Latest news with #ShantanuGaur
Business Wire
07-07-2025
- Business
- Business Wire
Allurion Announces Submission of PMA to FDA and Additional Analyses From Pivotal AUDACITY Study That Meet Both Endpoints
BUSINESS WIRE)-- Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced submission of the fourth and final module of the Pre-Market Approval (PMA) application to the Food & Drug Administration (FDA) and additional, supportive analyses from the AUDACITY Study that meet both of the pre-specified co-primary endpoints. Topline results announced previously showed that the AUDACITY Study met its first co-primary endpoint related to responder rate at 48 weeks. Allurion Balloon subjects also exhibited substantially greater weight loss compared to control subjects at 48 weeks, with a mean difference in total body weight loss of 3.77%, resulting in a 2.69% super-superiority margin. This margin was less than the pre-specified 3% super-superiority margin needed to meet the comparative co-primary endpoint and was impacted, in part, by higher-than-expected weight loss in control subjects. Additional analyses submitted in the PMA application were conducted to account for the results seen in the control group. Using imputation methods that account for the variations observed in the control subjects, the mean difference in weight loss between the treatment and control groups at 48 weeks was 4.34% with a super-superiority margin of 3.14%, exceeding the pre-specified 3% super-superiority margin in the second co-primary endpoint (p = .0142). At 40 weeks, using these imputation methods, the mean difference in weight loss between the treatment and control groups was 4.90% with a super-superiority margin of 3.75%, considerably exceeding the pre-specified margin in the second co-primary endpoint (p = .0006). 'We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon,' said Dr. Shantanu Gaur, Founder and CEO of Allurion. 'We believe that these analyses are more suitable for the trends observed in both groups in the AUDACITY Study and further strengthen our positive topline data. With the PMA now submitted, we are looking forward to working with the FDA toward an approval.' The AUDACITY Study is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. 550 subjects were randomized 1:1 to either two cycles of the Allurion Balloon 1 or a control group that received moderate intensity lifestyle therapy. Subjects in the treatment group received their first Allurion Balloon at Week 0, which passes at approximately Week 16, and a second Allurion Balloon at Week 24, which passes at approximately Week 40. Co-primary endpoints based on Allurion Balloon subject responders and a comparison of percent total body weight loss between groups were measured at Week 48, approximately eight weeks after the second Allurion Balloon passes at Week 40. About Allurion Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world's first and only swallowable, Procedureless ™ gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan. The Allurion Gastric Balloon is an investigational device in the United States. For more information about Allurion and the Allurion Virtual Care Suite, please visit Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world. Forward-Looking Statements This press release contains forward-looking statements that reflect Allurion's beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this release, these statements involve risks and uncertainties that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: the timing of the FDA's review of the Company's PMA application for the Allurion Balloon, the approval by the FDA of the Company's PMA application for the Allurion Balloon; the FDA's willingness to consider the Company's use of additional, supportive analyses regarding imputation methods with respect to achievement of the second co-primary endpoint; the uniqueness of Allurion's product and service offerings, including the Allurion Program; and other statements about future events that reflect the current beliefs and assumptions of Allurion's management based on information currently available to management. Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program, including the Allurion Balloon; the timing of, and results from, Allurion's clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Balloon; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; a changing regulatory landscape in the highly competitive industry in which Allurion competes; the impact of the imposition of current and potential tariffs and trade negotiations, and those factors discussed under the heading 'Risk Factors' in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ('SEC') on March 27, 2025, and updated from time to time by its other filings with the SEC, and its Quarterly Report on Form 10-Q filed with the SEC on May 15, 2025. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law.
