Disrupting the Ceramic Bone Graft Substitute Sector

Christopher J. Centeno, M.D., could arguably be considered the “father” of regenerative medicine. He claims, after all, to be the first person on the planet to perform stem cell injections to treat joint arthritis and various other conditions.
 
There are several worthy contenders, including Arnie Caplan, Ph.D., pioneer of mesenchymal stem cell use (late 1980s); Philippe Henigou, developer of bone marrow concentrate treatment for bone disease (early 1990s); or Svante Gehring, M.D., the first physician to document use of platelet-rich plasma in ophthalmology (1999).
 
Centeno, however, believes the title should go to Ohio surgeon George S. Hackett, M.D., who clinically and scientifically demonstrated the efficacy of irritating tissue to promote healing back in 1963. Hackett’s studies showed that creating controlled inflammation could increase ligament size by up to 35-40 percent (more recent analyses have confirmed those initial findings).
 
While certainly revolutionary, Hackett’s work nevertheless was pre-dated by several thousand years: The concept of irritating tissue to promote healing actually originated with the ancient Greeks. Hippocrates reportedly treated Olympic javelin throwers with unstable shoulders by touching a “slender hot iron” to the joint’s ligaments (the heat would irritate the ligament, causing it to tighten).
 
Chronologically speaking, then, Hippocrates is deserving of the regenerative medicine “father” title. Yet Centeno maintains that Hackett warrants a place in history, if only for his contributions to the evolution of the field.
 
“So, is there one modern ‘father’?” Centeno, an international expert and regenerative medicine expert, asked in a blog last spring. “You could make arguments for Hernigou, Caplan, the early users of PRP, and so on. However, if you had to award the title to one person, that honor likely goes to George Hackett, who figured out that you could help ligaments heal with injections.”
 
Regardless of its origins, regenerative medicine has become a fast-growing subsegment of the multi billion-dollar orthobiologics industry, thanks to an aging world population and advanced stem cell/gene therapy technologies in developed countries. ODT’s January/February feature “Natural Selection” examines the innovation being developed in this burgeoning sector that eventually will contribute to its double-digit annual growth over the next half-decade.
 
Albert Cornejo, leader, Biologics, at San Diego, Calif.-based NuVasive, shared his insights on the market 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.
Albert Cornejo: As NuVasive continues to advance its biologics portfolio based on identifying and filling gaps in the market, we’re seeing a growing need for smart biomaterials, particularly in advanced surface technology. This dovetails with trends that continue to drive innovation within our spinal implant hardware portfolio, emphasizing surface structure of the interbody and the important role it plays in supporting bone fusion with orthobiologics.

Barbella: What factors are driving innovation in the orthobiologics market?
Cornejo: The ability to deliver products designed to improve clinical outcomes for patients while also meeting the economic requirements for the hospitals has guided NuVasive’s approach to innovation within the orthobiologics market. To support better bone fusion outcomes for patients, the company is focused on the development of complementary orthobiologics products, with AttraX representing one of the company’s latest disruptive biologics portfolio additions. This ceramic bone graft offers a microarchitecture and microporosity optimized for bone formation.

Barbella: What factors are impeding growth in the orthobiologics market? How can these challenges be overcome?
Cornejo: Hospitals are more focused than ever on controlling spend and are looking for orthobiologic solutions that provide the most economic value. With this increased pricing pressure, we have seen the market shift away from higher-cost orthobiologics solutions, which has impacted overall growth. This has also influenced NuVasive’s focus on bringing products to market that meet a range of hospital economic requirements as well as surgeon preferences.

Barbella: What new technologies are in the works?
Cornejo: Aligning with our belief that smart biomaterials with advanced surface technology represent a key trend in the orthobiologics market. AttraX is one of the newest additions we’re currently focused on, as it represents a disruption of the ceramic bone graft substitute space. This ceramic bone graft has an optimized surface that has been shown to drive increased bone formation and faster fusion than traditional ceramic bone grafts. Unlike traditional ceramic materials that don’t generate bone formation by themselves when implanted in an intramuscular site, our product has a unique microstructure and microporosity that are optimized for bone formation in this environment. NuVasive believes surface optimization represents the next leap forward in ceramic bone grafting technology with promising potential to deliver better clinical outcomes for surgeons and their patients.

Barbella: Where does innovation come from in the orthobiologics market? How does NuVasive stay innovative amid all the competition?
Cornejo: At NuVasive, orthobiologics innovations evolve from a shared desire to continually offer best-in-class solutions that support bone fusion. Osteocel, NuVasive’s flagship allograft cellular bone matrix, helped create the space for cellular allografts in the orthobiologics market, and we are now further disrupting the bone graft market through the development of products that address the growing need for smart biomaterials. NuVasive is committed to driving innovative orthobiologic solutions that meet the clinical and economic needs of our patients, surgeons, and hospital partners.

Barbella: How does the regulatory landscape for orthobiologics differ from other sectors of the orthopedic market, and how does this affect product innovation?
Cornejo: There are diverse regulatory pathways for products in the orthobiologics category, from HCT/Ps, to medical devices, to biological drugs, each with their own regulatory requirements, which may have an impact on product innovation. With the well-being of patients at the forefront, NuVasive seeks out innovations that follow a more predictable regulatory pathway, making them more likely to be delivered to customers on a faster regulatory timeline. The sooner we can bring an innovation to market, the sooner we can equip surgeons to help patients.

Barbella: What is the dominant orthobiologics application—spinal fusion, trauma repair, reconstructive surgery? What factors are driving growth in this particular application?
Cornejo: Spinal fusion accounts for the dominant application of orthobiologics products. NuVasive believes the rising geriatric population, which is more prone to spondylolisthesis and degenerative disc disease, is the primary driver of growth in this area. We also believe there is some growth in orthobiologics applications for people in their 40s and 50s that require trauma repair or reconstructive surgery due to increasingly active lifestyles. While NuVasive has traditionally focused on spinal procedures, there are certainly opportunities to assist patients with our orthobiologics portfolio in other applications.