An Assessment of Market Opportunities for ReFilx: A Novel Soft Tissue Filler

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Lumpectomy or breast conserving surgery (BCS) is an essential component of most breast cancer (BC) treatments but it can often result in poor cosmetic outcomes due to large soft tissue defects from the procedure. There is an increasing demand for better cosmetic outcomes as these patients are now expected to survive long-term, and poor cosmesis can often serve as a constant reminder of their illness, which in turn may impact their quality of life. ReFilx, which is the invention discussed in this grant proposal, represents a simple, cost-effective, versatile, permanent and aesthetically superior solution for soft tissue defect correction with the potential of reducing surgery time/surgical dissection, complication rates and the incidence of positive margins. ReFilx is a sub-group of novel amino acid-derived biodegradable polyurethane (PU) porous foams that are intended for use as soft tissue fillers for breast volume restoration following BCS or biopsies associated with BC. Our in vivo porcine studies have shown that ReFilx satisfies the implant criteria of preserving breast shape/volume and natural stiffness, supporting cell/tissue infiltration, neovascularization and host tissue integration as well as promoting wound repair and low inflammation simultaneously. The main aim of the proposed market assessment is to assess the market potential of the proposed product through assessment of market size, competitive landscape, barriers to entry, and market trends. Analysis will also be performed to assess potential factors affecting the commercialization of the technology, including issues regarding product adoption by end-users, product positioning, potential distribution channels, regulatory factors, and reimbursement through insurance.