Cohesion Submits CoSeal PMA Application With FDA

CoSeal Is the World's Easiest to Use, Most Advanced, Synthetic Surgical

Sealant



Apr 17, 2001, 01:00 ET from Cohesion Technologies, Inc.

    PALO ALTO, Calif., April 17 /PRNewswire/ --
 Cohesion Technologies, Inc. (Nasdaq: CSON), a leader in developing and
 commercializing a wide range of BioSurgical products, today announced that it
 has filed a Premarket Approval ("PMA") application with the U.S. Food and Drug
 Administration ("FDA") for CoSeal(TM) surgical sealant ("CoSeal"), a
 resorbable synthetic, self-polymerizing gel used for sealing around vascular
 reconstructions and vascular incision lines to prevent the leakage of blood.
     (Photo:  http://www.newscom.com/cgi-bin/prnh/20001211/COHESIONLOGO )
     The Company estimates that there are approximately 250,000 surgical
 procedures each year in the U.S. in which CoSeal could potentially be used
 under the proposed indications.  Additional U.S. clinical studies are underway
 with CoSeal for further cardiac and thoracic indications, which could expand
 the market by an additional 100,000 to 150,000 surgeries annually in the U.S.
     The current standard for vascular sealing is to apply manual pressure to
 the graft site or to wait for a clot to occur, oftentimes taking 30 minutes or
 longer to achieve.  CoSeal consists of two synthetic liquids that
 self-polymerize in seconds at the site of application to form a flexible
 hydrogel seal.  Prepared in less than 60 seconds, CoSeal does not require a
 primer coat or extra equipment such as light sources or heat to be activated.
 CoSeal is designed for use in minimally invasive surgeries, as well as in
 standard open surgical procedures.
     "My initial clinical experience with CoSeal has been excellent, and I
 believe this product represents a significant advancement in surgical
 sealing," said Hazim J. Safi, M.D., Chairman Cardiothoracic and Vascular
 Surgery, University of Texas-Houston Medical School, and a CoSeal clinical
 investigator.  "CoSeal can be used to prevent blood leakage from native tissue
 grafts as well as from synthetic grafts, such as PTFE, which are notoriously
 difficult to seal.  CoSeal is very easy to apply and works immediately."
     John Martin, M.D., FACS, Director, Vascular Center, Anne Arundel Medical
 Center, Annapolis, Maryland, commenting on his experience with CoSeal in
 vascular sealing said, "Using CoSeal to stop suture line bleeding that occurs
 in nearly all vascular cases translates into time-saving and
 problem-preventing benefits to the surgeon, patient, and institution.  CoSeal
 is completely synthetic, quick to prepare, and provides an instant hydrogel
 seal that resorbs in less than 30 days.  CoSeal's performance in sealing PTFE
 grafts for hemodialysis access and other vascular bypasses has been most
 impressive."
     The CoSeal PMA presents safety and effectiveness data in sealing arterial
 or venous grafts compared with a commercially available hemostatic agent.
 Data was obtained from 264 treated sites involving 148 patients in a
 prospective, randomized, controlled clinical study conducted at nine hospitals
 across the U.S.  Sealing with CoSeal was immediate in 47% of treated sites,
 compared to 20% with the control.  Since it is a mechanical barrier to
 leakage, CoSeal can work in patients with normal or compromised coagulation,
 such as those on heparin.
     "Bleeding and blood leakage around arterial and venous sites are problems
 that can lead to longer operating times and to surgical complications.  In
 particular, anastomotic bleeding can result in more frequent post-surgical
 complications, including the need for re-operation if, for example, a graft
 begins leaking after the surgical site has been closed," noted David Foster,
 Cohesion's chief executive officer.  "CoSeal is the world's easiest to use and
 most advanced, completely synthetic surgical sealant.  It is fast-acting and
 forms a tight bond to both the tissue surface and around synthetic grafts.
 CoSeal holds the potential to significantly reduce surgery times and minimize
 complications.  We expect this innovative tool will enable surgeons to do
 their jobs more efficiently, resulting in improved patient outcomes and
 reduced costs."
     Cohesion Technologies expects the FDA review time of the CoSeal PMA to
 take approximately 12 months.
     CoSeal received the CE Mark from the European Union in 2000, and is
 currently being introduced across Europe by several independent distributors
 as well as by U.S. Surgical in certain countries.  During 2001, Cohesion
 expects its distributors to launch CoSeal in some Asian markets and to file
 for regulatory approval in Japan.
     Cohesion Technologies is developing products for the estimated
 $1.5 billion worldwide emerging market for BioSurgical materials.  For more
 information on Cohesion Technologies, please visit the Company's Web site at
 www.cohesiontech.com.
 
