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Cohera Medical, Inc.® Receives Expedited Access Pathway Designation from FDA for Sylys® Surgical Sealant

Jun 9, 2015

PITTSBURGH, June 9, 2015 /PRNewswire/—Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that its Sylys® Surgical Sealant has received Expedited Access Pathway (EAP) designation and priority...

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    TissuGlu® Surgical Adhesive is currently approved for sale in the United States for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. TissuGlu® Surgical Adhesive received European CE Mark in 2011, where it is approved for large flap surgical procedures such as abdominoplasty. TissuGlu® Surgical Adhesive is not approved for sale in any other region. Sylys® Surgical Sealant received European CE Mark in 2015, where it is approved for use as an adjunct to standard closure techniques in ileostomy reversal procedures. Sylys® Surgical Sealant is currently indicated for investigational use only in the U.S. and has not yet been approved for medical use by the Food and Drug Administration (FDA) in the United States. Sylys® Surgical Sealant is not approved for sale in any other region. Any questions related to the indication for use of TissuGlu® Surgical Adhesive or Sylys® Surgical Sealant should be directed to your Cohera Medical Account Manager or to Cohera Medical Corporate Clinical Affairs. Refer to the complete product Directions for Use for prescribing and usage information. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. The other Cohera products are currently limited to non-human investigational use only and have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or in any other region.

    ©2016 Cohera Medical, Inc. All Rights Reserved. Cohera Medical, Inc.®, TissuGlu® and Sylys® are registered trademarks of Cohera Medical, Inc. TissuGlu® Surgical Adhesive is covered by one or more of the following U.S. Patents 7,264,823; 8,182,647; 8,652,293; 8,950,629. Other Patents Pending.

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