The Insides Company is pleased to announce that The Insides™ Systemfi, a therapeutic solution for the effective chyme reinfusion treatment of enteroatmospheric fistulas and high output enterostomies, is now cleared for sale and commercially available in New Zealand.
This important commercial milestone follows the completion of the device’s IEC 60601 certification for the safety and performance of medical electrical equipment, ISO13485 certification for The Insides Company’s quality management system, biocompatibility testing, and clinical validation that was presented at the European Society of Coloproctology (ESCP) in Vienna, September 2019.
The Insides Company has also completed the registration of its devices on Medsafe’s WAND Database.
CEO Garth Sutherland said “it is a fantastic milestone for an innovative company, when it completes development of its 1st product, and launches in its home market. My congratulations and thanks go to all of the team and company’s founders on achieving this key milestone”.
About the Insides Company
The Insides Company Limited is a medical device company, spun out form the University of Auckland. The company is a leading provider of therapeutic Chyme Reinfusion solutions for the management of High-Output Enteroatmospheric Fistulas and High-Output Ileostomies.