Categories: MEDICAL DEVICES

INVO Bioscience Obtains Regulatory Approval to Commercialize INVOcell In Thailand

"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.
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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.”