     Except for the historical information contained herein, the matters
 discussed in this press release are forward-looking statements.   Such
 statements are indicated by words or phrases such as "anticipates,"
 "estimates," "projects," "believes," "intends," "expects" and similar words
 and phrases.  Actual results are subject to risks and uncertainties, including
 receipt of regulatory approvals, including approvals from the FDA,
 recommendations from FDA sponsored panels, clinical efficacy of and market
 demand for products, assessment of market size, Cohesion's position in the
 market, results of clinical studies, product performance, the rate of product
 adoption, usage, order and re-order rates, competition from other products,
 performance of direct or third-party sales representatives, the timing of
 product introductions, the success of scaling up product production, ability
 to achieve product revenue targets or market share, the timing and terms of
 sales arrangements with other companies, and potential unfavorable publicity
 regarding Cohesion Technologies or its products.  Such differences may be
 based upon factors within the Company's control, such as strategic planning
 decisions by management and reallocation of internal resources, or on factors
 outside the Company's control, such as scientific advances by third parties,
 court decisions in lawsuits filed by or against the Company, introduction of
 competitive products and delays by regulatory authorities, including approvals
 from the FDA.  Please see the Company's filings with the Securities and
 Exchange Commission including, without limitation, the Company's recent
 Form 10-K and Form 10-Qs, which identify specific factors that may cause
 actual results or events to differ materially from those described in the
 forward-looking statements.
 
 

