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WoundCure Report Summary

Project ID: 671970

Periodic Reporting for period 3 - WoundCure (Personalized Wound Dressings Based on Nanofiber Mats)

Reporting period: 2016-07-01 to 2016-12-31

Summary of the context and overall objectives of the project

Wound management is a major clinical and economic problem. In 2010, public spending on healthcare accounted for almost 15% of all government expenditure in Europe. Wound management alone is estimated to make up 2–4% with an average of €6,000 - €10,000 spent on each patient per year. The annual incidence of wounds is 8 cases per 1000, higher than cancer, diabetes and cardiovascular diseases. Despite the considerable progress that has been made over recent years, wound healing remains a challenge and the development of novel treatments remain desperately needed.

Traditionally, dressings fulfilled a number of functions: cosmetic, hemostasis, protection, support and absorption. Currently, a dressing is no longer a passive adjunct to healing, but is an active element of wound management designed to debride the wound, control infection and promote healing. The ideal dressing should be easy to apply, painless to remove, protect from infection, reduce change frequency and promote scar free healing.

NICAST is a pioneer in the development of medical devices made of electrospun polymer nano-fabrics. NICAST unique and patented electrospun dressing manufacturing technology is the focus of the Woundcure project and the SPINNER system. The SPINNER brings a new approach for the treatment of wounds by creating instantly applied, patient-specific, tailored dressings that are fine-tunable to surface area, shape, thickness, skin site and area to be covered. The personalized dressings are easy to use, protect from bacterial penetration, painlessly removed and are low cost in use.

Moreover, the dressing composition can be tailored according to the wound care required in each step of the wound healing. The new platform consists of the nanofiber based dressings produced on the spot by in-situ electrospinning using the portable, hand-held SPINNER device. The device is easy to operate and it dresses the wound area in a comfortable manner without human contact. The pre-clinical and preliminary clinical performance of the SPINNER indicates a number of distinct advantages such as fitting difficult anatomical regions, easy-stick/easy-peel, seal/breathe and anti-bacterial characteristics; the dressing is transparent and allows wound assessment without removal.

WoundCure primary goal is to reach commercialization.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Nicast achieved significant progress in the last 18 months concentrating on the development of the SPINNER device towards scalable design, validating the aseptic manufacturing line for the pre-filled solution syringes and preparing, setting and launching the clinical trial in donor site wounds.

The SPINNER device was developed to provide working prototypes to the on-going clinical study. Further work of industrial design and design towards scalability is in advanced stages incorporating improvements following device validation and clinical experience. The SPINNER specifications include ease of use, clear, safe and controlled process and multiple safety features. A special emphasis was given to the SPINNER user interface and operation including user feedback during operation and charging based on indicative LEDs. The current SPINNER design is light in weight and easy to use.

Significant efforts have been invested towards establishing of an in-house aseptic processing line for the polymer solution filling at Nicast clean room facility. The aseptic line is fully validated and final solution kit product is individually packed and labeled STERILE A.

The SPINNER device and Solution-Kit validation, demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of fibers.

The clinical study in donor site wounds is ongoing. Study was initiated and patients completed in December 2016. The study involves 40 patients and takes place in major hospitals in Israel; 20 patients receive treatment using the SPINNER device comparing to 20 patients receiving the current standard of care. The SPINNER study is a prospective, open label, double arm study. The purpose of the study is to confirm the product safety, and to assess its performance in the treatment of donor-site wounds. Data of 30 days FU was collected and is under evaluation. A new protocol dealing with superficial burns is now in approval process in three medical centers. Study initiation and patient recruitment is expected during January 2017.

In parallel, Nicast is continuously investigating the future generation of the dressing; trying to define specification and additional clinical applications according to market needs and dynamics. The investigation focus on the addition of anti-bacterial agent to our solution to yield anti-bacterial dressing.

Nicast is preparing towards CE mark; all development activities are run under the company established quality system; important processes and documents are in place or under preparation such as risk analysis, design history file, manufacturing SOP's, supplier approvals, technical file, literature review etc. NICAST performed a full risk analysis evaluation of the system addressing all failure modes related to the device, the care giver and patient according to applicable regulatory requirements. Risks related to the clinical trial such as skin irritation, local Infection, dressing malfunction, will be continuously evaluated during the study by following on the clinical data, adverse events and feedback from the investigators as well as patients. Up to date, no device related adverse events, skin irritation, dressing malfunction or infection cases are reported.

At this point, validation tests for the SPINNER system including validation of the solution, dressing and SPINNER device are complete. The SPINNER device is safe and reliable. A full validation including Electrical Safety has been performed. Solution validation demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of fibers.

Project website address:

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The analysis of the impact as presented in the Woundcure application (Section 2;page 10) is valid. No changes were introduced during this reporting period.

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