OrbusNeich Medical Company Ltd.
We are a global market leader in the development and manufacture of PCI/PTA balloons. Headquartered in Hong Kong, China, we sell products to over 70 countries and regions worldwide. In addition to PCI/PTA balloons, we also specialize in coronary stent products and are actively expanding into neuro vascular intervention and structural heart disease areas. Our Group’s history traces back to 2000 when Mr. Teddy CHIEN, our Chairman Emeritus and founder, commenced our cardiovascular interventional medical devices business. Mr. Teddy CHIEN has worked with the medical community over the past 50 years in various capacities at pharmaceutical and medical device companies.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
History
Mr. Teddy CHIEN first launched Cordis Neich, an exclusive distributor of medical devices for diagnostics and interventional procedures for Cordis Corporation in Asia. After Cordis Corporation and assets of Cordis Neich were acquired by Johnson & Johnson in 1996, Mr. Teddy CHIEN founded our Group to focus on the development and manufacturing of endovascular interventional devices. Mr. Teddy CHIEN also established the Chien Foundation to provide young interventional cardiologists with financial resources and opportunities for training in enhanced techniques in interventional cardiology, with an overall objective to raise the standard of healthcare for the benefit of the general public in countries in Asia-Pacific region.
Under Mr. Teddy CHIEN’s leadership, we further expanded our research and development and manufacturing capacity in 2005 by acquiring Orbus Medical Technologies Inc., which primarily focuses on developing and manufacturing stents, by way of merger.
In 2016, Mr. David CHIEN became our CEO. Under his leadership, the Group has grown rapidly through market expansion, market penetration, enriching product offerings and venturing into new business segments. In 2021, the Group opened to third parties for investment for the first time and successfully raised over USD200 million of funds, marking a new chapter for its development.
Our Mission
OrbusNeich designs and delivers innovative solutions for the treatment of vascular disease that improve patients’ quality of life.Our commitment is driven by Integrity, Passion, Innovation, and Performance. These respect the foundation of our core values that shape and reflect the company’s identity.
Key Development Milestones
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
- Our first generation “ScoreFlex” obtained CE Mark in May.
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
- We commenced selling our balloon products in the United States.
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
- Our latest generation Sapphire 3 obtained approval from PMDA in January.
- ScoreFlex PTA received FDA 510(k) clearance in May.
- COMBO Plus dual therapy stent obtained approval from PMDA.
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.