Ocumetics Announces Commencement of Regulatory Strategy Project with Clinical Research Consultants, Inc.
Calgary, Alberta - TheNewswire – February 3, 2022 - Ocumetics Technology Corp. (“Ocumetics”) (TSXV:OTC) is pleased to announce the commencement of its project with Clinical Research Consultants, Inc. (“CRC”) of Cincinnati, Ohio.
CRC and Ocumetics have entered into a consulting agreement whereby CRC will provide general regulatory, clinical, data management, statistical, quality and technical consulting services to Ocumetics to develop, support and implement the regulatory strategy for the Bionic Lens™.
“Phase 1 of our work with Dr. Barbara Fant and her team at CRC involves developing and implementing a regulatory strategy for the Bionic Lens™ in Canada, USA and other countries we identify,” said Dr. Mark Lee, President & CEO of Ocumetics. “Dr. Fant’s experience, guidance and contacts have already been invaluable as we prepare to commence Stage 2 of our preclinical studies on February 25, 2022,” adds Dr. Lee.
Dr Garth Webb, Founder and Chief Scientific Officer of Ocumetics, commented, “Dr. Fant is an absolutely phenomenal talent in regulatory affairs. The sheer depth of knowledge of Dr. Fant and her team is eclipsed only by her caring and insightful advice.”
“We at CRC are honored to be working with Ocumetics to bring its novel technology to the marketplace and help patients improve their vision,” said Dr. Barbara Fant, President and CEO of CRC. “Ocumetics has assembled a world class team that enables CRC to continue fulfilling its mission of working collaboratively with innovators to bring visionary excellence to ophthalmology.”
About Ocumetics
Ocumetics Technology Corp. (TSXV:“OTC”) is a Canadian research and product development company that specializes in adaptive lens designs. Ocumetics is in the preclinical study stage of a game-changing technology for the ophthalmic industry - the Bionic Lens. The Bionic Lens is an expandable intraocular lens that fits within the natural lens compartment of the eye potentially to eliminate the need for corrective lenses. It is designed to allow the eye’s natural muscle activity to shift focus from distance to near.
About Clinical Research Consultants, Inc.
Clinical Research Consultants, Inc. (“CRC”) was established in 1992 to provide assistance in the design, placement, conduct, and reporting of clinical research studies necessary to support the development of pharmaceutical products and medical devices. Since then, CRC has developed into one of the premier independent consulting firms that provide regulatory, clinical, and quality system consulting services to assist medical device, diagnostic, and pharmaceutical companies in obtaining FDA approvals, and maintaining compliance with FDA regulations before and after approval. Core areas of expertise include ophthalmic, orthopedic, surgical, and diagnostic medical devices. CRC’s client base includes established U.S. and international companies, as well as start-up and incubator companies developing novel medical devices. CRC has successfully filed over a hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. CRC is one of the premier independent consulting firms that provide regulatory, clinical and quality system consulting services to assist medical device, diagnostic, and pharmaceutical companies in obtaining FDA approvals, and maintaining compliance with FDA regulations before and after approval. www.crc-regulatory.com
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dr. Mark Lee
President and CEO
(604) 832-6052
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements include, but are not limited to, statements with respect to the commencement, timing and scope of the clinical trial program outlined above and that it will be conducted as expected. Forward-looking statements are necessarily based upon a number of estimates and assumptions 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. Such factors include but are not limited to: operational matters, historical trends, current conditions and expected future developments, access to financing as well as other considerations that are believed to be appropriate in the circumstances. 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. The Corporation 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.