Latest news with #Revita
Business Insider
6 days ago
- Health
- Business Insider
Fractyl Health announces two-year follow-up data from Revita study
Fractyl Health (GUTS) announced two-year follow-up data from the Germany Real-World Registry study that showed a single Revita procedure led to durable weight loss and improved glucose control in people with obesity and advanced T2D. These data underscore Revita's potential to provide a potent and durable non-drug alternative for patients struggling with long-term metabolic control. The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7%-10%, BMI of 45 kg/m, and were on at least one glucose-lowering agent. At baseline, the first nine participants with two years of follow-up had a median age of 62 years, median weight of 104 kg, and a median HbA1c of 9.6%, despite being on up to three GLAs. After a single Revita procedure, these nine participants achieved a median weight loss of 9.6% with weight decreasing from 104 kg to 97 kg at 1 year, a result that was sustained throughout 2 years. Notably, 7 of 8 participants experienced at least a 5% weight reduction, and 5 of 8 saw reductions of 10%. Only one participant, with a history of cortisone therapy known to cause weight gain, experienced modest weight gain. In parallel, median HbA1c reduced by 1.6%, from 9.6% at baseline to 7.2% at 1 year, and this improvement was sustained throughout two years, even as participants reduced or stabilized their use of GLAs. Three patients were on a GLP-1 drug at the time of study entry and were still on a GLP-1 drug through two years of follow-up. No device- or procedure-related serious adverse events have been reported to date. In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through two years of follow-up. These findings highlight the potential of a single Revita treatment to deliver durable weight maintenance in a real-world setting. Thirty-four participants are currently enrolled in the Germany Real-World Registry study. While the study is no longer enrolling new patients, Fractyl will continue protocol-defined follow-up of participants and share outcomes on an ongoing basis. Revita is being studied in an ongoing IDE-approved REMAIN-1 pivotal study to evaluate its potential safety and efficacy in post-GLP-1 weight maintenance. These new findings from Germany add real-world momentum to Fractyl's upcoming pivotal trial readouts, including Midpoint Cohort data from its ongoing REMAIN-1 study, which is expected in Q3 2025, and primary endpoint data from the Pivotal Cohort, anticipated in H2 2026. Together, these clinical milestones are designed to demonstrate Revita's potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes for patients with obesity.
Yahoo
29-07-2025
- Business
- Yahoo
Canaccord Genuity Reiterates Buy Rating on Fractyl Health (GUTS)
Fractyl Health, Inc. (NASDAQ:GUTS) is one of the 11 Best New Penny Stocks to Buy Right Now. On July 18, Canaccord Genuity reiterated its 'Buy' rating on Fractyl Health, Inc. (NASDAQ:GUTS) with a price target of $12. This decision came after the company had shared new data from its Phase 3 trial of its lead product candidate, Revita. A medical laboratory surrounded by advanced equipment, symbolizing the company's cutting-edge innovation in healthcare. Canaccord Genuity had follow-up discussions with several physicians following the data presented by Fractyl Health, Inc. (NASDAQ:GUTS) from the open-label group of its ongoing Phase 3 trial for Revita in weight maintenance at the American Diabetes Association meeting. These physicians who were consulted by the investment firm were all from large academic hospitals in the US. The physicians had different opinions on the mechanism behind the Revita procedure and the potential market size. However, they all agreed that controlled data is needed to fully assess the clinical profile. The physicians said the main concern is the durability of the effect. Canaccord pointed out that even conservative market share estimates from the physicians surpassed the firm's current modeling expectations. Canaccord Genuity expects Revita to reach 1% peak penetration in the weight maintenance population with a 60% probability of success. The investment firm projects that peak sales could reach $400 million in 2031. Fractyl Health, Inc. (NASDAQ:GUTS) is a metabolic therapeutics company focused on pursuing therapies that target root causes of obesity and type 2 diabetes. While we acknowledge the potential of GUTS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best American Semiconductor Stocks to Buy Now and 11 Best Fintech Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
26-05-2025
- Health
- Yahoo
HairSmart Voted #1 Post-Transplant Shampoo by Real Users in 2025 Consumer Survey
