Surgical wound closure and securement, market size versus growth

The worldwide market for products used in securement (sutures, staple, hemostasis, tapes, surgical sealants, high-strength glues) is characterized by both well established markets (sutures, staples and tapes) and novel products (surgical sealants, hemostasis and high-strength glues).

The attractiveness of the surgical securement market is that there are some sizable segments that continue to demonstrate high annual market growth, and these are the surgical sealant segment (fibrin and other biological sealants), in particular, and the high-strength glue segment.

Illustrating this is the bubble chart, below, with bubble sizes (and horizontal axis) representing market size and with position along the horizontal axis representing annual market growth for 2010.

securement-bubbles

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

While there is growth coming from the expanding market of new clinical applications for advanced surgical selants, glues, hemostats (and anti-adhesion, not shown in above graph), the established market and caseload for sutures and staples (represented by the big blue, low growth bubble in the upper left of the graph) is also a ripe target for the new products, which can improve outcomes and facilitate wound closure compared to traditional products.

 

Potential for neurological applications of sealants, hemostasis and closure treatments

neuro-sealantsThere is potential for new sealant, hemostasis and closure treatments designed to facilitate surgical treatments of neurological disorders; most existing alternative treatments are pharmological therapies limited to reducing symptoms and few cures exist. An important driver in this market segment is the increasing aging population, with a consequent growing prevalence of age-related disorders. Also, new improved systems for diagnosis promise the possibility of earlier intervention.

The major indications that will benefit from new sealant, hemostasis and closure products in neural tissue surgery are procedures to treat chronic stroke, spinal cord trauma, neurovascular defects, and brain tumor treatments.

There are an estimated 5.6 million Americans who may benefit from the use of closure and securement products for neurological disorders in 2008.
 


Excerpt from "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013," report #S175, published by MedMarket Diligence, LLC.

Analysis of global markets for sealants, glues, hemostats, anti-adhesion

Sutures and staples are at an aging stage in their product life cycle; there are numerous predicate devices, and the materials are well established and cover most of the spectrum of clinical need for suturing. However, a great number of procedure-enhancing devices have been developed in the last seven years, particularly as minimally invasive surgery and robotics have created a need for new instrumentation to secure tissue. Good examples of this are the development of stapling devices for pneumostasis and securement devices for arthroscopy. This illustrates the fact that once clinical evaluation of a new product has been completed to the satisfaction of regulatory authorities for launch of the new product, incremental developments and clinical evaluations are usually continued throughout the lifetime of the product.

The MedMarket Diligence Report #S175 on surgical sealants and related products is widely read in the industry for its comprehensive global coverage, product and company detail, market specifics and insights, benefitting readers with competitive intelligence, market awareness and opportunities. See the complete description and table of contents here.

Similarly, a number of hemostats and devices for preparation of autologous fibrin sealant have also been available for some time for prevention of blood loss (e.g., from Harvest Technologies). These materials and devices are generally approved for hemostasis, and companies have attempted to develop new physical forms, mixes, and delivery systems to speed up and improve the usefulness of these products.

Commercial forms of pooled human fibrin have been used clinically outside of the United States for many years, for reasons of preventing infection; however these products did not reach this stage of clinical evaluation in the United States for many years. In 1996, the FDA approved the clinical investigation of fibrin sealants and a number of trials commenced. These resulted in a cascade of approvals for specific indications and claims, and considerable off-label use and clinical evaluation. Fibrin sealants have been employed and reported to prevent bleeding in many types of procedures including cardiovascular (e.g., restiotomy), neurological (e.g., craniotomy), orthopedic (e.g., knee replacement), spinal (e.g., vertebral fusion), cosmetic (e.g., breast augmentation) and digestive (e.g., closure of temporary colostomy).

Alternatives to fibrin sealant have been developed and launched with specific claims and targeted at specific indications. Cyanoacrylates have been employed as external suture replacements since 1997 in the United States. These materials started life as off-label sports injury products; they were approved with limited claims, which were then expanded to include “reduced injection risk,” and general use of these products for topical application is well established; reports from major suppliers suggest that approximately 20% of the accident and emergency opportunity for treating lacerations in the United States is penetrated by cyanoacrylate glue products.  

