Good afternoon and welcome to the INVO Bioscience Science Third Quarter fiscal year 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note, this even it being recorded. I would now like to turn the conference over to Robert Blum with Lytham Partners. Please go ahead.

Thank you very much, Gary, and good afternoon everyone. Thank you all for joining us today during INVO Bioscience's third quarter 2020 update conference call. Joining us on today's call is INVO Bioscience's Chief Executive Officer, Steve Shum; as well as the Company's Chief Operating Officer and VP of Business Development, Michael Campbell. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session. We've also received questions that were submitted in advance of the event, and we'll try to get those addressed as well. Before we begin with the event we submit for the record, the following statements. Certain matters discussed on this conference call by the management of INVO Bioscience may be forward looking statements within the meaning of Section 27-A of the securities act of 1933 as amended, Section 21-E of the Securities Exchange Act of 1934 as amended and such forward-looking statements are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding the Company's 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, intended, may, could, should, will, and other similar expressions are forward-looking statement. All forward looking statements involve risks and uncertainties and contingencies, many of which are beyond the Company's control, which may call the actual results, performance or achievements to differ materially from anticipated results, performance or achievements. Factor that may cause actual results to differ-materially from those in the forward-looking statements include those set forth in the Company's filings with the Securities Exchange Commission. The Company is under no obligation to and expressly disclaimed any obligation to update or alter for forward-looking statements, whether as a result of new information, future events or otherwise. With that said, let me turn the call over to Steve Shum, Chief Executive Officer INVO Bioscience. Steve, please proceed.

Thank you, Robert. We appreciate everyone joining the call today including all of our new shareholders. As Robert mentioned, Mike Campbell, our COO and Head of Business Development, is on the call with us. As many of you know, Mike leads our commercialization efforts and he'll provide a few updates on our key activities. Before we jump into the details and highlights, I want to make a few summary points. This was an important week for INVO, as we put what we believe was a critical foundational piece in place for our long-term future success. We completed our large public offering this week, raising gross proceeds of $11.6 million and simultaneously moving the Company off the OTC markets and onto NASDAQ. Our dramatically strengthened balance sheet and financial position really compliments the other critical developments that have occurred over the last 18 months or so, starting with the partnership early last year, the building of our commercial team headed by Mike throughout this year, the second year of real market usage data, which was made available just this year, which further demonstrates the success of INVOcell. The clinic in Birmingham, Alabama, that we've highlighted recently that has really demonstrated a highly successful business model for implementing INVOcell in clinical practice, which we think is a real testament and really validates all the key attributes we often highlight with INVOcell, and now the financial resources to further execute, drive revenue growth and bring the business into a profitable position. Speaking for the whole INVO team, we could not be more excited about how we are positioned to accelerate INVO's sales presence in the marketplace. With respect to the offering, we recognize that we had to price the deal more aggressively than we originally envisioned, but it was important to complete this…

Yes, thanks Steve and thank everybody on the call today, if you're interested as well. So, I'm going to provide some updates on some of our ongoing commercialization activities in the various markets and of course I'll stop at the U.S. First, our distribution partner, Ferring continues to focus on integrating the INVO procedure into existing IVF practices while COVID has certainly had an impact on a number procedures being conducted this year. As Steve mentioned, many of these products are back online and we expect to see increased utilization going forward. I think one of the many benefits of INVO procedures is that employs have streamline process, which can allow when IVF up to increase its capacity of patient throughput without adding any additional resources in both equipment and people. So in addition to training several new IVF partners this year, Ferring is also focused on creating overall awareness within the market itself to help to drive patient demand. Another factor that should help with utilization, as Steve mentioned, is the recent release of the 2018 IVF outcomes data by the Society of Assisted Reproductive Technologies or SART. This is a unique industry in that most all IVF patient outcomes are reported in this database. And in 2017, they began to separate out the INVO procedure as IVC or intra-vaginal culturally in VIVO culturing. And in 2018, the IVC data was consistent with the 2017 data, which showed a combined clinical pregnancy rate of 52.1% on day five transfers, and this compares favorably to the IVF data during the same period, which demonstrated a 53.6% clinical outcome. And that is with our PVT, so I believe it is successful outcomes continuing to grow and what similar success rates to IVF at a much lower cost. So, we believe that…

