What ReNu Is
ReNu is described as a cryopreserved amniotic suspension allograft made from amniotic fluid cells and micronized amniotic membrane. The product contains cellular, growth factor, and extracellular matrix components, which is one reason it is often discussed within the broader field of regenerative medicine. For patients, the practical takeaway is that ReNu is not a steroid and not a simple lubricant. It is a biologic injection intended to provide cell-derived signals, growth factors, and supportive tissue components inside an arthritic knee.
May ReNu Involve Stem-Cell-Related Biology?
Many patients ask whether ReNu is a stem cell treatment. The most helpful answer is that ReNu is best described as an amniotic suspension allograft, but because it includes amniotic fluid cells and placental tissue components, it may involve stem-cell-related biology and other regenerative signaling. Florida law also places afterbirth placental perinatal stem cell therapies and related human tissue products within the state's stem cell therapy framework, which is why these treatments are often discussed together.
How ReNu May Work
ReNu is designed to improve the biologic environment inside the knee. Its cellular material, extracellular matrix, and growth factors may help support a healthier joint response, calm inflammation, and improve the signaling environment around damaged cartilage and irritated synovium. In patient terms, that means ReNu may help the knee feel and function better by delivering biologic signals that support healing and may help reduce some of the inflammatory pathways and enzyme activity that contribute to cartilage breakdown over time.
Why Patients Are Interested in ReNu
ReNu stands out because it combines a strong regenerative medicine concept with a substantial formal development program. It received FDA Regenerative Medicine Advanced Therapy, or RMAT, designation for knee osteoarthritis, which does not mean approval but does show that the FDA recognized its potential in a serious condition with unmet need. For patients comparing biologic options, that makes ReNu feel more established and more credible than products supported only by small case series or general marketing claims.
What the Clinical Evidence Suggests
ReNu has been studied in multiple randomized controlled trials in knee osteoarthritis. Company disclosures have reported encouraging pain outcomes, a favorable safety profile, and continued progress toward regulatory review. For patients, this is an encouraging signal that ReNu remains one of the more clinically developed nonsurgical biologic options in knee osteoarthritis.
What Treatment Is Like
ReNu has been studied as a single intra-articular knee injection. That is one of its practical strengths. It offers a relatively simple procedure compared with autologous treatments that require harvesting blood, bone marrow, or fat before the final injection can be prepared. For many patients, that simplicity makes the treatment easier to understand and easier to fit into a busy life while still offering a more advanced regenerative approach than standard injections.
Recovery and Expectations
Like most orthobiologic treatments, ReNu should be viewed as a treatment that may work gradually rather than instantly. The goal is to improve the knee's environment over time, not simply to numb pain for a few hours. Patients usually do best when the injection is paired with smart rehabilitation, strength work, movement optimization, and a broader strategy to reduce joint overload.
FDA and Florida Information
ReNu is actively progressing through the FDA approval process. It has already received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis, a meaningful recognition that the FDA sees potential in a treatment addressing a serious condition with unmet need. A Biologics License Application (BLA) has been initiated, which is the formal pathway toward full approval. While ReNu is not yet FDA-approved for orthopedic use, the product is processed in FDA-registered tissue facilities that must meet current good tissue practice standards. Florida has also established a structured regulatory framework that allows physicians to offer advanced biologic therapies for orthopedic and pain-management purposes with appropriate informed consent and patient protections in place.
Bottom Line
ReNu is one of the most promising donor-derived biologic injections currently being developed for knee osteoarthritis. It contains cellular material, growth factors, and extracellular matrix components, may involve stem-cell-related biology, and is intended to support a healthier joint environment rather than simply cover up symptoms. For the right patient, ReNu may be an encouraging way to pursue meaningful pain relief, better function, and a more active lifestyle while trying to postpone knee replacement and remain within a nonsurgical treatment plan.
Sources
- Organogenesis Holdings Inc. Organogenesis Provides Update on Second Phase 3 ReNu Study. September 25, 2025.
- Organogenesis Holdings Inc. Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu for Knee Osteoarthritis Pain. December 15, 2025.
- Organogenesis Holdings Inc. Organogenesis Announces Initiation of Biologics License Application for ReNu. December 23, 2025.
- Florida Statutes, Section 458.3245, Stem cell therapy.
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies.