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GT Metabolic™ expands MagDI™ System with FDA clearance of 50mm magnet

GT Metabolic (PRNewsfoto/GT Metabolic Solutions)

News provided by

GT Metabolic Solutions

Mar 11, 2025, 09:45 ET

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MINNEAPOLIS, March 11, 2025 /PRNewswire/ -- GT Metabolic™ Solutions, Inc., the world leader in magnetic surgery is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared a larger, 50mm MagDI™ System magnet1 to complement the system's existing 40mm magnet.2 This expansion enables surgeons to accommodate a broader range of patients in magnet-assisted surgery for duodenal-ileal anastomosis. The clearance also underscores GT Metabolic's commitment to driving innovative surgical solutions for improved patient outcomes.

The FDA has cleared a larger, 50mm MagDI™ System magnet to complement the system’s existing 40mm magnet.
The FDA has cleared a larger, 50mm MagDI™ System magnet to complement the system’s existing 40mm magnet.
The MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material.1-5
The MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material.1-5
With the new choice of the 50mm or 40mm magnet size, the MagDI System offers surgeons greater flexibility to tailor procedures to individual patient needs.
With the new choice of the 50mm or 40mm magnet size, the MagDI System offers surgeons greater flexibility to tailor procedures to individual patient needs.

The only FDA-cleared and commercially available product for magnetic compression anastomosis,1,2 the MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material.1-5

"I'm pleased with my early experience using the MagDI System," said Phil Gachassin, MD, MHCM, Medical Director of Metabolic and Bariatric Surgery at Ochsner Lafayette General Medical Center. "The results have been promising, and I'm especially impressed with how my patients are responding to the magnetic compression anastomosis technique." Gachassin and his team were among the first in Louisiana to use the MagDI System with the 40mm magnet.

Addition of 50mm MagDI magnet expands opportunities for surgeons and patients

With the new choice of the 50mm or 40mm magnet size, the MagDI System offers surgeons greater flexibility to tailor procedures to individual patient needs. The larger magnet will be used in the same procedure as the 40mm magnet to facilitate a seamless, non-invasive approach to anastomosis.1-5

"This expansion reinforces our commitment to pushing the boundaries of minimally invasive, magnetic surgery and providing surgeons with more advanced tools to improve patient outcomes," said Thierry Thaure, Chief Executive Officer and co-founder of GT Metabolic Solutions. 

"We are eager to bring this transformative approach to even more surgeons and patients," added Michel Gagner, MD, Chief Medical Officer and co-founder of GT Metabolic Solutions, who created the system. "The clinical success we've seen so far reinforces the role of magnetic compression for anastomosis in bariatric surgery today and bringing the option of a larger 50mm magnet allows us to broaden the impact of the MagDI System."

As demand for less invasive, more efficient surgical techniques grows, GT Metabolic is committed to accelerating the U.S. market release of the MagDI™ System in collaboration with leading surgeons and hospital centers. Clinical evidence continues to support the efficacy of this approach.2 To date, there are no reported leaks or bleeds attributed to this sutureless, staple-free technique.1-5

"We are thrilled by the growing interest in the MagDI System and what it means for the future of bariatric surgery," said Ronald Galovich, Vice President Sales & Marketing, GT Metabolic. "We look forward to expanding opportunities for surgeons who are eager for solutions that enhance anastomosis procedural efficiency while improving patient outcomes. The approval of the 50mm magnet is another step in meeting that demand."

About GT Metabolic Solutions Inc.

GT Metabolic Solutions Inc. is leading the world with its development of magnetic compression anastomosis technologies for next-stage minimally invasive procedures. An elegant approach that uses magnets to help achieve anastomosis, the incisionless, sutureless, staple-free technique leaves no foreign material to impede the natural tissue healing process.1-5

Working in tandem with renowned global experts, our team has engineered a magnetic compression solution called delayed anastomosis technology (DAT) that surgeons can use to create consistent anastomosis while helping minimize potential complications, such as leaks and bleeds, in challenging applications. Our solution democratizes the surgical approach to anastomosis. It can be used in procedure staging and is 100% reversible.

Committed to improving patients' lives and healthcare provider outcomes, GT Metabolic Solutions Inc. is disrupting the market by introducing magnetic compression anastomosis technologies to bariatric, metabolic, and digestive health providers in the U.S. and abroad.

1. U.S. Food and Drug Administration. 510(k) No. K243359. Clearance for Magnetic Compression Anastomosis System (MagDI System). Published February 2025.

2. U.S. Food and Drug Administration. 510(k) No. K242086. Clearance for Magnetic Compression Anastomosis System (MagDI System). Published October 24, 2024.

3. Gagner M, Almutlaq L, Cadiere GB, Torres AJ, Sanchez-Pernaute A, Buchwald JN, Abuladze D. Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: Early outcomes with prior or concurrent sleeve gastrectomy. Surg Obes Relat Dis. 2023. doi:10.1016/j.soard.2023.10.018

4. Gagner M, Abuladze D, Koiava L, et al. First-in-human side-to-side magnetic compression duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023;33:2282-2292. doi:10.1007/s11695-023-06708-x

5. Gagner M, Cadiere GB, Sanchez-Pernaute A, et al. Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results. Surg Endosc. 2023;37(8):6452-6463. doi:10.1007/s00464-023-10134-6. Epub 2023 May 22. PMID: 37217682; PMCID: PMC10202352.

Legal Disclaimer / Forward-Looking Statements

This release is for informational purposes only and is not an offer to sell securities or a solicitation of an offer to buy any securities and may not be related upon in connection with the purchase or sale of any security. This release may contain forward-looking statements regarding projected business performance, operating results, financial condition and other aspects of the company. These statements also include estimates of the technology developments, adoption of the company's products and improvement of patient outcomes. Please be advised that such statements are estimates only and there is no assurance that the results stated or implied by forward-looking statements will actually be realized by the company. Forward-looking statements may be based on management assumptions that prove to be wrong. The company's predictions may not be realized for a variety of reasons, including due to competition, hospital sales cycles, and engineering or technical issues, among others. The company and its business are subject to substantial risks and potential events beyond its control that would cause material differences between predicted results and actual results, including the company incurring operating losses and experiencing unexpected material adverse events.

Learn more about magnetic compression anastomosis and GT Metabolic Solutions, Inc.

Contact for US Medical Community and Technology:
Ronald Galovich, VP Sales & Marketing
GT Metabolic Solutions, Inc.
[email protected]

Contact for Investment and International:
Thierry Thaure, Chief Executive Officer, Co-Founder
GT Metabolic™ Solutions, Inc.
[email protected]

SOURCE GT Metabolic Solutions

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