PROJECT SUMMARY The goal of this Phase IIB SBIR project is to optimize, validate and obtain regulatory approval to support commercialization for PointCheckTM, the first non-invasive medical device that enables continuous monitoring of cancer chemotherapy patients from home, detecting severe neutropenia and enabling early intervention to prevent serious infections. Every year in the US, 850,000 cancer patients are treated with chemotherapy. A main side effect of treatment is neutropenia, a life-threatening condition caused by low levels of neutrophils that leads to hospitalization, increased risk of mortality and total associated costs of $6.4B annually. PointCheck uses noninvasive optical imaging of the microcirculation in nailfold capillaries to detect severe neutropenia without the need for a blood sample. It is intended for use by cancer patients undergoing chemotherapy, in order to identify patients with neutropenia and enable early intervention that could prevent 50% of serious infections, hospital readmission costs and morbidity. Because it is self- administered and does not require blood sampling or reagents, it ultimately may be used by patients at home to frequently monitor blood counts between chemotherapy sessions. In Phase I of this project, Leuko successfully validated a manually operated PointCheck prototype on a proof- of-concept study with 44 chemotherapy patients. In Phase II, we completed the design of a beta PointCheck unit that fully automates data acquisition in the hands of naïve users, executed a usability and feasibility study with 154 and 193 subjects, respectively, and validated that the usability (SUS=86.1) and diagnostic accuracy (Sensitivity/Specificity=100/84%) of the final device design exceed the requirements for regulatory approval that FDA communicated to us through a pre-submission meeting. The objective in this Phase IIB is to complete the remaining steps to bring PointCheck to market. In Aim 1, we will complete pilot production of 20 PointCheck units to support clinical trials and FDA approval. In Aim 2, we will execute our pivotal study (N=210 patients) following FDA pre-submission requirements. In Aim 3, we will submit a Class II De Novo application to the FDA. In Aim 4, we will conduct an initial healthcare outcomes study (N=50 patients) to support reimbursement and provide the basis for commercial adoption. Successful completion of this Phase IIB project will fulfill the requirements for a minimum viable product and enable initial commercialization of this first-in-kind technology that will drastically improve the management of febrile neutropenia in cancer patients undergoing chemotherapy.