Tag Archives: suture

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

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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.

Opportunities for surgical sealants, glues and hemostatic agents

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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.

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

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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

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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

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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").

Now, National Public Radio highlights the research 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 the forthcoming updated Report #S180, publishing October 2010.

Secrets of Bio Glues

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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

Applications of Fibrin and Other Surgical Sealants

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The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

Tisseel, Baxter BioSurgeryFibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures.

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.

For the vast majority of surgical procedures, sutures and staples remain the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.
 

Applications of Fibrin and Other Sealants

  • Local hemostatic measures for both surgical and trauma cases
  • Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
  • Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
  • Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
  • Nerve grafts
  • Skin grafts, particularly plastic surgery
  • Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
  • Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
  • Anastomosis of gastrointestinal, tract and other ductal organs

Source: MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013."

Adhezion Biomedical, LLC

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Below is a brief profile of Adhezion Biomedical, LLC, one of the companies active in the surgical sealants and glues market and profiled in the MedMarket Diligence report #S175.  We occasionally highlight companies whose products, in our opinion, are poised to make an impact on medtech markets.

Founded in 2001, Adhezion Biomedical (formerly Spartan Medical Products, LLC) is a private company developing and producing cyanoacrylate-based medical adhesives. The company’s SurgiSeal, DermaSeal, and FloraGuard products are based on the company’s proprietary OctylFlex technology and can bond skin tissue, replace sutures, staples and bandages, or be a protective barrier to prevent infection as an anti-microbial surgical sealant. The highly flexible products are biodegradable, do not require refrigeration or blending and dry quickly. SurgiSeal and FloraGuard have achieved CE Mark approval in Europe and 510(k) status in the United States. The company has received FDA approval for an OTC product in the United States.

Adhezion Biomedical received its first patent in 2003 and in 2006 received 510(k) and CE Mark approval for a consumer wound-care adhesive. In January 2008, Adhezion received 510(k) approval for the professional version of its topical wound closure adhesive and in February 2008, the company received FDA approval to begin clinical trials of this technology.

In March 2008, Adhezion Biomedical raised $3 million in a Series A financing from Originate Ventures to fund growth and product development.

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See MMD report #S175.

Hemostats market: dominant players, but many competitors

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Hemostats have been used for over a hundred years to stop bleeding in surgical and traumatic wounds. 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.

The value of hemostasis lies in its ability to quickly improve patient clinical status and/or improve surgeons’ ability to do so by clearing the surgical field in order to assess traumatic wounds or facilitate surgical procedures. Hemostats also play a less technically challenging role than providing closure of wounds, which is offered instead by a variety of sealants and glues.  Consequently, the barriers to entry for this market are relatively low — and getting lower, as many companies are developing formulations of collagen and gelatin for introduction in world markets. (Components of hemostats on the market and under development also include thrombin, fibrin, synthetics and others.) However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture. 

There are some well established companies controlling the current market, among King Pharmaceuticals, Ethicon, and Pfizer, with many competitors vying for increasingly larger shares of this market. 

hemostats

"Others" include CSL Behring, Hemcon Medical Technologies, BioCore Medical Technologies, BIOSTER, Ceremed, Collagen Matrix, C.R. Bard, CryoLife, Entegrion, FibroGen, Flamel Technologies, Gelita Medical, Harvest Technologies, Kensey Nash, Marine Polymer Technologies, MedTrade Products, Nycomed, Omrix (J&J), Pfizer, PlasmaSeal, Polyganics, PolyHeal, Resorba, Scion Cardio-Vascular, Starch Medical, Synovis Life Technologies, TissueMed, TramaCure, Vascular Solutions, Zymogenetics, and Z-Medica Corporation.

Source: MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Evolution of Commercial Markets for Surgical Sealants and Adhesives

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Man Holding Cut Hand

The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan, driven by the strong cultural desire to avoid the need for blood transfusions. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the U.S. FDA in the late 1980s and 1990s. As a result, the scientific literature from Asia and Europe records many novel and experimental uses for sealant and hemostasis products across all surgical disciplines from ENT to major open heart surgery.

In addition to commercial sources of sealant products, surgical centers in all regions of the world also prepare autologous fibrin for surgical procedures in efforts to save on commercial product costs and to avoid potential for product-borne infection. Delays to the introduction of fibrin-based products in the United States led to a pent-up unmet need, which was addressed in the 1990s by the preparation of autologous fibrin in medical centers prior to surgical operations.

Historically, closure of surgical incisions has been achieved through an ever-evolving portfolio of suture, staple and tape products. In the early 1990s, physicians involved in sports medicine were the first non-military practitioners to adopt cyanoacrylate glues to achieve immediate closure of small cuts and lacerations, and an awareness of this opportunity developed in large multinational manufacturers of sutures and staples. Joint development efforts were commenced at Davis and Geck/U.S. Surgical (now Covidien), and Ethicon (subsidiary of Johnson & Johnson), and in a number of companies manufacturing cyanoacrylates, which ultimately resulted in topical cyanoacrylate closure products being launched around the world during the 1990s.

Post-operative adhesion prevention evolved as a market in the early 1990s and expanded with the addition of new entrant products from Genzyme (including Focal), and others. Lifecore and Ethicon have developed a surgical adhesion prevention product based on hyaluronic acid. Angiotech, Fidia, Fziomed and Tissuemed all have adhesion-prevention products that are CE approved in the European Union.

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The above is an excerpt from Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013."

Purchase for download:  Report #S175, "Sealants, Glues, Wound Closure (2009) PDF" — $3,250.00
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