Market Size (Procedures per Year):

  • 10 million cardiovascular procedures in the US per year
  • 9 million musculoskeletal surgical operations worldwide
  • 450,000 fusions performed in the US per year
  • 200,000 diskectomies performed in the US per year
  • There are approximately 2.5 million joint reconstruction procedures worldwide

 

 

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Market

The Company’s technology as a tissue sealant has broad applications in:

  • General Surgery
  • Vascular Surgery
  • Neurosurgery
  • Spine Surgery
  • Ophthalmologic Surgery
  • Wound Care Tissue Sealants

The market potential for tissue sealants is extensive, as the total worldwide wound closures market is valued at approximately $1.7 billion. The US demand for medical and dental adhesives and sealants is expected to rise 7.6% annually through 2011, driven by continuing new product development and increasing acceptance in surgical and consumer settings (Frost & Sullivan).

According to a new report by Millennium Research Group (MRG), over $100 M worth of internal tissue sealant products were sold in the US in 2004. The global fibrin sealant market is well over $500 M annually. Frost & Sullivan estimates that the combined U.S. market for tissue sealants, hemostats and adhesion prevention products was over $300 M in 2002 and growing to more than $600 M by 2008. Others estimate the U.S. surgical sealant market will exceed $500 M annually in the United States within 5 years. Tissue sealants are already very important adjuncts in general surgery, vascular surgery, cardiac surgery, spine surgery, and brain surgery. Some reports suggest that in up to 40% of procedures, a tissue sealant could be utilized. Common scenarios where a sealant would be useful include: (1) water-tight closure across a suture line, (2) reinforcement of a high-stress suture line, (3) replacement of tissue approximation by using a sealant rather than sutures, (4) filling a dead space or void, and (5) sealing a vascular defect.

The market for surgical sealants is expected to grow in double digits over the next five years as aging populations drive increases in caseloads. In addition, less morbidity and better outcomes are seen with the latest fibrin sealants, high-strength glues and adhesion prevention products, thus spurring increased adoption of these technologies over traditional wound closure methods. Fibrin sealants are the most useful surgical hemostats because they can be used to clot blood but are also valuable for sealing around suture lines for organ transplants, mastectomies, and various resection procedures, as well as to prevent leakage of fluids and gases. A number of companies, including Harvest Technologies, Plasmaseal, ThermoGenesis, and Interpore Cross Medical, have developed active mixes of growth factors to aid repair and devices capable of preparing autologous fibrin and platelet formulations that can be used as sealants.