Regenaris Therapeutics is a biotechnology company developing regenerative, extracellular vesicle-based medicines for age-related and neurodegenerative diseases, starting with sarcopenia and Alzheimer's disease.
The two are linked: people with sarcopenia face a higher risk of cognitive decline, and muscle and brain health tend to decline together with age.
Muscle loss starts early. From about age 30, muscle mass declines by 3–8% per decade, and the loss speeds up after 60.
Age-related loss of muscle mass and strength leads to falls, frailty and loss of independence. There is no FDA-approved drug to treat it.
Sources: Yuan & Larsson, Metabolism 2023 (meta-analysis); Volpi et al., Curr Opin Clin Nutr Metab Care 2004
The most common cause of dementia. Current treatments modestly slow decline at best, and none restore lost function.
Extracellular vesicles (EVs) are nanoscale, membrane-bound particles that cells release to carry proteins, lipids and RNA to other cells. Skeletal muscle uses this route to send regenerative signals around the body, including to the brain, a signaling route known as the muscle–brain axis. Our EVs come from muscle progenitor cells derived from human induced pluripotent stem cells (iPSCs), and carry a specific cargo profile, enriched in regenerative proteins, that sets them apart from EVs made by other cell types.
EVs can cross biological barriers that block most large-molecule drugs, including the blood–brain barrier, which opens a route to treating disease in the brain.
Tetraspanin surface markers, together with particle size and purity, let us characterize every preparation against the MISEV guidelines from the International Society for Extracellular Vesicles.
EVs carry much of the signaling that makes regenerative cells useful. They avoid the risks of engraftment and uncontrolled growth, and they are easier to store and dose.
Making EVs at scale, with the same quality batch after batch, has held the field back. We are building a scalable, clinically translatable manufacturing process that turns one defined human cell source into consistent therapeutic vesicles.
Start from a defined, renewable source of human iPSC-derived muscle progenitor cells.
Manufacture vesicles with a scalable process designed from the start for clinical translation.
Measure size, particle count and surface markers in line with MISEV standards, and profile cargo by proteomics.
Tune vesicle cargo and surface properties to improve potency and delivery to target tissues.
Test candidates in human aging muscle organoids and human brain organoids, and in preclinical models of aging and Alzheimer's disease.
Both programs use EVs from human iPSC-derived muscle progenitor cells, and both have shown activity in preclinical studies.
| Program | DiscoveryPreclinicalIND-enablingClinical |
|---|---|
| SarcopeniaAge-related loss of muscle mass and strengthIn preclinical aging models: more muscle mass, larger fibers and stronger grip; aged muscle stem cells and their niche shifted back toward a youthful state. Published 2026. | |
| Alzheimer's diseaseNeurodegenerationHarnesses the muscle–brain axis, the natural signaling route from skeletal muscle to the brain. Demonstrated disease-relevant activity in preclinical neurodegeneration models. | |
| PlatformScalable EV manufacturingA clinically translatable process for consistent, high-yield production. |
Results so far come from preclinical studies; our candidates have not been tested in people.
Regenaris was founded to turn NIH-funded university research into medicines. Our programs build on our published, peer-reviewed research on sarcopenia and muscle–brain crosstalk.
The platform was developed under NIH-supported research programs, spanning sarcopenia and Alzheimer's disease.
We develop our programs in partnership with the University of South Florida, where the technology was invented.
Our team brings together expertise in stem cell biology, aging biology, vesicle biology, regenerative medicine and neuroscience, building on research from the University of South Florida.
Stem cell biologist and geroscientist at the University of South Florida.
Neuroscientist and Professor at the University of South Florida.
Stem cell biologist and extracellular vesicle expert.
We welcome conversations with investors, academic and industry partners, and scientists who want to join our team.
regenaris2026@gmail.com