Variables Associated With Clinical Evaluation of Closure and Securement and Related Products
 

Variable

Rapid Evaluation

Delayed Evaluation

Expense

Low cost if short follow-up, (e.g., cuts and grazes) and low-cost procedure

High cost if long-term follow-up required, (e.g., ligament repair) and high cost procedure

Follow-up period

Some procedures require short follow-up periods (e.g., hemostasis endpoints and use of cyanoacrylate on cuts)

Some procedures require at least two years follow-up (e.g., musculoskeletal sports injuries)

Surgical setting

Community care (lacerations)

Theater (surgery)

Doctor’s surgery (accidents)

Critical care (e.g., burns)

Technology

Some devices and developments have predicate devices which allow more rapid approval. Autologous products are also relatively quick to develop

New biologicals, complex mixtures of biomaterials, and new chemical entities require extensive validation and testing

Device for delivery

Can accelerate clinical approval and improve clinical efficacy

Can complicate clinical development if both device and product are new
 
Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

 

Hemostats in the surgical securement market

One of the more traditional segments in the securement products (sealants, glues, hemostats, sutures, staples, and anti-adhesion) market is hemostats. 

Hemostat products can be classified in six subsegments depending on their active principle: thrombin, gelatin, collagen, fibrin, synthetic materials, and other miscellaneous products that exhibit additional attributes.

In the MedMarket Diligence report #S175 addressing these products, the clinical and other utility is identified by quantifying procedure volumes for each product type and grouping them into the following categories:

Category I: 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.

Category II: 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).

Category III: Cost-Effective and Time-Saving
Immediate reduction in surgical treatment time and follow-up treatments.

Category IV: 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.

Accordingly, the category with the most significant procedure volume (over 40% of total) in securement products, particularly for hemostats, is Category II.

Category II procedures are those that benefit from use of adjunctive closure and securement products due to the effect they have in reducing morbidity, reducing surgical procedure time, and preventing fibrosis or infection. This category includes implant procedures where good hemostasis can have a beneficial effect in increasing implant integration, e.g., bone integration with metallic implants and prostheses. Also in this category are procedures where complications are reduced through the effect of hemostasis and adhesion prevention products. Category II also includes procedures where increased morbidity may result from the necessity to restrict blood flow during surgery; this can lead to substantially increased cell death and to acute and chronic conditions such as deep vein thrombosis as a result of poor blood flow. For example, knee replacement procedures often make use of a tourniquet to reduce blood flow and the requirement for blood replacement. Often there is considerable morbidity and longer rehabilitation required after these procedures.

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.

 

 

Manufacturers of medical and surgical sealants, glues, hemostasis, wound closure and anti-adhesion products

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

Companies profiled in the report include the following:

 

3DM, Inc. (3D-Matrix, Ltd.)
3M
Abbott Vascular
AccessClosure, Inc.
Adhezion Biomedical, LLC
Advanced Medical Solutions plc
Allerderm
Angiotech Pharmaceuticals, Inc.
Anika Therapeutics, Inc.
ARC Pharmaceuticals
Arch Therapeutics, Inc.
ArthroCare Corporation
Aso LLC
Aspen Surgical Products
Atrax Medical Group
Avery Dennison
B. Braun Melsungen AG 
Bastos Viegas, s.a.
Baxter International Inc.
Bayer HealthCare
BD (Becton, Dickinson and Company)
Berlin Heart GmbH
Bernsco Surgical Supply
Biocoral Inc.
BioCore Medical Technologies, Inc.
Biogentis, Inc.
Biomet Inc.
BIOSTER a.s.
BioSyntech Canada Inc.
BSN Medical
C.R. Bard
Cardiovascular Sciences, Inc.
Carl Auffarth GmbH & Co. KG
Cardiva Medical, Inc.
Ceremed, Inc.
Chemence Ltd.
Chemopharma, s.a.
Cohera Medical, Inc.
Collagen Matrix, Inc.
Coloplast A/S
ConvaTec
Covidien Ltd.
CryoLife Inc.
CSIRO PhotoMedical Technologies
CSL Behring

 

CSMG Technologies, Inc.
CuraMedical BV
Cypress Medical Products
Derma Sciences, Inc.
Distrex Ibérica S.A.
DuPont Applied BioSciences
Entegrion, Inc.
FibroGen, Inc.
Fidia Advanced Biopolymers
Flamel Technologies SA
Forticell Bioscience
FzioMed Inc.
Gelita Medical BV
GEM srl
Genzyme Biosurgery Inc.
GluStitch, Inc.
Graceduty Company Limited
GramsMed, LLC
Haemacure Corporation
HAPTO Biotech Israel Ltd.
Hartmann Group
Harvest Technologies Corporation
HemCon Medical Technologies, Inc.
Hemostasis, LLC
HyperBranch Medical Technology, Inc.
Incisive Surgical, Inc.
Innovasa Corporation
Integra Lifesciences Corporation
I-Therapeutix, Inc.
Johnson & Johnson
Kaketsuken (Chemo-Sero-Therapeutic
Research Institute)
Kensey Nash Corporation
Kimberly-Clark Health Care
Kinetic Concepts, Inc.
King Pharmaceuticals, Inc.
Kookbo Chemicals Co., Ltd. (KB Chem.)
Laboratoires Urgo (Urgo Medical)
Lewis Medical Supplies
LifeBond Ltd.
Lifecore Biomedical, Inc.
Lohmann & Rauscher
Marine Polymer Technologies
Medafor, Inc.
Medi Surgichem Pvt. Ltd.
MedTrade Products, Ltd.

