SBIR Phase I: Bio-erodible Contraceptive-Releasing Implant

SBIR 第一阶段：生物可蚀避孕释放植入物

• 批准号: 2304404
• 负责人: Sirsendu Bhowmick
• 金额: $ 27.5万
• 依托单位: HERA HEALTH SOLUTIONS INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304404&HistoricalAwards=false
• 关键词: SBIR; Phase; Bio; erodible; Contraceptive

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.

这一小型企业创新研究（SBIR）第一阶段项目的更广泛影响将是为6100万育龄期（15至44岁）的美国妇女提供一种高效、长效的植入式避孕药，其中70%的妇女有意外怀孕的风险。到2022年，意外怀孕占总怀孕人数的一半，超过60%的意外怀孕以堕胎告终，估计45%的堕胎是不安全的，导致所有孕产妇死亡人数的5-13%。今天，估计有750万15-49岁的女性通过长期皮下手臂植入物接受治疗或激素药物。一旦它们达到其寿命的终点，这些植入物必须被移除，并发症可能很快出现。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。该产品是世界上第一个可生物降解的避孕释放植入物。该技术将食品和药物管理局（FDA）批准的材料与已经上市的仿制药相结合。它使用了新的制造方法和可生物降解的材料，消除了植入物移除的需要，并实现了适当的时机和治疗剂量。这种新型的药物输送技术可以以可持续和可负担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，并且不必通过手术取出。该SBIR第一阶段项目的目标是表征药物递送支架并证明其实用性。该项目将降低原型的风险，以用于FDA要求的研究前新药申请（IND）研究。I期策略将包括两个方面：（1）通过在评价物理和化学性质后最终确定原型来降低操作风险，以及（2）在临床相关生物模型中测试长效避孕植入物原型，以提供成功IND上市的必要数据。该项目的进展将为推进生物可降解避孕产品的商业应用奠定坚实的基础。该奖项反映了NSF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。