Regenesis Biomedical, Inc. was founded in 1996 on a technology platform conceived and developed by Dr. Frank George and Dr. Mary Ritz. This technology, called Cell proliferation Induction, involves the use of a physical stimulus, rather than the traditional pharmacological approach, to induce a specific cascade of cellular responses leading to cell replication and regeneration. Following initial consultations with FDA, regulatory experts and focus group participants, Drs. Ritz and George initially focused the Company’s development efforts on a medical device to fill the existing void in effective chronic wound healing, anticipating a growing human need and substantial market potential.
As Co-Founder, Dr. Ritz successfully served as the Company’s President and CEO for over six years, then as the Company’s President until 2008. During her tenure with Regenesis, she lead funding efforts to raise $600, 000 in philanthropic funds to support early technology research and more than $8M USD in equity based financing, even in the most challenging venture capital markets. She successfully steered the Company through proof of concept, various clinical studies and trials, and FDA clearance of the Company’s first product. During her leadership of the Company, Regenesis developed its current sales, marketing and distribution strategies and hired a nationwide direct sales force by 2006. Sales revenues doubled from 2004 to 2005, tripled from 2005 to 2006, and experienced 60% growth from 2006 to 2007.
Dr. Ritz worked with key managers and top industry consultants to develop comprehensive pricing and reimbursement strategies, and successfully obtained the first Medicare code for the Company’s first product. Previously, she was a co-founder and CEO of Amethyst Technologies, a medical R&D company, where she took that company from inception to cash positive, raising over $3M USD in grant and debt financing in the process. She also has over twenty years of management and research experience, including six years spent at the National Institute of Health, where she received a number of prestigious awards and conducted some of the most highly cited research in her field. In addition, she has many years of experience developing networks and relationships within key industry and regulatory arenas, including the National Institutes of Health, the FDA and CMS.
Serving as Chief Science and Technology Officer, Dr George developed the Company’s technology platform. He creatively integrated cell biology results and engineering design factors to lead the original group of innovators in optimizing the stimulus parameters to most effectively target key cells in the skin necessary for initiating and progressing wound healing. In addition, using his broad array of skills related to laboratory science as well as electrical engineering, Dr. George worked with engineering experts to create a medical device that used only a single push button control switch. This meant, that for the first time in the wound healing industry, a device is so simple to use that patients can easily operate it themselves at home. Taking a very innovative approach to building Intellectual Property value for Regenesis, Dr. George worked with some of the best patent law firms to develop an IP portfolio that includes claims related to both device design and molecular effects of the technology. Dr. George has over 30 years of scientific research and R&D management experience in industry, government and academia. He has had the privilege of serving as a Senior Fellow and Chief of Behavioral and Biochemical Genetics at the National Institutes of Health and serving on several grant review panels for the NIH and other worldwide agencies. He has received more than $6.3M USD in basic research, clinical research and educational grant funding. He has published over 100 abstracts and nearly 100 peer reviewed manuscripts and has also contributed to several television broadcasts and video productions for which he has received a number of prestigious industry awards, and is an effective communicator with nonscientific audiences. Dr. George is listed in Who’s Who in America, Who’s Who in the World, Who’s Who in Medicine and health Care, and Who’s Who in Science and Engineering.