INVOBioscience A Unique New Fertility Treatment June 2009
Forward Looking Statement This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
Stock Overview (as of 6/18/09) Exchange: OTC BB Symbol: IVOB Recent Price: $.15 Market Cap: $8.2M 52 Week Range: $.05- $5.50 Shares Outstanding: 53.7 M Approximate Float: 14 M
Introduction • INVO Bioscience went public via a reverse merger in December 2008. INVO began trading under the symbol IVOB in February 2009. • INVO is introducing a new device for Intra-vaginal culture to the infertility market. • This is a fertility treatment similar to In-vitro Fertilization (IVF) but simpler to perform and can be made more available to the infertile population worldwide reaching patients that cannot currently be treated by traditional IVF. • The procedure may be provided without an IVF center and therefore can be available in many more locations than IVF. INVO is well positioned to capture a significant share of the unmet market needs.
Un-addressed Infertility • 150 million infertile couples worldwide (ESHRE 2007) • 1 million technological procedures that help infertile couples to conceive have been performed worldwide • Less than .5% are treated with and average of 2+ cycles per couple • Over 149 million infertile couples go untreated, this is the population INVO is targeting • Reasons for lack of treatment • Cost • Availability • Awareness
INVO Bioscience Goal Reach the unmet needs of the Infertility population through providing • A unique new fertility treatment • A geographically available treatment • A less expensive treatment • A more natural treatment
Market Strategy • INVO Bioscience is not competing with IVF • INVO allows IVF clinics to open low cost INVO centers to expand their geographical reach, increase their business and treat infertile couples who could not be treated before • Lower cost will allow patients to go directly to INVO vs. starting with IUI treatment ( low efficacy) • Offers a couple a more natural option to traditional IVF
INVO Procedure • During the INVO procedure fertilization and embryo development occur inside the woman’s vaginal cavity in a disposable single use device which is called the INVOcell. (This device holds the eggs, sperm and culture medium) • In the INVO procedure either mild ovarian stimulation or no ovarian stimulation are used. Using a mild stimulation protocol, 1-10 oocytes are retrieved under light sedation. • The INVOcell is then placed in the patient’s vaginal cavity for an incubation period of 3 days. After 3 days, the patient returns to the physician’s office where the INVOcell is removed. • The protective outer vessel of the INVOcell is discarded and the inner vessel is placed in INVO Bioscience’s patented Holding Block in a vertical position for 15 minutes. The embryos can be directly viewed from the micro chamber in the holding block by using a microscope. • Then the two potential best embryos are selected and loaded directly from the device with a transfer catheter and inserted back into the women. INVO procedures may be done in a fertility specialists office or satellite/physician center
INVOcell Illustration of the INVO procedure INVO Process
Advantages Similar efficacy to IVF • Over 800 published cases where INVO was equivalent to IVF Lower cost to achieve pregnancy • Low stimulation (lower drug costs) • No IVF overhead costs in satellite office centers • Potentially lower embryologist costs • INVO center equipment set –up $30,000, vs. $500,000 IVF • No need for stable power supply and clean lab maintenance.
Advantages Cont. Greater geographic availability • Offers an effective fertility treatment to the world through independent or satellite INVO centers Greater patient involvement • More natural incubation
Cost Per Pregnancy Europe Based on efficacy rates/cycles/cost • Intra-uterine insemination (IUI) =$12,000 per pregnancy (40 % indications) • INVO = $13,888 per pregnancy (90% of indication) • IVF = $21,354 per pregnancy • Cost Saving to payers and providers $7000 per pregnancy INVO vs. IVF
Current Regulatory Status • ISO 13485 certified and CE Mark • FDA • Required an IDE and clinical study • File of 510K submission planned 3rd quarter 2010
Sales Strategy • Physician Sales through Distributors- Current strategy in Canada, Austria, Germany, Switzerland and Italy • Direct Sales to Physicians and IVF centers-Current strategy in Africa, • INVO Centers, – Current strategy in Middle East, and Latin America • Strong profit margins worldwide
International Activities INVO Centers • TURKEY ..Initial INVO procedure performed in October 2008 • Middle East …INVO centers opening first quarter 2009 (8) • Austria…Initial INVO procedure performed in October 2008 • Canadian approval obtained in January 2009, launch planned for summer 2009 • In May 2009, INVO announced that the first South American INVO Center had officially opened in Cali, Colombia, and six existing In-Vitro Fertilization (IVF) centers located in Armenia, Cúcuta, Bogotá, Ibagué, Medellin and Ubate, Colombia are also now offering the INVO procedure
Market Opportunity The INVOcell and INVO process is a multi billion dollar business if INVO Bioscience penetrates 5% of the unmet need.