Great. Thanks Mike. Let me shift to our clinical activities for a minute, as many of, and as Mike mentioned, our original FDA clearance was based on a three-day incubation period, and that is what our product is labeled and currently marketed under here in the U.S. But many, if not, most of our current practitioners are doing day five. So, expanding our product labeling to encompass five day incubation is important and something we are pursuing actively. Our Ferring agreement also provides for a $3 million milestone payment upon completion of that effort. As we noted in our earnings release this week, we are pursuing two paths, the additional real world market usage data that came available earlier this year afforded us the second option, which was to file a 510k based on that retrospect data. We submitted a 510k a few months ago and have received follow-up questions from the FDA. We are preparing a response to those questions and we expect to submit that response by the middle of January. As previously noted, we also designed a prospective clinical study to achieve the five day label enhancement. We received IRB approval early this year to begin that study, although recruitment was put on hold due to COVID-19. We're looking to restart that activity near-term. We plan to keep this effort moving forward in parallel in the event we need the additional clinical data. Before I hand this back to Robert, to quickly recap, INVO is in a large and growing global market. And in the infertility space, there is a very large underserved patient base, which provides a significant opportunity for a technology solution like INVOcell, especially one that can address the capacity challenges. And we believe all the work to-date further validation has come available more recently, and the current foundation of existing users sets an exciting stage for us looking forward. While we're not prepared to give specific guidance for next year at a high level, we believe we can generate strong increase in revenue, especially as we bring our initial partnership activities online with that. With that Robert I'll open it up for some questions.

We will now begin the question-and-answer session. [Operator Instructions]

[Operator Instructions] Some questions that came in here, you described the retrospect data that you recently received. I get data compares 2018 data, if I'm not mistaken. There's a question here. Do you have a timeline on when the 2019 start data may be released?

Sure. If start is consistent with how they've released data or the timing of when they released data each year, we would expect to see that 2019 data probably somewhere around the April timeframe of next year. And we would expect that data to show further increases in the usage of INVOcell. And again, we were looking forward to seeing that additional data. We think that all, yes, it provides further validation.

The next question here in the press release, you obviously mentioned the 510k application utilizing real world data to support that label expansion you mentioned that yours as well in the in your prepared remarks. The question is, is there a timeline that you can provide as it relates to this FDA submission and perhaps any timeline that the FDA might have to respond back to you or a response?

Yes, it's important to know, we have a CRO helping us with this effort on both fronts. And they expect that, after we submit the response that we would probably likely hear back from the FDA late February, early March timeframe. And if the FDA feels like we have enough additional data to support the application, we'd like to receive clearance then. In the event, we need some additional data that is the exact reason why we will continue with our clinical trial to provide additional support, if in fact that's needed.

[Operator Instructions] We have one further question here. You discussed the OB/GYN market opportunity in terms of being an opportunity market for INVOcell here, beyond simply the IVF centers. Any updates you can provide as it relates to the OB/GYN opportunity?

Steve, I'll take that one and this is an interesting topic and what's most interesting is the market dynamics, and what we believe is the necessity to bring advanced fertility treatment downstream into the OB/GYN network to provide these solutions to the folks that need them. So, when I get into this IVF business in the early 2000s, there were approximately 450 IVF centers in the U.S. Well, today there are approximately 450 IVF centers in the U.S,. and we believe this is due to the significant capacity constraint and available qualified REIs and embryologist to administer the necessary amount of procedures needed to meet this demand. And I think the second major factor here is patient awareness. So, as you know, most patients stopped their fertility journey with their primary care physician and OB/GYN physician, and OB/GYN, they do have limited treatment options available such as IUI or intrauterine insemination, but these treatment options have extremely low success rate and 90% of the patients not successful at getting pregnant. At this point, the only option for these patients is to be referred -- best fertility treatment is to be referred out to an IVF center. And unfortunately, up to 90% of these patients do not have the economic means for this treatment plan. This is also one of the reasons why the utilization of INVO within the current IVF practices has been a slow process. Most patients are unaware of the INVO option and they're simply not showing up. So, yes, we believe with proper training of the OB/GYN can successfully perform or start retrieval and transfer process with INVO procedure, and we would support these practices with the embryology lab services requirements. I'd also like to note that, this is the same model that Dr. Arredondo and Dr. Ramirez planned to execute in Mexico. They're going to utilize the OB/GYN plan and bring OB/GYN into the practice for this process.

Yes. Perfect. Thank you, Mike. Steve, as I show no additional questions here, I will turn it back over to you for any closing remarks.

Great. Well, again, we really appreciate everyone listening in on the call today, and I guess if anyone has any follow-up questions, please do not hesitate to reach out to us. With that, I think we can close up the call.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.