HART will continue to focus primarily on completing preclinical work necessary to initiate clinical trials for its HART-Trachea product in the EU and US.
It has made recent progress in the US and EU, including the granting of orphan designation by the US Food and Drug Administration (FDA) and a productive meeting with the Medicines and Healthcare Products Regulatory Agency of the UK (MHRA, the equivalent of the FDA in the UK).
HART anticipates that during 2015 it will file its Investigational New Drug application to initiate a US clinical trial and a Clinical Trial Authorization application to initiate an EU clinical trial.
Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either physical trauma or trachea cancer.
Our trachea scaffold technology has been used in six human trachea transplants to date approved under compassionate use exemptions, but none of our products are yet approved by a government regulatory authority for marketing.
