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Innovation

With a mindset that pursues cutting-edge products, innovation is always the focus in our R&D process. We believe in the power of combination of creativity, outstanding engineering and determination to be essential to developing the best valued medical devices in our field. Innovation is not only technology, but also continuously discovering new opportunities in different activities where the patient comes first. Our aim is to strengthen the confidence of our customers as well as to create a better quality of life for our patients.

Technology

By applying the eG™ technology (electro-grafting) concept in the mechanism of Drug-eluting Stent, SINOMED has successfully launched its first DES in China. BUMA™ is a novel drug-eluting stent which is not simply a mimic of imported products. This coating system was originally developed by a French company named AlchiMedics S.A. The combination between the coating technology, polymer and drug creates optimal clinical effectiveness and long-term patient safety. 

eG™ technology, a new concept for a safer DES

What is eG™?

‘A process to generate a nanometric Velcro polymer layer to a metallic surface, on which a drug carrying polymer is attached.’

eG™ Offers the following benefits:

-       Very solid bonding properties;

-       Reproducible high yield process;

-       Seems to have bio-beneficial properties;

-       Versatile approach allowing the use of multiple stable or biodegradable polymers, with various drugs, on different metallic surfaces.

Clinical benefits of eG™ layer

-       Endothelialization of the eG™ layer of the BMS will leave no inflammatory material or drug in contact with the vessel wall when using biodegradable polymers, thereby reducing the risk of platelet aggregation:

       •     Potentially reduced need for prolonged antiplatelet therapy;

       •     Reducing LST rate;

-       Through strong adhesion properties it will ensure mechanical integrity of the coating throughout the stent life cycle, eliminating delamination, cracking etcetera. This should reduce the early and subacute thrombosis rate by preventing exposure to the vessel wall of materials of unsure biocompatibility.

-       Use of eG™ adhesion properties may facilitate bifurcated stenting procedures while maintaining coating integrity.

Background of BuMA™

Incomplete endothelial coverage is suspected as the most likely cause of late stent thrombosis, a recognized complication of the current generation of FDA approved non-biodegradable polymeric drug-eluting stents (DES). Recent autopsy studies of human coronary stents suggest that re-endothelialization of DES is impaired far beyond the three- to four- month period in bare metal stents, suggesting an influence of the drug, polymer, and/or a combination of both. Innovative technologies to provide sustained stent-based delivery have focused on non-biodegradable polymers as matrices for drug incorporation and elution.

" Bench testing of stents with or without electro-grafting showed that the eG underlayer allows the use of biodegradable matrices while other adhesion technologies are susceptible to delamination, chipping and cracking."  --- Renu Virmani, M.D.

The goal of developing BuMA™ is to tackle the problems of both 1st generation DES and BMS. We aim to create a decoupling concept between drug release time and endothelialization. The eG™ coating layer functions to diminish proliferation of smooth muscle cells which promotes early and mature endothelialization.

Clinical design

Striving for originality and innovative ideas, we continuously seek for challenging projects. In collaboration with Dr.Jingbo Hou from the 2nd affiliated hospital of Harbin medical university in China, we have conducted a unique clinical design based on OCT analysis. The goal of this study was to observe neointima growth and maturation with OCT method. In order to receive most accurate result, we implanted both BuMA™ and XIENCE V DES into the same patient, vessel and lesion. This prevents blood vessel variances. Because of the originality and superior results, this study was chosen for late-breaking trials at EuroPCR 2013 in Paris. (Click here to view full study)

An animal OCT study with the same study design is conducted in collaboration with Dr. Renu Virmani from CVpath in U.S. comparing BuMA™ with XIENCE V in Swine Porcine; we have gained results in histology and OCT analysis. (Click here to view full study) 

Production

SINOMED is engaged in various domestic and global R&D projects to enlarge its product pipeline. With its custom-made electro-grafting machines, the production site can reach a capacity of 3000 batches per year (40 stents per batch). With a production site of 2,300 m² and current expansion project of 70,000 m², SINOMED is continuously increasing its efficiency and is able to create production capabilities that meet high technical requirements. 

Projects running

Currently, the R&D division is developing the second generation of BuMA™ called BuMA Sumpreme™. This generation ensures faster and uniform neointimal growth that promotes early endothelial healing. Histological and clinical studies will be conducted in collaboration with professionals and institutes globally. At the beginning of 2014, European First-In-Man trial will set to a start a partnership with several influential hospitals and key opinion leaders. With these exciting activities, we believe to further pursue our mission of establishing healing processes that reduce long-term anti-platelet therapy and save  healthcare costs.

Further, SINOMED is continuously developing new high-end medical devices such as mitral valve replacement and intracranial DES.