Management Team
Biofisica’s Management Team has extensive experience in the medical device arena and has worked well together for many years, both within Biofisica and at other corporations.
The team has worked closely together over the course of the last seven years to build Biofisica from a conceptual idea to a viable corporate entity that is now launching a product and technology platform that could revolutionize the wound care market. It manages a global network of over 70 consultants, suppliers, manufacturers, and partners. The team created this network by carefully selecting from among the most talented and successful companies, individuals, and agencies from around the world; selecting those entities with which they had prior experience. Partnering with these key entities has enabled the Biofisica core team to leverage its expertise thus expediting the development and launch process. This has resulted in providing maximum value and return for the investment placed into the company.
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Rick Hillstead Ph.D., FAHA, – Chief Executive Officer
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Rick Hillstead joined Biofisica in 2009 to lead the the Company. He has been actively involved in the design and development of medical devices since 1983. Most recently, he was a founding member of The Innovation Factory (TIF) and a principal partner in Accuitive Medical Ventures I and II . At TIF he served as Chief Science Officer and was primarily responsible for technical due diligence and deal structure in areas of Interventional Cardiology and Orthopaedics. He is a past Chairman of Cerebral Vascular Applications, Inc. and a current director for Epitek Inc. Prior to TIF, he held several progressive, product research and development positions with Cordis Corporation (Johnson & Johnson) and then directed new technology development for Novoste Corporation. He is an inventor named on more than sixty issued U.S. patents and patent applications and dozens of international patents. His intellectual property has been referenced in over seventeen hundred issued U.S. patents and he has been directly responsible for the development of numerous, commercially successful medical devices. Dr. Hillstead holds M.B.A. and undergraduate degrees from Nova Southeastern University and a Ph.D. in Business Administration from Southwest University. He is a Fellow of the American Heart Association (FAHA) on the Council of Clinical Cardiology and the council on Nutrition, Physical Activity, and Metabolism. Rick can be contacted at rick@hillstead.com. |
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Rafael V. Andino – President
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Mr. Andino founded Biofisica, Inc. in 1999 with the vision of developing breakthrough products to expedite wound healing and regeneration of connective tissue in humans. Mr. Andino has successfully led the biotechnology company through five rounds of fundraising. In late 2006, Mr. Andino and his management team launched the first wound care product of its kind, POSiFECT® , in the United Kingdom. The product will be subsequently marketed throughout Europe in 2007 and beyond. In addition, the company has begun early stage submission and filing processes for POSiFECT® with the FDA in the United States.
Prior to founding Biofisica, Mr. Andino was a research & development director and senior project manager for CIBA Vision, a leading contact lens and lens care product company. CIBA Vision is a business unit of Novartis AG, one of the largest
healthcare companies in the world.
Mr. Andino received his bachelor’s degree in mechanical engineering from the Georgia Institute of Technology, a Masters of Science in biomedical engineering from the University of Alabama and an MBA from Mercer University.
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Tracy A. Weldon - Vice President, Operations and Regulatory Affairs
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Mrs. Tracy A. Weldon has been developing high impact medical devices for more than 10 years. Tracy joined Biofisica in July 2001 to oversee the research and development efforts of the company’s first product offering, POSiFECT®, and to set-up its manufacturing processes.
Under her direction, the company received its ISO 13485 certification in 2005 and the CE Mark in late 2006 allowing for the sell of POSiFECT® in Europe. She continues to closely manage both the company’s quality management system and Avail Medical, the contract manufacturer. Currently, she is leading the effort for obtaining marketing clearance from the FDA to enable the sale of POSiFECT® in the United States.
Prior to Biofisica, Mrs. Weldon worked for CIBA Vision where she was the project leader for the development of various new manufacturing technologies for both class II and III medical devices. In addition, she participated on several multinational project teams which brought new breakthrough devices to market, such as the world’s first true extended wear contact lens. Mrs. Weldon has a Bachelor of Science degree in Chemistry from Georgia Southwestern College and a Master of
Science in Management of Technology from the Georgia Institute of Technology. She has training and application in ISO 13485, Design Control, CFR Title 21-Part 58, and medical device regulatory compliance.
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Kate Crow - Operations Director - Biofisica (UK) Ltd
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Mrs Kate Crow has held senior management positions for over 14 years with responsibility for internal company operations. These have included finance, project monitoring, personnel and staff development, information technology and logistics. Kate has worked in a diverse range of industry sectors such as consulting actuaries, software houses and training providers.
More recently Kate has built her own consultancy providing data management and process support mainly to the pharmaceutical sector. Projects such as sales force management, vigilance systems, post marketing patients programs and asset management have been undertaken. Kate now joins Biofisica to ensure that the company has a solid foundation to support the product launch and the growth of the company into the future.
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Fred Baumbach – Chief Financial Officer
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Mr. Baumbach has 30 years of senior financial and operational management experience, primarily in service and technology companies. His experience ranges from $1billion companies to pre revenue start-ups, as well as 8 years as a CPA with Ernst & Young which included 3 years on E&Y’s national office accounting and auditing staff.
Fred’s private company experience includes serving as the senior financial executive for early stage technology ventures (Brickstream Corporation, Silverpop Systems) as well as holding senior financial positions at other technology and service companies (Cox Enterprises, Norrell Health Care, Lynk Systems). Fred also owned a software company for 4 years which sold software to homebuilders in the Atlanta market and nationwide. As a partner at TechCFO, he consults with numerous early stage bio science and technology companies. He has helped secure multiple rounds of both equity and debt financing for his previous companies and clients.
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