Medical technologies, once they have successfully traversed the harrowing straits of the R&D and regulatory process, find sales success by tapping a clinical need in patient caseload. That need is represented by either previously untapped need (patients are not treated at all or the outcome of existing treatments fall woefully short of adequate) or by displacing caseload from currently available, competing treatments.
A wholesale shift is taking place in the technologies used to close acute and chronic wounds. Traditionally, wounds have been simply physically closed via sutures or tapes, bringing together the wound edges so that the body’s normal physiologic process of wound healing can take place with a minimum of scar formation. While tapes are just about the easiest possible way to secure wound edges, and represent a very low cost to accomplish it, their efficacy at closely adhering edges, securing large wounds and achieving high strength wound closure is less than optimal. Suturing, the option used more often, represent a fundamental skillset of doctors (at least external sutures, placed surgeons or others) and accomplish a tight seal, strong closure and overall high clinical outcome.
The rate of surgical technology development in the past dozen or more years has been fairly intense, with the emergence and widespread adoption of minimally invasive (e.g., laparoscopic and NOTES) surgical formats and the simultaneous emergence of many novel wound sealing and closure technologies. Wound closure in the laparoscopic format for one has required the development of instrumented systems to either tie sutures or apply surgical staples as an alternative. Other wound closure development has evolved on the biophysical front, with the commercial development of synthetic and/or bioglues to adhere wound edges without the use of sutures (or staples). These include fibrin and other biologically-derived sealants that have been leveraged for their ability to secure wounds advantageously due to their biocompatibility and their ability to not only adhere wound edges but also to seal wounds, thereby preventing continued bleeding, loss of fluid, and introduction of infectious agents.
However, a performance gap remains between the physically maintained closure provided by sutures and the complete closure offered by fibrin sealants. Wounds closed by fibrin sealants, at their most optimal, cannot be as tight as those closed by sutures. Consequently, fibrin sealants have found acceptance for wounds requiring less significant structural closure, such as wounds likely to be affected by body movement or those with added need for “sealing” (such as, for example, in closure of intestinal, lung and other wounds).
Into the “gap” between high-strength sutures and lower-strength but biocompatible sutures have come two product alternatives from different perspectives — bioabsorbable sutures and high-strength medical adhesives. Bioabsorbable (or bioresorbable) sutures, such as PLLA (poly-L-lactic acid), polydioxanone, polyglycolic acid and others, perform as traditional sutures, but after a time during which normal healing is proceeding will dissolve leaving the wound edges to heal normally. High-strength medical adhesives, such as the cyanoacrylate and a wide range of biologically derived glues, or bioglues, provide for very tight, high-strength closure of wounds without need for the physical closure accomplished with sutures or clips. These products have the potential to provide complete (long-term) closure of wounds without the need for suture removal.
The theory of high-strength medical adhesives providing complete wound closure without complication has, however, not quite been met by products in practice. Cyanoacrylate-based glues are unfortunately associated with the formation of toxic byproducts, which has thus far limited their use largely to topical wound closure (which is less impacted than internal closure by toxicity). Biologically-derived or other non-cyanoacrylate-based high-strength glues still remain in relatively early stages of development, but their promise remains high, since the commercial hurdles to their use appear to be more in the refinement of their formulation and delivery than in the inherent properties of the adhesion they produce.
Therefore, what the global market for wound closure is experiencing is not the rapid adoption of surgical sealants or high-strength adhesives, but their slow and steady uptake as physicians gain confidence in applying them to specific wound types and as manufacturers refine their ability to position products for these uses as well as the adjunctive use of sealants and glues with sutures, wherein sealants/glues are applied to suture/staple lines to ensure a complete seal.
It is for this reason, that the uptake of high-strength adhesives is proceeding more slowly. Given adhesives for wound closure, the most direct competitor, especially for topic wound types, is traditional tapes:
Source: MedMarket Diligence, LLC; Report #S190
Source: MedMarket Diligence, LLC; Report #S190