U.S. Stem Cell

U.S. Stem Cell

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Private Company

Funding information not available

Overview

U.S. Stem Cell's mission is to advance regenerative medicine by harnessing a patient's own adipose-derived stem cells and stromal vascular fraction (SVF) to treat degenerative diseases. Its key historical achievement was establishing a network of treatment clinics, though this led to significant regulatory action, including a 2022 federal injunction that halted its commercial clinic operations. The company's current strategy is to pursue rigorous clinical trials under FDA oversight to validate its technology, aiming to secure regulatory approvals and partnerships for its therapeutic programs. It faces the dual challenge of advancing its science while overcoming a legacy of regulatory and reputational hurdles.

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Technology Platform

A point-of-care platform for isolating autologous stromal vascular fraction (SVF) and stem cells from a patient's adipose tissue, intended for same-day re-implantation to treat degenerative conditions.

Opportunities

If successful in clinical trials, the company's autologous, point-of-care platform could address massive unmet needs in degenerative diseases like osteoarthritis, representing a multi-billion dollar market.
A validated therapy could enable partnerships with treatment centers globally.

Risk Factors

The company operates under a permanent federal injunction prohibiting commercial activity without FDA approval, faces severe financial constraints with minimal cash, and lacks robust clinical data, creating existential regulatory, financial, and scientific risks.

Competitive Landscape

Competes against well-funded allogeneic stem cell developers (e.g., Mesoblast) and large pharma in degenerative disease markets. Its autologous, point-of-care model is logistically challenging and faces skepticism from the mainstream regulatory and scientific community.