Ocugen Announces New Cell Therapy Program Following FDA Regenerative Medicine Advanced Therapy (RMAT) Recognition & More Trending News




NeoCart® (autologous chondrocyte-derived neocartilage) receives regulatory designation meant to assist expedite improvement of latest regenerative medicines

MALVERN, Pa., May 24, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology firm targeted on discovering, growing, and commercializing novel gene therapies, biologicals, and vaccines, at present introduced that it’s diversifying its progressive pipeline by introducing a Phase 3, cell remedy platform expertise known as NeoCart® (autologous chondrocyte-derived neocartilage). Recently, the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to NeoCart® for the restore of full-thickness lesions of the knee cartilage in adults.

NeoCart® is a three-dimensional tissue-engineered disc of latest cartilage that’s manufactured by rising chondrocytes – the cells answerable for sustaining cartilage well being – derived from the affected person on a novel scaffold. NeoCart® has the potential to speed up therapeutic and scale back ache by rebuilding a affected person’s broken knee cartilage. It treats ache on the supply, creating an identical, practical joint floor because it was earlier than the harm. Ultimately, the purpose is to stop a affected person’s development to osteoarthritis. NeoCart® was acquired as part of Ocugen’s reverse merger with the unique developer of the remedy, Histogenics, in 2019.

“We’re excited that NeoCart® has received this RMAT designation, an important regulatory milestone, especially as we view this product as an enabling technology in cell and regenerative therapy for orthopedic indications. Our next step will be working with the FDA to construct the Phase 3 program to bring this innovation to this emerging treatment area,” mentioned Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen, Inc. “People living with articular cartilage lesions literally have holes in their knees that are extremely difficult to heal, and without proper treatment, they’re at high risk of getting osteoarthritis. We believe that NeoCart® offers the potential for an innovative new option where treatments in this area are still limited and results are not optimal.”

The Regenerative Medicine Advanced Therapy (RMAT) designation is a part of the 21st Century Cures Act. The program was created to expedite the event and evaluate of regenerative drugs therapies meant to deal with, modify, reverse or remedy a severe situation. Receiving an RMAT designation gives sponsor firms all the advantages of the quick observe and breakthrough remedy designation applications, together with early interactions with the FDA. Ocugen is working with the FDA to finalize the Phase 3 protocols essential to advance the medical improvement program of NeoCart® required for eventual market authorization.
Articular cartilage lesions are a severe and sometimes mobility-limiting situation. When the cartilage is wholesome, it makes motion simple, permitting the bones to glide over one another with little or no friction, however it may be broken by harm or regular put on and tear. Cartilage that’s broken can, over time, trigger ache and scale back one’s means to perform. Small articular lesions have a restricted capability to self-repair, and full thickness accidents haven’t any means to naturally heal. There are not any blood vessels or nerves to assist therapeutic, and as cartilage matures, chondrocytes have restricted means to copy. Untreated harm finally can result in osteoarthritis.

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Details of the NeoCart® improvement program might be shared at a future date.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology firm targeted on discovering, growing, and commercializing novel gene and cell therapies, biologicals and vaccines that enhance well being and supply hope for individuals and world communities. We are making an affect by brave innovation, taking science in new instructions in service of sufferers. Our breakthrough modifier gene remedy platform has the potential to deal with a number of illnesses with one drug and we’re advancing analysis in different therapeutic areas to supply new choices for individuals with unmet medical wants. Discover extra at www.ocugen.com and comply with us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press launch incorporates forward-looking statements inside the that means of The Private Securities Litigation Reform Act of 1995, that are topic to dangers and uncertainties. Ocugen could, in some circumstances, use phrases akin to “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or different phrases that convey uncertainty of future occasions or outcomes to establish these forward-looking statements. Such forward-looking statements embody, however are usually not restricted to, statements about Ocugen’s intention to work with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3 protocols essential to advance the medical improvement program of NeoCart® (autologous chondrocyte-derived neocartilage) required for eventual market authorization. Such statements are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such statements, together with, amongst different issues, the uncertainties inherent in analysis and improvement, together with the flexibility to fulfill anticipated medical endpoints, means to well timed enroll medical trial contributors, graduation and/or completion dates for medical trials, regulatory submission dates, regulatory approval dates and/or launch dates, Ocugen’s means to make the most of accelerated FDA evaluate designations, such because the Regenerative Medicine Advanced Therapy designation, which doesn’t assure an accelerated pathway or timeline for regulatory approval of any such product candidates, together with NeoCart® (autologous chondrocyte-derived neocartilage), or improve the probability of any such approvals, and the opposite dangers and uncertainties extra totally described in our periodic filings with the Securities and Exchange Commission (the “SEC”), together with the chance components described within the part entitled “Risk Factors” within the quarterly and annual studies that we file with the SEC. Any forward-looking statements that we make on this press launch communicate solely as of the date of this press launch. Except as required by regulation, we assume no obligation to replace forward-looking statements contained on this press launch whether or not because of new info, future occasions or in any other case, after the date of this press launch.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications

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For investor-related inquiries: IR@Ocugen.com

Ocugen Announces New Cell Therapy Program Following FDA Regenerative Medicine Advanced Therapy (RMAT) Recognition & More Latest News Update

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