2009 Précis of bioZhena Corporation

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    2009 Précis of bioZhena Corporation - Presentation Transcript

    1. Précis of bioZhena Corporation Company and Target Markets. Use of Funds and 5-Year Projections. Key People and Management Team Biographies. Company Description: Medical device and informatics company with disruptive technology for the very large women’s health markets, focused on female reproductive health including conception, birth control, ovulation, and screening for cancer and other conditions of the female reproductive system. Our core product - the Ovulona™ - is not just another entrant for the infertility market segment. It offers two big disruptions: birth control feasibility, and fetal sex pre-selection feasibility - both unavailable and unimaginable in the industry. The real fundamental disruption is the Ovulograph™, which provides to the physicians and to the health system an easy, yet highly informative, patients' profiling and longitudinal monitoring. We are well past the research stage: Our first consumer product manufacturing for launch is projected for month 7 after funding, whereas a predicate prototype has previously received the FDA 510(k) certification with proof of concept clinical studies. The first tranche of financing will fund repackaging of the clinical prototype of the Ovulona biosensor into the marketable product. The Ovulona is positioned as a life-long routinely used tool for health awareness, in a class of its own; far more than a conceptive aid. Photograph of pre-production model prototype of our core product - the Ovulona™ - with output for optional data transfer into the Ovulograph™ for medical professionals Our proprietary technology represents a totally new diagnostic modality for reproductive medicine and women’s health care. It uses a sensor that records, interprets (with an instant display – “fertile” or “not”), and stores data that chart reproductive cycles in terms of a previously unexplored but well understood biological process. Our core product will tell the user in plain language whether today is one of the 3 days that she can become pregnant, and it saves and makes the underlying folliculogenesis profile data available for optional use by physicians. This is a fundamental breakthrough. Target Markets: Virtually all women worldwide - from post-adolescence through menopause - seek solutions for one or more of the following health issues that our sensor addresses: Sex education tool. Self-help conception aid. Clinical infertility tool. Birth control aid, especially for those using Fertility Awareness Based Methods of birth control (FAM or NFP). Hormone replacement therapy (HRT) management. Premenstrual syndrome (PMS/PMDD) management. Disease pathology detection, i.e., cervical cancer screening. Aid in gender pre-selection & enhance the accuracy of expected delivery due dates (EDD). Early pregnancy detection. Use of Funds: The project is to repackage the proprietary technology into a manufacturability-designed and marketable Ovulona™ product. A contract has been negotiated with a Colorado engineering and contract manufacturing firm well suited for the job. Financial scenario V3 summary excerpts (only US marketing considered in this baseline): Projected US $ numbers in baseline scenario Year 1 Year 2 Year 3 Year 4 Year 5 Revenues 705,000 15,900,000 51,700,000 98,000,000 186,400,000 EBITDA (4,800,000) (3,200,000) 5,200,000 15,900,000 39,000,000 bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO vaclavkirsner@yahoo.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 1 of 5
    2. Year 1 Raise Initial seed capital of $1.2 million Series A round 1st tranche of $3.25 million in Month 6 Series A round 2nd tranche of $3.25 million in Month 10 Total of $7.7 million in Year 1 Year 2 Raise Series B round 1st tranche of $2.25 million in Month 4 Series B round 2nd tranche of $2.25 million in Month 8 Total of $4.5 million in Year 2 Cumulative Raise = $12.2 million Inventory: Initial stocking of $750k for launch, represents ~ 3 months of Manufacturing costs After launch inventory on-hand ~ 45 days. Accounts Receivable Calculated @ Days Sales Outstanding @ 60 days Cash Flow Positive: Positive cash flow from operations occurs in YEAR 3 Cost of Sales: Manufacturing Cost (3rd party) projected @ $50/unit Warranty Cost estimated @ 3% of revenue. Product Liability insurance estimated @ .15/unit Summary of bioZhena start-up operations plan In addition to our significant patent portfolio, we shall keep the electronic design aspect of the pre-production engineering a closely held secret. The manufacturing contractor will receive the chip (but not its design), and will incorporate that chip in the plastic body of the device in accordance with FDA regulatory controls. Should any competitor or any other party wish to buy out the manufacturing contractor or their knowledge of the bioZhena technology, the contractor will not have the design of the chip, only its input and output connections, and functional description. The chip will be obfuscated, protected against reverse engineering. This is perfectly practical with the programmable logic devices (PLDs), which are best suited for the implementation of the Ovulona product. The programming is done with a development kit that comes with the CPLD or FPGA units from the supplier, and it provides for an easy debugging, upgrading and/or possible transformation into an ASIC later on (for large volumes of product). Any changes are only in programming, not in manufacturability. Here is the planned 7 months timeline and minimum budget, modeled on the manufacturing contractor quote, with pre-production engineering in the first two phases. Phase Description Months Costs($000) 1 Engineering/Design of product 2 72 2 Ovulona Product Prototype Build -10 units 1 11 3 Ovulona Product Build – 25 - 50 units 2 25 4 Pilot Run of 100 units, 50 days ($310 per unit) or 31 Pilot Run of 500 units, 70 days ($218 per unit) 2 109 Documentation (per regulatory requirements) included above 23 Total contract cost estimate (500+ units) 240 Total budget estimate with 20% padding 288 Total budget estimate with 50% padding 360 Key People and Management Team Biographies Board of Directors Francesca Collopy BS (Chemistry) MBA is Vice President at Abbott Diagnostics, International Commercial Operations. She has been with Abbott since 1979, in marketing, sales, business development, R&D, training, technical support and general management. She has a track bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO vaclavkirsner@yahoo.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 2 of 5
