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Surgical sealants, new medical technology and lower costs

Covidien has announced the launch of DuraSeal sealant for the intra-operative sealing of dural membrane during spine procedures. In the U.S. alone, 150,000 spine surgeries annually are associated with leaks of cerebrospinal fluid (CSF), with each incident being reponsible for nearly $6,500 in additional costs.

What is telling in Covidien's emphasis on cost is that it directly targets a perceived problem with medical technologies -- that they are associated with unnecessary (or at least unreasonably high) costs. As such, medical technology, inclusive of medical devices and technologies like sealants, which serve roles like medical devices (e.g., sutures), are too often viewed as adding to cost, when they can in fact reduce cost.

The perspective of Covidien is not merely a marketing spin, and it is unfortunate that the prevailing view of medical technology outside of the industry misses the reality of the efforts of many manufacturers like Covidien, who recognize the compelling sales case that can be made when new technologies offer the benefit of lowered cost. Innovation is as much achieving this benefit as extending life or improving quality of life.

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See MMD report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

New Report Available on Advanced Wound Management Worldwide

The $5 billion global market for wound management products and technologies is comprised of commodity-like dressings and bandages (little differentiation beyond price) as well as advanced wound management products like physical wound healing systems (NPWT, others) designed to tackle the pervasive problem of high-cost, chronic wounds.

MedMarket Diligence's 2009 report, Worldwide Wound Management, 2009:  Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World, reveals the opportunities for the diversity of wound management products, with country-specific detail for the U.S., Japan, Germany, France, Italy, and United Kingdom, with breakdown also for the Rest of World category and the global market by product segment.

The report may be ordered for download online.

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.

 

Negative Pressure Wound Therapy (Gauze and Foam)

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.

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.

Spider web glue joins ranks of biologically based glues under study

A considerable number and type of different biologically-based glues and
adhesives are being studied for their potential use in human applications
for wound closure. We previously addressed this in our post Sandcastle worms, mussels, burrowing frogs and gecko feet. To that list, we can now add a
glycoprotein web glue from the golden orb weaving spider.

A sticky substance in spider webs may lead to the development of
a new generation of biobased adhesives and glues that could replace some
petroleum-based products.

See more at link.

The findings are being reported in the October 2009 issue of the ACS's
Biomacromolecules. While not explicitly noted (in abstract
information) for its potential use in humans, the development of any
bio-based glue represents this potential.

MedMarket Diligence has published its 2009 report, "Worldwide Market for
Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013." See
the report's description, table of contents and complete list of exhibits at
link.

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".)

Wound classification: Severity, Morphology, Etiology, Color

Different classification systems consider tissue wounds from the aspects of severity, morphology, thickness, and etiology. Several methods for classifying wounds have been developed, each determined by the interests of the specialty dealing with the wound. For example, burn specialists have historically classified according to degree of injury, surgeons categorize wounds by severity of tissue loss, while those treating pressure ulcers have their own classification of wounds by stages. Each classification system is useful in generating a prognosis and plan of intervention for each specialty, including the appropriate use of available products. Below are some of the more common classification schemes:

Severity. This classification considers wounds based on the amount of tissue loss or damage, whether the wound also involves nerve, muscle and/or bone, and whether infection is present.

Morphology. This common scheme differentiates wound types categorizes them as partial thickness, deep partial thickness, and full thickness based on the amount of epidermis, dermis, subcutaneous tissue, fascia, muscle and bone. Severity drives the range of therapeutic options necessary and dictates the healing time, the amount of scarring, and the resulting functional impairment

Etiology. The nature of the cause of the wound formation is a significant determinant of the wound and its severity. Classification by etiology therefore considers the causative event, including surgery, trauma, burns, pressure, venous and diabetic ulcers, radiation, and proliferative scars. Moreover, chronic wounds are understood for their evolution beyond the causative event to result in unique challenges to wound healing.

Classification of Wounds by Etiology

• Surgical wounds
• Traumatic wounds
• Burn wounds
• Ulceration, including pressure, venous, and arterial/diabetic
• Amputation
• Proliferative scars, such as keloids and hypertrophic scars
• Immunosuppressive wounds
• Disease-associated
• Pharmacological therapeutics
• Radiation wounds

Color. Dressings manufacturers (e.g., Molnlycke) have identified the relevance of wound color, particularly for chronic wounds:

• Black: containing necrotic tissue that needs to be removed.
• Yellow: requi ring autolytic debridement and moist wound healing.
• Red: granulating wounds that require moist wound healing products.

The classification methods, above, are further detailed in MedMarket Diligence Report #S247, “Worldwide Wound Management Market, 2009.”

