GT Metabolic™ Solutions, Inc., opens doors to new surgical platform as FDA grants De Novo marketing authorization to its novel magnet compression anastomosis technology
MINNEAPOLIS, Sept. 4, 2024 /PRNewswire/ — GT Metabolic™ Solutions, Inc., a company dedicated to reinventing bariatric, metabolic, and digestive surgery, today announced its first-generation MagDI™ System for side-to-side duodeno-ileal anastomosis was granted De Novo marketing authorization from the U.S. Food and Drug Administration (FDA).
“Creating a secure anastomosis free of complications bleeds or leaks is the goal of any minimally invasive surgical approach,” said Michel Gagner, MD, and Co-Founder of GT Metabolic. “Magnetic compression anastomosis is designed to allow for more consistent tissue alignment, central necrosis, and circumferential healing while leaving no foreign materials behind to impede the natural tissue healing process.”
Traditional anastomotic devices like staples or sutures can be difficult to apply in confined spaces during minimally invasive surgical procedures and can cause trauma by cutting or piercing the bowel tissue and leaves foreign material behind. Magnetic compression anastomosis is designed to: mitigate the need for incision to the bowel, reduce user technical variability during a procedure, and be naturally excreted from the body.
To date, seven peer-reviewed publications have been completed, including most recently a multi-center clinical consisting of 43 patients conducted by Gagner et al. which demonstrated no anastomotic leaks, bleeds, or obstruction in duodeno-ileal side-to-side anastomosis in bariatric and metabolic procedures. “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 in the journal Surgery for Obesity and Related Diseases” was published in November 2023 in the ASMBS journal for Surgery for Obesity and Related Diseases (SOARD).
Future planned studies may be able to broaden improvements in patient outcomes and potentially reach more patients with this less invasive anastomotic approach. Gagner said, “This technology has the potential to offer new standards of care in many procedures.”
“Obtaining Medical Device De Novo Classification to market our platform in just four years following the company’s inception is incredible. This was achieved due to the vision of the founders and the focus and leadership of the management team and its investors who support and share our dream to democratize anastomosis technique,” said Thierry Thaure, CEO, and Co-Founder, GT Metabolic.
Thaure went on to say, “The MagDI™ System offers the concept, for the first time, to democratize the surgical approach to anastomosis, enabling surgeons to potentially achieve a more consistent outcome in a less invasive and potentially less expensive solution. We are looking forward to worldwide launch of our incisionless anastomosis system later this year.”
“Surgeons are going to like this technology,” said Gagner.
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 behind no foreign material to impede the natural tissue healing process.
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.
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.
You can learn more about GT Metabolic™ Solutions, Inc. here.
Contact for US Medical Community and Technology:
Ronald Galovich, VP Sales & Marketing
GT Metabolic Solutions, Inc.|
Ron@gtmetabolic.com
Contact for Investment and International:
Thierry Thaure, Chief Executive Officer, Co-Founder
GT Metabolic Solutions, Inc.
thierry@gtmetabolic.com
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SOURCE GT Metabolic Solutions