Business Wire
29-05-2025
- Health
- Business Wire
Allurion to Present at Jefferies Global Healthcare Conference
NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. ('Allurion' or the 'Company') (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced that Dr. Shantanu Gaur, Founder and Chief Executive Officer, will present at the upcoming Jefferies Global Healthcare Conference in New York. The live presentation will take place on Wednesday, June 4 at 3:45 p.m. ET. A webcast of the presentation will be available in the Events & Presentations section of Allurion's investor relations website. About Allurion Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world's first and only swallowable, procedure-less TM gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers and Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor, and manage weight-loss therapy for patients regardless of their treatment plan. The Allurion Gastric Balloon is an investigational device in the United States. For more information about Allurion and the Allurion Program, please visit
Yahoo
29-05-2025
- Business
- Yahoo
Allurion Technologies Inc. (ALUR) Returns to France with 12.2% Weight Loss, 6.6% Muscle Gain Results
Allurion Technologies Inc. (NYSE:ALUR), a leader in innovative weight loss solutions, is set to resume patient treatments in France next month following the successful resumption of product shipments. This announcement comes on the heels of new clinical data presented at the meeting in Saint-Etienne, France. 15 States with the Best Healthcare in the US The study evaluated 1,962 French patients using Allurion Technologies Inc. (NYSE:ALUR)'s Program, which features a swallowable gastric balloon and AI-powered health coaching. Over just four months, participants achieved an average 12.2% reduction in total body weight. Notably, muscle mass as a percentage of body weight increased by 6.6%, and lean body mass rose by 6.0%. Fat mass and visceral fat index dropped by 11% and 12.2%, respectively. These results suggest significant improvements in metabolic health. Dr. Thibaut Coste, a leading bariatric surgeon, highlighted the importance of losing weight while increasing muscle mass for sustainable, long-term health benefits. Dr. Shantanu Gaur, Allurion Technologies Inc. (NYSE:ALUR)'s Founder and CEO, expressed enthusiasm about returning to the French market, emphasizing the company's commitment to metabolically healthy weight loss and the potential for continued success in France. While we acknowledge the potential of ALUR to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ALUR and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error 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
28-05-2025
- Business
- Yahoo
Allurion Technologies Inc. (ALUR) Returns to France with 12.2% Weight Loss, 6.6% Muscle Gain Results
Allurion Technologies Inc. (NYSE:ALUR), a leader in innovative weight loss solutions, is set to resume patient treatments in France next month following the successful resumption of product shipments. This announcement comes on the heels of new clinical data presented at the meeting in Saint-Etienne, France. 15 States with the Best Healthcare in the US The study evaluated 1,962 French patients using Allurion Technologies Inc. (NYSE:ALUR)'s Program, which features a swallowable gastric balloon and AI-powered health coaching. Over just four months, participants achieved an average 12.2% reduction in total body weight. Notably, muscle mass as a percentage of body weight increased by 6.6%, and lean body mass rose by 6.0%. Fat mass and visceral fat index dropped by 11% and 12.2%, respectively. These results suggest significant improvements in metabolic health. Dr. Thibaut Coste, a leading bariatric surgeon, highlighted the importance of losing weight while increasing muscle mass for sustainable, long-term health benefits. Dr. Shantanu Gaur, Allurion Technologies Inc. (NYSE:ALUR)'s Founder and CEO, expressed enthusiasm about returning to the French market, emphasizing the company's commitment to metabolically healthy weight loss and the potential for continued success in France. While we acknowledge the potential of ALUR to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ALUR and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
Business Wire
14-05-2025
- Business
- Business Wire
Allurion Reports First Quarter 2025 Financial Results and Provides Business Update
NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR) ('Allurion' or the 'Company'), a pioneer in metabolically healthy weight loss, today announced its financial results for the first quarter and provided a business update. Recent Company Highlights and Outlook Maintaining 2025 revenue guidance of approximately $30 million with a reduction of approximately 50% in operating expenses compared to 2024 First quarter revenue of $5.6 million and operating expenses of $11.4 million, a 37% decrease in operating expenses compared to prior year; adjusted operating expenses of $10.1 million, a 45% decrease compared to prior year Net operating loss of $7.3 million, a 36% reduction compared to prior year; adjusted net operating loss of $5.9 million, a 48% reduction compared to prior year Gross margin of 75% compared to 73% in the prior year and 45% in the previous quarter, with no material impact expected from tariffs Presented topline AUDACITY results to FDA, successfully completed Pre-PMA meeting, and on track for submission of final module of PMA by end of June Selected sites and drafted protocol for prospective trial on combination of Allurion Program with low-dose GLP-1 medications to maintain muscle mass and increase GLP-1 adherence 'We are excited about our strong start to 2025, a year we expect to be rich in potential catalysts,' said Dr. Shantanu Gaur, Founder and Chief Executive Officer. 