StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and launch new bioactive technologies. Within a year of its inception, StimLabs launched a suite of amniotic-derived products, developed an extensive product pipeline across a range of clinical applications, and established a portfolio of patent-pending technologies.
The StimLabs vision originates at the nexus of improved patient outcomes and unique bioactive technologies that advance the state of regenerative medicine. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the power of technologies at the intersection of these industries. In this promising space exist technologies that can capture the natural healing capabilities of the human body to dramatically improve healing – these technologies are the future of regenerative medicine. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.
StimLabs is committed to providing patients safe and high quality products, and our amniotic tissue donor screening process is a direct reflection of that commitment.
Tissues are donated by consenting mothers undergoing full term cesarean section deliveries and are individually evaluated by the StimLabs Quality Assurance Unit for suitability. All donors are screened for communicable diseases and a thorough medical history review is completed by the StimLabs Medical Director, a board certified pathologist with over 20 years of experience in determining donor eligibility.
StimLabs’ products are classified by the Food and Drug Administration (FDA) as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps) that are regulated solely under Section 361 of the Public Health Service (PHS) Act. StimLabs adheres to the stringent requirements outlined in 21 CFR Part 1271 including Establishment Registration with FDA, Donor Eligibility Determination, and Good Tissue Practice (cGTP) Quality System Regulations.