CLEVELAND, May 26, 2025 (GLOBE NEWSWIRE) -- In a comprehensive customer feedback survey conducted in Q1 2025, HairSmart Root Scalp Hair Therapy Shampoo has been voted the #1 shampoo for post-hair transplant care by over 600 verified users across the U.S., outperforming leading competitors like Nioxin, Revita, and Pura D'or. The survey, commissioned by an independent consumer insights firm, found that 92% of respondents reported increased scalp comfort and reduced irritation after switching to HairSmart, while 91% confirmed the shampoo met their key post-transplant needs, including gentle cleansing, soothing ingredients, and support for healthy hair regrowth. Why HairSmart Stands Out Hair transplant patients face a critical healing phase where scalp sensitivity and hair follicle strength are paramount. Survey respondents repeatedly praised HairSmart's: Sulfate & Paraben-Free Formula: Safe for delicate, healing skin Ayurvedic Blend of Anantmool, Amla, Ginger, and Neem: Reduces inflammation and promotes follicle health Balanced Scalp pH: Supports a clean, non-irritated environment for hair growth Clinically-Informed and Patient-Recommended: Trusted by transplant recipients and clinics alike Video Link One user shared, "HairSmart was the only shampoo gentle enough for my healing scalp. It soothed irritation and helped my new hair grow stronger." Survey Highlights Participants, all within 3 weeks to 12 months post-transplant, rated shampoos on scalp irritation, hair texture, shedding, and overall satisfaction. HairSmart led the pack: Rank Shampoo Highly Satisfied Users 1 HairSmart Root Scalp Therapy 94% 2 Revita Hair Stimulating Shampoo 72% 3 Pura D'or Anti-Thinning 68% - Nioxin Cleanser 51% Moreover, 76% of respondents noted their hair transplant specialist recommended plant-based or Ayurvedic shampoos, validating HairSmart's formulation approach. Prerna Video Link Real User Testimonials 'After my transplant, my scalp was very itchy and dry. Switching to HairSmart brought relief within days. My hair feels stronger and healthier now.' – Michael R., Los Angeles 'I tried several shampoos, but HairSmart was the only one my dermatologist approved for post-transplant care. It really made a difference.' – Sarah T., New York To learn more about how often to wash your hair, read more. The Ayurvedic Advantage HairSmart's carefully selected ingredients harness centuries-old wisdom alongside modern research: Anantmool: Calms inflammation and detoxifies the scalp Amla: Strengthens hair roots and boosts collagen Ginger: Enhances blood circulation and fights microbes Neem: Naturally controls dandruff and itching This unique formula meets the growing consumer demand for clean, effective, and traditional hair care solutions. Read the top 10 shampoos for hair growth! About HairSmart HairSmart is a leader in drug-free, plant-based hair care, offering clinically tested products designed for sensitive scalps and hair loss recovery. The Root Scalp Hair Therapy Shampoo exemplifies their commitment to blending natural science with wellness. For the full survey report and more details on HairSmart products, visit Press Contact:Manish GupraChief Marketing Officer, HairSmart manishg@ +91 8802821783 Videos accompanying this announcement are available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Health
- Yahoo
HairSmart Voted #1 Post-Transplant Shampoo by Real Users in 2025 Consumer Survey
CLEVELAND, May 26, 2025 (GLOBE NEWSWIRE) -- In a comprehensive customer feedback survey conducted in Q1 2025, HairSmart Root Scalp Hair Therapy Shampoo has been voted the #1 shampoo for post-hair transplant care by over 600 verified users across the U.S., outperforming leading competitors like Nioxin, Revita, and Pura D'or. The survey, commissioned by an independent consumer insights firm, found that 92% of respondents reported increased scalp comfort and reduced irritation after switching to HairSmart, while 91% confirmed the shampoo met their key post-transplant needs, including gentle cleansing, soothing ingredients, and support for healthy hair regrowth. Why HairSmart Stands Out Hair transplant patients face a critical healing phase where scalp sensitivity and hair follicle strength are paramount. Survey respondents repeatedly praised HairSmart's: Sulfate & Paraben-Free Formula: Safe for delicate, healing skin Ayurvedic Blend of Anantmool, Amla, Ginger, and Neem: Reduces inflammation and promotes follicle health Balanced Scalp pH: Supports a clean, non-irritated environment for hair growth Clinically-Informed and Patient-Recommended: Trusted by transplant recipients and clinics alike Video Link One user shared, "HairSmart was the only shampoo gentle enough for my healing scalp. It soothed irritation and helped my new hair grow stronger." Survey Highlights Participants, all within 3 weeks to 12 months post-transplant, rated shampoos on scalp irritation, hair texture, shedding, and overall satisfaction. HairSmart led the pack: Rank Shampoo Highly Satisfied Users 1 HairSmart Root Scalp Therapy 94% 2 Revita Hair Stimulating Shampoo 72% 3 Pura D'or Anti-Thinning 68% - Nioxin Cleanser 51% Moreover, 76% of respondents noted their hair transplant specialist recommended plant-based or Ayurvedic shampoos, validating HairSmart's formulation approach. Prerna Video Link Real User Testimonials 'After my transplant, my scalp was very itchy and dry. Switching to HairSmart brought relief within days. My hair feels stronger and healthier now.' – Michael R., Los Angeles 'I tried several shampoos, but HairSmart was the only one my dermatologist approved for post-transplant care. It really made a difference.' – Sarah T., New York