Clinical Knowledge Key to Advancing Orthobiologics Technologies

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. David Yonce, vice president of Innovation and R&D at DSM Biomedical, a global medical device materials developer and manufacturer, 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?
David Yonce: The overall orthobiologics market continues to be fueled by the need for products that deliver enhanced, consistent, and predictable healing across various clinical indications.  Increased focus on demonstrated effectiveness and the recent clarification and guidance from the FDA regarding Human Cellular Tissue and Products, combined with the general declining use of allografts and autografts, is driving increased attention towards alternative synthetic technologies.
 
Barbella: What opportunities does this sector present to companies that operate in this space?
Yonce: Lifestyle changes such as obesity and an increasingly active aging population contribute to higher demand for orthopedic biomaterial solutions such as meniscal repair and replacement, cartilage repair and viscosupplementation. It’s also likely we will see advances in orthobiomaterials with properties that offer the potential to replace traditional load-bearing or structural materials, such as PEEK.
 
Barbella: What challenges/concerns are facing the orthobiologics industry? How can the industry and companies in this sector overcome these challenges?
Yonce: Downward hospital pricing pressures drive the need for greater comparative and post-market data that demonstrate value. Conventional technologies often lack clinical evidence with cost differentiation, thereby gaiting approvals, reimbursement and coverage. DSM Biomedical recognizes the importance of improving clinical value by optimizing patient outcomes with innovative solutions that reduce healthcare costs.
 
Barbella: Why is it so difficult/challenging to mimic the body’s natural biological healing process for bone?
Yonce: The next generation orthobiologic technologies in development are based upon scientific and clinical knowledge gained through experience. These insights provide better understanding of the tissue’s response from cell-signaling, material-biology interactions, and the implants’ surrounding environment. Accounting for these multi-factorial elements will contribute towards an improved physiologic balance and better healing conditions.
 
Barbella: What factors are currently driving innovation in orthobiologics?
Yonce: We believe the next generation of orthobiologic materials will strike the appropriate balance of handling and structural properties while achieving the physiologic balance for accelerated healing.
 
Barbella: What interesting, new technologies are in the works?
Yonce: We are investigating disruptive technologies with advanced physical and biologic properties that will better meet patient and surgeon needs. We continuously leverage these advancements in our materials and devices, while simultaneously applying these technologies to our partners’ solutions.