Meyer-Haake GmbH Medical Innovations
Mölnlycke Health Care AB
Morris Innovative
Motex Healthcare Corp.
Myco Medical
NeatStitch Ltd.
Neose Technologies Inc. (Novo Nordisk)
Nycomed
Omrix Biopharmaceuticals Inc.
Pac-Kit Safety Equipment
Pfizer Inc.
Pharming Group NV
Plasma Technologies, Inc.
PlasmaSeal
Pluromed, Inc.
Polyganics
Polyheal Ltd.
ProFibrix BV
Progressive Surgical, Ltd.
Protein Polymer Technologies, Inc.
Radi Medical Systems AB
Resorba Wundversorgung GmbH & Co. KG
Scapa Group plc
Scion Cardio-Vascular, Inc.
Sea Run Holdings
Seton
Smith & Nephew plc
Starch Medical, Inc.
Steroplast Ltd.
Sutura, Inc.
Synovis Life Technologies
SyntheMed, Inc.
Teleflex Medical
ThermoGenesis Corporation
Therus Corporation
Thrombotargets Corp.
Tissuemed Ltd.
TraumaCure, Inc.
TyRx Pharma Inc.
Vascular Solutions, Inc.
Vectura Group plc
Vivostat A/S
Z-Medica Corporation
Zimmer
ZymoGenetics, Inc.

 

 

Proliferation of sealant/glue/hemostasis/anti-adhesion companies, developments

A truly striking amount of industry activity spanning company formation, industry consolidation, product developments and market introductions have taken place over the past two years in the markets for sealants, glues, hemostasis, wound closure and anti-adhesion.

With a relatively low barrier to entry for products with well established routes to FDA and CE Mark approval, application of products across a wide range of clinical applications, short learning curves and otherwise low resistance on the part of clinicians in adopting new products in practice, the markets for these products have been dynamic.

The report by MedMarket Diligence, pending publication in December 2008, illustrates the breadth and depth of this robust market, with nearly 100 companies profiled and active in this market.  

Globally, this is a $11+ billion market, with persistently double digit growth rate in some sectors.  The report is described below:

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 products in wound closure. 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 and medical adhesives. The report provides a worldwide current and annual forecast to 2013 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 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 ten-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 preliminary table of contents.

Sealants, Glues, Wound Closure, Anti-Adhesion

[Below is an excerpt from Report #S145, “Worldwide Surgical Sealants, Glues & Wound Closure”, published Feb. 2007.  This report is the subject of a new analysis, Report #S175, to be published December 2008.]

Introduction

The market for surgical closure and securement 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 surpassed $173 billion in 2006, and in the field of tissue repair and surgical securement, the total market reached almost $7 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.

Overall industry spending in the healthcare system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the USA) 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 out-patient 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.

Demographic trends

Many new surgical procedures have been established over the last ten years as products and procedures are modified to accommodate increased consumer (i.e. patient) awareness and to support practitioner based competencies. These procedures are often linked to new technologies. For example, minimally invasive procedures that were comparatively rare 10 years ago are now routine; more than 70% of gall bladder surgeries are performed laparoscopically and more than 60% of patients with angina pectoris receive image-guided PTCA (percutaneous transluminal coronary angioplasty) instead of open heart surgery. These procedures depend on new devices and instruments, including improved means of internal and external closures and securement. In addition, ageing of the population adds progressively to the surgical caseload. For example in the USA, Medicare beneficiaries (disabled and elderly patients) are forecast to increase from 34 million to 70 million between 2000 and 2030. Products that are targeted at this elderly population – and reimbursed – would be expected to reflect this trend by compound annual sales growth of 2-3 %. In other regions of the world, this trend is also seen as a major market growth rate determinant.

Consumer Driven Product Selection

Other important driving factors are accelerating public healthcare awareness and education, improved communication techniques and media, rises in gross domestic product in many countries around the world, and awareness of patient rights (including litigation potential). All lead to increased uptake for the best new products, technologies, and techniques, once these have been proven safe and effective. For example, it might now be viewed as negligent for a gynaecological surgeon to not use an adhesion prevention product on a female patient of child-bearing age. Patient access to clinical trial records and regulatory approval information is now becoming more universal, and this contributes powerfully to consumer-driven product selection.

