BURLINGTON, Mass. - Fractyl Health, Inc. (NASDAQ:GUTS), a company specializing in metabolic disease treatments, has announced promising 6-month follow-up data from its ongoing German real-world study of the Revita procedure for type 2 diabetes (T2D).
The data indicates that the first 14 participants in the registry study have shown sustained improvements in blood glucose levels and weight reduction, with a decrease in the need for T2D medications after a single Revita treatment.
These participants, with a median age of 62 and a history of advanced T2D for an average of 14 years, underwent Revita and experienced an average total body weight loss of 8.1% six months post-procedure.
Additionally, fasting blood glucose levels decreased from a median of 153 mg/dL to 116 mg/dL, and HbA1c levels—a measure of blood sugar control—improved from 9.2% to 7.6%. Notably, these improvements were achieved with patients stabilizing or reducing their glucose-lowering medication intake.
The Revita procedure, which involves remodeling the duodenal lining through hydrothermal ablation, has not resulted in any device or procedure-related serious adverse events among the registry participants to date. This study is part of Fractyl Health’s broader clinical development program aimed at providing durable weight maintenance and diabetes control.
Professor Stephan Martin, who presented the 3-month follow-up results at the German Diabetes Association annual meeting, emphasized the significance of the improvements in patients with long-standing and inadequately controlled T2D. The company's Chief Scientific Officer, Timothy Kieffer, echoed this sentiment, highlighting the potential of Revita in maintaining weight loss over time.
Currently, 26 out of 33 patients treated with Revita in Germany have consented to participate in the registry, with periodic updates expected as the study progresses. Fractyl Health is also advancing its Rejuva platform, which focuses on gene therapies for obesity and T2D, although it is still in preclinical development.
The information in this article is based on a press release statement from Fractyl Health, Inc.
InvestingPro Insights
As Fractyl Health, Inc. (NASDAQ:GUTS) continues to make strides in the treatment of metabolic diseases with its Revita procedure, the financial landscape of the company is equally important for investors to consider. With a market capitalization of 296.37 million USD, Fractyl Health is navigating the competitive biotech industry with a focus on innovation and clinical development.
The company is currently trading at a price that is significantly below its 52-week high, with the price being only 42.69% of that peak value. This could suggest a potential entry point for investors believing in the long-term prospects of Fractyl Health’s treatments. The InvestingPro Data also shows a notable decline in the stock price over the last six months, with a total return of -51.83%, reflecting the volatility and risks associated with biotech investments.
While the company has shown a gross profit margin of 35.83% over the last twelve months as of Q4 2023, it is important to note that Fractyl Health has not been profitable during this period, with an operating income margin of -42363.33%. This aligns with the InvestingPro Tips, indicating that analysts do not anticipate the company will be profitable this year. Moreover, the company does not pay a dividend to shareholders, which is a common characteristic of growth-focused biotech firms reinvesting earnings into research and development.
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