    3. record of identifying new opportunities, acquiring and developing products, and formulating and executing international commercial strategies to achieve global business growth. She has developed and built multiple Abbott organizations, including a sales force of 750 managers and representatives, and has been active in the women’s healthcare arena. She has specific infertility diagnosis and treatment experience, and considers the bioZhena technology superior to existing products. Jean-Francois Grenier MD DA brings his extensive International and women’s healthcare know-how. He held leading positions at Bristol-Myers Squibb in Canada, and with the German Schering Group, the global leader in birth control. At Schering, he was successively appointed as Vice President, Scientific Affairs of the Canadian subsidiary Berlex, Director of Marketing & Medical Affairs for Asia & Middle East, President of Leiras Oy/Schering Oy and Board Member of a number of joint ventures in Finland, and President of Schering SAS in France. Since 2007, he is advising the pharmaceutical industry and venture capital funds through PharmExpand, which he founded in Brussels, Belgium. John A. Norris JD MBA is a former Deputy Commissioner and COO of the US FDA, where he led the first successful FDA reform from 1984 to 1988 with Commissioner Dr. Frank Young. He has had considerable diagnostics and pharmaceuticals experience as an executive, lawyer, board member, regulator, Harvard Faculty member, and consultant in healthcare, life sciences, IT law and IT software. He has had four of the ten largest pharmaceutical companies as his clients, and others as employers. He has consulted with numerous business and government leaders, including US President Ronald Reagan, HHS Secretary Margaret Heckler, HHS Secretary Dr. Bowen, Pfizer President Bill Steere, Merck President Ray Gilmartin, and Partners Healthcare President Dr. Sam Thier. He has raised more than two billion dollars over the years, including the capital for a pioneering laser eye surgery inventor company in the 1990s. Board of Advisors John J. Sciarra MD PhD served as the Thomas J. Watkins Professor and Chairman of the Department of Obstetrics and Gynecology of Northwestern University Medical School and Northwestern Memorial Hospital from 1974-2003. He is presently Professor and Chairman Emeritus of Obstetrics and Gynecology at Northwestern. Dr. Sciarra served as president of the International Federation of Gynecology and Obstetrics (FIGO), to further maternal and child health worldwide, and as both a member and chairman of the Scientific and Ethical Review Group of the World Health Organization (WHO) Special Program of Research, Development and Research Training in Human Reproduction. He is the treasurer of the new Society of Family Planning, and has served as chairman of the American College of Obstetricians and Gynecologists (ACOG) Committee on International Affairs, as president of the American Association of Maternal and Neonatal Health, Secretary/Treasurer and President of the Association of Professors of Gynecology and Obstetrics (APGO), etc., etc. Lee P. Shulman MD FACMG FACOG is the Anna Ross Lapham Professor in Obstetrics and Gynecology and Chief of the Division of Reproductive Genetics in the Department of Obstetrics and Gynecology at the Feinberg School of Medicine at Northwestern University in Chicago. He is a member of numerous organizations that pertain to the health and care of women, has been recognized regionally and nationally, and was included in the list of “Top Doctors” in Chicago and the United States. He serves on various advisory boards and is currently the Chair of the Board of Trustees of the Central Association of Obstetricians and Gynecologists and a member of other reproductive health bodies. His major research focus is in reproductive genetics, birth control, botanical interventions in women’s health, and medical education. Patricia M. McShane MD is a renowned reproductive endocrinologist (REI) with 18 years experience as medical director of a leading ART center that she founded in 1988. She shaped the clinical, technical and business aspects of the program, growing from a start-up to one of the largest and most successful IVF centers in the world. She is experienced with broader bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO vaclavkirsner@yahoo.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 3 of 5
    4. business aspect as member of the board of directors of Integramed, a publicly traded infertility practice management company, and part time Vice President of Medical Affairs. She is an experienced public speaker, in regional and national lecturing (ACOG and ASRM), and media appearances on radio (International CNN) and national television (Today Show; Good Morning America). She served as the chair of the Council of Physicians and Scientists of Integramed, chair of the Women’s Council of the American Society of Reproductive Medicine, and president of the Boston Fertility Society. Licensed in Colorado, Massachusetts, Rhode Island and New Hampshire, she is an Assistant Professor at the University of Colorado at Denver and UC Health Sciences Center, Section of Advanced Reproductive Medicine (assisted reproduction and menopause). Jacqueline N. Gutmann MD is a Clinical Associate Professor of Obstetrics and Gynecology, Jefferson Medical College, Thomas Jefferson University Hospital, and a physician at Northern Fertility