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

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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.