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Biopharmaceuticals FDA

 News Release - October 18, 2022

FDA Approves First IND of its Kind for Allogenic Exosomal Treatment of Female Reproductive Disorder - Primary Ovarian Insufficiency

LIBERTY, Mo., Oct. 18, 2022 -- (Healthcare Sales & Marketing Network) -- Vitti Labs, an AATB Accredited Tissue Bank focused on life science research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) of EV-Pure, an allogenic exosomal product, for women with Primary Ovarian Insufficiency or POI. The approved human clinical trial is based on non-clinical studies in cell culture and animal models utilizing EV-Pure, which indicated a strong promise for the reversal of POI.

Primary Ovarian Insufficiency leads to infertility in about 1 in 100 women under 40 years of age, in general, and as high as 82% of cancer survivors. Complications of this disease are infertility, early osteoporosis, early onset heart disease, as well as significant issues with depression and anxiety from the inability to conceive.

Several experimental treatments have been tried for Primary Ovarian Insufficiency without success, making no current treatment available on the market. Philipp Vitti, the Chief Science Officer of Vitti Labs, said, "To the best of our knowledge, this is the first IND for evaluating allogenic exosomes in this indication. An off-the-shelf treatment such as this, could give women an economical solution for this devastating disease process who are unable to conceive."

The clinical trial under this IND is expected to begin recruiting patients early next year. Vitti Labs believes that with this study, they will be able to move forward with groundbreaking treatment modalities for other reproductive disorders such as Polycystic Ovary Syndrome (PCOS).

Source: Vitti Labs

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