949 315 7157

 

We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.

We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies. Often times working with our partners we can help our clients with stent, delivery system & FIH clinical trials also.

We have the unique talent of manufacturing, consulting, and strategizing services in the area of medical devices, especially transcatheter heart valves. Our specialty is customizing the solutions required based on the device and not recommending the whole “nine yards” for any device, thus saving our clients’ time and resources.

Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We come with an in-depth knowledge with many years of experience and offer customized solutions to each of our clients on an as needed basis with the utmost integrity.

We are a team of well-qualified PhD scientists, tissue engineers, delivery system and stent experts, and skilled technicians that will seem like a natural extension of your own R&D department and operations staff. Our associates work with your company at different levels to identify and recommend strategies which help your company in saving time and cost.