Since its 1995 launch, EXOGEN has been prescribed by more than 10,000 physicians and sold in 15 countries. The device uses low-intensity pulsed ultrasound waves to induce micromechanical stress in fractures, amplifying the body’s natural bone repair mechanism. Studies have linked EXOGEN to an 86 percent heal rate for stubborn fractures and a 38 percent quicker healing time for fresh fractures. Bioventus claims its technology is supported by 16 Level 1 studies, but a 2016 McMaster University clinical trial found the device to be ineffective.
Despite the study data disparity, EXOGEN has been a solid source of growth for Bioventus, accounting for roughly $100 million in annual worldwide sales. Part of its success can be attributed to the rising popularity of orthobiologics (a.k.a., regenerative cellular therapies), a category of biologically-based substances used to help orthopedic injuries heal more quickly. Orthobiologics are made from substances found naturally in the body, and they generally are used to improve the healing of fractures, injured muscles, tendons, and ligaments. The global orthobiologics market is forecast to grow 5.5 percent over the next seven years, driven by the world’s aging population, expanding waistlines, and increasing numbers of orthopedic conditions and musculoskeletal diseases. “Orthobiologics are revolutionizing orthopedic care,” Ignatios Papas, D.O., a non-surgical orthopedic physician in Tampa Bay, Fla., wrote in a blog last December. “Despite this, many patients don’t realize that these substances exist and can help them recover from orthopedic injuries, often without surgery.”
ODT’s January/February feature, “Nature’s Way,” explores the various trends and challenges driving the global orthobiologics market. James J. Cassidy, Ph.D., president and chief operating officer of Artoss Inc., was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the current trends you see shaping the orthobiologics market.
James J. Cassidy: Stem cells seem to be declining in popularity as price pressures from hospitals as well as a lack of solid clinical data has called into question stem cells’ value proposition. Surgeons have begun moving back to using Infuse as alternative treatments have come up short. NanoBone Bone Graft is one of a handful of truly novel technologies that have entered the market in the last 10 years. As surgeons continue to look for new and better technologies, NanoBone continues to gain market share.
Barbella: What factors are driving innovation in the orthobiologics market?
Cassidy: Regulatory changes continue to affect innovation as well as challenges in gaining hospital approvals for new technology. As the main market for orthobiologics, spine surgery, continues to consolidate, hospital contracts with the largest spinal device companies create a barrier to entry for emergent orthobiologics.
Barbella: What factors are impeding growth in the orthobiologics market?
Cassidy: Lengthy and expensive regulatory review cycles and lack of venture capital spending in medical devices hinder growth.
Barbella: How can these challenges be overcome?
Cassidy: Changes to existing FDA regulations would enhance time to market for new orthobiologics most.
Barbella: What new (orthobiologics) technologies are in the works?
Cassidy: Artoss is committed to developing a number of surgical tool kits that facilitate implantation of NanoBone. Most orthobiologics companies are content in providing only an orthobiologic to their surgeon customers. Artoss has five products under development that will help surgeons address difficult cases in new and unique ways using NanoBone.
Barbella: Where does innovation come from in the orthobiologics market? How does your company stay innovative amid all the competition?
Cassidy: Innovation comes mostly from the surgeons that face challenges using existing technologies. Surgeon creativity is where the best innovation originates. When this creativity is coupled with good engineering, truly unique products are the result. The starting point in this development process is to have good relationships with surgeon customers that lead to collaborative development efforts. Artoss is fortunate to have developed a number of great relationships with these key surgeons.
Barbella: How does the regulatory landscape for orthobiologics differ (if at all) from other sectors of the orthopedic market? (hips, knees,spine, etc.). How does this impact product innovation?
Cassidy: In general, the FDA device panel is the same across the orthopedic market. Orthobiologics regulatory submissions can be a little more science-driven, but ultimately the FDA reviewers have done a good job in keeping up with the innovation allowing for a reasonable regulatory review cycle. Product innovation slows only when a new product requires prospective randomized human data for approval. This process can cost over $50 million and take up to 10 years to complete. Due to the rapid evolution of medical devices, most companies are reluctant to invest in this process due to the risk that a "new" product under review would be obsolete by the time regulatory approval has been achieved.
Barbella: What is the dominant orthobiologics application - spinal fusion, trauma repair, reconstructive surgery? What factors are driving growth in this particular application?
Cassidy: The dominant application for orthobiologics for the last 20 years has been spinal fusions. Spinal fusions use the greatest volume per case and the case volumes are very high. Growth in spinal surgeries continues at a slow and steady pace mostly impacted by increased total surgical volume. The increase in spinal surgeries is mostly dependent on changing demographics—an aging population. Other areas of orthopedics continue to evolve and are starting to require higher volumes of orthobiologics.