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.
However, the steady pace of FDA approvals and market introductions for products with sealing capabilities illustrates the success manufacturers have had in surmounting many of the technical hurdles to these products providing strong roles in tissue sealing. These include approvals by Baxter (Tisseel), GluStitch (GluShield), Angiotech (CoSeal, Vitagel), CryoLife (BioGlue), and Syneture/Covidien (Indermil).
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, LLC
As an example, in trauma, uncontrollable bleeding and complications associated with the requirement for massive blood transfusion account for the majority of deaths in patients requiring surgery for intra-abdominal hemorrhage. Approximately 15% of trauma patient admissions involve intra-abdominal hemorrhagic injuries. Unfortunately, high rates of failure and mortality are seen with existing surgical procedures, which are based on the use of quantities of gauze for blood absorption, and application of localized pressure to treat hemorrhagic injuries such as these. This unsophisticated technique has the further disadvantage of the need for further intervention after a few days to remove the gauze. Fibrin and other sealants offer improved success rates for these operations.
In addition to controlling bleeding during trauma surgery, cardiovascular bypass, angioplasty, cranial and spinal sealing, total knee and hip replacement procedures, pneumostasis during lung surgery, and liver and spleen surgical operations are the most immediate untapped opportunities for sealant products in the United States. Research into current practice outside the United States has revealed that fibrin and other sealants have a role in many types of surgical procedures, as detailed in the table below.
Surgical Procedures Using Fibrin and Other Sealant Products
|Original Company/ Product||Acquiring or Collaborating Company||Date of Acquisition/Collaboration Deal||Financial Details (where revealed)|
|Bristol-Myers Squibb/ Recothrom¨ Thrombin topical hemostat||The Medicines Company||2012/2014||$105 million collaboration fee|
|Cohera Medical/TissuGlu¨||Collaboration with B. Braun Surgical S.A. to distribute in Germany, Spain and Portugal.||Jan. 2015||B. Braun Surgical S.A. will exclusively market and sell TissuGlu in the territories of Germany, Spain and Portugal through its existing Closure Technologies commercial teams.|
|Profibrix/ FibroCaps||The Medicines Company||2013||$90 million, with $140 million contingent upon milestones|
|Medafor/Arista¨ AH Absorbable Hemostatic Particles||CR Bard (Bard Davol)||2013||$200 million upfront payment|
|Tenaxis Medical, with ArterX (among other products)||The Medicines Company||2014||$58 million in upfront payments|
|The Medicines Company/ PreveLeakª (formerly known as ArterX), Raplixaª(formerly known as FibroCaps) fibrin sealant, Recothrom¨ Thrombin topical (Recombinant) sealant||Mallinckrodt plc||2016||The entire deal has a potential value of $410 million.|
|Xcede Technologies, Inc./Resorbable Hemostatic Patch||Collaboration with Cook Biotech||Jan-16||Signed three collaboration agreements with Cook Biotech, including a Development Agreement, a License Agreement and a Supply Agreement to complete development, seek regulatory clearance and produce XcedeÕs resorbable hemostatic patch.|
Source: MedMarket Diligence, LLC; Report #S180, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015."