INVO Bioscience

INVO Bioscience (formerly BioXcell) is a Massachusetts-based biotech company that provides a fertility treatment method with conception and embryo development taking place inside the woman's body. This is in contrast to traditional in vitro fertilisation where conception takes place in a container in a laboratory.
INVOcell Device
INVO Bioscience is a medical device company focused on creating simplified, lower cost treatment options for patients diagnosed with infertility. The company's product, the INVOcell, is a novel medical device intended for use in infertility treatment, which enables egg fertilization and early embryo development to occur inside the patient's vaginal cavity. The INVOcell device has received CE Mark approval and is currently being marketed in Europe, South America and other parts of the world.
Developed by INVO's President and Chief Scientist Dr. Claude Ranoux, more than 800 clinical cases using prototype devices have been published in medical journals, showing INVO was equivalent to IVF in terms of efficacy. Additionally, the company has 5 current patents on the INVOcell device and INVO procedure.
The five INVO patents include: (1) Process for intrauterine fertilization in mammals and device for implantation thereof. U.S. Patent #5084004; Invention ID BIE113394 (2) Spontaneous cycle fertilization. U.S. Patent #5532155; Invention ID BIE114519 (3) Container assembly for intravaginal fertilization and culture, and embryo transfer and method of intravaginal culture employing such a container. U.S. Patent #6050935; Invention ID BIE117061 (4) Incubation and/or storage container system and method. U.S. Patent #10/544990; Invention ID BIE117249 (5) Inspection Block for use in microscopic inspection of embryos or other biological matter insides a container unit. U.S. Patent #12/258874; Invention ID BIF117771.
INVO Procedure
The INVO procedure is a simple and effective infertility treatment, which uses the INVOcell device, eliminating the need for laboratory equipment required for conventional methods of IVF, thereby reducing the overall cost. During the procedure, eggs are combined with sperm inside the INVOcell device and placed inside the patient's vaginal cavity where it remains for three days. This allows the woman's body to provide a nurturing environment in which conception and early embryo development take place.
In late October 2009, INVO Bioscience (OTC: IVOB.OB) announced the results of a clinical trial conducted at the CECOFLES Center for Fertility and Sterility, revealing an ongoing pregnancy rate of 36%. On February 3, 2010, the company confirmed this 36% pregnancy rate, when they followed up with the results of a clinical trial with twice as many patients.
By averaging data from the Jones Institute for Reproductive Medicine, New York Center for Human Reproduction and national statistics from the American Pregnancy Association, IVF carries an average pregnancy rate of approximately 32% and a multiple birth rate of 23.7%.
Additionally, INVO's study showed a multiple pregnancy rate of just 6%, which is a significant decrease from the multiple pregnancy rate of conventional IVF procedures, with an average higher than 20%.
Infertility Treatment Market
The American Society for Reproductive Medicine (ASRM) considers a marriage barren or infertile when pregnancy has not occurred after a year of intercourse without contraception. For centuries, women around the world have been faced with ostracism, cultural backlash and negative stigmas attached to the inability to conceive and give birth to a child. Infertility places a large strain on women and married couples because it toys with our natural instinct as human beings to procreate and raise a family.
Some may view this as constant, growing problem within the human condition, while others in the field of medicine and biotechnology have taken matters into their own hands. In fact, it's quite interesting that something so primal has just started to turn into a bull market.
According to ASRM's 2004 figures for the infertility treatment market in the United States, infertility drugs made up 46% of the total market, while in vitro fertilization (IVF) came in as a close second, accounting for 36% of the $3 billion market. But, that was several years ago and many things in the medical field have changed.
The American Fertility Association (AFA) reports that 1 in 6 (or 17%) of couples are infected by infertility, with more than 7.3 million infertile couples in the United States alone. On a global scale, the European Society of Reproduction and Embryology (ESHRE) estimates there's an estimated 150 million infertile couples of reproductive age.
Why such a large number? The biological and environmental causes of infertility seem to be increasing as time moves on, with several large countries (e.g. Russia) actually reporting decreasing population rates.
Female factors of infertility include endometriosis, ectopic pregnancies, polycystic ovary syndrome (PCOS), pelvic inflammatory disease (PID), damage caused by sexually transmitted infections and diseases, obesity, malnutrition, ovulatory disorders and age.
Many people may be surprised at the massive number of infertile couples in the world, but people often forget that problems with infertility can be associated with male factors as well. In fact, male factors attribute to as much as 40% of infertility cases.
Male factors include, but are not limited to, low sperm count, sperm immobility, exposure to hazardous wastes and substances, testicular trauma or torsion, prescription drugs, history of cancer, hernia repair, obesity, smoking, alcohol use and lack of exercise.
Certainly, these factors come together to represent a market but only a small fraction (.5%) of the estimated 150 million infertile couples will be able to receive infertility treatment and have the chances of being blessed with a child.
INVO Bioscience does not intend to compete directly with conventional IVF procedures. Rather, INVO plans to target the remaining 99.5% of the 150 million infertile couples who would otherwise go untreated. In fact, The National Infertility Association suggests that the main reasons couples do not utilize IVF as an infertility treatment is because of its cost and geographic availability.
