Development of scale-up strategies for ReFilx: a novel soft tissue filler - I2I Phase 1

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Approximately 25,000 Canadian and 292,130 American women were estimated to be diagnosed with breast cancer (BC) in 2015, respectively. After several randomized controlled trials confirming the safety and efficacy of breast conserving surgery (BCS) or lumpectomy with radiation, it has replaced mastectomy as the preferred surgical treatment for BC. However, poor cosmetic outcomes and irregular soft tissue defects are commonly observed in patients that undergo BCS. In addition to impairing the patients' aesthetic appearance, soft tissue defects are a main source of psychological distress. Thus, there is a large unmet need for the correction of soft tissue defects in the breast which is currently being accommodated with limited success using other technologies that many key opinion clinicians recognize as being non-satisfactory. Using innovative biomaterials science conceived and studied over the past decade, the principle investigators (PIs) have developed ReFilx for the correction of irregular breast defects observed after lumpectomy. ReFilx constructs have a timely biodegradation rate while enabling immediate support for breast shape and form, allowing tissue ingrowth to replace the material and maintain the form. It resorbs into by-products at levels recognized by regulatory agencies as being non-toxic. Through two pilot studies using a pig model, we have identified a ReFilx formulation that satisfies the implant criteria. In this NSERC I2I application, we propose to support the commercialization of this product through development and validation of scale-up strategies for the raw materials involved in ReFilx synthesis, as well as the fabrication of the final formed constructs. This will be accomplished through two key milestones: (1) develop a scale-up strategy for the pre-polymer and (2) develop prototypes for high through-put and reproducible fabrication of ReFilx constructs. Developing and validating these processes will in turn expedite and reduce the cost of transitioning from laboratory to commercial production.******