Fidia Pharma USA Expands into Regenerative Medicine Markets with Launch of NuDYN.
M2 PHARMA-March 13, 2019-Fidia Pharma USA Expands into Regenerative Medicine Markets with Launch of NuDYN
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- US-based hyaluronic acid -based products provider Fidia USA is introducing NuDYN, its first product in the regenerative medicine category, the company said.
NuDYN is a shelf-stable, injectable, flowable amniotic membrane-derived allograft from donated placentas obtained via cesarean delivery. It is processed to be acellular to allow for shelf-stable storage while retaining the beneficial intrinsic properties of the amniotic membrane including hyaluronic acid, collagen, and growth factors.
These natural properties of the allograft provide benefits of protection, lubrication, and support.
NuDYN is the result of a scientifically developed manufacturing process. The amniotic membrane is extracted from the donor placenta, before undergoing a proprietary process that produces a product that is available as a convenient, shelf-stable product ready to use, not requiring any reconstitution.
As a true acellular amnion-derived allograft without any chorion, the product is non-immunogenic. Finally, third-party CLIA-certified labs conduct serological and endotoxin testing that exceed FDA requirements to ensure the safety and quality of this product.
Research has shown that amniotic membrane contains many natural components that may be used in a variety of speciality applications in regenerative medicine such as orthopedic, sports medicine, pain management, and podiatry.
NuDYN is currently offered, prescription-only, in 1 mL and 2 mL vials.
Fidia Pharma USA Inc. is a wholly-owned subsidiary of Italian pharmaceutical manufacturer Fidia Farmaceutici S.p.A., an established leader in the hyaluronic acid market segment.
Fidia Pharma USA is focused on expanding Fidia's position in the US and Canadian market. Fidia Pharma USA Inc. is headquartered in Florham Park, NJ.
NuDYN is regulated by FDA under section 361 of the Public Health Safety Act as a human tissue-based product. It has not been evaluated or approved by the FDA for specific uses. NuDYN should not be considered a stem cell therapy.
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|Date:||Mar 13, 2019|
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