The market for high strength medical adhesives is growing, and is expected to continue to grow due to regulatory approvals and sustained by ongoing research activity. Active programs are currently under development in three areas for high strength surgical adhesives:
- The use of cyanoacrylate adhesives and new application devices for new internal surgical procedures
- New adhesive products based on existing biomaterial adhesives such as fibrin and albumin compounds
- New polymer adhesives based on entirely new chemistries (e.g., polyurethanes, proteins from living organisms).
The global market for high-strength medical adhesives is forecast to show strong double-digit growth during the forecast period, growing from roughly $713 million in 2011 to $1.72 billion by 2017. The USA represents, by far, the largest share of the global high strength medical adhesives market, and this is not expected to change during the forecast period.
Worldwide Market for High Strength Medical Adhesives, 2010-2017
Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”
Although some form of suturing wounds has been used for probably thousands of years, sutures can be troublesome. There are procedures in which sutures are too large or clumsy, and locations in which it is difficult for the surgeon to suture. They can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot getting stuck and obstructing blood flow. In addition, sutures may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. These are some of the reasons why surgical adhesives are becoming increasingly popular.
As a logical derivative, surgeons want a product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. TissuGlu (Cohera Medical), a urethane adhesive suited for plastic surgery procedures, is both biocompatible and resorbable, making it ideal for internal applications. It is also strong, user-friendly, and does not contain human/animal product derivatives. TissuGlu is currently only available for sale in Germany, but the company is rapidly preparing to sell in the other major markets of the EU.
One of the top five plastic surgery procedures performed in the United States is abdominoplasty, which has a reported post-operative complication rate of 15-52%. The most common complication is the formation of seroma. Usual methods to combat seroma formation include the placement of closed suction drains, use of compression garments around the tissue, use of progressive tension sutures, and use of fibrin sealants to reduce fluid accumulation. However, most of these methods can still lead to further complications such as leakage from drain sites, skin necrosis and inconsistent adhesion.
Cohera Medical’s TissuGlu is held to be useful in preventing the formation of seroma in abdominoplasty. Using TissuGlu helps to reduce the fluid drainage that can lead to formation of seroma. It can also reduce the need for post-surgical drains. The adhesive is molecularly designed to bond biological tissue in the presence of moisture, and then later to harmlessly degrade by hydrolysis. This is a key point in determining the biocompatibility of an adhesive intended for internal use. Recent research has found that the cyanoacrylate adhesives broke down into relatively harmless by-products. More importantly the rate of cyanoacrylate breakdown was about the same rate at which the wounds healed. Today, cyanoacrylate surgical adhesives, such as those based on octyl cyanoacrylate resins, are approved by the U.S. Food and Drug Administration for many surgical procedures in the United States. Cyanoacrylates are also widely used by physicians in Canada, Europe and Japan.