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<SEC-DOCUMENT>0001157523-11-000875.txt : 20110215
<SEC-HEADER>0001157523-11-000875.hdr.sgml : 20110215
<ACCEPTANCE-DATETIME>20110215151232
ACCESSION NUMBER:		0001157523-11-000875
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20110214
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110215
DATE AS OF CHANGE:		20110215

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ANIKA THERAPEUTICS INC
		CENTRAL INDEX KEY:			0000898437
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				043145961
		STATE OF INCORPORATION:			MA
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-14027
		FILM NUMBER:		11613934

	BUSINESS ADDRESS:	
		STREET 1:		236 WEST CUMMINGS PARK
		CITY:			WOBURN
		STATE:			MA
		ZIP:			01801
		BUSINESS PHONE:		6179326616

	MAIL ADDRESS:	
		STREET 1:		236 WEST CUMMINGS PARK
		CITY:			WOBURN
		STATE:			MA
		ZIP:			01801

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ANIKA RESEARCH INC
		DATE OF NAME CHANGE:	19930309
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>a6613123.htm
<DESCRIPTION>ANIKA THERAPEUTICS, INC. 8-K
<TEXT>
<html>
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    <title></title>
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    <p>

    </p>
    <p style="text-align: center">
      <font style="font-size: 16pt; font-family: Times New Roman"><b>UNITED
      STATES</b></font><b><font style="font-size: 16pt; font-family: Times New Roman"><br style="font-family: Times New Roman; font-size: 16pt"></font><font style="font-size: 16pt; font-family: Times New Roman">SECURITIES
      AND EXCHANGE COMMISSION</font></b><br><font style="font-size: 10pt"><b>WASHINGTON,
      D.C. 20549</b></font><br><br><font style="font-size: 16pt; font-family: Times New Roman"><b>FORM
      8-K</b></font><br><br><br><font style="font-size: 12pt"><b>CURRENT REPORT</b></font><b><font style="font-size: 12pt"><br style="font-size: 12pt"></font><font style="font-size: 12pt">PURSUANT
      TO SECTION 13 OR 15(d) OF THE</font></b><br><font style="font-size: 12pt"><b>SECURITIES
      EXCHANGE ACT OF 1934</b></font><br><br><font style="font-size: 11pt; font-family: Times New Roman">Date
      of Report (Date of earliest event reported): </font><font style="font-size: 11pt; font-family: Times New Roman"><b>February
      14, 2011</b></font><br><br><font style="font-size: 16pt"><b>Anika
      Therapeutics, Inc.</b></font><br>(Exact Name of Registrant as Specified
      in Its Charter)
    </p>
    <p style="text-align: center">

    </p>
<div style="text-align:left">
    <table cellspacing="0" style="width: 100%; font-size: 10pt; margin-bottom: 10.0px; font-family: Times New Roman">
      <tr>
        <td valign="bottom" style="text-align: center; width: 33%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>Massachusetts</b>
          </p>
        </td>
        <td valign="bottom" style="text-align: center; width: 34%; white-space: nowrap; padding-left: 0.0px; padding-right: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>000-21326</b>
          </p>
        </td>
        <td valign="bottom" style="text-align: center; width: 33%; white-space: nowrap; padding-left: 0.0px; padding-right: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>04-3145961</b>
          </p>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: center; width: 33%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            (State or Other Jurisdiction of Incorporation)
          </p>
        </td>
        <td valign="top" style="text-align: center; width: 34%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            (Commission File Number)
          </p>
        </td>
        <td valign="top" style="text-align: center; width: 33%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            (I.R.S. Employer Identification No.)
          </p>
        </td>
      </tr>
    </table>
    </div>
    <p>

    </p>
<div style="text-align:left">
    <table cellspacing="0" style="width: 100%; font-size: 10pt; margin-bottom: 10.0px; font-family: Times New Roman">
      <tr>
        <td valign="top" style="text-align: center; width: 40%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>32 Wiggins Avenue, Bedford, Massachusetts</b>
          </p>
        </td>
        <td valign="bottom" style="text-align: center; width: 20%; padding-left: 0.0px">
          &#160;
        </td>
        <td valign="top" style="text-align: center; width: 40%; white-space: nowrap; padding-left: 0.0px; padding-right: 0.0px">
          <b>01730</b>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: center; width: 40%; padding-left: 0.0px">
          (Address of Principal Executive Offices)
        </td>
        <td valign="bottom" style="text-align: center; width: 20%; padding-left: 0.0px">

