INVO Bioscience Advances Commercialization into the European Fertility Market with Initial Orders of INVOcell (IVC) in Spain

Rhea-AI Summary

INVO Bioscience (NASDAQ: INVO) has announced its expansion into the European fertility market, securing initial orders for its INVOcell product in Madrid and Barcelona, Spain. The company will initially serve three clinics, which have started training staff. CEO Steve Shum highlighted the advantages of INVOcell, including a more efficient process for clinics and a patient-focused experience. With a CE-mark and previous successes in various global markets, INVO aims to enhance its presence in Europe, targeting the significant portion of the population affected by infertility.

Positive

• Secured initial orders of INVOcell in Madrid and Barcelona, Spain.
• Launching in three fertility clinics with ongoing staff training.
• INVOcell offers a more efficient, patient-centered approach to fertility treatment.
• Possesses CE-mark, enabling entry into the European market.

Negative

• None.

SARASOTA, Fla., Jan. 27, 2021 /PRNewswire/ -- INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world's only in vivo Intravaginal Culture System (IVC), INVOcell®, an effective and affordable treatment for patients diagnosed with infertility, today announced it has advanced its commercialization efforts into the European fertility market by securing initial orders of INVOcell in Madrid and Barcelona, Spain. INVOcell will initially be available at three separate existing fertility clinics which have placed orders and commenced training.

"We are excited to launch the commercialization of INVOcell into the European market, which represents a sizable portion of the overall global fertility market," commented Steve Shum, CEO of INVO Bioscience. "With the advancement of our initial efforts in Spain, we plan to capitalize on this entry to further expand our activities both within Spain and across other European markets. We believe INVOcell offers patients and physicians a number of advantages, including the ability to provide the patient with a more connected experience and provide the clinic with a more efficient, less resource-consuming process, thereby enhancing capacity and providing an ability to treat more patients in need. With the CE-mark we received in late 2019, which we subsequently expanded to include 5-day labeling in 2020, INVOcell can now be launched into Europe.  We are excited with our entry into Spain and these early adopting clinics which will help establish INVOcell's initial presence in the region." 

The Company is working with a logistics provider to assist with all customs details relating to importing the INVOcell into the country and it will continue to evaluate distributor type relationships and joint venture opportunities to further expand INVOcell's presence throughout the region.

Spain has a total population of approximately 47 million people. According to the World Bank, Spain has one of the lowest fertility rates in Europe, affecting approximately 15% of the population, or one in seven couples of reproductive ages. According to reports, in 2010, there were approximately one million couples requesting assisted reproductive treatment, however only 22% received one or more assisted reproductive treatment cycles. The average waiting time for an IUI or IVF cycle in a public health facility was 339 days.

"We believe Europe is a significant opportunity for INVOcell and a region that has a substantial underserved patient population," added Michael Campbell, COO and VP of Business Development for INVO Bioscience. "According to our research, there has been increased awareness and interest in the INVOcell solution across the continent over the last year and we are evaluating the best long-term opportunities to ensure wide-scale commercial adoption of the product. We have made the decision to address the inbound demand for the product within Spain through a direct sales approach initially with the support of a logistics partner, while continuing conversations with potential distribution partners that we believe can best serve to help accelerate our efforts to meet the long-term needs of the patients, physicians and INVO Bioscience combined."

INVO Bioscience's entry into Spain compliments its previous announced distribution and JV agreements covering the United States, Mexico, India, Malaysia, Turkey, Jordan, Nigeria, Uganda, Sudan, Ethiopia, North Macedonia, Iran and Pakistan.

About INVO Bioscience®

We are a medical device company focused on creating simplified, lower-cost treatments for patients diagnosed with infertility. Our solution, the INVO® Procedure, is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience. Our lead product, the INVOcell®, is a patented medical device used in infertility treatment and is considered an Assisted Reproductive Technology (ART). The INVOcell® is the first Intravaginal Culture (IVC) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development, as an alternative to traditional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost of care and increase the availability of care. For more information, please visit https://invobioscience.com/. 

Safe Harbor Statement

This release 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.

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SOURCE INVO Bioscience, Inc.

FAQ

What recent expansion did INVO Bioscience announce?

INVO Bioscience announced its expansion into the European fertility market by securing initial orders for its INVOcell product in Spain.

Where in Spain is INVOcell being launched?

INVOcell is being launched in Madrid and Barcelona, Spain.

How many clinics will initially offer INVOcell?

Initially, three clinics in Spain will offer INVOcell.

What advantages does INVOcell provide?

INVOcell provides a more efficient, less resource-consuming process for clinics and a more connected experience for patients.

What is the significance of the CE-mark for INVOcell?

The CE-mark allows INVOcell to be marketed in Europe, enhancing its commercial opportunities.