FLORHAM PARK, N.J.--(BUSINESS WIRE)--Fidia, a world leader in the research, development, and manufacturing of hyaluronic acid (HA)-based products, is introducing NuDYN™, its first product in the regenerative medicine category.
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.
“The introduction of NuDYN™ is the first product in the new Fidia Orthobiologics Portfolio and the first step in our vision for Fidia’s growth in the U.S.,” said Giorgio Masetti, president at Fidia Pharma USA Inc. “Supported by over 50 years of research, Fidia’s aim is to continue to bring new top-quality products to the U.S. market, expand our product lines and evolve by diversifying into new, emerging product categories that are in line with our mission of innovating and pioneering new solutions to help people move forward through life. We are excited to offer more options than ever to patients seeking non-surgical solutions with our convenient, non-surgical quality products.”
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.
“NuDYN™ provides an alternative for healthcare providers to offer their patients non-surgical options for musculoskeletal and orthopedic care,” said Dr. Saad Nasir, medical director for Fidia Pharma USA Inc. “Beyond that, it has the potential to provide possible added benefit for cartilage, soft tissue, tendon, and ligament health. As an option for non-operative care, it complements the current HA-based products, HYALGAN® and HYMOVIS®, which are used for treating osteoarthritis knee pain.”
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.
Further information can be found at www.nudynus.com and at the Fidia Pharma USA Inc. Booth #1625 at the AAOS Annual Meeting, March 13 – 15, 2019.
About Fidia Pharma USA Inc.
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 Inc. is focused on expanding Fidia’s position in the U.S. and Canadian market, while upholding the company’s mission to provide consumers with innovative products that offer quality, safety, and performance. Fidia Pharma USA Inc. is headquartered in Florham Park, NJ.
For more information, please visit www.fidiapharma.us.
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. This information is being supplied for educational purposes only and not as a guide for diagnosis or treatment of any specific conditions. For Rx Only.
Manufactured in the USA for FIDIA PHARMA USA INC. NuDYN™ is a trademark of FIDIA FARMACEUTICI S.P.A.
©2019 FIDIA PHARMA USA INC., Florham Park, NJ 07932 FID-719-03-2019