Company inception
Became eligible for tax incentives programs under the Act for the Development of Biotech and New Pharmaceutical Industry, Minister of Economic Affairs
Turned public in compliance with regulations governed by Securities and Futures Bureau of Financial Supervisory Committee
Stock trading on Emerging Stock Board of Taipei Exchange, stock ticker: 6499
U.S. Food and Drug Administration 510(k) clearance for ClickClean™ (LAP-A01) Laparoscope Lens Shield Device
Successful First-in-Man Studies for XPro™ (IVC-C01, now Cross-Seal™) Large Bore Suture-Mediated Vascular Closure Device
Publicly listed (IPO) on Taipei Exchange, stock ticker: 6499
U.S. Food and Drug Administration 510(k) clearance for AbClose™(LAP-C01) Trocar Wound Closure Device
Invested in Prodeon to develop the Mercury Project (URO-T01) for treatment of Benign Prostatic Hyperplasia (BPH)
Invested in Delta Asia International Co. to enrich manufacturing capability
Entered into an Asset Purchase Agreement with Terumo for XPro™ System (IVC-C01, now Cross-Seal™) Large Bore Suture-Mediated Vascular Closure Device
Received FDA 510(k) Clearance for the PUMA™ System
Successful secondary public offering (SPO) at Taipei Exchange
Delta Asia International Co. publicly listed (IPO) on Taipei Exchange, stock ticker: 6762
Announced positive interim clinical results of 32 patients for XFLO™ Minimally Invasive BPH Treatment Device
Cross-SealTM received PMA Approvable Letter from U.S. FDA
The group has established a new business entity and has successively acquired MediBalloon and Second Source Medical to expand its business in medical device contract development and manufacturing (CDMO).
Urocross™ Expander system – treatment for lower urinary tract symptoms (LUTS) associated with benign Prostatic Hyperplasia (BPH) (URO-T01) was approved by the US FDA for Investigational Device Exemption (IDE) and successfully complete first randomization.
Cross-SealTM announced the completion of US FDA cGMP on-site inspection
Duett received U.S. FDA clearance for its first-in-human clinical trial
Medeon wins U.S. FDA PMA for Cross-Seal™
Aquedeon Medical Announces First Patient Enrolled in the IDE Study of Duett™