SBIR Phase I: Bio-erodible Contraceptive-Releasing Implant

这项小企业创新研究（SBIR）第一阶段项目的广泛影响将是为6100万处于育龄期（15至44岁）的美国妇女提供一种高效、长效的植入避孕药，其中70%的妇女有意外怀孕的风险。2022年，意外怀孕占怀孕总数的一半，60%以上的意外怀孕以堕胎告终，其中估计有45%的堕胎是不安全的，导致孕产妇死亡总数的5-13%。今天，估计有750万15-49岁的妇女通过长期皮下手臂植入物接受治疗或激素药物。一旦它们的使用寿命结束，这些植入物必须被移除，并发症很快就会出现。这些手术不仅昂贵，而且会留下严重的瘀伤和疤痕，有些情况下甚至需要手术切除。拟议中的产品是世界上第一个可生物降解的避孕释放植入物。这项技术将美国食品和药物管理局（FDA）批准的材料与市场上已有的仿制药结合起来。它采用新颖的制造方法和可生物降解的材料，消除了移除植入物的需要，并使适当的时间和治疗剂量成为可能。这种新的给药技术可以以可持续和负担得起的方式应用于不同的药物治疗。这个小企业创新研究（SBIR）第一阶段项目旨在通过创造一种可生物降解的手臂植入物来推进长效可逆避孕的未来，这种植入物可以提供一致的激素剂量，而不必通过手术切除。这个SBIR一期项目的目标是表征药物递送支架并展示其效用。该项目将降低原型用于FDA要求的研究前新药申请（IND）研究的风险。第一阶段的战略将包括两个方面：(1)在评估物理和化学特性后，通过最终确定原型来降低手术风险；(2)在临床相关的生物学模型中测试长效避孕植入物原型，为IND的成功推出提供必要的数据。该项目的进展将为生物可降解避孕产品走向商业化提供坚实的基础。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.