About Us

CH BIOMEDICAL

Our company


CH Biomedical, Inc.(CHB) was founded in 2008 by a team of scientific and technological experts with overseas experience with the goal of bringing improved survival and quality of life to end-stage heart failure patients. The headquarters of CH Biomedical is located in Suzhou Industrial Park, while the wholly-owned subsidiary, CH Biomedical USA, Inc., is in LA, California. CH Biomedical focuses on the research and development of the world’s state-of-the art ventricular assist device (VAD), promotes the commercialization of the VADs, and brings benefits to patients with end-stage heart failure.

Ventricular assist device (VAD) represents the scientific and technological level of a country's high-end medical devices. It integrates many cutting-edge technologies and advanced sciences in the fields of biomedical engineering such as mechanical design, software control, integrated circuit, and fluid dynamics, as well as experience in the development, management, and manufacturing of high-end medical devices. After more than 10 years of independent research and development in the field of VAD, Our company has developed a new generation of LVAD CH-VAD® with full magnetic levitation technology, and continues to show its strength as a global technology leader in this emerging segment. CHB has completed its initial clinical trial in China. Plans are underway to expand global access to CHB’s lifesaving technology and next-generation maglev CH-VAD® in the United States and other countries.

Adhering to the core values of “Integrity, Truth, Respect, Excellence”, CHB is committed to leading the global artificial heart technology advancement and service improvement, so that more patients with advanced heart failure and their families can enjoy a healthy and happy life again.

  • Vision

    To become a global leading science and technology company in advancement of VAD research and development.

  • Mission

    To enable more patients with heart failure and their families to enjoy a healthy and happy life again.

OUR FOUNDERS

OUR FOUNDERS


  • Dr. Chen Chen
    Founder, CEO
    Dr. Chen has been devoted to magnetic levitation technology research and development in artificial heart field and corporate governance since 1996. He was engaged in the R&D of artificial heart Levacor™, which was based on magnetic levitation technology in an American enterprise. He invented the magnetic levitation device and put forward the effective method of multidisciplinary design optimization, therefore being considered the key contributor who made decisive contributions to Levacor’s significance.

    After the establishment of CH Biomedic
    al, Inc., he invented a more advanced magnetic levitation device, led the team to complete several other technological innovations, and successfully developed the CH-VAD® LVAS. Because it's outstanding performance CH-VAD® has become a benchmark for the R&D of the industry. Meanwhile, Dr. Chen has been leading the team and has established Quality Management System (QMS) in compliance with the FDA requirements for the high-risk medical device in design, production and commercialization under PMA category, also built the corresponding quality systems for headquarters and the subsidiary, therefore, making CH Biomedical, Inc. the pioneer among the high-risk medical device companies in developing the full process of quality control in accordance with international standards.

    Dr. Chen graduated from Tsinghua University with a bachelor's degree in thermal engineering, and then received PhD degree from Sichuan University in biomedical engineering. He had been a visiting scholar at the University of Tokyo, and a postdoctoral researcher at Ibaraki University, Japan. Currently, Dr. Chen is a professor at Soochow University, a leading expert member of National Talent Pool Program, and a standing director of the Mechanical Circulation Support Society – Branch of Chinese Society of Biomedical Engineering. Dr. Chen enjoys international reputation in VAD maglev technology with profound understanding of the industry and R&D trend. He also led the team to undertake the NIH grants; led the National 863 projects of "The 11th National Five-Year Plan", and led the international scientific and technological communication and cooperation program of the Ministry of Science and Technology, "The 12th National Five-Year Plan", international science and technology cooperation projects of the Ministry of Science and Technology, and other high-level research projects as well.
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  • Dr. Frank Lin
    Founder, CTO, US Subsidiary President and CEO
    Dr. Lin has over 25 years of technical and managerial experience in the fields of biomedical and aerospace engineering. He served as the Senior Scientist and Principal Staff Engineer at Kriton Medical, the predecessor of HeartWare International (now Medtronic), and led the computational fluid dynamics (CFD) design of the third-generation ventricular assist device HVAD®. Later, he joined Honeywell as the principal aerodynamicist and leader of the global aerodynamics Technical Excellence Team (TET) in the United States. He also served as the chief aerodynamic designer of ECS turbines and compressors for Airbus A350, Boeing 777 and other passenger aircrafts, becoming a well-known expert in the field of aviation fluid mechanics. Dr. Lin co-founded CH Biomedical with Dr. Chen and shoulders full responsibility for the operations of CH Biomedical USA, Inc. Dr. Lin has rich experience in CFD and artificial heart blood flow optimization with 15 turbomachinery and VAD related U.S. and international patents. He translated these experiences into the CH-VAD® design by putting forward the unique and advanced flow path structure and driving the core technology R&D for CH-VAD® in fluid dynamics.

