Invo Bioscience Inc.
World Health Organization statistics imply that infertility and sterility will be the third most serious diseases in the 21st century after cancer and cardiovascular diseases, according to a Life Times report.
InvoBioscience is engaged in providing its InvoCell technology to help infertile couples have a baby. It has one principal product, the manufacturing and distribution of the InvoCell technology.
InvoBioscience has rapidly conquered many countries with a big market potential. Distributor contracts have been signed all over the world; registration process for clearance when it is needed has been started as well. Their strategy to focus on other countries first rather than the classic USA FDA path was very well done. InvoBioscience’s incomes have started to growth on each part of the world.
While InvoBioscience has many distribution agreements coming up or already signed for many countries, this article focuses here only on the biggest markets potential.
Couples in China, the world’s most populous nation, are having difficulty conceiving. Infertility in the country has risen from 12.5 to 15 percent but that number could climb quickly to about 20, according to a report released recently at a forum in Beijing.
However the price tags are prohibitive for most people – worth several or many times their annual salary – but an increasing number of Chinese families are now able to afford the treatment.
“Actually more than 10 million Chinese families need artificial fertilization”, according to Xinhua news agency.
Professor Lu Bodong, vice president of the Second Hospital of Zhenjiang Chinese Medical University in Hangzhou, east China’s Zhejiang Province, attributes rising infertility rates to stressful and unhealthy lifestyles that include excessive drinking and smoking, over-indulgence, and also environmental problems, all of which are side effects of China’s dramatic social and economic changes.
“Now, more and more people are becoming open to fertility treatment. There are more than 200 reproduction centers in China, but this is not enough to meet the demand.”
“The industry is believed to be huge in China.” says Zhao Lixin, deputy director of the reproduction center in east China’s Shandong Province Hospital.
InvoBioscience has signed a distributor contract with The Progressive Group; they are one of the larger med device and equipment distributors in this area. The registration process has been started with Chinese FDA authorities; INVO is waiting to know if a trial will need to be done in China or if the FDA will look to the European guidelines of acceptance and grade InvoCell as a Class II med device.
India has a population of 1.15 Billion people with an estimated 14 million infertile couples. India has power infrastructure issues throughout most of the country therefore traditional IVF is not widely available and unreliable to support. InvoCell’s lack of reliance on electric power will make infertility treatment an option that most of the population does not currently have.
India does NOT need any sort of regulatory clearance.
InvoBioscience is working with potential distributors and has trained and most likely continue to train doctors in India over the next few months.
In Brazil, with a current population of more than 182 million, the 2000 census indicated more than 15 million people of reproductive age had difficulty procreating.
“Each day we are more convinced that environmental factors are contributing to the reduction of spermatozoids, and also affecting the fertility of women,” the centre’s director, Edson Borges Junior, said in a Tierramérica interview.
The declining fertility rate is a global problem, but especially in the industrialised countries, and is getting worse, said Maria do Carmo Borges de Souza, president of the Brazilian Assisted Reproduction Society.
A direct relationship between atmospheric contamination and human reproduction was identified in a recent study by the medical school at the University of Sao Paulo, which found that the greater presence of particulate matter in the air reduces the number of births of male offspring.
InvoBioscience is in the process of registering their products in Brazil and hopefully will be cleared to train and distribute in the first half of this year. Daxley Group is the local distributor; they cover almost all the South American countries such as Ecuador, Panama, Argentina, Uruguay, Chile, and Brazil as well.
Russia is losing approximately 7% of their population and has one of the highest infertility rates in the world. The Russian government is giving incentives to couple to have children and is looking for a low cost infertility treatment.
The Washington Post headline said it all: “Russians Feel Abortion’s Complications: Used as Birth Control in Soviet Times, Practice Has Led to Widespread Infertility.” Indeed, the number of abortions is incredible and the ramifications are nothing short of staggering.
According to the Post, “About 5 million–or 13 percent–of Russian married couples are infertile, and doctors report that diagnoses of infertility are on the rise. In nearly three out of four cases, infertility is attributed to the woman, typically because of complications from one or more abortions, according to Vladimir Serov and other health experts.”
The ensuing infertility epidemic, in turn, has compounded the impact of an already dangerously low birth rate: “On average, Russian women now bear just more than one child,” the Post reported.
The InvoCell is currently being registered in Russia by a distributor. The clearance process by local authorities might take up to 6 months and InvoBioscience will be able to enter the huge Russian Market. With Russian government funding up to 9000$ to help infertile couples having baby, it is a huge potential market here for InvoBioscience.
FDA Status in USA
INVO Bioscience is planning on starting the process of FDA clearance in 2010. The product development, testing, and pre clinical work required to support the 510 (k) is complete and INVO has an open IDE to start a clinical study to support the 510 (k). While InvoBioscience is preparing to start the clinical study, INVO also focus on developing sales in other parts of the world. INVO targets early 2011 for clearance of the InvoCell device in the United States of America.
On October 28, 2009 INVO Bioscience signed an agreement with AGS capital for a Reserve Equity Financing for up to $10,000,000 over a period of two years, “Many different forms of financing were evaluated during the process and the financing chosen was deemed the least dilutive for the INVO stock holders.” says Katie Karloff CEO of InvoBioscience. INVO Bioscience filed a S-1 Registration Statement on December 21, 2009 and it was declared Effective by the SEC on December 30, 2009. With the Registration Effective it cleared the way for the Company to start drawing funding from AGS Capital. INVO put in its first request into AGS Capital on December 31, 2009 to purchase 65,000 shares of common stock.
Among the InvoCell benefits there are some points that needed to be mentioned and understood by investors; almost all the infertile couples will prefer the InvoCell procedure rather than the lab incubation because it is a “natural way”. Women will feel more comfortable and more confident by looking after this incubation period by themselves.
Another point to consider is that a multiple pregnancy seems to be avoided with the use of InvoCell device. When it may be good news of having multiple babies in one time, it seems that parents yet prefer to have one baby at a time.
InvoBioscience will be a major actor in the infertility treatment. With a unique product with already a successfully pregnancy rate proven, and a worldwide potential market in increasing demand, InvoBioscience is already embarking on these enormous markets such as India, China, Brazil and Russia; even with just a few countries to do just a few thousand procedures a year; it would be millions in revenue. InvoBioscience has a bright future in a tremendous potential worldwide market; there is no doubt that this company is a good long term investment.
Disclosure: No positions