TORONTO, ONTARIO–(Marketwire – Jan. 10, 2012) – BioExx Specialty Proteins Ltd. (TSX:BXI) (“BioExx” or the “Company”) announced today that it has received a letter from the US Food & Drug Administration (“FDA”), wherein the FDA confirms that it has no questions regarding BioExx’s conclusion that its canola protein products are Generally Recognized As Safe (“GRAS”) for use in a variety of foods and beverages.
The FDA response was pursuant to a GRAS Notice submitted by BioExx to FDA documenting its conclusion that Isolexx® (canola protein isolate) and Vitalexx™ (hydrolyzed canola protein isolate) are GRAS for use in a variety of foods and beverages. The Notice also included a report with such a conclusion from a panel of qualified experts. The Notice informed FDA that Isolexx® and Vitalexx™ are GRAS, through scientific procedures, as ingredients in foods such as bakery products, snack foods, beverages, soups, dairy products, dry instant milkshake mixes and protein drinks, instant powdered nutritional beverages, processed meat and poultry products, vegetarian food products/meat analogues and meal replacement and nutritional bars.
While BioExx already has self-affirmed GRAS status for its protein products, the enhanced stature of being GRAS Notified is expected to assist in market recognition and market acceptance, particularly in specialty applications. The Company believes this enhancement to its product portfolio will also assist its current global strategic partnering initiative.
The Company also notes that its progress continues towards Novel Food Registration with the European Food Safety Authority, and it anticipates completion of the process in the coming months. EU market size and growth, and a strong orientation towards healthy living and sustainability, make this market a key long-term focus for BioExx.
Isolexx® is a protein isolate with at least 90% purity (protein content), comprised of un-denatured soluble proteins from non-GMO canola. This allows Isolexx® to have excellent solubility, strong foaming and emulsification characteristics, and an excellent nutritional profile. The protein delivers more than 109% of the recommended essential amino acids (WHO/FAO ref. 2007) and is well-digested with a true digestibility of 95%. Isolexx™ is well suited to a wide variety of applications where soy, whey, or milk proteins are traditionally used. BioExx has also established a self-affirmed GRAS position for Advantexx™, which is a canola protein currently being produced by the Company at approximately 86% purity (protein content).
Vitalexx™ is a hydrolyzed protein with at least 80% purity (peptides and amino acid content) and a very low average molecular weight. This characteristic allows excellent digestion and absorption. Vitalexx™ is 100% water soluble, forming a clear solution across a wide pH range. It has an excellent amino acid profile, with more than 117% of the recommended essential amino acids (WHO/FAO ref. 2007). The BioExx protein hydrolysis process also lowers the prospective risk of immunological response, making it appropriate for sensitive immune systems and lower tolerance applications. The true digestibility of Vitalexx™ is 98%, being easily metabolized and biologically available. Vitalexx™ is intended for use in human food products including nutritional beverages (protein drinks, fruit juices, infant formula, clinical nutrition), and a range of healthy food applications such as protein bars.
About BioExx Specialty Proteins Ltd.
Headquartered in Toronto, Canada, BioExx is a technology and processing company focused on the separation of oil and high-value proteins from oilseeds for global food, beverage, nutrition, and other markets. BioExx employs trade secret, patented and patent-pending technologies that utilize significantly lower temperatures than conventional oilseed processing, in order to enable the improved separation of proteins from oilseeds. BioExx believes that these processes cumulatively have the potential to make a valuable contribution to global food and protein supply while maintaining an environmentally sustainable footprint.