Allurion Technologies, Inc. ALUR recently announced the submission of the first three modules of its premarket approval application (PMA) to the FDA for the Allurion Balloon.

Allurion capitalized on the opportunity provided by the FDA's modular submission program to improve the efficiency of the application process. The company expects to file the fourth and final module of the PMA, containing the clinical data from its AUDACITY trial, early next year.

Likely Trend of ALUR Stock Following the News

Following the announcement, shares of the company moved nearly 3.8% south to $0.71 at yesterday’s close. For the year-to-date period, ALUR shares have declined 80.9% against the industry’s rise of 14.4%. The S&P 500 increased 22.7% in the same time frame.

Meanwhile, ALUR currently has a market capitalization of $47.8 million.

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More on Allurion Gastric Balloon & AUDACITY Trial

The Allurion Gastric Balloon is the world’s first and only swallowable, procedureless gastric balloon for weight loss. It has been designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and placed under the guidance of a healthcare provider without surgery, endoscopy, or anesthesia. The placement takes approximately 15 minutes during an outpatient visit.

Once swallowed, the balloon fills and occupies space in the stomach, helping to control appetite and thus facilitating weight loss. Approximately four months after placement, a time-activated release valve opens, allowing the balloon to empty and pass naturally through the gastrointestinal tract. The balloon is crafted to the stomach's shape, ensuring a snug fit. It is made from polyurethane, which is thinner and more flexible and provides comfort as the stomach moves.

The Allurion Balloon is being evaluated in AUDACITY, a randomized, pivotal controlled trial involving 550 patients at 17 sites in the United States. The trial completed enrollment in the fall of 2023 and the company expects the trial to conclude by the end of 2024.

Other Positive Data for Allurion Balloon

In June, ALUR announced three scientific presentations at the American Society for Metabolic and Bariatric Surgery Annual Meeting. One of the studies highlighted the success of the company’s gastric balloon technology for weight loss.

Per data from a study of 121 individuals treated with two consecutive, four-month courses of Allurion balloon therapy at 11 obesity centers lost an average of 22.1% of their body weight after a year. Comparatively, data indicates that individuals who underwent 12-month endoscopic intragastric balloon therapy lost 15.4% and 16.2% of their total body weight.

Evidence from multiple studies also suggested that Allurion's balloon had a lower intolerance rate than 12-month endoscopic balloons. The overall serious adverse event rate of the procedure-less, liquid-filled balloon is significantly lower than that of other liquid-filled balloons on average.

These findings showcase the potential of the Allurion Balloon to deliver superior outcomes compared to other intragastric balloons, approaching those of weight loss surgery, for patients seeking effective and safe weight loss solutions.

Favorable Industry Prospects for ALUR

Per a report by Grand View Research, the global weight management market size was valued at $142.6 billion in 2022 and is expected to witness a growth rate of 9.9% from 2023 to 2030.

The market growth can be attributed to the rising volumes of bariatric surgeries, rapid adoption of online weight loss and management programs, growth in disposable income levels in developing countries, increasing government initiatives for creating awareness about weight management, and growing cases of obesity due to sedentary lifestyles.

Given the market potential, Allurion’s gastric balloon technology is likely to boost the company’s business and generate additional revenues.

AngioDynamics’ Zacks Rank & Stocks to Consider

ALUR carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the broader medical space are Addus HomeCare ADUS,  Quest Diagnostics DGX  and RadNet RDNT. While Addus HomeCare sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and RadNet carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Addus HomeCare has an estimated long-term growth rate of 12.1%. ADUS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 11.5%.

Addus HomeCare shares have rallied 85.5% compared with the industry's 16.9% growth year to date.

Quest Diagnostics has an estimated long-term growth rate of 6.8%. DGX's earnings surpassed estimates in each of the trailing four quarters, with the average being 3.3%.

Quest Diagnostics has gained 42% compared with the industry's 14.9% growth year to date.

RadNet’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 98.2%.

RDNT's shares have surged 93.7% year to date compared with the industry’s 14.8% growth.

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