LifeBond's LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant

(This post drawn in part from Medgadget)

 

LifeBond of Israel is developing, and seeking FDA and European approval for marketing in 2010, protein-based surgical sealants that the company claims provide greater adhesive strength than blood-derived fibrin sealants.  The LifeBond products, formulated in the LifeSeal SLR staple  line reinforcement sealant and the LifeSeal Surgery sealant are crosslinked gelatin that are applied as an adhesive hydrogel matrix.

 

 

 

 

 

 

A key aspect to take note of in the LifeBond products is that they are protein-based and provide adhesive strength that is competitive with fibrin and other blood-based sealants.  This is crucial because on blood-based sealants allow for internal use, while cyanoacrylate-based medical glues (like Ethicon’s Dermabond) provide greater adhesive strength, but are prohibited from internal use due the toxicity of cyanoacrylate and its by-products.

 

 

Excerpt from MedMarket Diligence’s Report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013.”:

 

“LifeBond was established in Israel in 2007 to develop sealants and active hemostats that incorporate a proprietary adhesive formulation that mimics the biochemical cross-linking cascade of late-stage blood coagulation. The sealant forms a network similar to the fibrin network of blood clots but has demonstrated adhesive strength the company claims is greater than that of blood-derived fibrin sealants. The LifeBond adhesive comes in gelatin-based hemostat form (LifePatch Surgery and LifePatch Heavy absorbable hemostats) and LifeSeal GI (gastrointestinal) and LifeSeal (general surgery) sealants.”

 

See the MedMarket Diligence report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013.”

ScienceBlog: Math used as a tool to heal toughest of wounds

Scientists at Ohio State University have developed a mathematical model designed to facilitate the development of treatment alternatives for ischemic, chronic wounds.

 

COLUMBUS, Ohio -- Scientists expect a new mathematical model of chronic wound healing could replace intuition with clear guidance on how to test treatment strategies in tackling a major public-health problem.

 

The Ohio State University researchers are the first to publish a mathematical model of an ischemic wound -- a chronic wound that heals slowly or is in danger of never healing because it is fed by an inadequate blood supply. Ischemic wounds are a common complication of diabetes, high blood pressure, obesity and other conditions that can be characterized by poor vascular health.

 

continued.

I find this article fascinating. With chronic wounds representing a nagging source of high costs in healthcare, it is imperative that treatments be developed to accelerate the wound healing process. But, if the process of healing (or lack thereof) in chronic wounds is not understood, treatment alternatives will be hit or miss at best. (Please note that we characterize the status of wound management technology development, and global markets, in report #S247, "Worldwide Wound Management, 2008-2017".)

 

Advanced wound care technologies target high costs, according to New MedMarket Diligence report

September 21, 2009 (For Immediate Release)

While the huge $5 billion global market for wound management technologies may not suggest it, many of its products are designed to target the high cost of wound healing. Chronic wounds and non-healing wounds. See the 2009 MedMarket Diligence report.

FOOTHILL RANCH, CA --- Advanced wound management technologies — those used in the clinical management of wounds (not OTC) — represent a $5 billion global market that will triple in the next ten years.  These technologies have continued to evolve beyond simple dressings and bandages to be able to accelerate wound healing, improve clinical outcomes and, in particular, attempt to reduce the cost of managing wound types like arterial, venous, diabetic and stasis ulcers.

The distribution of the advanced wound care market across these different wound care types has continued to shift, especially with the development and application of more expensive wound care technologies, which have been incentivized by the high cost of chronic wounds.  Physical therapies, which include negative pressure devices, positive pressure devices, mechanically assisted wound closure, hydrotherapy, electrical stimulation, ultraviolet therapy and others, are demonstrating the largest relative growth.

"The intense focus of healthcare reform on the cost of medical technologies might examine wound management as a cost driver, but the reality of products and development in this area is that the high cost of chronic or non-healing wounds is the prime target of the wound management industry's efforts," says Patrick Driscoll of MedMarket Diligence, publisher of the 2009 Worldwide Wound Management Market report.  According to Driscoll, the high direct and indirect costs of chronic wounds have created an economic opportunity that sustains advanced technology development.  This does not make wound care exempt from the focus of healthcare reform, but does weaken the argument against the "high costs" of advanced technology development.

The MedMarket Diligence report, "Worldwide Wound Management, 2009:  Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World," published September 2009, details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, tissue engineered products, physical treatments and others. The report details current clinical and technology developments in this huge worldwide market with high growth sectors, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year (actual) 2008 market size and share data, with forecast market data to 2017, for the U.S., Europe, Asia/Pacific and Rest of World.

The report is described in detail at http://mediligence.com/rpt/rpt-s247.htm. It may be purchased online at http://www.mediligence.com/store/page31.html or it may be ordered via fax order form http://mediligence.com/order_forms/s247_order.pdf.

Tags: woundcare, wound management