INVO Bioscience Obtains Regulatory Approval to Commercialize INVOcell In Thailand
INVO Bioscience, Inc. (NASDAQ: INVO) has received approval from FDA Thailand to import and commercialize its IVC system, INVOcell®, in Thailand. This follows an exclusive distribution agreement with IVF Envimed Company Ltd., which has a strong network in the fertility sector. Training for local physicians and embryologists has commenced, with plans for further 'in-person' training in early 2022. INVOcell offers a more natural and cost-effective approach compared to traditional IVF and IUI methods, aiming to improve access to fertility treatments in Thailand.
- FDA Thailand approval for INVOcell commercialization.
- Exclusive distribution agreement with IVF Envimed increases market presence.
- Training initiatives for local fertility specialists enhance product adoption.
- None.
SARASOTA, Fla., Dec. 1, 2021 /PRNewswire/ -- INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world's only in vivo culture system (IVC), INVOcell®, today announced the Company has received approval by Medical Devices Control Division for FDA Thailand to import and commercialize INVOcell in Thailand. In April 2021, INVO Bioscience entered an exclusive distribution agreement with IVF Envimed Company Ltd. to distribute the INVOcell system within Thailand. Established in 1993, IVF Envimed Company Ltd. has established a wide network of clinics and hospitals across Thailand primarily focused on fertility solutions. IVF Envimed is a member of the 'Thai Society of Reproductive Medicine' which organizes congresses and educational programs where IVF Envimed participates.
In November 2021, INVO Bioscience started to train physicians and embryologists from both private and government hospitals. In early 2022, INVO Bioscience and IVF Envimed will organize several 'in person' trainings in Bangkok with key fertility experts to supplement currently ongoing online trainings. INVO Bioscience is also planning to conduct a locally-based evaluation study to have localized data, a key element for both physicians and patients.
"Following months of efforts and interactions with the governmental authorities in Thailand, we are thrilled to have received approval by FDA Thailand to commence commercialization of the INVOcell solution within Thailand," commented, Steve Shum, CEO of INVO Bioscience. "Over the past number of months, we have been working closely with our partners at IVF Envimed to educate key opinion leaders within the country, including the recent training of several physicians and embryologists that should allow us to begin scaling up our commercialization efforts within the country. Further, we have identified physicians to help us with localized data collection on initial patients to assist in our longer term marketing efforts within the country. We look forward to working with Envimed and supporting their efforts to deliver the INVOcell solution in Thailand help address the underserved patient market in need of advanced reproductive treatment."
About INVOcell
The INVOcell procedure is the first in-vivo culture (IVC) system in the world used for the incubation of eggs and sperm during fertilization and early embryo development within the body, as an alternative to conventional In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI). Through its in vivo approach, INVOcell offers patients a more natural and intimate experience with comparable results at a lower cost.
About INVO Bioscience
We are a medical device company focused on creating simplified, affordable 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 http://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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/invo-bioscience-obtains-regulatory-approval-to-commercialize-invocell-in-thailand-301434704.html
SOURCE INVO Bioscience, Inc.
FAQ
What is INVOcell?
What recent approval did INVO Bioscience receive?
What partnership did INVO Bioscience establish in Thailand?
When will training for physicians in Thailand begin?