'Our financial results reflect increased efficiency as we move toward profitability, with expenses continuing to reduce, gross margin expanding, and operating loss narrowing. After completing our pre-PMA meeting with FDA, where we discussed our topline results from our AUDACITY trial, we expect to complete our PMA submission on schedule. 'We believe there is a massive and largely untapped opportunity for the Allurion Program to be not just an alternative to GLP-1 medications, but complementary to them,' continued Dr. Gaur. 'Our focus on 'Metabolically Healthy Weight Loss'—losing weight, keeping it off, and maintaining muscle—through the combination of the Allurion Program with low-dose GLP-1s has resonated with providers, patients, and potential partners, because we believe the combination addresses the shortcomings of GLP-1s. We look forward to further strengthening the evidence behind this combination approach in our prospective trial, which we expect to start enrolling this year.' First Quarter Financial Results Total revenue for the quarter ended March 31, 2025 was $5.6 million, compared to $9.4 million for the same period in 2024. Gross profit for the first quarter ended March 31, 2025 was $4.2 million, or 75% of revenue, compared to $6.9 million, or 73% of revenue, for the same period in 2024. Total operating expenses for the first quarter ended March 31, 2025 were $11.4 million, compared to $18.3 million for the same period in 2024. Adjusted operating expenses for the first quarter were $10.1 million, excluding $1.4 million of one-time costs related to financings. Sales and marketing expenses for the first quarter ended March 31, 2025 were $3.6 million, compared to $6.1 million for the same period in 2024. The reduction in expense was primarily driven by increased operating efficiency and the restructuring initiatives implemented during the fourth quarter of 2024, which re-focused spending on more efficient channels. Research and development expenses for the first quarter ended March 31, 2025 were $2.6 million, compared to $5.7 million for the same period in 2024. The reduction was primarily driven by reduced costs related to the AUDACITY trial and restructuring initiatives implemented during the fourth quarter of 2024. General and administrative ('G&A') expenses for the first quarter ended March 31, 2025 were $5.2 million, compared to $6.4 million for the same period in 2024. Adjusted G&A expenses were $3.8 million, excluding one-time financing costs of $1.4 million. The reduction was primarily driven by the restructuring initiatives implemented during the fourth quarter of 2024. Net operating loss for the first quarter ended March 31, 2025 was $7.3 million, which included $1.4 million of one-time financing costs, compared to $11.4 million for the same period in 2024. Adjusted loss from operations for the first quarter ended March 31, 2025 was $5.9 million, which excluded one-time financing costs of $1.4 million. The reduction compared to prior year was driven by restructuring initiatives implemented during the fourth quarter of 2024. Cash balance on March 31, 2025 was $20.4 million. Conference Call and Webcast Details Company management will host a conference call to discuss financial results and provide a business update on May 14, 2025 at 8:30 AM ET. To access the conference call by telephone, please dial (888) 330-3417 (domestic) or +1 646 960 0804 (international) and use Conference ID 1905455. To listen to the conference call via live audio webcast, please visit the Events section of Allurion's Investor Relations website at Allurion - Events & Presentations. About Allurion Allurion is a pioneer in metabolically healthy weight loss. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world's first and only swallowable, procedure-less™ intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan, which may include a gastric balloon, surgical treatment, medical treatment, or nutritional solutions. The Allurion Gastric Balloon is an investigational device in the United States. For more information about Allurion and the Allurion Program, please visit Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world. Non-GAAP Financial Measures Relevant income statement items contained in this release are also presented on an 'adjusted' basis, which exclude items that are of a one-time nature that do not impact the ongoing performance of the business and reflect the way the Company's management and the Board of Directors view the performance of the Company internally. The Company believes that excluding the effects of these items from its operating results allows management and investors to effectively compare the true underlying financial performance of its business from period to period and against its global peers. Forward-Looking Statements This press