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Lexington, SC, and Colorado Springs, CO-Biosyntrx Corp. is partnering with Wellosophy Corp. to include a professional-strength version of a proprietary hydrogel gastric bulking technology (Swell) into Biosyntrx’s new mealtime portion-control product (Avantrx).
Lexington, SC, and Colorado Springs, CO-Biosyntrx Corp. is partnering with Wellosophy Corp. to include a professional-strength version of a proprietary hydrogel gastric bulking technology (Swell) into Biosyntrx’s new mealtime portion-control product (Avantrx). The new formula will be delivered in a certified kosher and bovine spongiform encephalopathy-free, two-piece gelatin capsule containing 750-mg microbeads, according to the companies.
“We have identified more than 50 peer-reviewed studies that suggest a direct correlation between excess weight and an increased risk for each of the four major vision-loss or blinding diseases: cataracts, glaucoma, diabetic retinopathy, and age-related macular degeneration,” said Ellen Troyer, Biosyntrx executive vice president and chief research officer.
The proprietary gastric bulking agent was invented by Richard C. Davis, MD, the founder, chief executive officer, and chief scientific officer of several companies, including the publicly traded OccuLogix Inc. and UroQuest Medical Corp.
The hydrogel material is a member of the same chemical class as other bio-inert polyacrylate hydrogel compounds that are marketable under the FDA’s 1994 GRAS (generally recognized as safe) exemption; the basic chemical molecule is similar to the polyacrylate used in IOLs, according to the companies.
When a capsule is taken 45 to 60 minutes before a meal with an 8- to 12-ounce glass of room-temperature water, the hundreds of microbeads within the capsule collectively expand within minutes to fill a volume the size of a large apple, according to the companies. The microbeads are retained in the stomach for 2 to 3 hours then pass through the gastrointestinal tract and are eliminated naturally.
The technology recently was evaluated in a multicenter clinical trial that included 30 overweight volunteers at four physician-managed weight-loss clinics. Although not definitive, the study found that participants were able to reduce meal portions by an average of 34% and had progressive weight loss averaging 7.6 pounds over the 4-week study period; no significant side effects were reported, according to the companies. Additional studies are being planned to evaluate the safety and efficacy of the product in adolescent children and in adults with type 2 diabetes.