        </td>
        <td valign="top" style="text-align: center; width: 40%; padding-left: 0.0px">
          (Zip Code)
        </td>
      </tr>
    </table>
    </div>
    <p>

    </p>
    <p style="text-align: center">
      Registrant's Telephone Number, Including Area Code: <b>(781) 457-9000</b><br><br><b>N/A</b><br>(Former
      name or former address, if changed since last report)
    </p>
    <p style="text-align: center">

    </p>
    <p>
      <font style="font-family: Times New Roman; font-size: 10pt">Check the
      appropriate box below if the Form 8-K filing is intended to
      simultaneously satisfy the filing obligations of the registrant under
      any of the following provisions:</font>
    </p>
    <p>
      <font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Written
      communications pursuant to Rule 425 under the Securities Act (17 CFR
      230.425)</font>
    </p>
    <p>
      <font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Soliciting
      material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
      240.14a-12)</font>
    </p>
    <p>
      <font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Pre-commencement
      communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
      240.14d-2(b))</font>
    </p>
    <p>
      <font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Pre-commencement
      communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
      240.13e-4(c))</font>
    </p>
    <p>
      <br>
      <br>

    </p>
    <div style="width: 100%; margin-left: 0pt; margin-right: 0pt; margin-bottom: 10pt; text-indent: 0pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
      <div style="page-break-after: always">
        <div style="text-align: center">

        </div>
        <div style="text-align: center">
          <hr style="height: 1.5pt; color: black">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p>
      <b>Item 8.01&#160;&#160;&#160;Other Events.</b>
    </p>
    <p style="text-indent: 60.0px">
      On February 14, 2011, Anika Therapeutics, Inc. issued a press release
      announcing the date of its fourth-quarter and year-end financial results
      conference call and providing a regulatory timing update.&#160;&#160;A copy of the
      press release is filed as Exhibit 99.1 hereto and is incorporated herein
      by reference.
    </p>
    <p>
      <b>Item 9.01&#160; Financial Statements and Exhibits.</b>
    </p>
    <p>
      (d) <u>Exhibits</u>.
    </p>
<div style="text-align:left">
    <table cellspacing="0" style="width: 100%; font-size: 10pt; margin-bottom: 10.0px; font-family: Times New Roman">
      <tr>
        <td valign="bottom" style="text-align: left; width: 15%; padding-left: 0.0px">
          <b>Exhibit No.</b>
        </td>
        <td valign="bottom" style="text-align: center; width: 1%; padding-left: 0.0px">
          &#160;
        </td>
        <td valign="bottom" style="text-align: center; width: 84%; padding-left: 0.0px">
          <b>Description</b>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: left; width: 15%; white-space: nowrap; padding-left: 0.0px; padding-right: 0.0px">
          99.1
        </td>
        <td valign="top" style="text-align: left; width: 1%; padding-left: 0.0px">

        </td>
        <td valign="top" style="text-align: left; width: 84%; padding-left: 0.0px">
          Press Release issued by Anika Therapeutics, Inc. on February 14, 2011
        </td>
      </tr>
    </table>
    </div>
    <div style="width: 100%; margin-left: 0pt; margin-right: 0pt; margin-bottom: 10pt; text-indent: 0pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
      <div style="page-break-after: always">
        <div style="text-align: center">

        </div>
        <div style="text-align: center">
          <hr style="height: 1.5pt; color: black">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p style="text-align: center">
      <font style="font-family: Times New Roman; font-size: 10pt"><b>SIGNATURES</b></font><br>
    </p>
    <p>
      Pursuant to the requirements of the Securities Exchange Act of 1934, the
      registrant has duly caused this report to be signed on its behalf by the
      undersigned hereunto duly authorized.
    </p>
    <p>

