieldApplications
CNS surgery:* Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
* Repair of dural defects.
* Others
Eye surgery:* Conjunctival closure in strabismus.
* Wound closure in glaucoma.
* Lower blepharoplasties (for lower eyelids).
* Others
ENT surgery:* Myringoplasty in large persistent tympanic membrane perforation.
* Repair of laryngotracheal separation with cricoidectomy.
* Narrowing of nasal fossa in atrophic rhinitis.
* Others
Oral and dental surgery:* Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
* Sealing of oro-antral fistula.
* Others
Head and neck:* Parotidectomy closure.
* Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
* Prevention of mastectomy seroma.
* Others
Cardiovascular thoracic surgery:* Reduced postoperative bleeding and intrapericardial adhesion.
* In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
* Others
Chest surgery:* Sealing of prolonged air leak after thoracotomy in lung cancer.
* Bronchopleural fistula.
* Percutaneous lung biopsy.
* Others
Vascular surgery:* Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
* Others
Gastrointestinal surgery:* Gastrointestinal sutureless anastomosis-stent.
* Esophagus perforation.
* Esophago-jejunal anastomosis.
* Recurrent tracheo-esophageal fistula.
* Upper gastrointestinal tract fistula: Endoscopic obliteration.
* Cholecysto-jejunostomy (sutureless) using absorbable intraluminal stent.
* Others
Liver surgery:* Liver resection in benign and malignant diseases.
* Others
Uro/Gynecological system:* Colpofixation in stress urinary incontinent.
* Intractable transplant-ureteral fistula.
* Transvaginal colpo-urethropexy.
* Others
Gynecological surgery:* Recto-vaginal and ano-rectal fistula.
* Anastomosis of the fallopian tube in animals.
* Others
Bone & orthopedic surgery:* Joint replacement.
* Brachial plexus injury repair.
* Others
Plastic surgery:* Face lift procedure. Fibrin glue reduces major hematomas and ecchymoses.
* Musculo facial plastic surgery, dorsal hand burns, infected skin graft.
* Decrease wound contraction in skin graft.
* Others

Note: “Others” are detailed in Report #S190.

Source: MedMarket Diligence, LLC; Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017.”

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. The report provides a worldwide historic (from 2008), current and annual forecast to 2015 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a five-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

See link for complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Secrets of Bio Glues

Researchers at the University of Akron have revealed the evolutionary strength of spider web glue. Published in the May 17, 2010, issue of Nature Communications, the research revealed that the effectiveness and strength of the spider web glue ensues from the highly entangled, cross-linked polymers in each droplet of the glue, which enables the adhesive force to be transmitted throughout the glue.

UA researcher Vasav Sahni notes:

[The] stickiness of the glue droplets depends on the speed at which they are stretched.

Subsequently, the glue droplets can hold on to fast-flying insects when they initially impact webs and retain trapped insects for a time period long enough for them to be subdued by the spider.

“This finding should significantly benefit the development of synthetic adhesives for biomedical, orthopedics and wound-healing applications. The understanding of how spiders use this unique glue will allow scientists to develop reversible adhesives that work in the presence of water,” says Dhinojwala.

As we have often highlighted in the past ("Sea life and other sources of glue to mend people" link or "Bio Glues" link), a wide range of biological sources have been identified and are under evaluation (or adaptation) as medical and surgical glues due to their evolutionarily-designed strength, biocompatibility and other inherent advantages.

See also the MedMarket Diligence, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013." Report #S175

Recent Global Medtech Reports

Below are recent global medical technology market reports from MedMarket Diligence:

  • “Worldwide Drug-Eluting, Bare and Other Coronary Stents Market, 2008-2017.”. See details.
  • “Worldwide Market for Surgical Sealants, Glues, Wound Closure, 2009-2013.” See details.
  • “Ablation Technologies Worldwide Market, 2008-2017:Products, Technologies, Markets, Companies and Opportunities.” See details.

Tissue closure and securement as benchmark for medical device usage

surgical-suturesThe market for surgical closure and securement (sealants, glues, sutures, staples, tapes, hemostasis, anti-adhesion) has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances. There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.

Worldwide expenditure on all medical devices is estimated to have surpassed $180 billion in 2007, and in the field of tissue repair and surgical securement, the total market reached $7.3 billion, underpinned by product advances reflecting our improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products available.

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.

fibrin-sealantOverall industry spending in the health care system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.

This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time-savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.

The total market potential by 2013, driven by procedure volumes, for hemostats, sealants, and glues, addressable by currently available products, nearly $4.5 billion for hemostats and sealants, and more than $1.3 billion for skin wound closure using high-strength glues. The introduction of a high-strength, elastic glue without toxicity concerns would revolutionize the market further and lead to even higher sales potential.

In the field of postoperative adhesion control, newly developed products improve on early prototypes and have substantial clinical efficacy data to allow for a significant premium cost. Over $700 million revenues were generated in 2007 in this market segment, and we expect that this market will grow to nearly $1.5 billion dollars in the next five years.


The above is excerpted from Report #S175.