Various countries around the world have problems with infertility and the statistics are quite striking:
o China has an infertility rate of 15% to 20%, with approximately 10 million infertile couples
o India has an infertility rate of 15%, with an estimated 14 million infertile couples
o Brazil has an estimated 16 million infertile couples
o Russia has a 13% infertility rate, 18 million infertile couples and a decreasing populate rate of 7%
o Canada has a 17% infertility rate
o Pakistan has the highest infertility rate in the world (29%) and has an estimated 5 million infertile couples
o Australia has an infertility rate of 17%
Due to the high cost of infertility treatments, there are a growing number of countries around the world whose governments offer reimbursement and other funding for IVF. Currently, this list includes Australia, Belgium, Denmark, Finland, Netherlands, Sweden, Israel, Austria, Germany, parts of Canada and 15 states in the United States. Some of the main reasons why government funding for infertility treatments is not widespread is because of the ethical and moral issues and overall cost associated with traditional IVF. This includes the creation, storage and disposal of excess and frozen embryos.
Again, the INVO procedure could become a more favorable form of infertility treatment because it does not advocate for the production of excess embryos. Furthermore, the freezing and storage of excess embryos is not an issue with the INVO procedure because the embryos are taken from the INVOcell device and transferred directly to the womb. Additionally, no more than two embryos are transferred during the INVO procedure. Not only does this follow ASRM guidelines of transferring a maximum of two embryos, it also dramatically reduces the chances of multiple births, advocating for the health and safety of mother and unborn child, and an overall lower-cost of care.
Price Comparison
INVO Bioscience (OTC: IVOB.OB) has positioned its INVO procedure as a more natural and cost effective infertility treatment. In fact, the approximate cost of setting up an INVO center is $30,000, compared to $500,000 for an IVF laboratory, which requires a stable power supply, clean lab maintenance and additional equipment needed to imitate the environmental conditions inside a woman's body.
In the United States, most IVF procedures range in price from $12,000 to $15,000 per cycle, with most procedures requiring three cycles. That means IVF can cost as much as $45,000 and that does not include the cost of additional assisted reproductive technologies (ART) associated with IVF, including IUI (intrauterine insemination), sperm donor, egg donor, frozen embryo transfer (FET), intracytoplasmic sperm injection (ISCI) and the storage of embryos. Depending on the specific problems associated with a couple's infertility, these additional technologies may or may not be necessary.
Nevertheless, it's quite interesting to know that the approximate cost of the INVO procedure is $13,888 per pregnancy. Even if we give IVF the benefit of the doubt and a low-end estimated cost of $36,000, the INVO procedure is 60% less expensive.
Market Penetration
Over the past year, INVO Bioscience has made tremendous progress, penetrating the infertility treatment markets in five continents. Currently, the company has thirteen distribution partners, including CECOFLES Center for Fertility and Sterility, CER Center for Human Reproduction, Galaxy Pharma, Daxley Group, Nacer Infertility Clinic, Gonagen, STAR IVF, Progressive Group, ENVI Med, Meditech, Medek Medikal, and Delfran Pharmaceuticals.
With this network, INVO Bioscience has been able to establish distribution of the patented INVOcell device to 24 countries---Canada, Columbia, Guatemala, Egypt, Argentina, Brazil, Chile, Uruguay, Ecuador, Panama, Mexico, Peru, Turkey, Pakistan, Bulgaria, South Africa, Madagascar, Seychelles, Mauritius, Namibia, Botswana, Mozambique, Kenya and Angola; 5 countries with direct product sales---Togo, Cameroon, Benin, Spain and Austria. And, based on an investor update issued by the company in December 2009, INVO has started and/or received product registration in 4 additional countries including China, Hong Kong, Taiwan and Thailand, with negotiations pending in 5 more territories---Cyprus, Italy, India, Greece and Russia.
With a presence in more than 30 countries on 5 continents, INVO Bioscience is certainly working towards their goal of providing a more natural, cost-effective infertility treatment geographically available to millions of infertile couples that may otherwise go without treatment.
Financial Analysis
Revenue figures originally projected by the company in 2009 were created assuming that appropriate funds would be available. INVO Bioscience spent most of 2009 with their attention geared towards acquiring this funding. With the $10,000,000 financing through AGS Capital now in place, the company expects FY2010 revenues between $433,000 - $671,000).
The INVOcell is sold for $125-$400 per unit depending on the market. For instance, in developed countries like Canada the INVOcell is sold for $400 per unit whereas in developing countries the price per unit is significantly less expensive. The cost to manufacture a single INVOcell unit is under $15 which means that gross profit margins will range between 88% - 96%.In order for INVO Bioscience to generate $25 million sales, they would need to attain approximately 57,000 patients out of the 150,000,000 infertile couples worldwide. That’s less than 1/30th of 1% (0.00033333%) of the market. Penetrating 1% of the world market (150 million infertile couples) equates to $660 million in potential revenues.
Looking Forward
INVO Bioscience plans to start the FDA clearance process this year. In fact, the product development, testing and preclinical work required to support the 510(k) filing is complete and the company has an open IDE (investigational device exemption) to start a clinical study to support the 510(k). Additionally, the company has reported its confidence in this process being completed within the year with FDA clearance in 2011. On October 28, 2009, INVO Bioscience entered into a Reserve Equity Financing Agreement with AGS Capital Group, LLC (“AGS”), pursuant to which AGS committed to purchase, from time to time over a period of two years, shares of IVOB common stock for cash consideration up to $10,000,000.
More recently, the company announced that the National Institutes of Health (NIH) and World Health Organization (WHO) has approved a 100 patient study, which will be conducted by Galaxy IVF in three separate INVO centers in Pakistan, and recruitment for the study is underway. The resulting data from this clinical study will support the widespread acceptance of the INVO procedure in the Middle East and could further validate the efficacy of the company's infertility treatment as comparable to IVF procedures currently in use around the world.
By establishing the INVO procedure as an effective, less expensive and more geographically available treatment, INVO Bioscience has taken more than baby steps towards becoming a leader in the world infertility market.

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