Milestones2026-05-27T10:42:52+08:00

MILESTONES

2026

  • In January, the HT Supreme™ healing targeted drug coated coronary stent system, SC HONKYTONK® PTCA balloon dilatation catheter, and NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Ministry of Health of the Republic of Kazakhstan
  • In February, the neurovascular product GHUNTER® Revascularization Device received the EU Medical Device Regulation (MDR) certification
  • In May，interim one-year results of the PIONEER IV study of HT Supreme™ in all comers European population were published in the European Heart Joumnal, demonstrating that a one-month dual antiplatelet therapy (DAPT) regimen followed by monotherapy after PCI is feasible, with favorable safety and efficacy outcomes in a prospective，large-scale,multicenter randomized controled trial conducted across seven Western European countries

2025

  • In January, the SC HONKYTONK® PTCA balloon dilatation catheter was approved by the National Directorate of Pharmacy and Drugs (DIGEMID) of Peru
  • In February, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the National Administration of Drugs, Foods and Medical Devices (ANMAT) of Argentina; The NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter was approved by the Medical Device Authority (MDA) of Malaysia; the HT Supreme™ healing targeted drug coated coronary stent system Tytrak® PTCA Balloon Dilatation Catheter, and NC Thonic® Non-Compliant PTCA Balloon Dilatation Catheter were approved by the National Agency for Health Regulation, Control and Surveillance (ARCSA) of Ecuador
  • In March, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the Ministry of Health of Vietnam
  • In April, the  SC HONKYTONK® PTCA balloon dilatation catheter was approved by the Medical Device Authority (MDA) of Malaysia
  • In May, the SC HONKYTONK® PTCA balloon dilatation catheter and the NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico and the National Agency for Health Regulation, Control and Surveillance (ARCSA) of Ecuador; AUCURA™ coated flow diverter was approved by NMPA for commercialization
  • In July, HT Supreme™ DES became the first China-originated Class III implantable medical device to receive conditional PMA approval from the FDA
  • In August, our COMETlU® intracranial self-expanding DES and COMEX™ balloon micro-catheter received Breakthrough Device Designation from the FDA; The neurovascular product AURALINE Microcatheter was approved by China’s National Medical Products Administration (NMPA); The latest findings of PIONEER IV Clinical Trial were presented at the 2025 European Society of Cardiology (ESC) Congress. A meta-analysis combining data from the PIONEER IV and PIONEER III clinical trials showed that patients treated with the HT Supreme™ healing-targeted drug-coated coronary stent had improved clinical outcomes without an increased risk of bleeding when discontinuing aspirin (oral antiplatelet therapy) early; The TRADENT™ Coronary Scoring Balloon Catheter was approved by the Thai Food and Drug Administration (FDA); the neurovascular product APEX TRA SYSTEM® Radial Access Catheter System, paired with the Rayline® Microcatheter System, facilitated a charitable medical mission in Africa. Volunteer doctors successfully performed a transradial intracranial aneurysm embolization procedure in Ethiopia
  • In November, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the Drug Regulatory Authority of Pakistan (DRAP); The TRADENT™ Coronary Scoring Balloon Catheter was approved by the Ministry of Food and Drug Safety (MFDS) of South Korea; The  SC HONKYTONK® PTCA balloon dilatation catheter was approved by the Brazilian Health Regulatory Agency (ANVISA)

