Sona Nanotech Secures Bentley Biomedical as Regulatory Affairs Advisor for its THT Colorectal Cancer Therapy Development
Halifax, Nova Scotia — (Newsfile Corp. – April 13, 2023) – Sona Nanotech Inc. (CSE: SONA), (OTCQB: SNANF) (the “Company” or “Sona”) is pleased to announce it has engaged Bentley Biomedical Consulting to advise Sona on all regulatory, pre-clinical and clinical study preparations and oversight. Shepard Bentley, President and Principal Consultant will act as lead consultant to Sona. Bentley Biomedical will be responsible for regulatory strategies leading towards Federal Drug Administration (“FDA”) and Health Canada approvals and clearances. “Shep” has more than 15 years of regulatory affairs advisory experience working with emerging and Fortune 100 companies, having most recently advised on the successful granting of an FDA interventional device exemption (“IDE”) and subsequent 501(k) approval for both a photothermal therapy system and the intravenous injection of nanoparticles.
Shep was a founder of Rising Star, a contract manufacturer for digital medical assemblies which was acquired by Standard Industries. He was also a founder of Volcano Therapeutics, Inc. which was acquired by Philips and is a member of the American Society for Quality – Biomedical Section, the Association for Advancement of Medical Instrumentation, and the Regulatory Affairs Professional Society.
“I am excited to begin working with Sona on the development of its targeted hyperthermia therapy (“THT”) and I look forward to working with THT developer Len Pagliaro to take it to the next level as the Company develops pre-clinical studies as it prepares to submit for an IDE and eventual clinical trials for this innovative therapy. THT offers the potential for a significant leap forward for colorectal cancer therapy and understanding the opportunities and demands of the regulatory environment will be key to the Company’s near and medium-term success.” – Shep Bentley, President, Bentley Biomedical Consulting.