MILESTONES
2023
- In February, the COMETIU™ intracranial self-expanding drug stent system, independently developed by SINOMED Neurovita , completed all patient enrollments, taking only 7 months from the first to the last case; SINOMED’s semi-compliant balloon dilation catheter SC HONKYTONK™ obtained FDA certification, marking the second product from SINOMED to receive FDA approval in the United States.
- In March, the NOVARAIL™ distal access catheter, APACHI™ intracranial thrombosis aspiration catheter, Rayline™ micro catheter, and APEX TRA™ radial access catheter system, developed by SINOMED Neurovita , were approved by the NMPA; the intracranial aneurysm coated flow diverter by SINOMED Neurovita completed its first patient enrollment and successfully implanted in 4 subjects on the same day.
- In April, the Ghunter™ intracranial thrombectomy stent, developed by SINOMED Neurovita, was approved for market launch by the NMPA.
- In June, the BuMA Supreme® drug-eluting stent system added a 4.5-5.0 size and was approved for market launch by the NMPA; SINOMED successfully passed the CNAS laboratory accreditation.
- In July, the APEX TRA™ radial access guide catheter, developed by SINOMED Neurovita, was approved for market launch by the NMPA; the clinical trial for the intracranial aneurysm coated flow diverter by SINOMED Neurovita completed nationwide patient enrollment.
- In August, the APEX TRA™ radial access catheter system, developed by SINOMED Neurovita, was approved for market launch by the NMPA; SINOMED underwent an on-site inspection by the FDA for market entry of high-risk medical devices (Class III) in the United States and successfully completed the on-site audit with a Voluntary Action Indicated (VAI) outcome.
- In September, SINOMED’s TRADENT™ coronary scoring balloon catheter was approved; the company’s HT Supreme® healing targeted drug coated coronary stent system received approval from the French Health Products Economic Committee and was included in the French health insurance reimbursement catalog.
- In November, the company’s HT Supreme® healing targeted drug coated coronary stent system received approval from the TFDA Taiwan under the Executive Yuan’s Department of Health, and also obtained EU MDR certification.
2022
- In January, the clinical outcomes of the NOVA DES® intracranial drug-eluting stent system were published in the prestigious journal JAMA Neurology.
- In April, the product was recommended in the “2022 Chinese Expert Consensus on Endovascular Treatment for Symptomatic Intracranial Atherosclerotic Stenosis” and was selected as one of the significant medical advancements in the field of biomedical engineering and information by the Chinese Academy of Medical Sciences in 2021. This recognition reflects the international community’s endorsement of Chinese manufacturing and highlights the potential of the intracranial drug-eluting stent as a developmental direction.
- In April and June, the TORR® vacuum aspiration pump and the LEATUBE® aspiration tubing respectively received approval from the NMPA for official marketing. These products are independently developed by SINOMED Neurovita , after its operational independence.
- In August, SINOMED Neurovita ,’s intracranial aneurysm coated flow diverter won the first prize in the product category at the inaugural CNIT Innovation Competition.
- In November, during the coronary stent bulk procurement renewal, two new-generation drug-eluting stents (HT Supreme, BuMA Supreme) were successfully shortlisted and entered over 1000 hospitals, with more than 60% being top-tier hospitals.
- In September, October, and December, the BuMA Supreme® drug-eluting stent system, Mariyana™ coronary guide extension catheter, a new generation of non-compliant balloon dilation catheters(NC Rockstar™ non-compliant PTCA balloon dilatation catheter), and coronary balloon dilation catheter(SC Honkytonk™ PTCA balloon dilatation catheter) respectively obtained approval from the NMPA for official marketing.
- In December, the new generation of NC Rockstar™ non-compliant PTCA balloon dilatation catheter received certification from the U.S. Food and Drug Administration (FDA).
- Significant breakthroughs were achieved in the neuro field with the world’s first self-expanding drug-eluting stent officially entering the clinical phase, with rapid clinical enrollment progress.
- The intracranial aneurysm coated flow diverter completed pre-clinical evaluation preparations and is about to enter the clinical enrollment phase.
