Haemacure Corp. , a specialty bio-therapeutics company, reported Tuesday a wider net loss for the third quarter on lower revenue and higher operating expenses. The Montreal, Quebec-based company reported a net loss of C$2.0 million for the third quarter, wider than net loss of C$856 thousands in the same quarter last year. On a per share basis, the loss was flat year-over-year at C$0.01. Quarterly revenues declined to C$25 thousands from C$31 thousands in the previous year, reflecting the changes in the Canadian/US dollar exchange rate. The major source of revenues was from the sale of legacy fibrin sealant application devices. Operating expenses increased to C$2.0 million from C$869 thousands in the preceding year due to salaries and benefits for increase in personnel, purchase of supplies and raw material for the production of fibrin sealant, and clinical trials-related activities. As of July 31, the company had cash, cash equivalents and temporary investments of C$7.7 million. During the quarter, the company completed the construction phase of its manufacturing facility and started plasma processing in the unit. The company said that plasma processing is in line with expectations, and anticipates commercial launch of the product on the U.S. market at the beginning of 2011.In addition, Haemacure said it was carrying out development activities for expansion of its lead product candidate, human fibrin sealant, beyond its primary haemostatic and tissue sealant function.
Wednesday, September 3, 2008
Haemacure posts wider loss in Q3 - Update
Haemacure Corp. , a specialty bio-therapeutics company, reported Tuesday a wider net loss for the third quarter on lower revenue and higher operating expenses. The Montreal, Quebec-based company reported a net loss of C$2.0 million for the third quarter, wider than net loss of C$856 thousands in the same quarter last year. On a per share basis, the loss was flat year-over-year at C$0.01. Quarterly revenues declined to C$25 thousands from C$31 thousands in the previous year, reflecting the changes in the Canadian/US dollar exchange rate. The major source of revenues was from the sale of legacy fibrin sealant application devices. Operating expenses increased to C$2.0 million from C$869 thousands in the preceding year due to salaries and benefits for increase in personnel, purchase of supplies and raw material for the production of fibrin sealant, and clinical trials-related activities. As of July 31, the company had cash, cash equivalents and temporary investments of C$7.7 million. During the quarter, the company completed the construction phase of its manufacturing facility and started plasma processing in the unit. The company said that plasma processing is in line with expectations, and anticipates commercial launch of the product on the U.S. market at the beginning of 2011.In addition, Haemacure said it was carrying out development activities for expansion of its lead product candidate, human fibrin sealant, beyond its primary haemostatic and tissue sealant function.
CSMG Technologies Subsidiary Live Tissue Connect Awarded European Union CE Mark Certificate
CORPUS CHRISTI, Texas, Sep 02, 2008 (BUSINESS WIRE) -- CSMG Technologies, a technology management company, announced its subsidiary, Live Tissue Connect Technologies (LTC), has been awarded CE Mark (ConformitA(C) EuropeA(C)ne) certification for its Bipolar Forceps by BSI Product Services in its capacity as Notified Body for the Council Directive 93/42/EEC.The CE Mark allows LTC to market its forceps with the previously CE Mark certified VAD.400 generator within the 30 countries of the European Economic Area (EEA) and Switzerland. This announcement follows LTC Technologies previously announced 510(k) clearance from the FDA to market both the aforementioned generator and forceps in the United States.
Obtaining CE Mark certification is an extensive process that requires evaluation of the device by the Notified Body to ensure compliance with EU directives and standards. To become certified, a company must have an established quality system and must submit a technical file providing evidence of compliance that the product meets applicable directives and standards.
The LTC Bipolar Forceps consist of two configurations of disposable instruments and are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins, and ducts. The Bipolar Forceps system is an alternative to mechanical clamping (clips or staples) and suturing, and can be used on veins and arteries up to 7mm diameter, on ducts up to 2mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased to announce LTC has received this CE Mark certificate. Combined with their FDA 510(k) clearance, LTC may now begin the process of marketing their sealing system in both Europe and the United States. I want to congratulate the LTC Technologies division, headquartered in Santa Barbara, whose efforts succeeded in securing this very important certification."Frank D. D'Amelio, President of LTC Technologies added, "We have set forth an aggressive schedule for commercialization of LTC's technology and we continue to execute against that plan as evidenced by the receipt of this CE Mark certificate and our recent FDA 510(k) clearance. In addition, achieving this CE certification demonstrates our commitment to be a global organization with world-wide distribution. Our sales recruitment efforts are proceeding according to plan and potential dealers have expressed much enthusiasm for our technology and the opportunity to join the LTC sales team."
Bayer Submits Recombinant Human Thrombin for European Approval
2 Sep 2008 , Berlin : Bayer Schering Pharma has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for recombinant human thrombin (INN: thrombin alfa) as a topical aid to control surgical bleeding.Thrombin alfa is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the global rights to thrombin alfa for all markets outside the US. ZymoGenetics retains US market rights and Bayer provides its sales force to support the first three years of the US market launch. Thrombin alfa received United States Food and Drug Administration (FDA) approval in January 2008 and is 
marketed as Recothrom® Thrombin, topical (Recombinant). Bayer plans using the product name Recothrom® globally, pending regulatory approval.Thrombin alfa is a recombinant form of human thrombin that is structurally and functionally similar to the natural enzyme which is an important factor in the blood clotting cascade. Used in surgery, the product is applied topically to the operation wound and may be administered as a spray or with a surgical sponge. Upon application, thrombin alfa activates the final steps of the coagulation cascade to stop the bleeding. The biotechnologically produced recombinant thrombin alfa provides surgeons with a plasma-free thrombin alternative for surgical hemostasis. As it is not derived from animal or human blood, it does not imply the risk of infections which is generally associated with plasma products.In Europe, there are in excess of 4 million surgical procedures performed annually where a hemostatic product may be used and surgeons currently have to rely on either sponges or tissue sealants. Thrombin alfa would be the first stand-alone thrombin product to control bleeding during surgery and may improve the therapeutic options in Europe.
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