    Dr. Lin graduated from Fudan University with his bachelor's degree in applied mechanics and graduate studies in biofluid mechanics. He attained his master's degree in fluid mechanics and doctoral degree in computational fluid dynamics from the University of Maryland, USA. He is adjunct professor of Fudan University enjoying international reputation in the fluid dynamics field. He is also a member of the International Society for Mechanical Circulatory Support, American Society for Artificial International Organs (served on program committee), American Society of Mechanical Engineers, American Society for Testing and Materials (serving on medical and surgical materials and devices committee), and a life member of Chinese Scholars Association Southern California. He also served as the president and chairman of the Society of Chinese American Aerospace Engineers.
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Milestones

Milestones


2008

  • July 2008 | CH Biomedical, Inc. was founded in Suzhou Industrial Park.
  • October 2008 | Awarded as one of the “Leading Talents of Science and Technology in Suzhou Industrial Park”.

2009

  • June 2009 | The US subsidiary was officially founded.
  • September 2009 | Prototype X1 was successfully developed.
  • November 2009 | Selected as one of the international cooperation projects of the Ministry of Science and Technology.
  • December 2009 | Selected as one of key projects of National High Technology Development Program.

2010

  • January 2010 | Awarded as one of the Gusu Leading Talent Projects by Suzhou Science and Technology Bureau.
  • May 2010 | Selected into “The Planned Science and Technology Projects” by Department of Science and Technology, Jiangsu Province.

2011

  • October 2011 | X2 prototype was completed, and the animal study was conducted.

2012

  • March 2012 | Selected in the National High Technology Development Program.
  • April 2012 | X3 prototype was successfully developed.
  • December 2012 | X4 prototype was completed.

2013

  • January 2013 | The research and development of VAD X5 prototype began.

2014

  • December 2014 | The X5 bump design was completed, and the animal test succeeded.

2015

  • October 2015 | CH-VAD Ventricular Assist Device was officially finalized.

2016

  • January 2016 | Officially started establishing manufacturing Quality Management System.
  • June 2016 | CH-VAD received Fast Track Designation from NMPA for Investigational Medical Devices application.

2017

  • June 2017 | CH-VAD was successfully applied to the first patient, that was the first in human (FIH) implantation after the successful completion of the new medical technology research.
  • July 2017 | Selected as one of The National Key Research and Development Projects governed by Ministry of Science and Technology.

2018

  • November 2018 | The company was invited to present at the 26th annual conference of the International Society for Mechanical Circulatory Support.
  • December 2018 | The company received approval for clinical trial from National Medical Products Administration (NMPA).

2019

  • March 2019 | Clinical trial officially started in China.
  • April 2019 | The research article “Evaluation of in vitro hemolysis and platelet activation of a newly developed maglev LVAD and two clinically used LVADs with human blood” was publish on Artificial Organs 2019 Sep;43(9):870-879. doi: 10.1111/aor.13471.

2020

  • January 2020 | CH-VAD LVAS GLP animal studies were completed by Texas Heart Institute (THI) in the United States.
  • November 2020 | The research article “Computational characterization of flow and blood damage potential of the new maglev CH-VAD pump versus the HVAD and HeartMate II pumps” was published in Artificial Organs, 2020 Oct;43(10):653-662.
  • December 2020 | The company passed the GMP inspection of National Medical Products Administration.

2021

  • November 2021 | CH-VAD LVAS was approved by the National Medical Products Administration (NMPA) for marketing (Registration No.: GXZZ 20213120987)