In Search of Orthobiologics’ ‘Holy Grail’

Kevin R. Stone, M.D., helped usher in the Age of Anabolics.
 
The San Francisco, Calif.-based orthopedic surgeon invented the world’s first orthopedic tissue regeneration template in 1986, giving hope to countless numbers of patients with torn knee cartilage. Debuting in 2000, Stone’s collagen meniscus implant (CMI) induces the body’s self- healing prowess to repair torn or missing segments of the knee’s main shock absorber. The implant is comprised of highly purified collagen, which acts as a trellis for new meniscus tissue growth.
 
Since gaining market admittance, Stone’s invention has helped repair more than 4,000 injured knees worldwide. Perhaps more importantly, though, it laid the groundwork for the cultivation of biological treatments for orthopedic injuries, a sector that was valued at $5 billion in 2015 and is expected to swell to $10.2 billion in 2025, according to Million Insights data. Driving this growth over the next seven years will be the planet’s aging population, technological advancements, changing (more active) lifestyles, and a steady increase in musculoskeletal-related conditions like arthritis and osteoporosis.
 
There will likely be no shortage of technologies available in 2025, as the orthobiologics field is already brimming with companies jockeying for market share. ODT’s January/February feature story “Biological Building Blocks” examines the trends and challenges shaping the orthobiologics market as well as some of the latest technologies available to patients. Curtis Matthews, chief operating officer at Reinvent Biologics, was among the experts interviewed for the feature; his full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the current trends in orthobiologics. What forces are driving these trends? Have they changed in recent years?
Curtis Matthews: Over the past few years, innovation in orthobiologics has been driven by the desire to discover a solution that is either equivalent or superior to the “Gold Standard” in bone grafting, the iliac crest wedge harvest. As co-morbidities such as increased harvest site pain, increased infection rates, and/or slower healing due to second site injury may exist when harvesting a wedge of iliac crest, researchers have been looking for an equivalent or superior solution without the significant risk of certain co-morbidities. The cycle of possible solutions has oscillated from synthetic bone graft extenders and pharmaceutical solutions to differently processed human allografts to different harvesting methods and processing of autologous grafts.
 
Barbella: What opportunities does this sector present to companies that operate in this space?
Matthews: The goal is to provide products for the use of more effectively and elegantly healing patients. We strive to strengthen the tools in the armamentarium of a medical provider. The opportunity to supply an efficaciously superior product to the market is the driving force in our company. Great products, giving superior results, with effective marketing equals endless opportunities. 
 
Barbella: What challenges/concerns are facing the orthobiologics industry? How can the industry and companies in this sector overcome these challenges?
Matthews: In all industries there are “bad actors” that shortcut the system for the sake of a short-term gain. This industry is no different and, many times, the actions of one or more nefarious characters may color the perception of the entire industry. Reputable companies are charged with the task of examining their claims and backing them up with substantiated results. When evidence-based claims become the standard, we will be beginning to overcome these challenges.
 
Barbella: Why is it so difficult/challenging to mimic the body’s natural biological healing process for bone?
Matthews: On a basic level, for bone to grow there needs to be three needs met. There needs to be an osteoconductive scaffold on which bone will form. An osteoinductive environment full of growth factors needs to exist in which the cells are signaled to grow and replicate. Finally, there needs to be an osteogenic component in which actual cells are secreting signaling factors and orchestrating the growth of new bone. All three of these components—osteoconductivity, osteoinductivity, and osteogenicity—need to exist and be in the correct ratio for bone to grow effectively. In a healthy, growing body, these factors are all in concert with one another. When a body is unhealthy or damaged, the challenge is to recreate the ratio as accurately as possible to achieve bone growth and ultimately, healing.  
 
Barbella: What factors are currently driving innovation in orthobiologics?
Matthews: Innovation in bone healing is focused on trying to achieve the “holy grail” combination of the osteoconductive, osteoinductive, and osteogenic components. We all are striving to achieve superior results to “gold standard” methods. In addition to bone healing, there are evolving uses of autologous platelet-rich plasma and bone marrow aspiration concentration in soft tissue and joint health applications. Although these uses are not indicated, based on the 510(k) indication statements of the commercial products, physicians are using their own medical discretion. There are some exciting results that have been reported in increasingly more peer-reviewed journals.
 
Barbella: What interesting, new technologies are in the works?
Matthews: As the goal is to develop products to aid in the effective and efficient healing of patients, advances are being made in differing processing techniques of donated human allografts, inductive properties of synthetics, and the concentration techniques of platelet-rich plasma and bone marrow concentration. The U.S. Food and Drug Administration is constantly evaluating products for their safety and effectiveness as well as their degree of manipulation. We will continue to see market growth and the expansion of indications.