"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(se abrirá en una nueva ventana)
