CALON'S HISTORY BODES WELL FOR A POSITIVE FUTURE
What is the challenge?
In 2007, Prof Stephen Westaby, an eminent heart surgeon and pioneer of mechanical circulatory support and Prof Marc Clement, a chartered engineer, chartered physicist and serial entrepreneur met and founded Calon Cardio-Technology Ltd. They set off with a mission to develop an Implantable Heart Pump that is best-in-class.
Blood is a very delicate fluid and the application of a mechanical pumping action exposes the blood to potential damage. Damage can originate from the action of moving parts, contact with certain materials, non-uniform flow or by heat generated by the device. While the benefits of the pumps currently approved for implant outweigh their drawbacks, Calon has applied Computational Fluid Dynamics, Multi-Physics Analysis, Materials Science and design and engineering to develop the Calon MiniVAD™. Pre-clinical testing supports the outcomes of the modelling in terms of improved blood handling compared with the heart pumps currently on the market.
In 2020, Calon is poised at the start of a 3.5 year clinical testing process for the MiniVAD™ aimed at achieving approval for the device in Europe (CE Mark) and the USA (FDA).
Based on the clinical experience of leading cardiac surgeon Professor Stephen Westaby, Calon established itself in Swansea under the guidance of Professor Marc Clement in 2007.
Now led by CEO Stuart McConchie, who has unparalleled experience of Ventricular Assist Device development, and chairman Marc Clement, Calon has brought together expertise in mechanical and electrical engineering, design, testing, production and quality control.
Calon has assembled a first class team with world leading expertise in the areas required to deliver the next generation implantable blood pump and associated control system.
Extensive computer modelling, design, engineering and testing (both in vitro and pre-clinical in vivo studies) have demonstrated the Calon MiniVAD™'s potential for reducing blood damage significantly when compared with market released pumps. This improved blood handling is expected to correspond to a reduction in the incidence of adverse events such as stroke, internal bleeding and damage to other organs.
The Technical Team has prepared the MiniVAD™ to be ready for a human clinical study in the UK / Europe and an Early Feasibility Study in the USA. The first clinical implants for human patients are scheduled for late 2021 with initial First-In-Man data expected in 2022. CE Mark approval for Europe is targeted for late 2022 with FDA approval for the USA in late 2023.
Calon's development and testing is carried out in the offices and laboratories of the Institute of Life Science at the University of Swansea in Wales. Pilot production of the MiniVAD™ is located in a nearby purpose-built facility.