Modulated Imaging: Toward commercialization of a wide-field optical imaging platform for wound care

组织结构和功能的定量表征是最具挑战性的问题之一 医学影像。光学方法可以潜在地为生物组织成像提供单一平台 分辨率和深度灵敏度从微米到厘米，受基本光组织的限制 互动。在NIAMS第二阶段SBIR的资助下，我们已经建立了一个广域光学成像平台 能够测量组织中的循环损害的系统。我们的底层技术基于 空间频域成像(SFDI)非接触式多光谱成像组织测量方法 氧合、浮肿和散开。经过一系列的试验研究，我们相信我们的设备很好- 适用于伤口应用。例如，在2900万糖尿病人口中，25%的人形成了可预防的 在他们的一生中导致了腿部溃疡，并导致了每年130亿美元的支出。在新的 商业准备计划(CRP)，我们建议进行必要的技术准备以推进我们的 从测量循环危害的设备到提供可操作的 伤口应用信息-在医疗实践中采用的关键一步。要实现这些目标 目标，我们建议监管战略工作和准备，以支持创伤中的510(K)应用 关心。我们还建议进行设计转移工作，将生产转移到合同制造。第三，我们 将与顾问合作导航报销环境，以便插入到医疗保健中 系统。最后，我们将利用所有这些来支持和计划实现我们的 监管和报销目标。在CRP结束时，我们预计我们的公司将 由于我们在降低风险方面的工作，我们是外部投资的理想人选。我们期待着筹集资金 外部资金，以增加销售/营销，以进入创伤市场和完全商业化 我们在医疗保健方面的技术。

Quantitative characterization of tissue structure and function is one of the most challenging problems in Medical Imaging. Optical methods can potentially provide a single platform for imaging biological tissues with resolution and depth sensitivity from microns to centimeters, limited by fundamental light-tissue interactions. Under NIAMS Phase II SBIR funding, we have built a platform wide-field optical imaging system capable of measuring circulatory compromise in tissue. Our underlying technology is based on Spatial Frequency Domain Imaging (SFDI) non-contact multi-spectral imaging method to measure tissue oxygenation, edema, and scattering. After a series of pilot studies, we believe that our device is well- suited for wound applications. As an example, 25% of the 29M diabetic population forms a preventable lower limb ulcer in their lifetime and resulting in $13 billion in annual expenditures. Under the new Commercial Readiness Program (CRP), we propose necessary technical preparation to advance our technology from a device that measures circulatory compromise to a device that provides actionable information for wound applications - a critical step for adoption in medical practice. To achieve these goals, we propose regulatory strategy work and preparation to support 510(k) applications in wound care. We also propose design transfer work to migrate production to contract manufacturing. Third, we will work with consultants to navigate the reimbursement landscape for insertion into the health care system. Finally, we will use all this to support and plan for independent clinical studies that achieve our regulatory and reimbursement goals. At the conclusion of the CRP, we anticipate that our company will be ideal candidate for external investment due to our work in reducing risk. We anticipate raising external funds to ramp up sales/marketing for entry into the wound market and full commercialization of our technology in health care.