Orthobiologics’ High Reward

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.

Jeff Sauter, director of business development at Fremont, Calif.-based Steri-Tek, 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.
Jeff Sauter: The growing application of regenerative medicine in osteoarthritis and sports medicine is the major driver for the growth of the market and Steri-Tek has seen major developments in this space. Major orthopedic device companies are investing heavily in the orthobiologics space developing new innovative technologies with smart acquisitions, R&D, and academic collaboration.

Barbella: What factors are driving innovation in the orthobiologics market?
Sauter: The key drivers of innovation are the increasing number of elderly population suffering with orthopedic degenerative diseases, use of regenerative therapies in sports medicine, demand for minimally invasive therapies by patients, technological advancements and R&D, and orthopedic device companies moving into the regenerative medicine space. 

Barbella: What factors are impeding growth int he orthobiologics market? How can these challenges be overcome?
Sauter: High costs associated with innovative treatment and products are the prime factor restraining the growth of the global orthobiologics market. Demand is driving innovating and major orthopedic companies moving into the orthobiologics space will accelerate innovating and drive down c @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } osts.

Barbella: What new technologies are in the works?
Sauter: Steri-Tek—having X-ray sterilization capabilities—is the pioneer, at least in the United States, for this technology. Companies looking to move away from gamma are very interested in X-ray. We have plans to build another high-volume E-beam/X-ray facility within the next couple of years, and we believe X-ray will be vary attractive vis-à @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } -vis to gamma (sterilization).   

Barbella: Where does innovation come from in the orthobiologics market? How does Steri-Tek stay innovative amid all the competition?
Sauter: Innovation is driven by demand and necessity. Academic institutions, large orthopedic companies as well as startups are developing new innovative products to serve this growing market. Steri-Tek is the leading innovator for advanced methods to optimize E-beam sterilization of these types of products because we collaborate on an R&D level with all of these types of organizations to further the advancement of E-beam sterilization for these types of products.

Barbella: What is the dominant orthobiologics application—spinal fusion, trauma repair, reconstructive surgery? What factors are driving growth in this particular application?
Sauter: Demand has surged for minimally invasive procedures such as bone grafting and growth factor treatment. The growing elderly population, the rates of obesity and osteoarthritis, rising cases of sports injuries and road accidents, and patients’ growing preference for minimally invasive procedures will drive growth and innovation in the coming years. @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { } @font-face { font-family: “ＭＳ 明朝”; }@font-face { font-family: “Cambria Math”; }@font-face { font-family: Cambria; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Cambria; }.MsoChpDefault { font-family: Cambria; }div.WordSection1 { }