The following table sets forth certain key development milestones of our Group:

Year: Milestone

2001

Our Group launched our R&D, product development and manufacturing base in Shenzhen, the PRC.
Our Group received our first regulatory approval for our balloon catheter from PMDA in September.

2005

Our Group acquired Orbus Medical Technologies Inc. and its subsidiaries for a research and development center in the United States and a manufacturing base in the Netherlands, and expanded our sales network in Europe.

2007

Our first generation “Sapphire” received CE Mark in April, marking the beginning of our Sapphire balloon catheter product family.

2008

2016

Mr. David CHIEN became our CEO, resetting the business strategy of our Group.
We launched our second generation COMBO Plus dual therapy stent with an advanced delivery system in June.

2017

2018

Jade PTA received FDA 510(k) clearance in February.
Sapphire II Pro received FDA 510(k) clearance in March and became the first 1.0mm diameter balloon in the United States.
Teleport, our first microcatheter product, obtained CE Mark and FDA 510(k) clearance in March and November, respectively.
We commenced worldwide distribution of coronary artery and peripheral orbital atherectomy products for a United States medical device developer and manufacturer.

2019

2020

Sapphire 3 and Sapphire NC 24 received CE Mark in March.
We acquired our distributor in Switzerland in August to actively expand our direct sales network.
COMBO dual therapy stent obtained NMPA approval in August.
We formed a strategic joint venture with Products & Features International, LDA for the development, manufacturing and distribution of structural heart products in certain countries in Asia Pacific regions in October.
Sapphire II Pro OTW version and Jade PTA 14”/18”/35” OTW series were launched in the United States.

2021

We first opened to third party investments and completed two rounds of financing within a few months, raising US$202.5 million in aggregate from well-known institutional investors and family offices.
We expanded our direct sales network and established our direct sales team in China.

OrbusNeich Medical Company Ltd. Downloads

Sapphire 3 - Coronary Dilatation Catheter Brochure