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Allurion Technologies Reports Early Success in U.S. Program Launch
Allurion Technologies announced "successful early traction" in the launch of the Allurion Program in the United States, marked by strong clinical outcomes, rapid account growth, high re-order rates, and performance exceeding internal expectations. The company said, "First shipments of the Allurion Smart Capsule were completed in April, with the first U.S. patients treated that same month. Early clinical outcomes have been highly encouraging, with patients losing between 8-11% of their total body weight in just the first four weeks, reinforcing the program's potential to deliver rapid, meaningful weight loss without surgery or invasive procedures. Of note, nearly all patients treated to date in the U.S. had previously tried a GLP-1 medication and ultimately discontinued. Commercial momentum in the U.S. has accelerated rapidly. In the largest obesity market in the world, the company is on track to grow two-fold within the quarter, while the number of treatment sessions is expected to increase four-fold, reflecting strong provider demand and increasing patient flow. Notably, early adoption in the U.S. is exceeding internal expectations for the quarter during just the second month of launch with key business metrics also outperforming plan: Re-order rates robust, with over half of quarterly business coming from re-ordering accounts; Average Selling Price tracking ahead of expectations; Gross margins exceeding internal targets, with the first quarter of U.S. launch expected to be profitable; Strong pipeline, with the number of accounts trained or currently in training already in line with full-year goals. This re-order dynamic highlights rapid account adoption and early profitability for providers, signaling strong product-market fit in the U.S. obesity care landscape."
Allurion Treats First Obesity Patients in the U.S.
Allurion Technologies announced the commercial treatment of its first patients in the United States-an inflection point that formally launches the company into the world's largest and most dynamic obesity market. Allurion is seeing growing demand from patients who have discontinued GLP-1 therapy due to side effects, long-term commitment concerns, or weight regain following discontinuation. These early patient profiles reinforce Allurion's positioning as a compelling, non-surgical, non-pharmaceutical option that delivers fast weight loss results within the rapidly evolving obesity treatment landscape. Early feedback from trained centers has been highly encouraging, underscoring the differentiated value of the Allurion Program, especially among patients who are searching for alternatives to GLP-1 medications. Clinicians have highlighted the Program's simplicity and scalability as a competitive advantage, with the entire placement taking only about 15 minutes and requiring no endoscopy or anesthesia. In addition to its growing network of clinical partners, Allurion also announced that it is actively exploring partnerships with self-insured employers. These initiatives aim to substantially expand the pool of patients who can access the Allurion Smart Capsule through employer-sponsored coverage, while helping employers address the rising health and productivity costs associated with obesity.
Allurion Appeals NYSE Delisting Decision
Allurion Technologies announced that it has appealed the decision by the New York Stock Exchange to initiate delisting proceedings against Allurion's securities pursuant to Section 802.01B of the NYSE's Listed Company Manual, which requires listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least $15,000,000. The Company's recent FDA approval of the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule, catalyzed a detailed plan to regain compliance with NYSE listing standards or to relist its securities on the NYSE American, strengthen its balance sheet, and fund commercialization of the Allurion Smart Capsule in the U.S. This plan has been shared with the NYSE and is currently being executed by the Company's management.
Allurion Notified by NYSE of Delisting Proceedings
Allurion Technologies has received notice from the NYSE that it intends to initiate delisting proceedings against Allurion after the company was unable to demonstrate that it had regained compliance with Section 802.01B of the listed company manual requiring listed companies to maintain either at least $50M in stockholders' equity or at least $50M in total market capitalization on a 30-trading day average basis. The company has a right to a review of this determination by a committee of the board of directors of the exchange. Allurion intends to appeal, and the company expects its common stock to continue to trade on the NYSE during the appeal process. The company's efforts to regain compliance with the continued listing requirements of the NYSE or gain compliance with the initial listing requirements of another exchange are ongoing and include discussions and negotiations with existing creditors and security holders, as well as capital raising efforts. In furtherance thereof, the company has previously announced an agreement with its largest creditor to exchange all of its outstanding debt securities for shares of preferred stock at an exchange ratio representing a substantial premium to the company's current trading price, subject to certain conditions, and the completion of a warrant inducement transaction on February 24. While the company is working diligently to regain compliance and intends to appeal the NYSE staff determination, there is no guarantee that the company will regain compliance with, and remain listed on, the NYSE, or be able to relist on another national exchange.
Allurion Gastric Balloon System Approved by FDA
Allurion Technologies announced that the U.S. Food and Drug Administration has approved the premarket approval application for the Allurion Gastric Balloon System, featuring the Allurion Smart Capsule. "Today's approval is a watershed moment for Allurion and for obesity care in the United States," said Shantanu Gaur, founder and CEO. "Our goal is to deliver patients metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle. The Allurion Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery, and it should become a standard tool in the comprehensive treatment of obesity in the United States."
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