    </p>
<div style="text-align:left">
    <table cellspacing="0" style="width: 100%; font-size: 10pt; margin-bottom: 10.0px; font-family: Times New Roman">
      <tr>
        <td style="width: 50%">

        </td>
        <td colspan="2" valign="top" style="text-align: left; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            ANIKA THERAPEUTICS, INC.
          </p>
        </td>
      </tr>
      <tr>
        <td style="width: 50%">

        </td>
        <td colspan="2" valign="top" style="text-align: left; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: left; width: 50%; padding-left: 0.0px; padding-bottom: 2.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            February 15, 2011
          </p>
        </td>
        <td valign="top" style="text-align: left; width: 5%; padding-left: 0.0px; padding-bottom: 2.0px">
          By:
        </td>
        <td valign="top" style="text-align: left; width: 45%; padding-left: 0.0px; border-bottom: solid black 1.0pt">
          <p style="margin-top: 0px; margin-bottom: 0px">
            /s/ Kevin W. Quinlan
          </p>
        </td>
      </tr>
      <tr>
        <td style="width: 50%">

        </td>
        <td valign="top" style="text-align: left; width: 5%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
        <td valign="top" style="text-align: left; width: 45%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Kevin W. Quinlan
          </p>
        </td>
      </tr>
      <tr>
        <td style="width: 50%">

        </td>
        <td valign="top" style="text-align: left; width: 5%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
        <td valign="top" style="text-align: left; width: 45%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>Chief Financial Officer</i>
          </p>
        </td>
      </tr>
    </table>
    </div>
    <div style="width: 100%; margin-left: 0pt; margin-right: 0pt; margin-bottom: 10pt; text-indent: 0pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
      <div style="page-break-after: always">
        <div style="text-align: center">

        </div>
        <div style="text-align: center">
          <hr style="height: 1.5pt; color: black">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p style="text-align: center">
      <b>Exhibit Index</b>
    </p>
<div style="text-align:left">
    <table cellspacing="0" style="width: 100%; font-size: 10pt; margin-bottom: 10.0px; font-family: Times New Roman">
      <tr>
        <td valign="top" style="text-align: left; width: 12%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>Exhibit No.</b>
          </p>
        </td>
        <td valign="top" style="text-align: center; width: 88%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <b>Description</b>
          </p>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: left; width: 12%; white-space: nowrap; padding-left: 0.0px; padding-right: 0.0px">
          99.1
        </td>
        <td valign="top" style="text-align: left; width: 88%; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Press Release issued by Anika Therapeutics, Inc. on February 14,
            2011
          </p>
        </td>
      </tr>
    </table>
    </div>
    <p>