2024

  • In January, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the Directorate General of Drug Administration (DGDA) of Bangladesh
  • In March, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the Medical Device Division, Department of Health, Hong Kong;The SC HONKYTONK® PTCA balloon dilatation catheter and the NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Drug Regulatory Authority of Pakistan (DRAP); The HT Supreme™ healing targeted drug coated coronary stent system, SC HONKYTONK® PTCA balloon dilatation catheter, and NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Ministry of Food and Drug Safety (MFDS) of South Korea; COMETlU® received NMPA innovative device designation
  • In August, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) of Mexico; The HT Supreme™ healing targeted drug coated coronary stent system and the NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Moroccan Directorate of Medicines and Pharmacy (DMP)
  • In September, the latest results of PIONEER-IV Clinical Trial presented at the French GRCI meeting demonstrated that using the HT Supreme™ healing targeted drug coated coronary stent system with a shortened dual antiplatelet therapy (DAPT) duration of 1 month further validates its safety and efficacy; The one-year follow-up results of the BASIS study, demonstrating that the Company’s intracranial-specific balloon significantly outperformed best medical therapy in treating intracranial atherosclerotic stenosis, were published in JAMA, marking the first clinical evidence showing the superiority of endovascular intervention over medical therapy in this field
  • In October, PIONEER-III Trial: The 5-year follow-up results of PIONEER-III Clinical Trial were prominently presented at the TCT conference in the United States, demonstrating the advantages of the HT Supreme™ healing targeted drug coated coronary stent system in terms of safety and efficacy based on its outstanding performance in the clinical study; The SC HONKYTONK® PTCA balloon dilatation catheter was approved by the Moroccan Directorate of Medicines and Pharmacy (DMP); The neurovascular product COVESTAR® Balloon Guide Catheter was approved by China’s National Medical Products Administration (NMPA)
  • In November, the HT Supreme™ healing targeted drug coated coronary stent system was approved by the National Directorate of Pharmacy and Drugs (DIGEMID) of Peru
  • We further acquired 72.73% equity interest in eLum; upon completion of the acquisition,eLum became a subsidiary of the Company

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 STSTEM® 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 BuMA Supreme® Drug-Eluting Stent System received the Medical Device Product Registration Certificate from the Indonesian Ministry of Health. The APEX TRA SYSTEM® radial access guide catheter, developed by SINOMED Neurovita, was approved for market launch by the NMPA. In addition, the clinical trial for SINOMED Neurovita’s intracranial aneurysm coated flow diverter completed nationwide patient enrollment
  • In August, the APEX TRA SYSTEM® 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, the TRADENT™ coronary scoring balloon catheter received approval from China’s National Medical Products Administration (NMPA). The HT Supreme™ Healing-Targeted Drug-Coated Coronary Stent System was approved by the French Health Products Economic Committee (CEPS) and included in the French national health insurance reimbursement list. In addition, the HT Supreme™ Healing-Targeted Drug-Coated Coronary Stent System received approval from the Turkish Ministry of Health
  • In November, the HT Supreme™ Healing-Targeted Drug-Coated Coronary Stent System successfully obtained certification under the European Union’s Medical Device Regulation (EU MDR). The system was also approved by the Taiwan Food and Drug Administration (TFDA) and the Brazilian Health Regulatory Agency (ANVISA)
  • In December, the HT Supreme™ healing targeted drug coated coronary stent system and the NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter were approved by the Medical Device Authority (MDA) of Malaysia; The NC ROCKSTAR® non-compliant PTCA balloon dilatation catheter was approved by the Taiwan Food and Drug Administration (TFDA)

2022

  • Our two 2nd generation DES, HT Supreme™and HT Infinity®, were included in the national volume-based procurement to enter over 1,000 hospitals
  • In January, the one-year follow-up results of the NOVA study, demonstrating that intracrania drug-eluting stents significantly reduce restenosis and recurrent stroke rates compared with bare-metal stents, were published in JAMA Neurology
  • In April, the neurovascular product NOVA intracranial drug-eluting stent system was recognized by the Chinese Academy of Medical Sciences as a major biomedical innovation (2021) and recommended in the 2022 Chinese Expert Consensus on Endovascular Treatment for Symptomatic Intracranial Atherosclerotic Stenosis
  • 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 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

