ReGen Biologics Responds to FDA Request for Additional Information on Pending 510(k)



    ReGen Biologics (OTC: RGBI) today announced that the Company has
    recently responded to the FDA's request for additional information
    regarding the Company's December 2006 510(k) pre-market notification
    for its collagen scaffold device.

    "The FDA had a number of questions and requests for additional
    data to support its review of substantial equivalence for the ReGen
    collagen scaffold", commented Gerald E. Bisbee, Jr., Ph.D., Chairman
    and Chief Executive Officer of ReGen Biologics. "Based upon recent
    meetings with the FDA, we believe this submission together with
    previously submitted information responds fully to FDA questions, and
    provides sufficient information to support a clearance decision." Dr.
    Bisbee continued, "We expect to continue our support of the FDA's
    review, and will provide an update as soon as we have more definitive
    information."

    Dr. Bisbee concluded, "Pending a final decision from the FDA, we
    have been hard at work developing our U.S. marketing and distribution
    plans, including establishing an independent network of specialized
    sales agents, which will allow us to efficiently engage experienced
    sales professionals with existing surgeon relationships."

    About ReGen Biologics, Inc.:

    ReGen Biologics is an orthopedic products company that develops,
    manufactures and markets innovative tissue growth and repair products
    for U.S. and global markets. ReGen's patented collagen scaffold
    technology includes applications in orthopedics, general surgery,
    spine, cardiovascular and drug delivery. ReGen's first approved
    product using its collagen scaffold technology is the CMI(TM), a
    meniscus application, which is cleared for sale in Europe and marketed
    through ReGen's European subsidiary, ReGen Biologics AG. ReGen has
    submitted a 510(k) to the FDA in the U.S. for clearance of its
    collagen scaffold device.

    ReGen is headquartered in Franklin Lakes, NJ and manufactures its
    collagen scaffold products in its ISO Certified facility located in
    Redwood City, CA. For more information on ReGen, visit
    www.regenbio.com.

    This press release contains forward-looking statements within the
    meaning of the Safe Harbor Provisions of the Private Securities
    Litigation Reform Act of 1995. Such statements are based on the
    current expectations and beliefs of the management of ReGen and are
    subject to a number of factors and uncertainties that could cause
    actual results to differ materially from those described in the
    forward-looking statements, including those discussed in the Risk
    Factors section of ReGen's 2006 annual report on Form 10-K and
    additional filings with the SEC. ReGen's filings with the SEC are
    available to the public at the Company's website at
    http://www.regenbio.com, from commercial document-retrieval services
    and at the Web site maintained by the SEC at http://www.sec.gov.