Intellectual Property The INVOcell device was specially developed and manufactured to optimize the ease of use and effectiveness of the procedure at an affordable price. This product development process has resulted in 5 active patents world wide covering the INVOcell device, the INVO process and the Holding Block.
Funding • INVO Biosciences has raised $1.3 M to date and is a public company through a reverse merger as of December 5th. • We are currently looking for $5 million in PIPE transactions to expand the rate of launch throughout the world and bring INVO Bioscience to break even position. • The funds will be used to expand the sales and training efforts of the company, to launch the product worldwide, perform a US clinical study to obtain 510(k) clearance and for general operations to get to profitability
Management Team • Claude Ranoux, M.D., M.S,President and Chief Scientist, has more than 30 years of experience in the treatment of infertility; he is the inventor and developer of INVO™ procedure and INVOcell device. • Kathleen Karloff, Chief Executive Officer has over 25 years of experience in medical device manufacturing, clinical operations, regulatory affairs and quality systems with 13 years at Boston Scientific and 10 years on the senior management teams of start-up organizations. • Robert Bowdring- CFO has a strong history in senior financial management with over 25 years experience as CFO, VP Finance and Controller. Rob has been in both public and private manufacturing and service companies during his career primarily in start up to midsize companies. • Nancy Harrington, Vice President of Clinical Services, is an accomplished senior executive with over twenty years of healthcare and pharmaceutical experience in reproductive health. Ms Harrington was the Vice President of Reproductive Health Services at IVP Care providing services to infertility patients nationwide. • Jill Wollins PhD, Regulatory Consultant, Jill Wollins, Ph.D. has more than twenty years of experience in Global Clinical and Regulatory Affairs in the medical device and biotech industry. She holds a Ph.D. in Biomedical Engineering and received US Regulatory Affairs Certification (RAC) in 1999. She has worked successfully with the FDA to bring class II and III devices to market in the US as well as obtained product approvals in the EU, Asia and the rest of the world.
Advisory Board • Dr. Richard Rawlins Ph.D.: Professor and Director of In Vitro Fertilization laboratories, Rush Center forAdvanced Reproductive Care/Dept of Ob/Gyn, Rush University, Chicago, IL. • Dr Paul Zarutskie: Dr. Zarutskie was the Medical Director of the Fertility and Endocrine Center of the Department of Obstetrics & Gynecology at the University of Washington. He has also held professorships at the University of Washington and the University of Pittsburgh School of Medicine, and has been an instructor in the Department of Obstetrics & Gynecology at Harvard Medical School. Society. He has served as President of the Society of Assisted Reproductive Technology (SART) and was appointed Chairman of the National Coalition of Assisted Reproductive Technologies (NCOART). • Dr . Jake Mayer: Dr Mayer has been with the Jones Institute since 1982 . Dr. Mayer earned his PhD in reproductive physiology at Johns Hopkins University. He has been a member of the Executive Council of the Society for Assisted Reproductive Technologies ( SART ) since 1995 . Dr. Suheil Jamil Muasher: Dr. Muasher has been Medical Director of the Jones Institute from 2001 to 2004. He is the Medical Director of The Muasher Center for Fertility and IVF. Dr. Muasher is Clinical Professor of the Department of Obstetrics and Gynecology at George Washington University, Associate Professor of Department of Gynecology and Obstetrics at Johns Hopkins University School of Medicine and Professor of the Department of Obstetrics and Gynecology at Virginia Commonwealth University.
Why Invest in INVO Bioscience, Inc. ? INVO Bioscience’s INVOcell and INVO technology will revolutionize the Infertility world by expanding fertility treatment to millions of couples who are suffering from infertility by providing: • A geographically available treatment • A cost effective treatment • A more natural treatment • A very effective treatment
Contact Information Kathleen Karloff - CEO INVO Bioscience Inc. Telephone 978-878-9505 KatieKarloff@INVOBioscience.com www.invo-bioscience.com Investor Relations: Tony Schor – President Investor Awareness, Inc. 847-945-2222 www.investorawareness.com