DermiSphere™: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery, CRP

PROJECT SUMMARY/ABSTRACT Due to the inability of the dermis to regenerate on its own, large full thickness skin loss cannot be restored naturally. The current gold standard treatment involves autologous tissue transfer in which the patient serves as their own donor, which may be challenging due to limited availability of full thickness skin donor sites and donor- site morbidity. Dermal Replacement Scaffolds (DRS) aim to recreate dermis, thereby preventing wound contraction. Being cell-free products, these serve as a scaffold for the infiltration of cells from the wound bed that organize to a functional, vascularized neodermis tissue, able to support a skin graft which is implanted as a second step procedure, resulting in a healed wound with normal skin dermal/epidermal architecture. However, because currently available DRS lack unique cues to guide such cell infiltration, they may fail to vascularize sufficiently. The critical barrier to progress in this field is to create a scaffold that 1) promotes rapid cellular infiltration and angiogenesis as required for neodermal formation in full thickness wounds, and 2) increases the incidence and quality of healing in both typical/healthy wounds and difficult to heal sites. To address this significant clinical gap, Fesarius Therapeutics, Inc. is developing DermiSphere™, an innovative DRS product that will regenerate dermis in full thickness skin loss wounds much faster (≤7 days, i.e. >75% faster) than the regeneration achieved using the market-leading DRS product, Integra®. Once dermis has regenerated it can be covered with a thin epidermal skin autograft, yielding skin that is more flexible, functional, and resilient than wounds healed with split thickness skin grafts alone. The commercialization of DermiSphereTM is expected to improve clinical practice in the surgical fields where full thickness skin loss is common including, but not limited to, trauma, burns, infection and post oncologic reconstructive surgery, by significantly decreasing the time required to achieve a healed wound in a scenario of large full thickness skin loss, which will directly result in decreased patient suffering as well as lower expenditure of valuable health care resources. The objective of this Commercial Readiness Pilot (CRP) is to complete late-stage development and enable Fesarius to achieve 510(k) clearance. Development of scaled manufacturing capabilities of the DermiSphereTM product represents one of the most important obstacles that must be surmounted in order to achieve broad-scale clinical impact of this promising technology. The Specific Aims for this proposed project are to (1) Establish and validate a cGMP-compatible manufacturing process which will prepare the DermiSphereTM product for commercial release (2) Design and validate packaging and validate sterilization of the DermiSphereTM product; (3) Complete real-time and accelerated stability validation for DermiSphereTM and its barrier packaging; and (4) Submit the 510(k) application and obtain clearance from the FDA.