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FORT LAUDERDALE, Fla., Feb. 29, 2024 /PRNewswire/ -- Spatz Medical, a global leader in gastrointestinal weight loss solutions, is delighted to announce the commencement of commercialization of the Spatz3 Adjustable Gastric Balloon. With over 150,000 patients benefiting from the Spatz3 across more than sixty markets globally, the company is now poised to launch this revolutionary technology in the United States.

Spatz3 – Transforming Weight Loss with Adjustability

The Spatz3 Adjustable Gastric Balloon, renowned as the first and only adjustable gastric balloon, has earned widespread acclaim for its outstanding weight loss results and an impressive 84% success rate, as demonstrated in the FDA Pivotal trials and real-world applications. Developed by Dr. Jeffrey Brooks, CEO of Spatz Medical, the Spatz3 introduces a unique adjustability feature, allowing physicians to customize the balloon volume during the treatment period, addressing key challenges faced by traditional gastric balloon systems.

Clinical Trial Results from Pivotal Study:

The Spatz3's efficacy and safety profile, as reported in the FDA Pivotal Study and published in The Lancet, established a new threshold for Intragastric Balloon results. Noteworthy outcomes include:

• Fivefold Greater Weight Loss: Spatz3 Balloon patients achieved a remarkable 15% reduction in initial weight, in contrast to the control group's 3% weight loss.
• Successful Weight Maintenance: 74.3% of patients maintained clinically significant weight loss for six months after balloon removal.
• Customized Adjustments: The adjustability feature played a crucial role, with down adjustments alleviating intolerance in 82% of cases and up adjustments at 18 weeks resulting in an additional 15.2% excess weight loss.
• Extended Treatment Time: the Spatz3 is approved for an 8-month treatment period, leading to more successful patient outcomes when compared to a standard, non-adjustable 6-month balloon.

Dr. Jeffrey Brooks on the Milestone Achievement

Dr. Jeffrey Brooks expressed his enthusiasm for this milestone, stating, "The completion of the FDA Post Approval Study enrollment and the affirmation of our clinical trial results mark a pivotal moment for Spatz Medical. For the first time in gastric balloon history, an adjustable gastric balloon affords patients a decision making role in their weight loss therapy, customized to their needs. That is reflected in the outstanding 15% weight loss and 84% success rate, not previously achieved by gastric balloons in FDA trials. With a substantial global presence and over 150,000 patients benefiting from Spatz3, we are thrilled to bring this proven solution to individuals across the United States."

Comments from Professor Barham Abu Dayyeh MD, Internationally Renowned Innovator and Investigator of Bariatric Endoscopic procedures in the US.

Professor Abu Dayyeh, Principal Investigator of the Spatz3 FDA Pivotal Trial and Post Approval Study stated,

"The Spatz3 brings a new dimension in endoscopic bariatrics with its proprietary adjustability technology. The ability to change balloon volume during the course of treatment yielded an impressive 15% total body weight loss and 84% response rate in FDA clinical trials. Spatz will be an important and welcome addition to the endoscopic bariatric options in the US."

Continued Commitment to Innovation

Spatz Medical remains committed to advancing the field of bariatric endoscopy through continued innovation. The Spatz3's adjustability feature is a paradigm shift for intragastric balloons. It offers new possibilities for patients, including alleviating symptoms of balloon intolerance, preventing early intolerance with gradual filling of the balloon, and a rejuvenation option for those experiencing weight loss plateaus.

The Spatz3 is approved for use in adults with obesity and provides a customizable approach to weight loss for individuals who have not achieved desired results through supervised weight control programs, or who have failed with standard non-adjustable balloons.

For more information about Spatz Medical and the Spatz3 Adjustable Gastric Balloon, please visit www.SpatzMedical.com.

Media contact:

Mickey Nave

mickey@spatzmedical.com

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SOURCE Spatz Medical