SBIR Phase II: In-vivo validation of a volume-manufacturable and factory-calibrated wearable NT-proBNP monitoring system for heart failure treatment

SBIR II 期：用于心力衰竭治疗的可批量生产和工厂校准的可穿戴 NT-proBNP 监测系统的体内验证

• 批准号: 2335105
• 负责人: Aleksandar Karajic
• 金额: $ 99.98万
• 依托单位: KILELE HEALTH LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2026-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2335105&HistoricalAwards=false
• 关键词: SBIR; Phase; II; vivo; validation

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will directly address the growing national economic and individual burden of cardiovascular disease as it becomes a reality for more than half of all Americans entering their sixties. Heart-failure is a cardiovascular disease that is particularly challenging given that many patients end up readmitted to the hospital just months after initial hospitalization. Greatly improved outcomes for patients are already possible, keeping patients from returning to the hospital, but only if the patient treatment can be rapidly optimized for the medications prescribed for heart failure. This rapid optimization requires multiple trips back to the doctor for blood tests to guide the treatment plan, adjusting patient medication levels accordingly. Cardiologists have therefore been asking for new technologies to aid their ability to care for heart-failure patients, with an increasing call for remote monitoring technology. This Small Business Innovation Research (SBIR) Phase II project will create the first-ever wearable, heart-failure monitor for a peptide molecule released by the heart when the heart is struggling, therefore providing a direct and continuous measurement of how well heart-failure treatment is progressing. Specifically, aptamers, which are oligonucleotides, will be used to capture heart-failure peptide molecules on a tiny electrical wire sensor embedded painlessly a few millimeters beneath the skin surface. As these aptamers capture the peptides, they provide a continuous measurement of the peptide concentrations in the form of an electrical signal. The project will create a working prototype that is like the proven success of wearable continuous glucose monitors, leveraging decades of investment in glucose monitors and significant doctor and patient trust in glucose monitors. Under the Phase II project, the wearable heart-failure monitor prototype will be validated for more than one week of operation in an animal model, a key proof point that will enable further commercial investment in developing the wearable heart-failure monitor for 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.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力将直接解决日益增长的国民经济和个人心血管疾病负担，因为这已成为一半以上进入六十多岁的美国人的现实。心力衰竭是一种特别具有挑战性的心血管疾病，因为许多患者在初次住院几个月后就再次入院。显着改善患者的治疗结果已经成为可能，使患者不再返回医院，但前提是可以针对心力衰竭处方药物快速优化患者治疗。这种快速优化需要多次返回医生进行血液检查，以指导治疗计划，相应地调整患者的药物水平。因此，心脏病专家一直在寻求新技术来帮助他们护理心力衰竭患者，并且对远程监测技术的呼声越来越高。这个小型企业创新研究 (SBIR) 第二阶段项目将创建有史以来第一个可穿戴式心力衰竭监测仪，用于检测心脏挣扎时心脏释放的肽分子，从而直接、连续地测量心力衰竭的状况治疗正在取得进展。具体来说，适配体（寡核苷酸）将用于在无痛地嵌入皮肤表面下几毫米的微型电线传感器上捕获心力衰竭肽分子。当这些适体捕获肽时，它们以电信号的形式提供肽浓度的连续测量。该项目将利用数十年来对血糖监测仪的投资以及医生和患者对血糖监测仪的高度信任，创建一个工作原型，就像可穿戴连续血糖监测仪所取得的成功一样。在第二阶段项目中，可穿戴式心力衰竭监测仪原型将在动物模型中进行一周以上的运行验证，这是一个关键的证据点，将有助于进一步商业投资开发人类使用的可穿戴式心力衰竭监测仪。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。