September 26, 2016 – Download PDF
Dear INVO Bioscience shareholders and friends,
This is an update to all shareholders who have supported us throughout the years and who have been waiting for INVO Bioscience to become a solid investment and a growing and profitable company. We thank all of you for your patience and support. As we have stated previously, we are a long-term investment, which means we are building for the future. We are still an underfunded start up with very limited resources, and we are all wearing multiple hats to get things accomplished. We are starting to build our revenue through launching the INVO procedure to fertility clinics in the US and training physicians and embryologists.
Over the past several months we had slowed down a bit partly because of our physician/partner schedules. In addition and more importantly, the Company has been going through some significant growing pains in determining the best path for it to follow. Primarily around how to grow the business by branding and promoting the INVOcell through our partnerships as well as evaluating strategic new relationships.
Unfortunately, we came to an impasse and it was decided some organizational changes needed to be made, which is not atypical of a company expanding into the commercialization phase of its life cycle. That is the main reason why we have not had an investor update for a couple of months. We were working through a number of items internally, they had to be completed before we could update you.
As documented in the SEC 8K filing earlier today, Dr. Claude Ranoux, the inventor of the INVOcell and founder of BioXcell, INVO Bioscience’s predecessor has moved out of the daily operations of the Company. Dr. Ranoux will still be involved with INVO Bioscience as a member of the Board of Directors.
On behalf the Board of Directors, the shareholders and all couples who may have an “INVO” baby someday, we want to thank Claude for his service to the Company and for all of his years of perseverance working toward getting the product launched in US and globally. Claude will always be a key part of INVO Bioscience and its history.
As reported in the last update, we have trained a number of clinics on the INVO procedure, they are excited to be using the INVOcell in their facilities. They have all stated the summer has been slow but are looking forward to a busy fall. Since then we have had an additional 12 physicians contact us with the desire and intent to use the INVOcell and INVO procedure in their clinics. We continue to work with our small staff to contact, educate and train physicians to expand the use and sales of the INVOcell device.
Our partner in Canada, Effortless IVF, is in construction of a dedicated center in Calgary, Alberta scheduled to open in November offering only the INVO treatment. Effortless IVF also has plans to add two additional INVO centers in 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 support fertility treatments.
Sanzyme our partner in India recently launched a large marketing campaign. In addition Sanzyme recently completed training for over 100 associated physicians in August. Orders for the INVOcell from India have increased and are now received on a regular basis. We expect this market to grow substantially as Sanzyme has increased their training and sales resources and has put a large emphasis on INVO in their business plan.
Getting back to the US, the clinics that have been trained in the past six months have started INVO cycles and patient and physician feedback has been excellent as well as clinical pregnancy rates. 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 also adopting our mission of offering the full INVO procedure at approximately ½ the cost of traditional IVF pricing, inclusive of low ovarian stimulation medications. We continue to assure that our mission, to treat additional patients that could not currently afford costly IVF treatments, remains intact.
We are presenting the INVO system at the American Society of Reproductive Medicine Scientific Congress (ASRM) October 15-19 in Salt Lake City, one of the largest fertility conferences that is held annually in the world. This will be the first ARSM INVO has attended with the approved INVOcell device. We have secured a presentation booth, number 2000 and will take the opportunity to inform reproductive doctors and staff about the INVOcell from all over the world as well as from the United States. We are very excited about this opportunity to share our recent market success to a large group of physicians and to expand our reach in the market. If you are attending ASRM, please stop by we would like to meet you.
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. As you know we only have 1 person with financial expertise to work on the financials and all of the requirements of the audit. Unfortunately this resource was taken away from working on the financials over the past 3 months as we worked through and had many, many discussions on the structure of the organization. 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 10K. Once this is complete we will go right into the preparation of the Q1, Q2 and Q3 2016 reviews and filing of the 10Q forms with the SEC.
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 to secure the long term financing we require.
We have manufactured additional inventory to assure we have an adequate supply of INVOcells to meet the demand of our customers. We are in the design phase to manufacture our own retention system to decrease the cost to INVO, to our customers and ultimately to the patients. This cost cutting measure is being taken to stay with our mission of providing a truly low cost, highly effective reproductive treatment.
We are taking steps to improve our website as we know it has been lacking information and content to provide a more up to date method of communication with all people interested in INVO. The new website should be up very soon so stay tuned….
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.