    </p>
  </body>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a6613123ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<html>
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    <title></title>
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    <p style="text-align: right">
      <b>Exhibit 99.1</b>
    </p>
    <p style="text-align: center">
      <font style="font-size: 12pt; font-family: Times New Roman"><b>Anika
      Therapeutics Announces Date of Fourth-Quarter and Year-End 2010
      Financial Results Conference Call and Provides Regulatory Timing Update</b></font>
    </p>
    <p style="text-align: center">
      <i><font style="font-size: 12pt; font-family: Times New Roman"><b>Revises
      Anticipated Timeline for Pending U.S. Product Approvals and Clearances
      and Final FDA Approval of Bedford Manufacturing Facility</b></font></i>
    </p>
    <p>
      BEDFORD, Mass.--(BUSINESS WIRE)--February 14, 2011--Anika Therapeutics,
      Inc. (Nasdaq: ANIK) today announced that it plans to issue its
      fourth-quarter and year-end 2010 financial results after the close of
      the market on Wednesday, March 9, 2011. The Company plans to hold a
      conference call the next day, Thursday, March 10, at 9:00 a.m. ET to
      discuss its financial results, business highlights and outlook. The
      Company will also answer questions concerning business and financial
      developments and trends, and other business and financial matters
      affecting the Company, some of the responses to which may contain
      information that has not been previously disclosed.
    </p>
    <p>
      In addition, the Company announced a Regulatory timing update.
    </p>
    <p>
      MONOVISC<sup>&#174;</sup>: After extended dialogue with the FDA, and
      disappointment in the speed of the FDA&#8217;s process, the Company recently
      requested review of MONOVISC through the Orthopedic Advisory Panel. The
      Company has not yet received a date for an Advisory Panel meeting, but
      continues to believe that MONOVISC should receive FDA approval.
    </p>
    <p>
      Bedford Facility Manufacturing Approval: As previously disclosed, the
      Company is in the process of moving the manufacturing of its products
      from its Woburn, Massachusetts, facility to its Bedford, Massachusetts,
      facility. The Company received FDA approval to manufacture its
      terminally sterilized product, ELEVESS&#8482;, in its Bedford facility in
      November 2010. The Company has certain critical equipment used to
      manufacture its ophthalmic and orthopedic products which cannot be
      duplicated due to timing and expense factors. The Company believed that
      it had an agreement with the FDA to move that equipment, validate its
      use in Bedford and then briefly return it to service in Woburn, and have
      the validation data and reports reviewed as part of a final inspection
      of the Bedford facility, scheduled in December 2010. That final
      inspection did not occur and will not occur now until the equipment is
      permanently installed in Bedford. In order to fill product orders and
      build sufficient safety stock to accommodate any further approval
      delays, manufacturing of the ophthalmic and orthopedic products will
      continue in Woburn into June 2011. During this period, expenses will be
      managed in Bedford to minimize the impact of operating duplicate
      facilities.
    </p>
    <p>
      510(k) Submissions: As previously disclosed, the Company filed three
      510(k) premarket notifications for Anika Therapeutics S.r.l. products in
      October 2010, originally anticipating clearance by the end of 2010 for
      one of the products and clearance for the other two products in the
      first quarter of 2011. Although there has been delay in the FDA&#8217;s review
      process, the Company still believes that all of the products should
      receive clearance as submitted. Given the delay, however, the Company is
      unable to predict the timing of receipt of these clearances.
    </p>
    <p>
      To listen to the financial results conference call, dial 866-202-4367
      (international callers dial 617-213-8845) and use the passcode 69151063.
      Please call approximately 10 minutes before the starting time and
      reference Anika Therapeutics. In addition, the conference call will be
      available to interested parties through a live audio webcast in the
      &quot;Investor Relations&quot; section of the Company&#8217;s website, <u>www.anikatherapeutics.com</u>.
      An accompanying slideshow presentation also can be accessed via the
      Company&#8217;s website. The call will be archived and accessible on the same
      website shortly after the conclusion of the call.
    </p>
    <p>
      The webcast also is being distributed through the Thomson StreetEvents
      Network. Individual investors can listen to the call at <u>www.earnings.com</u>,
      Thomson's individual investor portal, powered by StreetEvents.
      Institutional investors can access the call via Thomson StreetEvents (<u>www.streetevents.com</u>),
      a password-protected event management site.
    </p>
    <p>
      <b>About Anika Therapeutics, Inc.</b>
    </p>
    <p>
      Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops,
      manufactures and commercializes therapeutic products for tissue
      protection, healing, repair and regeneration. These products are based
      on hyaluronic acid (HA), a naturally occurring, biocompatible polymer
      found throughout the body. Anika&#8217;s products range from orthopedic/joint
      health solutions led by ORTHOVISC&#174;, a treatment for osteoarthritis of
      the knee; to surgical aids in the ophthalmic and anti-adhesion fields.
      The Company also offers aesthetic dermal fillers for the correction of
      facial wrinkles. Anika&#8217;s Italian subsidiary, Anika Therapeutics S.r.l.,
      provides complementary HA products in orthopedic/joint health and
      anti-adhesion, as well as therapeutics in new areas such as advanced
      wound treatment and ear, nose and throat care. FAB&#8217;s regenerative tissue
      technology advances Anika&#8217;s vision to offer therapeutic products that go
      beyond pain relief to protect and restore damaged tissue.
    </p>
    <div style="margin-left: 0pt; width: 100%; margin-right: 0pt; margin-bottom: 10pt; text-indent: 0pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
      <div style="page-break-after: always">
        <div style="text-align: center">

