First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction

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NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons outside the Government, except for purposes of review and evaluation. Project Summary/Abstract DuraSorb™ is poised to significantly improve the lives of the over 100,000 US women undergoing post- mastectomy breast reconstruction every year. The current standard of care in implant-based breast reconstruction (IBBR) is the use of cadaveric acellular dermal matrix (ADM) as a sling for the implant, rather than placing the implant fully under the pectoralis muscle. ADM was introduced 10+ years ago to provide technical benefits of decreased pain, fewer return visits between reconstructive stages, better cosmetic results, and decreased rates of capsular contracture around the implant. However, it has been associated with a 10% increase in risk of surgical site complications including seroma, infection, and flap necrosis. Furthermore, it has an unsustainable cost of $3,500-$4,850 per breast. Alternative synthetic meshes have been being investigated as early as 2007. However, to date, studies are limited to small case series with short follow-up and utilize meshes that may be tolerated in a hernia repair, but present clinical problems in the setting of a mastectomy skin flap with tenuous vascularity. DuraSorb™ is made of polydioxanone, a well-known polymer that is among the least inflammatory used in implantable devices. The minimal inflammatory response to the material and its full-degradation over 6-9 months prevent chronic inflammation and give DuraSorb™ the characteristics of a biologic mesh. Additionally, its open-knit, macroporous design allows for tissue integration. Further, it is produced with monofilament fibers, which are less prone to biofilm formation than ADM. The unique properties of synthetic DuraSorb™ could deliver the technical benefits of ADM without the increased complications, and at a fifth of the cost. In this Direct to Phase II SBIR proposal, SIA will acquire the clinical data required to achieve the first and only FDA clearance for prosthetic breast reconstruction in the US, above and beyond the clinical data collected for 510(k) clearance (August 2018, K181094). A 100 patient multi-center single arm trial will be conducted with a retrospective, propensity-matched control to demonstrate performance and safety of DuraSorb™ and to evaluate patient reported outcomes in a clinical trial. NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons outside the Government, except for purposes of review and evaluation.