November 10, 2016 – Download PDF
Dear INVO Bioscience shareholders and friends,
This is an update to all shareholders on the recent activities of the company.
Clinic and Distributor Activities
We continue to make progress in the adoption of the INVOcell device and INVO procedure. As we are sure you have seen we have announced partnerships with Marin Fertility Center and Alta Bates IVF, as well as UCSF in California have begun to offer INVO, along with Strong Fertility Center in Upstate New York. We have14 clinics and centers that are now offering the INVOcell device and INVO procedure in the United States.
We are getting excellent pregnancy rates in our early clinics and will be following up with press releases on this when we hit certain milestones. Patient and physician feedback has been excellent, expressing satisfaction with a more natural and cost effective route to pregnancy. Successful pregnancies in these early clinics will allow us to have additional US data to market our INVOcell device and INVO procedure to additional facilities and make the INVO procedure the standard of care.
All clinics that are adopting and offering the INVOcell and INVO procedure are continuing to adopt our mission of offering the full INVO procedure at pricing of approximately half the cost of traditional IVF, inclusive of low ovarian stimulation medications. We continue to assure that our mission, to treat additional patients that could not afford current costly IVF treatments, remains intact.
Our partner in Canada, Effortless IVF, is in construction of a dedicated center in Calgary scheduled to open before the end of the year offering only the INVO treatment. Effortless IVF also has plans to add two additional INVO centers in 2017. The Calgary center completed a kick-starter campaign to attract initial patients to Effortless IVF Canada and currently over 100 patients have been screened and enrolled for the INVO procedure. This is expected to be a huge success in Canada, as the health care system does not currently support fertility treatments.
Our partner in India, Sanzyme Ltd., has recently launched a large marketing campaign. Sanzyme has been doing additional training and more than 100 physicians completed training in August. Orders of the INVOcell from India have increased and are now received on a regular basis. We expect this market to grow as Sanzyme has added resources and is putting an emphasis on INVO.
As you know INVO Bioscience attended the American Society of Reproductive Medicine Congress (ASRM) in Salt Lake City in October. We had a presentation booth this year for the first time since the INVOcell received clearance by the US FDA. The meeting was outstanding and our presentation booth was extremely active for the 3 straight days. We met many physicians who are interested in starting with the INVO procedure. Currently, we have many new physicians / IVF clinics that are interested in receiving training and starting with the INVOcell procedure from the ASRM Congress.
Dr. William Kutteh from the Fertility Associates of Memphis stopped by our booth at ASRM. Watch the video below to hear Dr. Kutteh discuss the benefits of the INVO Solution. Dr. Kutteh will be offering the INVO Solution to his patients in early 2017.
In addition, Dr. Ranoux conducted a roundtable presentation and discussion on Intravaginal Culture that was well attended and appreciated. Please see the media coverage section on this website page for pictures of the INVO Booth and activities at ASRM: https://invobioscience.com/2016/06/29/2016-asrm/
Continued Physician Training
On October 27th, we held an INVO procedure training for the Reproductive Endocrinologists and Embryologists at Dr. Kevin Doody’s Effortless IVF clinic in Bedford, Texas. The training was first-rate and the physicians and clinicians were excited about the ease of use of the INVOcell. Dr. Doody will continue to provide the INVO procedure training for the Company. Currently we are scheduling the next training in January with a full house of physicians/clinicians scheduled to attend, many of the participants are new contacts from the ASRM Congress.
We have started a marketing campaign to OB/GYN’s in the surrounding areas of our current INVO participating facilities. The intent is to inform and educate the local physicians about the INVO procedure so they can refer their patients to our INVO offering physicians/clinics. Many of the infertile patients that cannot afford to go to the IVF centers can now get referred to an INVO offering center.
Also in October, we launched our new and improved website. This website has all the required information for physicians, investors and patients to get familiar with our state-of-the-art INVOcell and INVO process. All new information of importance will be posted on the website and will be updated on a regular basis so that the investors can be kept informed
SEC Filing Update
Most of you know through our shareholder updates, since receiving FDA clearance we have been making our best efforts to become current with our SEC filings. We have secured the necessary funding to allow us to complete the full audit, filing and review process through 2016. We have taken significant steps to get these filings complete but are not there yet do to the complexity of the process and our limited resources. We assure you that the INVO team and the auditor’s main focus are on completing all of the steps necessary to complete the 5 year Annual Report on Form10K. We are very close to wrapping up the audit then moving to generate the 5 year SEC filing. Once this is complete we will be go right into the Q1, Q2 and Q3 2016 reviews and filing of the 10Q forms.
Becoming current with our SEC filings is key and we are doing it as quickly as we can along with running the Company. Again, as we stated in the last update, this is a requirement for raising the additional capital needed to expand our resources to support the growth and sales of INVO to become the standard of care for infertility. We continue to have discussions with the same interested investment banks we mentioned earlier in the year as well as a few new firms have approached us to secure the long term financing we require.
System Upgrades – Product improvements
We have finalized the design of our new retention system, which will be commercialized in 2017. This retention system will be a high quality product at a fraction of the cost and will benefit our patients and doctors. These cost cutting measures are being taken to stay with our mission of providing a truly low cost highly effective reproductive treatment.
A few shareholders have asked us direct questions that we could not answer due fair disclosure obligations, but we will share with all in this public vehicle.
The Company or its officers and directors are not selling or buying shares and trying to hold the stock price down. It is not our intention to “hold on the financials” to impact the stock, it is only internal resources. It is in the best interest of the Company and all shareholders who want to see the company succeed to have the market price of the stock increase. Unfortunately there may be people out there who want to see either the stock price be reduced or have INVO fail. We have been and will continue to do our best to see that neither of those happen.
We will continue to send out updates and press releases as we develop relationships across the US and beyond.
We thank you as we continue to take the necessary steps to build INVO Bioscience into an international reproductive medical organization.
Kathleen Karloff, CEO
Private Securities Litigation Reform Act of 1995
This letter to the shareholders 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. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. 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.