Skin graft fixation for burn victims using fibrin sealant represents
multi-million dollar market opportunity for Company
MONTREAL, Dec. 9 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX:HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, disclosed today the positive results of a preclinical study conducted on the use of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN, in skin graft fixation for burn victims.
"We are very excited with the results of this preclinical study, which suggest that Haemacure's fibrin sealant technology may provide a safe and effective alternative to staples and sutures and reduce discomfort of burn patients receiving skin grafts" said Joseph Galli, Chairman and CEO of Haemacure. "Skin graft fixation is the second new potential product indication based on the formulation of our lead hemostasis product candidate. This demonstrates again our commitment to leveraging our technology platform to meet major medical needs and position Haemacure as the only global, independent fibrin sealant-centric company", concluded Mr. Galli.
The results of this preclinical study strongly suggest that the use of Haemacure's fibrin sealant, with a reduced thrombin concentration, may provide advantages over staples and sutures, the current standard of care, when used to secure skin grafts to recipient wound sites. The use of staples or sutures in skin graft fixation for burn patients can often lead to post-operative complications such as wound infection, and create anxiety over pain during removal.
The objective of the study was to evaluate the effectiveness of tissue fixation, rather than hemostasis. As a result, the thrombin concentration of the fibrin sealant was reduced to provide additional time for the manipulation and positioning of the skin grafts. There were no alterations to any of the other components of the fibrin sealant.
The use of the fibrin sealant between the skin graft and the wound bed interface was shown to (1) provide adhesive qualities allowing fixation of the graft without the use of staples or sutures, (2) seal the tissue bed layer, thereby inhibiting seroma or hematoma formation without compromising the healing process, and (3) likely provide more even healing, resulting in a higher percentage of graft take with a more acceptable cosmetic outcome than using mechanical fixation.
Previous preclinical studies have demonstrated the effectiveness of Haemacure's fibrin sealant hemostasis formulation in preventing the formation of post-surgical adhesions. The ability to utilize the fibrin sealant hemostasis formulation for the additional indications of adhesion prevention and skin graft fixation is anticipated to reduce manufacturing and clinical risks and to significantly shorten time-to market, by as much as three to five years. Haemacure plans on conducting additional studies to support and confirm these findings.
Haemacure Corporation is a specialty biotherapeutics company developing high-value human plasma-derived protein products for commercialization. Haemacure's research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical haemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. Haemacure has identified eleven additional specialty proteins and enzymes in one if its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure is headquartered in Montreal, Canada and operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX.
Certain of the statements contained in this news release are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the biotech industry, changes in the regulatory environment in the jurisdictions in which Haemacure does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. Haemacure disclaims any intention or obligation to update these statements.
|SOURCE Haemacure Corporation|
Copyright©2008 PR Newswire.
All rights reserved