  • We initiated investment to eLum，a US company, through SINOMED Neurovita with intention to take control of the company, among others, enriching our product pipeline in the field of neurointerventional medical devices
  • Based on the “healing window” theory, invention patents for our paradigm different new drug-eluting stent were granted in China
  • Our NOVA NEO™ intracranial drug-eluting stent system was approved by the NMPA, being the world’s first drug-eluting stent for the treatment of intracranial arterial stenosis and the first healing-oriented intracranial stent globally
  • The one-year follow-up results of the PIONEER III study, being the first FDA clinical trial with a China-originated drug-coated cardiovascular implant, were published in Circulation, demonstrating it has same efficacy vs best brands
  • 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
  • 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
  • We established wholly-owned subsidiaries in Suzhou and SINOMED Neurovita started planning the construction of our Suzhou facility
  • NOVA obtained approval from the NMPA as an innovative medical device and was recognized as one of China’s Important Medical Advances for 2021 in the field of biomedical engineering and information in 2022

2019

  • Our A Shares were listed on the Shanghai Stock Exchange STAR Market with the stock code of 688108
  • HT Supreme™ received CE Mark approval
  • Completed enrollment of 1,632 patients from Canada, Europe, Japan and the U.S. in the PIONEER III clinical trial

2018

  • The Company was converted into a joint stock limited company
  • The BASIS study, the first and globally largest clinical study comparing intracranial balloon angioplasty vs pharmacological therapy, was initiated
  • The clinical trial notification application for HT Supreme™ in Japan was submitted to the PMDA and approved
  • The results of the PlONEER II OCT study led by the PLA General Hospital in collaboration with Cardialysis (Europe), demonstrating superior healing performance of the HT Supreme™ stent compared to the XlENCE stent at one month post implantation, were published in EuroIntervention., which identified the first one is the most critical time period for healing
  • SINOMED expanded its overseas organization with operational subsidiaries in Hong Kong, US, Japan and Europe

2017

  • The IDE clinical study for HT Supreme™  was approved by the FDA. The trial was launched across the U.S., Canada and Western Europe.This is the first PRC developed stent study receive approval to be conducted in the US by the FDA
  • We established overseas business platforms comprising subsidiaries in Hong Kong，the United States and Japan
  • We established our neuro intervention department
  • 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

  • The IDE application for PMA for HT Supreme™ in the US was submitted to the FDA
  • Our rapid-exchange balloon catheter for the treatment of intracranial vascular stenosis Neuro RX®was approved by the NMPA, being the first product of its kind approved by the NMPA
  • The one-year clinical results of the PANDA-III study, a perspective, multi-centers, random RCT clinical trial led by Fuwai Hospital in Beijing, were published in the Journal of the American College of Cardiology (JACC), which validated one of the theoretical prediction that, the PK of drug release is a critical factor for patients safety
  • 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

  • Series clinical trial for HT Supreme™ were initiated. PIONEER I was launched in four European countries for getting CE mark approval. Pioneer II was launched in China for getting NMPA approval
  • “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
  • BuMA® was awarded the inaugural “Innovative Product Award” by the China France IP Committee in celebrating 50th years of established diplomatic relationship between two countries

2013

  • Dr. Sun originally formorlized a “Window of Opportunity for Healing after PCI” theoretical hypothesis, and subsequently published in Medical Hypothesis Journal in 2015
  • The research and development of the 2nd generation of coronary DES, HT Supreme™, the first intracranial DES Nova, and the first rapid-intracranial rapidexchange balloon catheter commenced
  • We expanded into neurovascular and structural heart disease businesses and started developing innovative products for ischemic stroke and transcatheter mitral valve replacement

2012

  • Sinomed Holding acquired AlchiMedics S.A., a French company, through which our Company obtained its proprietary coating technology in the medical field

2010

  • Our first core product, the biodegradable drug coating coronary stent system BuMA® , was approved by the NMPA

2008

  • Sleek PTCA Balloon Catheter received CE mark

2007

  • The predecessor of our Company, Sino Medical Sciences Technology Inc, was established

2002

  • Sleek PTCA Balloon Catheter and SUN Bare Metal Stent approved by China SFDA

2001

  • Fuji Yangguang was found by Dr. Sun