        </div>
        <div style="text-align: center">
          <hr style="height: 1.5pt; color: black">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p>
      <i>The statements made in this press release which are not statements of
      historical fact are forward-looking statements within the meaning of
      Section 27A of the Securities Act of 1933, as amended, and Section 21E
      of the Securities Exchange Act of 1934, as amended, including, without
      limitation, statements that may be identified by words such as &#8220;expect,&#8221;
      &#8220;remains,&#8221; &#8220;focus,&#8221; &#8220;prospective,&#8221; &#8220;expanding,&#8221; &#8220;building,&#8221; &#8220;continue,&#8221;
      &#8220;progress,&#8221; &#8220;plan,&#8221; &#8220;efforts,&#8221; &#8220;hope,&#8221; &#8220;believe,&#8221; &#8220;objectives,&#8221;
      &#8220;opportunities,&#8221; &#8220;will,&#8221; &#8220;seek,&#8221; &#8220;anticipate&#8221; and other expressions
      which are predictions of or indicate future events and trends do not
      constitute historical matters and identify forward-looking statements.
      These statements also include those relating to: (i) the potential
      success of the Orthopedic Advisory Panel regulatory pathway we are
      taking for MONOVISC and the likelihood, timing and impact of, and
      requirements and reasons for, FDA approval of this product, if at all;
      (ii) the timing of the reinstallation of certain critical equipment in
      our Bedford, Massachusetts manufacturing facility and our expectations
      regarding the amount and impact of the increased expenses associated
      with operating duplicate facilities in both Woburn, Massachusetts and
      Bedford, Massachusetts; (iii) the consolidation of Anika&#8217;s manufacturing
      operations in Bedford, Massachusetts, and our expectations regarding the
      likelihood, timing and impact of, and requirements for, the FDA&#8217;s
      inspection and subsequent approval of this facility, if at all; (iv) the
      likelihood, amount and impact of, or reasons for, any increased expenses
      associated with delays in receipt of FDA approval of MONOVISC or our
      Bedford, Massachusetts manufacturing facility; and (v) the likelihood,
      timing and impact of, and reasons for, clearance of our 510(k) premarket
      notifications submitted with the FDA for Anika Therapeutics S.r.l.
      products (Hyalofast, Hyaloglide and Hyalonect), and the potential
      expenses associated with obtaining clearance of these products, if at
      all.</i> <i>These statements are based upon our current beliefs and
      expectations and are subject to significant risks, uncertainties and
      other factors. Our actual results could differ materially from any
      anticipated future results, performance or achievements described in the
      forward-looking statements as a result of a number of factors including:
      (i) our ability to obtain panel review of MONOVISC through the
      Orthopedic Advisory Panel and the timing and results of such review;
      (ii) our ability to timely file and receive FDA or other regulatory
      approvals or clearances of our products (including MONOVISC, Hyalofast,
      Hyaloglide and Hyalonect) and our Bedford, Massachusetts manufacturing
      facility, or that such approvals or clearances will not be obtained in a
      timely manner or without the need for additional clinical trials, other
      testing or regulatory submissions, as applicable; (ii) our ability to
      efficiently reinstall certain critical equipment in a timely fashion in
      our Bedford, Massachusetts manufacturing facility to the satisfaction of
      the FDA; and (iii) our ability to minimize the impact of operating
      duplicate facilities in Woburn, Massachusetts and Bedford, Massachusetts.</i>
      <i>Any delay in receiving any regulatory approvals or clearances may
      adversely affect our competitive position, which may have a material
      adverse effect on our business and operations. Certain other factors
      that might cause our actual results to differ materially from those in
      the forward-looking statements include those set forth under the
      headings &#8220;Business,&#8221; &#8220;Risk Factors&#8221; and &#8220;Management&#8217;s Discussion and
      Analysis of Financial Condition and Results of Operations&#8221; in our Annual
      Report on Form 10-K for the year ended December 31, 2009, as well as
      those described in our other press releases and SEC filings.</i>
    </p>
    <p>

    </p>
    <p>
      CONTACT:<br>Anika Therapeutics, Inc.<br>Charles H. Sherwood, Ph.D., CEO<br>Kevin
      W. Quinlan, CFO<br>781-457-9000
    </p>
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