Optiscan Imaging (ASX:OIL) has announced the establishment of its US Regional Office in Rochester, Minnesota, and the appointment of two US-based heads of clinical and regulatory affairs.
Ken Lock has been appointed the company’s clinical affairs head. He has extensive experience with the FDA, including clinical strategy development, protocol negotiation, trial submissions and outcome reporting. He worked as a senior director of clinical affairs for both large and small companies, including AGA Medical, St. Jude Medical, Boston Scientific, and vice president of clinical affairs for Stereotaxis and Occlutech.
Nicole Williams has been appointed as the head of regulatory affairs and comes to Optiscan with significant experience in medical devices, sterilisation, and medical device reprocessors at leading companies, including STERIS, Richard Wolf Medical Instruments, and more recently, Sterilucent, where she worked as director of clinical and regulatory affairs.
Optiscan CEO and managing director, Dr Camile Farah, said, “We are delighted to welcome both Ken and Nicole to Optiscan at a pivotal moment in the Company’s evolution as we grow our US operation and cement our presence in the Minnesota medtech landscape. Both Ken and Nicole bring a wealth of relevant and critical experience and expertise to support the Company’s expansion in the US as we roll out our portfolio of new clinical devices. Both will play key roles leading our clinical and regulatory portfolios as the Company establishes clinical studies in the US and progresses its regulatory submissions to satisfy the FDA before clinical deployment.”
Dr Farah added, “The Company has taken up premises at the Minnesota BioBusiness Center that serves as an incubator for private research and development companies to promote biotechnology development and research in the Rochester area. We are confident that our presence at the Minnesota BioBusiness Center and the appointment of new Heads of Clinical and Regulatory Affairs will buttress our US strategy, as we work toward securing US regulatory approval. The complexity of the FDA regulatory pathway and that of our device/drug combination product necessitates that the Company has local experts to support both the clinical and regulatory effort required to secure appropriate approvals for our precision surgery and digital pathology solutions. This process will be ongoing as we rollout various hardware and software clinical solutions and continue to innovate.”
