Tag Archives: hemostat

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.

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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.

Potential for Surgical Sealants, Glues, Hemostats and Anti-adhesion Products

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

Surgical sealants, glues, hemostats, anti-adhesion and other wound securement products have potential based on the the clinical/economic and other benefits they offer, a value that varies from one clinical specialty to another.

Below is illustrated the potential caseload segmented by the benefit offered by these products in each clinica area.

Source: “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.” Report #S180.

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.

Sealants, glues, wound closure, anti-adhesion market segments by country

The global market for surgical sealants, glues, other wound closure and anti-adhesion products (collectively referred to as "securement "products) is, like many medtech markets, dominated by the U.S., followed by Europe.  But as one examines the performance of individual product segments in this market, it becomes clear that local markets have enough differences in their drivers to result in surprising variation from one another.

Below are illustrated the absolute size of the markets for products in securement by country and the relative contribution of revenues from each securement product type by country.  The differences stand out.

Source: Preliminary findings, Report #S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015". (Publishing October 2010)

Oysters, mussels, and (a growing list of) other bioglue sources

(Updated, 3 March 2014)

Previously, we have highlighted multiple types of naturally occurring biological glues (“bioglues”) that have been studied for their potential to be applied to human surgical/medical applications. (See “Bio Glues: Crab shells, spider webs, gecko feet, burrowing frogs, mussels and c. crescentus bacteria“).

Add to this list:

Nature-inspired surgical glue. Researchers at Brigham and Women’s Hospital and Boston Children’s Hospital are developing a poly(glycerol sebacate acrylate) (PGSA), a gel-like biomaterial that is composed of glycerol, a common ingredient in pharmaceutical, food and other human use, and sebacic acid, a naturally occurring fatty acid. This biomaterial compound will potentially enable strong, non-toxic adhesion of tissues while being water insoluble, a set of key requirements for effective surgical glues that can function in internal (as opposed to topical) applications. See link.

Oysters. Research is being done by Jonathan Wilkder at Perdue University on the naturally occurring cement used by oysters to secure their shells to each other and to reefs making extensive structures. The “cement” has turned out to be 10% organic (a protein) and 90% inorganic calcium carbonate, which turns out to be only slightly different in proportions than the oysters’ shells.  Most importantly, and this is an important consideration in the study, this cement is wet-setting, which is a valuable characteristic of surgical glue or bone cement.

Since manufacturers wish to develop a surgical glue with the requisite strength while also being biocompatible, the bioglues of oysters, mussels and other organisms become acutely of interest.  By contrast, synthetically developed high strength glues are often cyanoacrylate-based or similar and are therefore characterized by toxicity in local tissues, limiting their use to topical applications.


Bioglues are a topic of coverage in MedMarket Diligence’s analysis of the global products, technologies and markets surgical sealants, glues and wound closure.  See “Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2012-2017″, Report #S190, publishing February 2012.

Surgical sealants, glues and hemostats market expanding with new products, clinical acceptance

definitions-sealants

Approximately 70 million surgical and procedure-based wounds are created each year in surgeries worldwide that offer potential for adjunctive products for surgical closure and securement. Some 23 million of these wounds are created during surgical procedures in the United States. Although it is possible that healing of all these wounds would be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures which receive sealant products around the world, generating $1.6 billion in sales in 2007. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures. New sealant products are also being launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.

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.


Sealants, glues, hemostats and other wound closure and anti-adhesion are the subject of the MedMarket Diligence report #S175