IVOB Invocell

INVOCELL Google Chart
So, I bought into IVOB at .11, and took some profits yesterday when I doubled my money. The company just reported this news at 9:18 am this morning, hence the 200% increase we've seen in 48 hours:
INVO Bioscience Signs Major Distribution Agreements in South America Covering Fifteen Countries
BEVERLY, Mass.--(BUSINESS WIRE)--INVO Bioscience, Inc. (OTC BB: IVOB - News), a medical device company focused on treatment options for patients diagnosed with infertility, announced today the signing of 3 distribution contracts in South and Latin America. The Daxley Group, will distribute for INVO Bioscience in Columbia, Venezuela, Ecuador, Panama, Mexico, Brazil, Chili, Argentina and Uruguay. Daxley also distributes for Medicult, Conception Technologies, Biogenics and Rocket Medical, all who offer infertility treatment products such as culture media, catheters, needles and equipment in these countries.

Nacer, Center for Human Reproduction in Lima Peru has started treating patients with the INVO procedure under Dr. Julio Diaz and has been contracted to distribute the INVOcell to IVF centers and OB/GYN’s in Peru. "Dr. Diaz and his embryologist are convinced of the simplicity and the efficacy of the INVO procedure,” said Ranoux. “As a result, four specialists in infertility were also trained. They plan to start INVO units in the next two months with the technical support of the Nacer Infertility Clinic.”CER, Center for Human Reproduction, under the direction of Vivian Lopez Leon, has started treating patients with INVO and has contracted to distribute the product in Guatemala, Belize, El Salvador and Honduras.
“These agreements will allow INVO to begin the process of treating over 9 million estimated infertile couples in South and Latin America. INVO Bioscience’s goal is to develop this untapped market and treat 5% of this population over the next 5 years,” said INVO Bioscience CEO Kathleen Karloff.

Dr. Claude Ranoux has been kindly invited to attend a meeting of the Association of Columbian Fertility and Sterility being held August 22nd by Dr. Elkin Lucena. Dr. Ranoux will lecture and hold a training seminar on the INVO procedure for over 17 OB/GYN’s and embryologists from South America. This training will allow them the capability of performing the INVO procedure in their facilities. Dr. Ranoux will also be holding a training session with the Daxley Group in order to train other physicians from Chili, Argentina and Bolivia.

WHY I OWN THE STOCK:
Ok, I see this as highly speculative, but given how cost prohibitive IVF is, if this seems at all effective, I imagine they'll make $$. IVF treatment is becoming more common and insurance doesn't usually cover the cost because it is so expensive. If this product gets insurance approval, or is just cheap enough for the average person to be able to have a shot at IVF without mortgaging their house, this stock might really grow some legs. From the pics on the website it looks like a small shaker and, well, just read about it yourself. It's used in conjunction with traditional IVF medications, but is markedly less expensive and less traumatic/difficult (IVF can be hell on a woman) as inception can take place inside a woman's body. This stock was $8.5 within the last year, low is .05, as of right now it is .12 (when I originally posted on MSB).

About Invocell from the company website:
Dr. Ranoux, the inventor of the INVOcell and process, has 30 years of experience treating infertility. He developed the INVOcell to make having a baby simpler, less expensive and to promote more involvement by the woman. The INVO procedure uses a lower stimulation approach to produce eggs for fertilization. This is easier on the woman and her partner and is less expensive than the conventional approach. With the low stimulation approach egg retrieval is more comfortable for the woman and fewer drugs are required. Eggs are combined with sperm in the INVOcell device and placed in the woman?s vaginal cavity where it remains for 3 days. This step eliminates the need for a complex IVF laboratory and allows the woman?s body to provide the nurturing environment in which conception and early embryo development take place. The patient can perform her normal daily activities knowing that conception and embryo development are taking place inside her body. After three days, the woman returns to the doctor?s office where the INVOcell is removed. The embryos will be removed and two will be placed into the woman's uterus. Company Background (from Scottrade):I can't get the Reuters report to upload to the site for some reason, so send me a message if you want me to email it to you. INVO BioScience Inc. (INVO Bioscience), formerly Emy's Salsa Aji Distribution Company, Inc., 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. The Company invoiced its first sales of the INVOcell selling 215 units along with 16 INVO Blocks during the year ended December 31, 2008. Further, it has signed contracts for the purchase of INVOcell devices in various countries, such as Turkey, Peru, Pakistan and Canada. On December 5, 2008, INVO Bioscience completed a reverse merger with Emy's Salsa AJI Distribution Company, Inc. (Emy's). In connection with the reverse merger, INVO Bioscience acquired control of Emys.

About the INVO Procedure:
The INVOcell and INVO Procedure combine a natural or mild (mild medication) stimulation infertility treatment cycle, using lower amounts of injectable fertility hormones than used in traditional IVF (in vitro fertilization), with intra-vaginal incubation (IVC) of sperm and eggs. Following standard egg retrieval, the woman's eggs (oocytes) are combined with sperm in the INVOcell, a small device, which is then sealed and placed in the woman's vaginal cavity to incubate for three days. When the INVOcell is removed, the anticipated one to two developing embryos are transferred directly into the woman's uterine cavity, where implantation and continued pregnancy can take place. The company has received European CE Mark approval for the INVOcell and, in 2008, launched the product in select countries outside the U.S. The company is also pursuing U.S. Food and Drug Administration 510(k) clearance for the INVOcell.

FDA Calendar Updates, New Extreme Trades - BioMedReports.com:
On 5/15/09, INVO Bioscience (IVOB.OB) provided the following update on obtaining FDA marketing clearance for its fertility technology. INVO technology assists infertile couples in having a baby. In-vitro fertilization (IVF) is an effective treatment option for most infertile couples, and the Company's patented and proven INVOcell technology is a low cost alternative to IVF that is much simpler to perform. INVO uses a device, the INVOcell, which is currently priced at $75-225 to distributors in developing countries and $125-300 in Europe and U.S. While IVOB penetrates the infertility markets in Europe, Canada, and select developing countries, the Company has also completed the first step for medical device companies who manufacture Class 2 devices with the filing of a Premarket Notification 510 (k) submission with the FDA. Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the U.S. as the Agency issues "clearance" for them to be sold and marketed. IVOB hopes to receive U.S. marketing clearance by 2010 upon completion of its clinical trial.

About Class II 510K consideration:
Class II: General Controls with Special Controls
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material, and acupuncture needles.

OTHER NEWS:
INVO Centers in Operation in the Developing Nations Indicate Progress for INVO Bioscience, Inc.
VFC's Reader Stock Picks from August 6th, 2009______