Tag Archives: wound closure

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.


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.

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

CryoLife Gets IDE Approval BioFoam Use in Hemostasis of Liver

CryoLife's BioFoam, a protein hydrogel, received FDA approval today to begin an IDE for sealing of liver parenchymal tissue when conventional methods (e.g., ligature) prove ineffective.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."

See link .

The use of hemostatic and sealing agents in liver surgery represents a significant opportunity for developers of biologically based sealants and glues. CryoLife has a good start, having received approval earlier this year to market BioFoam in the EU.

See report #S715 for the worldwide analysis of surgical sealants, glues and wound closure products.

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Negative Pressure Wound Therapy (Gauze and Foam)

See the newest global wound management market report (published December 2012), Report #S249, “Wound Management, Worldwide Market and Forecast to 2020:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

In results presented in a poster session at the 24th Annual Clinical Symposium on Advances in Skin and Wound Care (San Antonio, TX), the Advanced Wound Management Division of Smith & Nephew highlighted that gauze-based negative pressure wound therapy (NPWT) can achieve the same treatment goals as foam-based NPWT, which are a reduction in wound dimension, exudate, and improvement in granulation tissue.negative-pressure

Excerpt from Report #S247 on the background of NPWT:

One of the most dramatic, and perhaps surprising, recent developments in the advanced wound management sector has been the meteoric rise of negative pressure wound therapy (NPWT) technology, spearheaded by the V.A.C. approach developed by Kinetic Concepts Inc. (KCI). This has driven growth in the “physical treatment” market segment to exceed $1.2 billion. In 1989, Mark Chariker and Katherine Jeter developed a technique utilizing standard surgical dressings and wall suction to create a “vacuum” that aided in wound healing. In 1997, Dr. Michael Morykwas and Dr. Lewis Argenta studied the use of suction applied to polyurethane foam in wounds. Shortly after, KCI launched its product, the V.A.C.® and later received Medicare B approval. In early September 2009, Kinetic Concepts received Japanese regulatory approval to begin selling the V.A.C. device in that country. The company expects sales to commence in the first half of 2010.

Further innovations into the use of closed wound suction were made by BlueSky Medical with the Versatile One® System. Then in 2007, Smith & Nephew acquired BlueSky Medical and brought all that company’s products under the Smith & Nephew umbrella. Since the purchase of BlueSky, S&N has devoted considerable resources to contest KCI’s hold on the lion’s share of the market for NPWT devices.

More details on the study and its results from Smith & Nephew are given here. The trial was a prospective, multi-center clinical evaluation assessed 131 non-grafted patients at 21 centers in the United States, Canada, United Kingdom,  Saudi Arabia and the United Arab Emirates.

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