The field of orthobiologics continues to rapidly change. At the AAOS 2025 Annual Meeting, AAOS held its third annual AAOS/Biologic Association Symposium, “Orthobiologics in 2025 and Beyond,” which explored currently available and future orthobiologic techniques.

“The Academy does not like to have the same symposium year after year but has made a special exception for this symposium to continue as a testament to the interest in orthobiologics,” said moderator Jason L. Dragoo, MD, FAAOS, chair of the AAOS Devices, Biologics, and Technology Committee and vice chair of academic affairs at the University of Colorado. The symposium featured more than a dozen speakers covering a wide variety of topics, including bone marrow lesions, peripheral blood stem cells, exosome microRNAs, bone marrow aspirate concentrate, and more.

A new cartilage implant
Kenneth Zaslav, MD, FAAOS, of the Cartilage Repair Center at Northwell Health, talked about a new product in the next generation of cartilage-regeneration technology called CartiHeal Agili-C. Agili-C is a porous, biodegradable cartilage-repair implant, an off-the-shelf scaffold made of aragonite, which is derived from the coralline inorganic exoskeleton.

“This is the first new cartilage procedure approved by the FDA in recent years,” Dr. Zaslav said.

The implant is approved for the treatment of International Cartilage Repair Society grade III or higher knee joint surface lesion(s), with a total treatable area of 1-7 cm². The approval was based, in part, on a phase 2 study of 251 patients with cartilage or osteochondral lesions of the knee who were randomly assigned 2:1 to Agili-C or a control arm with standard surgical care.

“There was a clear improvement in Knee Injury and Osteoarthritis Outcome Score values over time compared with standard surgical care,” Dr. Zaslav said. “That was true whether it was large lesions or Kellgren-Lawrence grade 2 to 3 [lesions]. All patients did well.” The four-year data appear to be confirming these outcomes, he added.

Amniotic-derived products
Eric Strauss, MD, FAAOS, of NYU Langone Health, gave a brief presentation with updates on perinatal products currently in the FDA pipeline for knee osteoarthritis (OA) in 2025. Many clinicians use a pyramid approach to treatment, starting with intra-articular corticosteroids, then intra-articular hyaluronic acid injections, then orthobiologics, and finally surgery.

“Orthobiologics have been developed due to limitations of corticosteroids and hyaluronic acid treatments for symptomatic knee OA,” Dr. Strauss explained. “However, according to guidelines, intra-articular steroids could provide relief and hyaluronic acid injections are not recommended for routine use.”

One potential new option for knee OA is placental biologics, which are processed from consented human-tissue donors and may contain amnion, chorion, amniotic fluid cells, umbilical cord, or a combination. In 2021, the FDA updated its guidance on homologous use and minimal manipulation, resulting in reclassification and removal of products from the market. However, there has been a resurgence of research into amniotic-derived tissues, according to Dr. Strauss. He conducted a search of ClinicalTrials.gov for the term “knee osteoarthritis” plus “amnion” or “placental,” limiting the search to recent trials.

“While a handful [of trials] failed to meet their primary endpoint or were discontinued, there are two products that have shown promise,” he said. These are MOTYS and amniotic suspension allograft (ASA).

MOTYS is a sterile lyophilized human placental tissue preparation containing amnion, chorion, and umbilical cord. A phase 2b randomized study with more than 600 patients showed a 70% improvement in pain and mobility scores at six months.

ASA is micronized amniotic membrane and cells from amniotic fluid. In the initial phase 3 trial with more than 500 patients, ASA significantly reduced knee pain at six months compared with saline control.

“We are still looking for the best approach for patients with symptomatic knee OA who do not warrant arthroplasty,” Dr. Strauss said. “Injectable amniotic fluid is once again getting more attention.”

Staying informed on regulatory updates
Stephen C. Weber, MD, assistant professor at Johns Hopkins School of Medicine, closed out the symposium with a brief discussion of FDA regulations as they relate to orthobiologics. He urged orthopaedic surgeons to take responsibility for knowing about the products they are using and any federal regulations related to them.

One available resource to aid in this process is the AAOS Biologics Dashboard, a free member benefit. The dashboard combines the most recent and readily available clinical evidence with guidance released by the FDA. Members can search by tissue type, graft type, how the product is processed, and intended use. The system utilizes a red light/yellow light/green light status and includes relevant guidance information. See the Sidebar for more information.

The symposium featured several more presentations highlighting the current and future state of orthobiologics, including platelet-rich plasma and blood-derived therapy, exosome micro-RNAs, and more. A recording is available through AAOS Annual Meeting OnDemand. Visit aaos.ondemand.org to get started.

Leah Lawrence is a freelance writer for AAOS Now.

Stay current with the AAOS Biologics Dashboard 

The AAOS Biologics Dashboard is your go-to resource for navigating the evolving landscape of orthobiologics. Designed exclusively for AAOS members, this dynamic, interactive tool consolidates the latest FDA guidance and clinical evidence into one searchable platform, empowering orthopaedic surgeons to make informed decisions about biologic-based interventions.

Whether you are exploring treatment options or staying ahead of regulatory updates, the dashboard offers clarity on the approval status of biologic products and interventions. Built with input from the AAOS Committee on Devices, Biologics, and Technology and updated regularly, the tool reflects the most current thinking in the field, making it a trusted resource for evidence-based decision-making. Filter by product type, regulatory status, or device pathway to find exactly what you need, when you need it.

Access the Biologics Dashboard today at aaos.org/BiologicsDashboard25 to explore how this tool can support your clinical practice.