SOURCE Cohesion Technologies, Inc.
    PALO ALTO, Calif., April 17 /PRNewswire/ --
 Cohesion Technologies, Inc. (Nasdaq: CSON), a leader in developing and
 commercializing a wide range of BioSurgical products, today announced that it
 has filed a Premarket Approval ("PMA") application with the U.S. Food and Drug
 Administration ("FDA") for CoSeal(TM) surgical sealant ("CoSeal"), a
 resorbable synthetic, self-polymerizing gel used for sealing around vascular
 reconstructions and vascular incision lines to prevent the leakage of blood.
     (Photo:  http://www.newscom.com/cgi-bin/prnh/20001211/COHESIONLOGO )
     The Company estimates that there are approximately 250,000 surgical
 procedures each year in the U.S. in which CoSeal could potentially be used
 under the proposed indications.  Additional U.S. clinical studies are underway
 with CoSeal for further cardiac and thoracic indications, which could expand
 the market by an additional 100,000 to 150,000 surgeries annually in the U.S.
     The current standard for vascular sealing is to apply manual pressure to
 the graft site or to wait for a clot to occur, oftentimes taking 30 minutes or
 longer to achieve.  CoSeal consists of two synthetic liquids that
 self-polymerize in seconds at the site of application to form a flexible
 hydrogel seal.  Prepared in less than 60 seconds, CoSeal does not require a
 primer coat or extra equipment such as light sources or heat to be activated.
 CoSeal is designed for use in minimally invasive surgeries, as well as in
 standard open surgical procedures.
     "My initial clinical experience with CoSeal has been excellent, and I
 believe this product represents a significant advancement in surgical
 sealing," said Hazim J. Safi, M.D., Chairman Cardiothoracic and Vascular
 Surgery, University of Texas-Houston Medical School, and a CoSeal clinical
 investigator.  "CoSeal can be used to prevent blood leakage from native tissue
 grafts as well as from synthetic grafts, such as PTFE, which are notoriously
 difficult to seal.  CoSeal is very easy to apply and works immediately."
     John Martin, M.D., FACS, Director, Vascular Center, Anne Arundel Medical
 Center, Annapolis, Maryland, commenting on his experience with CoSeal in
 vascular sealing said, "Using CoSeal to stop suture line bleeding that occurs
 in nearly all vascular cases translates into time-saving and
 problem-preventing benefits to the surgeon, patient, and institution.  CoSeal
 is completely synthetic, quick to prepare, and provides an instant hydrogel
 seal that resorbs in less than 30 days.  CoSeal's performance in sealing PTFE
 grafts for hemodialysis access and other vascular bypasses has been most
 impressive."
     The CoSeal PMA presents safety and effectiveness data in sealing arterial
 or venous grafts compared with a commercially available hemostatic agent.
 Data was obtained from 264 treated sites involving 148 patients in a
 prospective, randomized, controlled clinical study conducted at nine hospitals
 across the U.S.  Sealing with CoSeal was immediate in 47% of treated sites,
 compared to 20% with the control.  Since it is a mechanical barrier to
 leakage, CoSeal can work in patients with normal or compromised coagulation,
 such as those on heparin.
     "Bleeding and blood leakage around arterial and venous sites are problems
 that can lead to longer operating times and to surgical complications.  In
 particular, anastomotic bleeding can result in more frequent post-surgical
 complications, including the need for re-operation if, for example, a graft
 begins leaking after the surgical site has been closed," noted David Foster,
 Cohesion's chief executive officer.  "CoSeal is the world's easiest to use and
 most advanced, completely synthetic surgical sealant.  It is fast-acting and
 forms a tight bond to both the tissue surface and around synthetic grafts.
 CoSeal holds the potential to significantly reduce surgery times and minimize
 complications.  We expect this innovative tool will enable surgeons to do
 their jobs more efficiently, resulting in improved patient outcomes and
 reduced costs."
     Cohesion Technologies expects the FDA review time of the CoSeal PMA to
 take approximately 12 months.
     CoSeal received the CE Mark from the European Union in 2000, and is
 currently being introduced across Europe by several independent distributors
 as well as by U.S. Surgical in certain countries.  During 2001, Cohesion
 expects its distributors to launch CoSeal in some Asian markets and to file
 for regulatory approval in Japan.
     Cohesion Technologies is developing products for the estimated
 $1.5 billion worldwide emerging market for BioSurgical materials.  For more
 information on Cohesion Technologies, please visit the Company's Web site at
 www.cohesiontech.com.
 
     Except for the historical information contained herein, the matters
 discussed in this press release are forward-looking statements.   Such
 statements are indicated by words or phrases such as "anticipates,"
 "estimates," "projects," "believes," "intends," "expects" and similar words
 and phrases.  Actual results are subject to risks and uncertainties, including
 receipt of regulatory approvals, including approvals from the FDA,
 recommendations from FDA sponsored panels, clinical efficacy of and market
 demand for products, assessment of market size, Cohesion's position in the
 market, results of clinical studies, product performance, the rate of product
 adoption, usage, order and re-order rates, competition from other products,
 performance of direct or third-party sales representatives, the timing of
 product introductions, the success of scaling up product production, ability
 to achieve product revenue targets or market share, the timing and terms of
 sales arrangements with other companies, and potential unfavorable publicity
 regarding Cohesion Technologies or its products.  Such differences may be
 based upon factors within the Company's control, such as strategic planning
 decisions by management and reallocation of internal resources, or on factors
 outside the Company's control, such as scientific advances by third parties,
 court decisions in lawsuits filed by or against the Company, introduction of
 competitive products and delays by regulatory authorities, including approvals
 from the FDA.  Please see the Company's filings with the Securities and
 Exchange Commission including, without limitation, the Company's recent
 Form 10-K and Form 10-Qs, which identify specific factors that may cause
 actual results or events to differ materially from those described in the
 forward-looking statements.
 
 SOURCE  Cohesion Technologies, Inc.