HERE'S THE NEWS ON OUR STOCK...............
CoStasis Surgical Hemostat Granted Streamlined Review by FDA
Business Wire - July 29, 1999 07:20
PALO ALTO, Calif.--(BW HealthWire)--July 29, 1999--
-U.S. Approval Could Occur Sooner Than Projected-
Cohesion Technologies (Nasdaq NM: CSON) today reported that the U.S. Food and Drug Administration (FDA) has accepted for filing its pre-market approval (PMA) application for CoStasis(TM) Surgical Hemostat (CoStasis), a liquid hemostat designed to stop or control surgical bleeding.
The FDA has also informed the company that CoStasis will be given streamlined review status. Because CoStasis represents a class of devices that is very well understood by the Agency, an advisory panel hearing will not be required. The company had originally anticipated the review process, including a panel meeting, could take approximately one year from its early June 1999 filing date but, as a result of the FDA's recent decision to streamline the review process by not requiring the panel meeting, the company believes that total review time could be reduced to as little as 180 days.
"We are delighted with this determination by the FDA and pleased that the potential review time for CoStasis could be significantly reduced," commented Frank DeLustro, Ph.D., president and chief operating officer. "We look forward to working with the FDA over the next several months and plan to meet with the Agency around the 100th day of review to discuss any outstanding issues related to the PMA."
The PMA submission for CoStasis includes data on 318 patients treated at 10 major U.S. Medical Centers. CoStasis stopped bleeding in 99% of soft tissue sites within 10 minutes, compared with only 66% of those in the control group treated with a collagen hemostatic sponge. Examples of soft tissue bleeding include coronary by-pass surgery anastomotic sites, liver surgery, muscle flaps and the removal sites of cancerous tumors.
CoStasis is a liquid, sprayable hemostat and is the only product that provides all four of the important components for blood clotting -- platelets, fibrinogen, thrombin and collagen. CoStasis is designed to stop or control surgical bleeding when sprayed on the intended area. In addition to clinical data showing that the product is faster at controlling bleeding than traditional methods, CoStasis is quick and easy to prepare, easy to use and has the added safety benefit of using the patient's own fibrinogen and platelets, rather than blood pooled together from multiple donors. CoStasis does not require reconstitution to prepare the product nor does it require tamponade or ancillary equipment to activate it.
The Company estimates that other hemostatic products currently in use generate international sales (excluding the U.S.) of approximately $250-$300 million per year, while the potential global market (including the U.S.) is estimated at $850 million annually.
Cohesion Technologies is developing products for the estimated $1.3 billion worldwide surgical hemostasis and sealant markets. For more information on Cohesion Technologies, please visit the Company's Web site at www.cohesiontech.com.
Cohesion Technologies discovers, develops and commercializes innovative resorbable biodevices, adhesive technologies and delivery systems in the fields of tissue repair and regeneration.
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," "estimate," "projects," "believes," "intends," "expects" and similar words and phrases. Actual results are subject to risks and uncertainties, including the timing of product introductions, the success of scaling up product production, the timing and terms of sales arrangements with other companies, receipt of regulatory approvals, clinical efficacy of and market demand for products, results of clinical studies and potential unfavorable publicity regarding Cohesion Technologies or its products, among other matters discussed in this release. 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, introduction of competitive products and delays by regulatory authorities. Please see the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's Form 10-K and Form 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. The company disclaims any obligation to update any of the forward-looking statements contained herein to reflect future events or developments.
CONTACT: Company Contact:
Cohesion Technologies, Palo Alto
Lisa Morgensai, 650/320-5633
www.cohesiontech.com
or
Investor Relations:
Lippert/Heilshorn & Associates, New York
Bruce Voss (bruce@lhai.com), 310/575-4848
www.lhai.com
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