An investigational breakthrough regenerative biologic for knee osteoarthritis — designed to provide durable pain relief, restore mobility, and preserve cartilage with a single, once-yearly injection.
Knee osteoarthritis is one of the fastest-growing sources of disability worldwide, yet current treatments fall short. Doron is investigating whether MOTYS can address limitations of steroids, hyaluronic acid, and surgery.
Derived from donated human placental tissue, MOTYS concentrates over 300 disease-relevant growth factors and proteins into a formulation that has the potential to work on multiple fronts to restore joint homeostasis.
Designed as a single in-office injection — off-the-shelf, refrigerator stable, and ready to use with no special preparation.
Granted RMAT and Fast Track designations by FDA. Ongoing pivotal Phase 3 study across U.S. and Australian sites (NCT07219771).
RMAT and Fast Track are FDA expedited development programs.
The placenta is a transient but remarkable tissue made up of three key components: the amnion, the chorion, and the umbilical cord. Healthy mothers undergoing planned Caesarian sections generously donate this tissue — which would otherwise be discarded — to Doron Therapeutics. Using a proprietary process, Doron transforms it into a user friendly formulation containing growth factors, cytokines, multipotent signaling molecules, and extracellular matrix, giving it an exceptional ability to support tissue repair and reduce inflammation.
The human placenta is naturally free from the decades of aging and comorbidities that accumulate in other adult tissues. This translates into consistent quality across donors and reduces the variability that can complicate other allogeneic regenerative therapy outcomes. The placenta is also inherently immunotolerant when used therapeutically — a meaningful advantage over other adult donor tissues.
Doron has developed a proprietary manufacturing process that is designed to support consistency across production runs, with release testing applied to each lot. This process is supported by a rigorous and proprietary analytical testing regimen, developed specifically for MOTYS by Doron, that evaluates every placental tissue and the resulting MOTYS product batch for identity (presence of key proteins meeting acceptable thresholds), potency (performance in relevant mechanistic / functional assays), and most importantly, safety (donor eligibility, screening and testing for relevant communicable disease agents per 21 CFR 1271 along with sterility and endotoxin testing)). This ensures that every product meets the highest standards of quality.
Furthermore, comprehensive stability analyses are performed to confirm that its efficacy and safety are maintained throughout the duration of its shelf life.
Doron's quality system ensures that the manufacturing and testing of MOTYS complies with cGMP requirements set forth by regulatory bodies, reflecting Doron's commitment to worldwide compliance and patient safety.
Taken together, these properties are intended to make placental tissue a biologically potent and reproducible platform for advancing regenerative medicine applications.
MOTYS has been granted RMAT + Fast Track designations. The clinical evidence database spans more than 300 patients across real-world registries, Phase 1 and Phase 2 studies:
Extensive clinical experience across multiple studies
In clinical investigations to date, no evidence of systemic or immunogenic effects has been observed.