ALUR News & Events

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 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."

Allurion Technologies announced a partnership with Bionut to provide patients with access to discounted Mounjaro to be used in combination with the Allurion Smart Capsule. Previously reported results have shown that the combination of the Allurion Smart Capsule with low doses of tirzepatide can significantly enhance outcomes. In 76 patients treated with the Allurion Smart Capsule and started on low-dose tirzepatide after completing their first 45 days of balloon therapy, the average total body weight loss at 12 months was 23%, and lean body mass as a percentage of total body weight increased by 14% from 62% to 70%. No patients discontinued early, and all patients remained adherent to tirzepatide for the duration of the study. Importantly, only low doses of tirzepatide were used in the study. Allurion is exploring similar partnerships in other regions to increase the accessibility of GLP-1s for use in combination therapy.