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Sigrid Therapeutics Secures U.S. Market Access for SiPore® Technology

Sigrid Therapeutics, a pioneering company in the health technology sector, has proudly announced that it has gained access to the U.S. market for its cutting-edge SiPore® technology. This landmark achievement follows the impressive outcomes of the SHINE study, which is recognized as the largest of its kind focusing on prediabetes treatments.

The Significance of SiPore® Technology

SiPore® technology is poised to play a vital role in addressing the growing challenge of diabetes and obesity in the United States. This proprietary technology supports the innovative medical food, Carb Fence™, which is specifically designed for individuals with prediabetes—a condition that affects approximately one-third of adults in the U.S.

The SHINE study demonstrated the efficacy of Carb Fence™, a fast-acting liquid formula utilizing SiPore®. The study results highlighted that the formula effectively leads to long-term reductions in blood sugar levels, improves glucose metabolism, and assists in weight management while preserving muscle mass. Given these outcomes, Carb Fence™ has been positioned as a groundbreaking medical food, setting a new standard in dietary management for such conditions.

Clinical Validation and Evidence

The SHINE study was meticulously designed as a double-blind, placebo-controlled trial that enrolled 318 participants with elevated blood sugar levels and excess body weight across 27 clinics in three European countries. The robust data revealed a significant reduction in HbA1c levels among participants using Carb Fence™ compared to those on placebo.

Particularly noteworthy was that female participants experienced statistically significant reductions, demonstrating clear evidence of Carb Fence™'s mechanism of action. Males also observed clinically meaningful reductions, although not statistically significant due to a notable placebo response that is well-documented in clinical trials.

Interestingly, many participants in the male placebo group exhibited improvements in liver health, likely attributable to lifestyle changes such as reduced alcohol consumption, despite detailed instructions to maintain their usual habits. When analyzing the data, excluding those with significant liver health improvements from the placebo group helped eliminate the observed placebo effect on A1c.

Future Outlook and Expansion

Sana Alajmovic, Co-Founder and CEO of Sigrid Therapeutics, expressed enthusiasm about these developments. She stated, “These achievements not only validate SiPore® as a safe, effective, and accessible solution to the diabetes and obesity crises but also position the platform for growth across multiple industries.” This sentiment reflects Sigrid’s commitment to innovating for better health outcomes.

With the U.S. medical food market rapidly expanding, the introduction of Carb Fence™ represents a crucial step in battling prediabetes and related health issues, opening doors for future innovations in health technology.

As the healthcare landscape continues to evolve, Sigrid Therapeutics remains dedicated to delivering pioneering solutions that empower individuals in managing their health. The research backing the SiPore® technology underscores its potential and adaptability in a variety of therapeutic areas, ensuring a promising future for those affected by metabolic disorders.

For further information or inquiries, please contact Sana Alajmovic, Co-Founder and CEO of Sigrid Therapeutics.