release contains forward-looking statements that reflect Allurion's beliefs and assumptions based on information currently available. In some cases, you can identify forward-looking statements by the following words: 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'ongoing' or the negative of these terms or other comparable terms, although not all forward-looking statements contain these words. Although Allurion believes it has a reasonable basis for each forward-looking statement contained in this release, these statements involve risks and uncertainties that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company's financial outlook for 2025, including the anticipated impact of the 2024 restructuring plan on the Company's operating expenses and its ability to achieve profitability; the outcome of the Company's PMA seeking FDA approval of the Allurion Balloon following the topline readout of the AUDACITY clinical trial; the performance and market acceptance of Allurion's products for patients using different weight loss therapies, as well as the Company's ability to expand this aspect of its business further in 2025; the outcomes of anticipated studies on the combination of GLP-1s with the Allurion Balloon and the impact on demand for our products and services; ; and the market and demand for our products and weight-loss solutions in general, including GLP-1 drugs and elective procedures. Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program; the timing of, and results from, Allurion's clinical studies and trials, including with respect to the combination of GLP-1s with the Allurion Balloon; the evolution of the markets in which Allurion competes, including the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; a changing regulatory landscape in the highly competitive industry in which Allurion competes; and those factors discussed under the heading 'Risk Factors' in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission ('SEC') on March 27, 2025, and updated from time to time by its other filings with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Allurion undertakes no obligation to update any forward-looking statements to reflect any new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events, other than as required by applicable law. Condensed Consolidated Balance Sheets (dollars in thousands, except share amounts)(unaudited) March 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 20,408 $ 15,379 Accounts receivable, net of allowance of doubtful accounts of $6,455 and $6,701, respectively 8,309 7,134 Inventory, net 3,352 3,400 Prepaid expenses and other current assets 1,097 1,243 Total current assets 33,166 27,156 Property and equipment, net 2,297 2,469 Right-of-use asset 1,870 2,079 Other long-term assets 1,081 1,109 Total assets $ 38,414 $ 32,813 Liabilities and Stockholders' Deficit Current liabilities: Accounts payable $ 4,976 $ 6,572 Current portion of lease liabilities 829 869 Accrued expenses and other current liabilities 10,092 11,422 Total current liabilities 15,897 18,863 Convertible notes payable 30,960 35,710 Warrant liabilities 9,264 4,567 Revenue Interest Financing liability 50,000 49,200 Earn-out liabilities 180 1,090 Lease liabilities, net of current portion 1,186 1,344 Other liabilities 717 17 Total liabilities $ 108,204 $ 110,791 Commitments and Contingencies Stockholders' deficit: Preferred stock, $0.0001 par value — 100,000,000 shares authorized as of March 31, 2025; no shares issued and outstanding as of March 31, 2025 and December 31, 2024 — — Common stock, $0.0001 par value - 1,000,000,000 shares authorized as of March 31, 2025; 5,963,549 and 2,710,607 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 5 3 Additional paid-in capital 157,843 152,596 Accumulated other comprehensive income 3,930 8,370 Accumulated deficit (231,568 ) (238,947 ) Total stockholders' deficit (69,790 ) (77,978 ) Total liabilities and stockholders' deficit $ 38,414 $ 32,813 Expand Non-GAAP Net Operating Loss Reconciliation (dollars in thousands)(unaudited) Three Months Ended March 31, 2025 GAAP Results One-time Financing Costs Adjusted Results Revenue $ 5,580 $ — $ 5,580 Cost of revenue 1,419 — 1,419 Gross profit 4,161 — 4,161 Operating expenses: Sales and marketing 3,621 — 3,621 Research and development 2,624 — 2,624 General and administrative 5,198 1,390 3,808 Total operating expenses: 11,443 1,390 10,053 Loss from operations (7,282 ) (1,390 ) (5,892 ) Other income (expense): Interest expense — — — Changes in fair value of warrants 5,669 — 5,669 Changes in fair value of debt 6,170 — 6,170 Changes in fair value of Revenue Interest Financing and PIPE Conversion Option 2,220 — 2,220 Changes in fair value of earn-out liabilities 910 — 910 Other income (expense), net (213 ) — (213 ) Total other income: 14,756 — 14,756 Income before income taxes 7,474 (1,390 ) 8,864 Provision for income taxes (95 ) — (95 ) Net income $ 7,379 $ (1,390 ) $ 8,769 Expand Additional Non-GAAP Reconciliations (unaudited) Three Months Ended March 31, 2025 Change in Operating Expenses, as reported (37 )% Non-GAAP adjustments (8 )% Change in Operating Expenses, adjusted (45 )% Expand Three Months Ended March 31, 2025 Change in Net Operating Loss, as reported (36 )% Non-GAAP adjustments (12 )% Change in Net Operating Loss, adjusted (48 )% Expand
