Becker's Spine Review

36 DEVICES & IMPLANTS Stem cell sales skyrocket despite lacking FDA approval, study finds By Alan Condon T he number of businesses and medical clinics advertising stem cell-based therapies has skyrocketed in the U.S. over the past five years, according to a study published in Cell Stem Cell Nov. 4. In 2016, there were 351 U.S. businesses and 570 clinics selling unlicensed and unprov- en stem cell products, the study found. As of March 2021, the numbers multiplied by more than four times to 1,480 businesses op- erating 2,754 clinics. e largest concentrations of such clinics were found to be in California (347), Flor- ida (333) and Texas (310). According to the study, these three states comprise 35.9 per- cent of all U.S. clinics. "One of the most troubling features of this marketplace is that businesses selling un- proven and non-FDA-approved stem cell products oen use marketing misrepre- sentations and aggressive sales tactics to exploit the hope, suffering, fear or desper- ation of patients," said Leigh Turner, PhD, author of the analysis and a professor of health, society and behavior at the Univer- sity of California Irvine. Stem cell-based therapies, unlicensed and unapproved by the FDA, began being sold in the U.S. nearly two decades ago and claim to renew and repair damaged tissues in var- ious orthopedic, cardiovascular and autoim- mune conditions, among others. Of 1,480 businesses, 1,262 claim to use stem cells to treat painful symptoms, 689 claim to treat orthopedic diseases and injuries and 339 purportedly treat sports-related inju- ries, the study found. Other products' claims range from targeting hair loss and aging to boosting the immune system as a way to protect against COVID-19. "Many of these 'clinics' are promoting unlicensed and unproven stem cell prod- ucts and claim their interventions do not require FDA approval," Dr. Turner said. "However, that couldn't be further from the truth. I found that there is widespread promotion of products that do, in fact, re- quire premarketing authorization by the FDA. In many cases, these clinics are us- ing misleading advertising and predatory marketing techniques." Patients are spending thousands on stem cell-based products — out-of-pocket costs range from $1,200 to $28,000, with an average price of about $5,100. Such un- licensed and unapproved products pose various risks to patients, and adverse events resulting from their administration are likely underreported to the FDA, ac- cording to the study. n Bioventus to bolster Tennessee presence, add 40 jobs By Alan Condon O rthobiologics company Bioventus has signed a lease agreement to double its current operations and manufacturing space in Cordova, Tenn. The company said it will move its 116 staff into a new facility in the third quarter of 2022 and add 40 jobs over the next five years. Bioventus Senior Vice President of Operations Miguel Bel- tran-Delgado said in a Nov. 18 news release that the ex- pansion is "required to manage our organic growth, vertical integration of key manufacturing capabilities and our addi- tional growth through acquisitions." The new 90,000-square-foot facility — directly across the street from its current one — will include 55,000 square feet for light manufacturing and operations and 35,000 square feet for offices, conference rooms and shared workspaces. In October, Bioventus finalized its acquisition of spine de- vice company Misonix for a reported $518 million. n Stryker to close Florida facility, lay off 532 staff By Marcus Robertson K alamazoo, Mich.-based medical device compa- ny Stryker is closing its Lakeland, Fla., produc- tion facility over the next two years and laying off 532 employees, according to a Nov. 1 Business Observer report. The first round of layoffs begins Dec. 31 with 26 job cuts, according to the report. The company expects to cut another 497 jobs by the end of 2023, when the facility permanently closes, according to the report. "After a careful and detailed analysis, we have decid- ed to close our Lakeland, Florida, facility and move these operations to other Stryker locations," a Stryker spokesperson said, according to the Business Observ- er. "People are one of our most important values and we will support impacted employees throughout the closure process." n

• Cover