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.
David Regan, CEO of Sona, commented, "Bentley Biomedical is one of the few regulatory consultants with direct experience achieving regulatory approvals for systems involving both nanoparticles and photothermal therapy. Shep's experience will be important for Sona as we establish our pre-clinical study designs, medical device engineering requirements and scaled gold nanorod manufacturing approach."
David Regan, CEO
About Sona Nanotech Inc.
Sona Nanotech is a nanotechnology life sciences firm that has developed multiple proprietary methods for the manufacture of various types of gold nanoparticles. The principal business carried out and intended to be continued by Sona is the development and application of its proprietary technologies for use in multiplex diagnostic testing platforms that will improve performance over existing tests in the market. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. It is expected that Sona's gold nanotechnologies may be adapted for use in applications, as a safe and effective delivery system for multiple medical treatments, subject to the approval of various regulatory boards, including Health Canada and the FDA.
About Siva Therapeutics, Inc.
Siva Therapeutics Inc is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by SivaRods™ gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (44°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. The size, shape, and surface chemistry of the nanorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments. Siva's initial clinical targets include colorectal, esophageal, and pancreatic cancers.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding possible submissions seeking FDA and Health Canada approvals and clearances for Sona and Siva's products under development. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona and Siva may not be able to successfully secure animal and human clinical studies, obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital or develop the envisioned therapy. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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