SBIR Phase I: Bio-erodible Contraceptive-Releasing Implant

Hera Health Solutions Inc., Frisco TX

Investigators

Abstract

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be to provide a highly effective and long-acting implantable contraceptive for the 61 million American women in their childbearing years (ages 15 to 44), 70% of whom are at risk for unintended pregnancies. Unintended pregnancies accounted for half of the total pregnancies in 2022, and over 60% of unplanned pregnancies end in abortion, with an estimated 45% of abortions being unsafe, resulting in 5-13% of all maternal fatalities. Today, an estimated 7.5 million women aged 15–49 receive a treatment or hormonal drug via long-term subcutaneous arm implants. Once they reach the end of their lifespan, these implants must be removed, and complications can quickly arise. Not only are these procedures expensive, but they leave behind heavy bruising and scarring and some instances even require an operation for removal. The proposed product is the world’s first biodegradable contraceptive-releasing implant. The technology combines Food and Drug Administration (FDA)-approved material with a generic drug already on the market. It uses novel manufacturing methods and biodegradable materials, eliminating the need for implant removal and enabling the proper timing and therapeutic dosage. This novel delivery drug technology can be applied to different drug treatments in a sustainable and affordable manner. This Small Business Innovation Research (SBIR) Phase I project aims to advance the future of long-acting reversible contraception by creating a biodegradable arm implant that delivers a consistent hormone dose and does not have to be surgically removed. The goal of this SBIR Phase I project is to characterize the drug delivery scaffold and demonstrate its utility. This project will de-risk the prototype to be used in Pre-Investigational New Drug Applications (IND) studies required by the FDA. The Phase I strategy will be two-fold: (1) de-risking operations by finalizing the prototype after evaluating the physical and chemical properties and (2) test the long-acting contraception implant prototype in a clinically relevant biological model to provide the necessary data for a successful IND launch. Progress of this project will provide a solid foundation for advancing the biodegradable contraception product toward commercial utility. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.