To learn more about how often to wash your hair, read more. The Ayurvedic Advantage HairSmart's carefully selected ingredients harness centuries-old wisdom alongside modern research: Anantmool: Calms inflammation and detoxifies the scalp Amla: Strengthens hair roots and boosts collagen Ginger: Enhances blood circulation and fights microbes Neem: Naturally controls dandruff and itching This unique formula meets the growing consumer demand for clean, effective, and traditional hair care solutions. Read the top 10 shampoos for hair growth! About HairSmart HairSmart is a leader in drug-free, plant-based hair care, offering clinically tested products designed for sensitive scalps and hair loss recovery. The Root Scalp Hair Therapy Shampoo exemplifies their commitment to blending natural science with wellness. For the full survey report and more details on HairSmart products, visit Press Contact:Manish GupraChief Marketing Officer, HairSmart manishg@ +91 8802821783 Videos accompanying this announcement are available at while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
04-04-2025
- Business
- Yahoo
Fractyl Health, Inc. (GUTS): Insider Were Buying In Q1 2025
We recently published a list of . In this article, we are going to take a look at where Fractyl Health, Inc. (NASDAQ:GUTS) stands against other micro-cap stocks insiders were buying in Q1 2025. The White House announced Tuesday that Trump's tariffs would take effect immediately after being unveiled on Wednesday. In anticipation of these 'reciprocal tariffs,' which will apply to all countries, the stock market reacted. By Tuesday morning, the broader market index and Nasdaq Composite dropped by about 0.2%, while blue-chip companies lost 0.06%. Amid ongoing market uncertainty, insider trading often comes under the spotlight. Executive stock purchases can signal optimism, but sales may reflect personal financial decisions or a need to diversify investments. To maintain transparency, executives typically follow pre-arranged strategies, like 10b5-1 plans. While insider trading can offer valuable information, it's important to evaluate it in the broader context of the company's financial stability and current market trends. Today, we're focusing on stocks with micro market capitalizations that have seen significant insider buying in the first quarter of the year. Using Insider Monkey's insider trading screener, we identified companies with market caps under $250 million where at least three insiders purchased shares in the past three months. From this list, we ranked the top 10 stocks with the highest number of insiders making purchases. Stocks that have been recently covered were excluded from our analysis. Our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds, focusing on insider trading and stock picks from hedge fund investor newsletters and conferences. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). With each stock, we note the number of insiders who acquired shares in the first quarter and market capitalizations. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. Number of insiders buying: 5 Market Capitalization: $54.30 million Fractyl Health is a metabolic therapeutics company focused on developing treatments for type 2 diabetes (T2D) and obesity. It is developing the Revita DMR System, a procedure targeting duodenal dysfunction, and Rejuva, a gene therapy platform aimed at long-term remission of T2D by altering metabolic hormone function in the pancreas. In January, the company announced a strategic decision to focus Revita exclusively on weight maintenance, prioritizing the REMAIN-1 pivotal study to address the most pressing need in obesity care, while advancing its novel Rejuva gene therapy platform into first-in-human studies. Fractyl paused investment in its Revita programs for T2D, which consisted of the REVITALIZE-1 study, and the Germany Real-World Registry study. In March, the company announced positive early data from its REVEAL-1 cohort in the REMAIN-1 pivotal study, suggesting that Revita may help prevent weight regain after stopping GLP-1 drugs. This addresses an unmet need in obesity treatment as the demand for scalable, non-pharmacologic solutions grows with increasing GLP-1 discontinuation rates. During the first quarter, five insiders acquired approximately $193,475 worth of Fractyl Health shares at an average price of $1.24 per share. Currently, the stock trades at $1.11 per share, having declined 46.12% year-to-date and 83.53% over the past 12 months. Net loss amounted to $68.69 million, compared to net loss of $77.09 million in 2023. For the full year 2024, Fractyl Health reported revenue of $93,000, compared to $120,000 in 2023. Gross profit was $43,000, flat compared to the previous year. Based on two Wall Street analysts' estimates, Fractyl Health stock is a 'Moderate Buy' with a price target of $8.00. The average price target suggests a 620.72% potential upside from the latest price. Overall, GUTS ranks 8th on our list of micro-cap stocks insiders were buying in Q1 2025. While we acknowledge the potential of GUTS our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than GUTS but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
