David McNally, president and CEO of Titan, said, “We are pleased to announce our expanded engagement of CDP, and welcome them as a shareholder. Since engaging with them only a few months ago, their highly qualified engineers have leveraged their deep domain experience while demonstrating an ability to understand the exacting requirements of Titan’s robotic surgical system. CDP engineers have improved Titan’s multi-articulating instrument designs with the objective of demonstrating performance improvements, along with the potential for reductions in the target costs of commercial devices. The location of CDP’s U.S. office in Raleigh, North Carolina is ideally situated in close proximity to our planned Chapel Hill, North Carolina facility. Yet, CDP’s corporate culture and level of integration with their headquarters in Cambridge, U.K., allows Titan to draw upon CDP’s depth of experience and breadth of capabilities. Based on early initial indications, and once sufficient additional financing is secured, we envision an expanding role for CDP in the development and manufacturing of surgical instruments and accessories.”
Jez Clements, partner at CDP, said, “We share Titan’s vision for improving patient outcomes with their unique single-port robotic surgical system. We believe the core system architecture to be sound, and once adequate funding is secured, we are confident in the ability of Titan’s management team to resume the development of its single-port robotic system. We are delighted to have the opportunity to apply our deep medical instrument product development experience. It is for these reasons that we are participating with an equity position in the company.”
Titan Medical recently received ISO 13485 certification from a European Notified Body. ISO 13485 certification is the most common path to meet the QMS medical device requirements in the European Union, Canada and Australia, and serves as the basis for QMS compliance in other countries including Japan, Korea and Brazil.
In addition to the ISO certification Titan Medical also announced the achievement of its two other previously stated milestones during the fourth quarter of 2019:
- The company obtained the final independent report from its validation testing of system safety and usability for the intended users and use environments under simulated robotic manipulation exercises, which are intended to replicate essential surgical tasks.
- The company completed the robotic system setup user manual for operating room staff and surgeon operation of the surgeon workstation, patient cart, instruments and accessories.