Dermal repair and market for securement products worldwide

Skin securement (sealing, closure, hemostasis, etc.) has always been an essential final step in surgical procedures. In early years, the skin surface was sutured; in recent years a number of advances have been made, including new tapes, sutures, staples, hemostats, and glues.

Treatments for skin or dermal repair by surgical securement products represent a worldwide caseload of over 20 million annually.  Burns represent the most serious of these cases, but roughly 25% of patients with burns die from them and overall are far fewer than ulcers.  Ulcers, which may be caused by inadequate circulation, biochemical deficience or other causes, are a high volume, high cost caseload worldwide and, as such, drive considerable interest in the development of improved treatments.  Nonetheless, the highest volume application in dermal repair in western civilization is plastic surgery.

Potential caseload is segmented by geography and skin repair type for the use of securement products, and is shown below:

ulcer-usa1

ulcer-europe

ulcer-row

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.

Growth, development and consolidation in the sealants, glues, wound closure and anti-adhesion industry

In the last few years, there has been a significant consolidation in the sealants, glues, wound closure and anti-adhesion industry (the "securement industry") as venture-based companies have been acquired and assimilated 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 are seen in the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses to full acquisitions of companies.

Recent Acquisitions in the Securement Industry

sealant-consolidation1

Source: MedMarket Diligence, Report #S175.