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KYMA

cosmetic surgery | anti-aging center

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What is Infinivive?

InfiniViveMD Stem Cell Serum is designed to moisturize and hydrate the skin to reduce the appearance of fine lines and wrinkles. This beautifying serum was developed from proprietary stem cell technology to help promote natural healing. Clients will notice visibly smoother, softer and younger looking skin.


How is Infinivive used?

The Infinivive MD cosmetic serum is intended for topical cosmetic use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent. The Infinivive MD cosmetic serum is a single use vial and intended for use with a single client.


Are there live cells in InfiniVive?

The product vial contains live cells in a solution in to be easily applied to the skin. Live stem cells in the product are obtained from a tissue processed in a manner that results in generating a type of stem cell called a Mesenchymal Stem Cell derived from the Wharton’s Jelly of a human umbilical cord. These cords are ethically sourced and are collected through an American Association of Tissue Banks (AATB) accredited facility, under strict regulations that involve donor qualification, and tissue assessment as required by the FDA. The cord tissue is transferred to the Vitro Biopharma facility for processing and production of the cosmetic product in a cGMP facility. Infinivive Stem Cell serum is produced as a sterile and nonpyrogenic product, with appropriate Quality Control evaluation prior to distribution.

Where does InfiniVive come from?

The Infinivive product is manufactured by Vitro Biopharma, which has over 30 years of experience in working with tissues like umbilical cord and related research in the area of stem cells. Over the years, they’ve developed proprietary methods in stem cell technology, currently sell stem cell research products and tools to leading research institutions worldwide and have filed more than 10 patents. Their facility is FDA registered, ISO 9001:2015, ISO 13485:2016 and CLIA certified. Vitro Biopharma’s cGMP facility is a world class manufacturing center with ISO 7 clean rooms and IS0 5 processing hoods. They're experts in umbilical cord mesenchymal stem cells.


Is InfiniVive safe?

Vitro Biopharma works closely with an AATB accredited facility to ensure that umbilical cords are ethically sourced and obtained with full consent of the donor. Any umbilical cord accepted by Vitro Biopharma will have met strict donor eligibility criteria and pre-screen testing. Once a cord has passed all pre-screening and eligibility requirements, it is processed in the cGMP facility. Vitro Biopharma preforms strict quality control assessments (sterility, endotoxin, karyotyping, DNA fingerprinting, and phenotypic analysis) prior to releasing a production lot of the InfiniVive product.


Does this affect my genotype?

The Infinivive product is applied on the skin, so there is no influence on a person’s genotype. As a cosmetic, these are not intended to diagnose, treat, cure or prevent any disease.

What is the regulatory status of Infinivive?

InfiniVive MD is considered a cosmetic under the FD&C Act Subchapter VI, Sections 361-364. According to the FDA, a cosmetic is “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Code of Federal Regulations (CFR).


Are cosmetic products regulated?

Yes. The FDA regulates the manufacturing of cosmetics. However, there is no requirement for cosmetic products to be approved or cleared by the FDA prior to being sold, since cosmetics aren’t drugs or devices. The FDA has established a program for companies that manufacture cosmetics called the Voluntary Cosmetic Registration Program (VCRP). Our manufacturer (Vitro Biopharma, Golden, CO) of MFD is registered with the VCRP. The VCRP assists FDA in the regulation of cosmetics by providing information about cosmetic products and ingredients, their frequency of use, and firms involved in their manufacture and distribution to evaluate cosmetic products on the market.


Is this FDA approved?

No. Cosmetic products are not required to be reviewed by the FDA prior to sale. However, the manufacturer is registered under the FDA’s Voluntary Cosmetic Registration Program. InfiniVIve is a beautifier that’s applied topically onto a person’s skin. This product is not intended to treat, cure, prevent, mitigate or diagnose diseases.