Periodic Reporting for period 5 - WoundCure (Personalized Wound Dressings Based on Nanofiber Mats)
Reporting period: 2017-07-01 to 2017-12-31
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 SpinCare system. The SpinCare 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 SpinCare 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 SpinCare indicate 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.
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 SpinCare system. The SpinCare 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 SpinCare 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 SpinCare indicate 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.
"Nicast achieved significant progress in the last 30 months concentrating on the development of the SpinCare device towards scalable design, setup of aseptic manufacturing line for the pre-filled solution syringes and preparing, setting and launching clinical trials in donor site wounds and burns.
Today, the SpinCare device is fully developed, successfully completed validation and verification and is CE marked . The SpinCare System is easy to use, with clear, safe and controlled process and safety features. Industrial and mechanical designs are finalized. The SpinCare solution demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of nanofibers.
Significant efforts have been invested towards establishing of an in-house aseptic processing line for the polymer solution pre-filling at Nicast clean room facility, yielding individually packed and labeled STERILE A solution kits.
The SpinCare device and Solution-Kit validation, demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of fibers.
In parallel, Nicast is continuously working on the future generation of the dressing; defining specifications and additional clinical applications according to market needs and dynamics.
The clinical study ""Evaluation of the SpinCare™ device for the application of wound dressing: treatment of split skin-graft donor sites"" was launched on March 2016. 40 patients in 5 major hospitals in Israel were recruited; patients in the study group received treatment using the SpinCare device comparing to the control group, where patients were treated according to the standard of care. Follow up time is 12 months. The purpose of the study was to confirm the product safety, and to assess its performance in the treatment of donor-site wounds.
The clinical study ""Evaluation of the SpinCare™ System in the treatment of partial thickness burns"" was launched in 3 major medical centers in Israel. Study was initiated on March 2017. Patient recruitment (20 patients) is complete.
System industrial design and design towards scalability are complete. The SpinCare specifications include ease of use, clear, safe and controlled process and multiple safety features. A special emphasis was given to the SpinCare user interface and operation including user feedback during operation. The current design is light in weight and easy to use.
At this point, validation tests for the SpinCare System including validation of the solution, dressing and device are complete. The SpinCare System 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.
Nicast completed its file submission towards CE mark; All processes and documents such as risk analysis, design history file, manufacturing SOP's, supplier approvals, technical file, literature review etc have been submitted as part of the full technical file.
The SpinCare System is now CE marked and approved for marketing. The company is planning the marketing phase and system launch.
Project website address: http://www.nicast.com
Today, the SpinCare device is fully developed, successfully completed validation and verification and is CE marked . The SpinCare System is easy to use, with clear, safe and controlled process and safety features. Industrial and mechanical designs are finalized. The SpinCare solution demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of nanofibers.
Significant efforts have been invested towards establishing of an in-house aseptic processing line for the polymer solution pre-filling at Nicast clean room facility, yielding individually packed and labeled STERILE A solution kits.
The SpinCare device and Solution-Kit validation, demonstrated effective and functional dressing process with homogenous dressings and multi size distribution of fibers.
In parallel, Nicast is continuously working on the future generation of the dressing; defining specifications and additional clinical applications according to market needs and dynamics.
The clinical study ""Evaluation of the SpinCare™ device for the application of wound dressing: treatment of split skin-graft donor sites"" was launched on March 2016. 40 patients in 5 major hospitals in Israel were recruited; patients in the study group received treatment using the SpinCare device comparing to the control group, where patients were treated according to the standard of care. Follow up time is 12 months. The purpose of the study was to confirm the product safety, and to assess its performance in the treatment of donor-site wounds.
The clinical study ""Evaluation of the SpinCare™ System in the treatment of partial thickness burns"" was launched in 3 major medical centers in Israel. Study was initiated on March 2017. Patient recruitment (20 patients) is complete.
System industrial design and design towards scalability are complete. The SpinCare specifications include ease of use, clear, safe and controlled process and multiple safety features. A special emphasis was given to the SpinCare user interface and operation including user feedback during operation. The current design is light in weight and easy to use.
At this point, validation tests for the SpinCare System including validation of the solution, dressing and device are complete. The SpinCare System 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.
Nicast completed its file submission towards CE mark; All processes and documents such as risk analysis, design history file, manufacturing SOP's, supplier approvals, technical file, literature review etc have been submitted as part of the full technical file.
The SpinCare System is now CE marked and approved for marketing. The company is planning the marketing phase and system launch.
Project website address: http://www.nicast.com
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.