and Reproductive Associates. She is board certified in Obstetrics and Gynecology and Reproductive Endocrinology and Infertility, and was a Robert Wood Johnson Clinical Scholar and an attending physician at the Yale-New Haven Hospital. She has been with the Women’s Institute for Fertility, Endocrinology and Menopause for almost 15 years. She is active in several local, national and international professional organizations, and has published numerous articles on infertility, polycystic ovarian syndrome, assisted reproductive technology, and complementary and alternative medicine in fertility care. Her research has been presented in a variety of national and international forums. She currently serves on the medical advisory board of the American Fertility Association and Philadelphia RESOLVE. Management team Raz Itzhaki BA (Accountancy & Economics) MBA LLB (Law) CPA has held CFO positions with high end consumer products companies and brings skills in corporate restructuring, shaping strategy, fund raising, M&A transactions, negotiation of contracts, cash management, financial modeling and analysis and dealing with board of directors, investors and media relations. He is expert in US GAAP, SEC, SOX, IFRS, financials, accounting, tax considerations, and corporate legal issues, and has extensive knowledge of retail and consumer markets and business development. His background includes successful management in the U.S, Europe, Middle East and the Far East, with companies in the Retail/Consumer, Distribution, High-Tech and Feminine Hygiene arenas. Ted Dimas BS (Biology) MBA has a track record of commercializing and bringing to market women’s health devices with Cooper Surgical, FEI Women’s Health and Organon (now Schering Plough). He brings sales and marketing experience working with successful start up ventures at FEI Women’s Health and Rexton Interactive. He was one of an executive team recruited in 2003 from Organon to the FEI Women’s Health start up, which three years later was sold to Barr Laboratories for $280 million. He successfully launched new products through channel marketing strategies, which accelerated market penetration at both Cooper Surgical and FEI Women’s Health. Mr. Dimas holds a Bachelor of Science in Biology from the University of Nebraska and a Master of Business Administration from the New York Institute of Technology with an emphasis in Finance and Marketing. Lewis Ward BS (Microbiology) is a seasoned consultant to medical product manufacturers, specializing in FDA compliance and ISO 9001 implementation. His corporate experience includes Vice President positions with three Colorado medical device companies: HealthWatch Technologies, where he established a manufacturing operation; Cybermedic, where he was responsible for engineering design and sustaining engineering, technical service, quality assurance, facilities, manufacturing and materials management; and Valleylab, where he managed company product liability legal issues and a quality assurance program, and was involved in all aspects of product manufacturing. Mr. Ward started his quality control management career with Travenol Laboratories in Arkansas where he progressed up through the organization to the management of a 300-person quality organization including 38 professionals on a three-shift operation. bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO vaclavkirsner@yahoo.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 4 of 5
    5. Michael D. Halleck BSEE is the President of our product manufacturing development contractor company, HWI Manufacturing. HWI has been involved with the custom development of nearly a hundred different products in industries including medical and food, telecommunications, industrial controls, and computer peripherals, and HWI engineers have earned over a hundred patents between them for HWI clients. Before joining HWI in 1990, he was an electrical engineer working in the robotics, factory automation and systems integration industry for Monroe Automation, Inc. HWI Manufacturing (Halleck-Willard, Inc.) was founded in Frederick, Colorado in 1984 by Mr. Halleck’s father, the inventor of the TENS device for pain treatment. Vaclav Kirsner PhD is the founder CEO and Chairman. He is a seasoned scientist- entrepreneur, the inventor and developer of the bioZhena technology. He was a Senior Research Scientist at the pharmaceutical firm of Wellcome Research Laboratories of the Glaxo Wellcome Group (England), where he specialized in exploratory research and interdisciplinary biomedical applications. He was also CEO/Investor Relations Officer for Checkpoint Genetics, a California holding corporation over a biotechnology operating company. Based on objective tests of the early prototypes by independent medical researchers, he has made an unwavering commitment to the development of the ovulographic folliculogenesis-tracking technology and the associated intellectual property, including the business plan and the management team with which to guarantee successful implementation of the plan. Having invented the technology originally to solve a family problem (in collaboration with his biomedical-scientist wife), he has extensive experience with in vivo electronics and start-up venture development in the area of fertility status monitoring and related aspects of women’s healthcare. He earned his Ph.D. in physical chemistry-electrochemistry from the University of Southampton, England and his Masters degree from Charles University in Prague, Czechoslovakia (now Czech Republic). The Ovulona™ is positioned to be a product that practically every woman will want to use. The woman of the 21st Century is envisaged to become accustomed to using her daily Ovulona self-check ---- about as routinely as she is using her toothbrush. bioZhena Corporation 83 Davis Ranch Road, P.O. Box 122, Bellvue, Colorado 80512, USA Vaclav Kirsner, Ph.D., Founder CEO vaclavkirsner@yahoo.com 970-484-1272 Copyright Vaclav Kirsner, bioZhena Corporation Page 5 of 5
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