Periodic Reporting for period 1 - SkinKer (Absorbable and wearable keratin-based nanofibers for wound healing and skin reconstruction)
Periodo di rendicontazione: 2018-09-01 al 2019-02-28
KerLine proprietary process allows to produce high molecular weight keratin (45-60 KDa) solutions (named FullKer®) extracted by a denaturing process from waste wool. Different types of FullKer® have been studied in the feasibility study, to evaluate their properties and select the optimal for the use in biomedical and wound healing application. FullKer® B is the one targeted to advanced medications, biomedical devices and pharmaceuticals applications: it is a biodegradable, bioabsosbable and water-soluble keratin-based biomaterial usable for controlled drug release, drug reformulation and regenerative medicine applications. SkinKer targets the production of patches for chronic wound healing produced through nanofibers obtained by means of a patented keratin electrospinning process in aqueous solution. Once obtained, nanofibers are stabilized through chemical or thermic processes that are also useful to control kinetic parameters for drug release and biosorption. The final preparation is a nanofibrous self-absorbable transdermal patch / membrane for wound healing. The specifications of the SkinKer membranes were defined through discussion with producers of biomedical devices. The certifications and testing steps required to commercialize SkinKer were analyzed in detail both regarding use (safety and clinical tests) and certifications /compliance required for production. The investment to validate and scale up the production were defined including the production of a business plan for the initiative and engagement of potentially interested industrial partner.
The activities carried out during the feasibility study include: 1) Definition of the specifications of the SkinKer membranes through discussion with producers of biomedical devices; 2) Definition of the certifications and testing steps required to commercialize SkinKer both regarding its use (safety and clinical tests) and certifications /compliance required for production; 3) Analysis of the production process for SkinKer dressings in terms of equipment scale-up and production costs; 4) Definition of IPR strategy for protection of the production process and refinement of the business model for the production and commercial exploitation of the technology; 5) Analysis of the potential market and competitive landscape; 6) Validation with industrial partners of the production capacity, pricing, specifications and development strategy; 7) Preparation of a Business Plan with definition of investment required and strategy.
The competitive landscape was analyzed globally confirming that only one competitor producing dressing for wound healing based on full length keratin is present in USA, targeting to repair acute and chronic wounds, including diabetic foot ulcers, venous leg ulcers, pressure ulcers. However, SkinKer is the only product based on keratin nanofibers produced through electrospinning, with the advantage of allowing to incorporate active ingredients (e.g. phythotherapeutic compounds, drugs, vitamins, supplements) directly in the fiber, without addition of toxic cross-linkers and/or toxic organic solvents that might be harmful for the body. In addition, the production cost is by far more competitive.