- The world’s first healing-targeted coronary drug-eluting stent, HT Supreme, entered the substantive review phase of the U.S. FDA.
2021
- In July, the company’s intracranial drug-eluting stent system received a medical device registration certificate issued by the NMPA, marking it as the world’s first drug-eluting stent specifically designed for the treatment of intracranial arterial stenosis, and also the first healing-oriented intracranial stent globally.
- In August, SINOMED’s subsidiary, SINOMED Neurovita , invested $4 million in the U.S. company eLum, aiming to extend the company’s industry chain, optimize its industrial layout, and enrich its product pipeline in the field of neurointerventional medical devices.
- In December, the company’s HT Supreme™ drug-eluting stent system application for premarket approval (PMA application) was accepted by the FDA and entered the final premarket approval review process.
2020
- In July, the company’s new generation Intracranial Balloon Dilatation Catheter Neuro LPS received the national medical device registration certificate from NMPA.
- From August to October, the company established three wholly owned subsidiaries in Suzhou, and started planning to build the southern base.
- In December, the company’s new generation Drug Coated Coronary Stent System HT Supreme received the national medical device registration certificate from NMPA, and proposed the idea of “Healing Targeted” for the first time in the industry.
2019
- Completed enrollment of 1,632 patients from Canada, Europe, Japan and the U.S. in the PIONEER III clinical trial.
- SINOMED was listed on the STAR Market (Stock code: 688018.SH) of the Shanghai Stock Exchange.
- HT Supreme Drug-Eluting Stent receives CE mark.
2018
- SINOMED Group completed the Shareholding System transformation and became a joint-stock company
- SINOMED expanded its overseas organization with operational subsidiaries in Hong Kong, US, Japan and Europe
- The BASIS study enrollment begins in China. This is the world’s first clinical study comparing intercranial balloon dilation to medical therapy
2017
- BuMA Supreme becomes the first DES from China to be granted approval for a simultaneous US FDA, Canadian Health Canada, Japanese PMDA and European trial. The PIONEER III study began enrollment of patients in these regions
- Established the company’s Neurointervention Department and spearheaded the “Intervention without Implantation” hypothesis in the neurological field
- Formed a Sino-foreign joint venture after company restructuring and financing from Co-Stone Capital, China Securities, CITIC Securities, Tao Capital and LYFE Capital
- Tytrak®, NC Thonic® and Sleek Prime Balloon Catheters receives CE mark
- BuMA® DES registered in Brazil and Kazakhstan
- Tytrak®, NC Thonic® Balloon Catheter registered in Thailand
2016
- Results of the PANDA III study are published in the Journal of the American College of Cardiology (JACC)
- Neuro RX® became the first rapid exchange intercranial balloon catheter approved by China CFDA
- Tytrak® PTCA balloon catheter approved by China CFDA
- BuMA® DES registered in Indonesia and Thailand
- Sleek Prime PTCA Balloon Catheter registered in South Korea
2015
- BuMA Supreme’s clinical study, PIONEER I, began enrollment in the Netherlands, Belgium, Spain and Portugal
- “Vascular restoration: Is there a window of opportunity” by Dr. Jianhua Sun, Xiaoran Kang and Tianzhu Li was published in the journal of Medical Hypotheses
- SINOMED’s Accufit® TMVR was introduced by Prof. Patrick W. Serruys at PCR Innovators Day
2014
- NC Thonic® Non-compliant PTCA balloon catheter approved by China CFDA
2013
- SUN Bare Metal Stent received CE mark
2012
- SINOMED wholly acquired Alchimedics, a French technical company
2010
- Novel Biodegradable Drug Coating Coronary Stent BuMA® approved by SFDA
2008
- Sleek PTCA Balloon Catheter received CE mark
2007
- SINOMED established in China
2002
- Sleek PTCA Balloon Catheter and SUN Bare Metal Stent approved by China SFDA
2001
- Beijing Sun Technology Inc. (prior entity of SINOMED) established in China