SBIR Phase I: Cryogenic probe development and testing for post-lumpectomy margin ablation treatment

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是一种新的冷冻消融治疗方法，用于改善接受乳房肿瘤切除术的患者的预后。该系统旨在为手术干预后的乳腺癌治疗提供更有效的治疗方法，比目前的放射治疗更快愈合，副作用更少。该技术旨在成为乳房肿瘤切除术市场的标准护理，预计到2027年将达到75亿美元，并解决女性发病和死亡的主要原因。这项小企业创新研究（SBIR）一期项目旨在探索该公司专有的冷冻消融系统在临床前测试中以高（99%）准确性杀死乳腺癌细胞的可行性。该项目将使用公认的肿瘤动物细胞模型验证该设计。该项目旨在设计并降低探针设计的风险，以确保在固定的实验环境下与肿瘤细胞的最佳接触和热透射率。该项目旨在确保在癌症切除时在一小时内的临床可用性。这些结果可以作为进一步临床前产品研究和开发的基础，然后再用于人类。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/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel cryoablation treatment for improving the outcomes for patients undergoing a lumpectomy procedure. The system aims to provide a significantly more effective treatment for treating breast cancer following surgical intervention, enabling more rapid healing and fewer side effects than current radiation treatments. The technology aims to serve as a standard of care in the lumpectomy market projected to reach $7.5 billion in 2027 and address a leading cause of female morbidity and mortality. This Small Business Innovation Research (SBIR) Phase I project seeks to explore the feasibility of the company’s proprietary cryoablation system to kill breast cancer cells with high (99%) accuracy in preclinical testing. This project will validate the design using an accepted animal cellular model of tumors. The project aims to design and de-risk the probe design to ensure optimal contact and thermal transmissivity with the tumor cells in a fixed experimental setting in vitro. The project will be designed to ensure clinical usability in under an hour at the time of cancer removal. The results may serve as the foundation for furthering preclinical product research and development prior to human use.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.