Country-specific variations in wound management clinical protocols, markets

Clinical protocols for the treatment of specific wounds can vary considerably from country to country. Venous stasis ulcers, which account for approximately 4% of wounds and 75% of leg ulcers, are treated with short stretch compression bandages in Germany, elastic adhesive bandages in Italy, high compression bandages in France and multi-layer compression systems in the UK. As in the US, the routine use of strong antiseptics is discouraged in the UK and Germany but still prevalent in East European countries as well as the Netherlands and Italy.

worldThe quest for standardized modern approaches to wound healing is aided by groups such as the European Wound Management Association and European Tissue Repair Society, which encourage pan-European dialogue on issues pertaining to wound care. Such organizations have had significant effect on the development of US wound care policy and practices.

The proliferation of different wound care products and strategies leads to confusion and uncertainty over the best practice options. Clinical comparisons between treatment modalities have been minimal, with reliance on small, product-focused studies that often omit the wider context under which wounds are treated. Users of wound care products rely on manufacturers for performance data and increasingly turn to the larger manufacturers for staff education and wound care treatment protocols that will naturally include the use of the large number of products in the manufacturer’s line. In many countries in Europe, testing procedures have been developed by government-supported cross-company working panels that meet regularly to define specific protocols for testing products. These tests gradually become adopted by manufacturers as first lines of evaluation for new technologies.

The emerging use of electronic devices for wound documentation and assessment is expected to allow the comparison of large numbers of wounds undergoing different integrated approaches to wound care and begin to differentiate those activities that provide the most benefit to wound healing. As in the rest of the world, studies need to become larger, more standardized and complete to allow scientific comparison of products and practices that include multiple product classes and the management of the underlying conditions that create chronic wounds.

In addition, electronic devices for recording individual patient data are becoming available. These devices are important to ensure continuity of treatment, particularly in the home environment where several visiting nurses may see a single patient over a period of weeks. Without a good monitoring tool a complex and inconsistent mix of products and strategies could be applied.


See report #S247 from MedMarket Diligence.

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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Global markets in medtech are the sum of local market drivers

Following on the post, What medtech company isn’t globally focused?, the premise of which is that opportunities are too large globally to focus on one geographic, especially considering the competition, it is important to understand how the dynamics of each market can come to be understood in juxtaposition with each other.  Each market has its own demographics, its own clinical practice patterns, its unique rates of technology adoption.  

For example, companies who market products in the U.S. can find opportunities in non-U.S. markets by understanding the differences in the drivers and limiters in those non-U.S. markets.

Consider the wound management market in Japan.

It is estimated that more than 1 million people in Japan are treated for wounds every day. There are roughly 5,500 new cases of diabetes every year. There are now roughly 8.2 million Japanese suffering from diabetes with a total 18.7 million people including pre-diabetic subjects, according to The Japan Diabetes Society.

The potential market opportunity offered by the caseload of decubitus ulcers may be gauged from the fact that the total of infirm elderly is expected to be 3.5 million in 2010. Among elderly individuals who are bedridden, 75% have been in this situation for more than one year and 53% for more than three years.

Other important differences exist between Japan and other countries, but the above give a glimpse of how the wound management market in Japan  can be understood on the basis of the underlying drivers in its market.

Below is a segmentation of Japanese advanced wound management market in 2008 and 2017.  Like other well developed markets, Japan illustrates similar shifts — but in different relative rates — toward or away from the use of specific wound management technologies.

Japan-wound-market-segments

Source: MedMarket Diligence Report #S247.
 

 

Applications of Fibrin and Other Surgical Sealants

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

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.

See MMD report #S175.

Hemostats market: dominant players, but many competitors

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

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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Covidien Introduces V-Loc for Knotless Wound Closure

Today at the 95th Annual Clinical Congress of the American College of Surgeons, Covidien introduced its V-Loc absorbable device for knotless, soft tissue repair. 

"The V-Loc device is a breakthrough in dermal wound closure technology, and the feedback we are getting from surgeons who have tested the device is overwhelmingly enthusuastic," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, at Covidien.

 Continued at link.

The V-loc is a self-anchoring loop and barb device that eliminates the need to tie knots while providing even tension across the wound through multiple tissue layers. (See more about V-Loc.)

 —

Covidien is also covered in the MMD report #S247, "Worldwide Wound Management Market, 2008-2017", and report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013".

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Country-specific wound management markets, drivers

Products and technologies used in advanced wound management have found varying degrees of success in global markets, stemming from differences in clinical practices, cultures, sensitivities, demographics and other geographically-driven differences.  At the macro view, the size of the advanced wound management market by countries falls in a typical pattern based on the relative size of the populations and healthcare markets:

world-wound-pie-countries

Source: MedMarket Diligence report #S247

The differences between these markets in their relative adoption and use of advanced wound management technologies is illustrated in the graph below, showing the percent of each country’s total market that is represented by each wound product type.

wound-countries-and-segments

Source: MedMarket Diligence report #S247.

 

(From "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World", report #S247.)

Mechanisms of tissue repair and commercial development

Mechanisms of Tissue Repair

As recently as 10 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 review 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 United States, a new medical device is usually marketed after the FDA approves a pre-market application (PMA) or clears a 510(k) pre-market notification submission. Through a conscious effort by the FDA, the time required for the agency to carry out this approval has been steadily reduced and is now around 3 months for a 510(k) and 13 months for a PMA. The FDA has also worked to make the approval process less arbitrary.

Regulatory bodies in Europe and Japan also have achieved significant advances in the last 10 years to streamline their approval processes so that clear guidelines are given for approval and reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval 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 device 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.

(The above is an excerpt from "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013", Report #S175.  See also Report #S247, "Worldwide Wound Management Market, 2008-2017".)