Mechanisms of Tissue Repair

As recently as ten years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. By 2003, many companies had abandoned this approach due to disappointing results. A better understanding of the underlying mechanisms of tissue repair has led to the evaluation of more complex approaches, combining structural repair materials with active pharmacological agents, biologically-derived and cellular components. This improved knowledge of physiological healing processes has led to formulation and adoption of new securement and adjunctive surgical devices, resulting in improved hemostasis, reduction in post-surgical adhesion (PSA) formation, and stronger and quicker biological repair.

Commercial Imperatives

MedMarket Diligence carried out a survey of the companies exploiting medical devices targeted at the surgical securement market, to examine the products they market and the timelines associated with their approvals. A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the USA, a new medical device is usually marketed after the FDA approves a pre-market application, or clears a 510K pre-market notification submission. The time required for the FDA to carry out this approval has been steadily reducing (around 3 months now for a 510k and 13 months for a PMA). The FDA has improved to accelerate this process and make the approval process less arbitrary.

Regulatory bodies in Europe and Japan have also made marked advances in the last ten years to streamline their approval processes, so that clear guidelines are given for approval and for reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval (KFA), and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.
We also found that all medical devices businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer term, more risky breakthrough opportunities.

Industry Consolidation

In the last few years there has been a significant consolidation of the securement industry, as venture-based companies are incorporated into larger market-based corporations with critical mass in their sales effort. This represents a welcome development for investors in leading-edge technologies, which are now being developed into marketable ventures. Examples exist covering the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses through to full acquisitions of companies.

In addition, regulatory progress in the securement field has led to a continued stream of new approvals around the world offering real value to the patient, and demonstrating improved awareness of regulatory needs, understanding of the biochemical mechanisms of repair, and offering real potential to build market value.

Clinical Caseload

The market potential for products in the surgical securement field is driven by a combination of new technologies coming to market, and expanding caseload for which these technologies are applicable. The potential for these products continues to grow as surgical practices improve and the benefits of new products address the requirement for fast and effective closure.
We forecast that approximately 70 million procedures around the world might benefit from products in this category in the future, and due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3-5%.
In the forthcoming decade we will see strong penetration of new therapies into new procedure areas, and some new introductory techniques for treatment of orthopedic, cardiovascular and neurological procedures.

Market Segmentation and Dynamics

This market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products. The total securement market is forecast to grow from almost $7 billion in 2004 to reach $10 billion in 2011 at a CAGR of 7.5%.

Aggregate growth rates worldwide per segment are shown for illustrative purposes below:

 

 


The 2007 report #S145 on worldwide sealants, glues and wound closure is available for purchase and immediate download. The December 2008 report may also be purchased with pre-paid advance discount (price noted below is $1,500 off the publication price).

 

Report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase in advance at this link or purchase via Google Checkout, below.

























Report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase for immediate download at this link or purchase via Google Checkout, below.

























Fibrin sealants reducing the incidence, extent and severity of anti-adhesion

Haemacure Corporation last month disclosed the apparent clinical utility of its fibrin sealant in the prevention of post-surgical adhesion:

Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, disclosed today the positive results of a second preclinical study conducted on the use of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN, in preventing the formation of post-surgical adhesions in a bleeding surgical model.

In two preclinical studies, this utility was demonstrated in the statistically significant reduction in the incidence, extent and severity of post-surgical adhesions when Haemacure’s fibrin sealant was compared to Interceed(R) Absorbable Adhesion Barrier (Ethicon) and Seprafilm(R) Adhesion Barrier (Genzyme).

A collegue pointed out to me that Angiotech’s CoSeal is being investigated by Baxter for its use as both a sealant and adhesion protection product.

The topic of anti-adhesion has been addressed in prior business reports by MedMarket Diligence, including the February 2007 report and is being addressed in the Report #S175 in process, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013.”

Quite a counterintuitive idea to take a glue and use it for anti-adhesion, but the data supports it.

The Uses of Adjunctive Surgical Closure and Sealant Products

From MedMarket Diligence report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.” See link.

  • The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.
  • Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.
  • Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost effective for topical wound closure and there are also many potential internal applications for these products.
  • Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anaesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anaesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.
  • Effective haemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2000 to $10000 per hour). For example, a $115 haemostat needs to shave 4 minutes off the operating time to ‘pay its way’. Often, these materials can save from five minutes to two hours depending on procedure.
  • Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures which have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.
  • Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate haemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g. 5-10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).
  • Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.

The sealants and securement market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products. This total market is forecast to grow from almost $7 billion in 2006 to reach $10 billion in 2011 at a CAGR of 7.5%.


The complete report on “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011” is described with complete table of contents and list of exhibits here.  This report is available for purchase online or via Google Checkout (below).