June 7, 2013 — AngioLight has successfully completed an initial animal study of the AngioLight System at Fu Wai Hospital, a leading cardiovascular center located in Beijing. The study paves the way for AngioLight to go forward in China with full-scale animal and clinical testing of the system, which will begin following the anticipated completion of study protocols, hospital review and required China Food and Drug Administration (CFDA) approvals.
The AngioLight System is a novel light-based diagnostic catheter designed to provide interventional cardiologists and radiologists with vessel diameter and area measurements that will help improve proper stent sizing and placement, which studies have shown can improve outcomes for patients. The device has been designed with the goal of delivering diagnostic data beyond the capability of fluoroscopy and at a fraction of the cost of vascular imaging modalities such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT).
“The initial studies have shown that the AngioLight System can quickly and easily provide advanced diagnostic information to physicians that may enable better patient outcomes,” said Ge Bai, managing director of Medical Technologies Innovation Asia (MTIA), Hong Kong, AngioLight’s strategic partner responsible for completing safety, animal and clinical studies of the AngioLight System in China. “We believe this technology has widespread application in China and beyond in vascular stenting and other interventional procedures.”
The market for AngioLight’s technology is significant. Within the interventional cardiology market alone, stenting and angioplasty represent $12 billion worldwide. All indications point to continued growth, particularly in China, where interventional cardiology procedures are rising rapidly and the adoption of IVUS and OCT has been limited.
“The results of the Fu Wai study have demonstrated significant additional validation for the AngioLight System and have provided us with a clear path forward,” said Gary Saxton, AngioLight president. “We are eager to proceed with MTIA through the regulatory process and into commercialization, first in China and then into other worldwide markets.”
For more information: www.angiolight.com