Titan SGS® from Standard Bariatrics, Inc. Passes 1,000 Clinical Case Uses

CINCINNATI, Jan. 19, 2022 /PRNewswire/ -- Bariatric surgeons are seeing benefits delivered to patients from the anatomy-based approach of Titan SGS® surgical stapler technology from Standard Bariatrics®, Inc. Since the first use in gastric sleeve surgery on August 24, 2021, the Titan SGS has now been used in over 1,000 clinical cases and efficacy data continues to build.

Surgeons who have used the Titan SGS in sleeve gastrectomy are reporting less operative time and less post-op patient nausea. Surgeons are also describing clean staple lines and the ease of sleeve pouch reproducibility available by using the Titan SGS. "We are very excited with the early clinical outcomes surgeons are achieving for their patients. Industry excitement continues to grow. We are fielding significant surgeon clinical interest in the technology as well as general inbound interest in Standard Bariatrics," said Matt Sokany, CEO.

Standard Bariatrics is a Cincinnati-based company focused on developing medical devices for surgical treatments of obesity. Working alongside bariatric surgeons, they are growing a portfolio of solutions with medical devices that meet bariatric surgeons' needs while delivering repeatable and consistent results. Technologies developed by Standard Bariatrics have been utilized in an estimated 15,000 clinical cases since the first products were commercialized.

The Titan SGS is designed to help surgeons achieve more consistent and symmetrical gastric sleeve pouch anatomy, setting patients up for the best possible outcomes. This first-of-its-kind design received FDA clearance in April 2021¹.

In October 2021, the FDA issued guidance on surgical staplers and staples for internal use². The new guidelines include labeling recommendations that cover the risks specifically associated with the crossing of staple lines ². The Titan SGS 23cm continuous staple line enables surgeons to plan and place staples in one firing^3,4, minimizing variations often associated with the current use of multiple overlapping short-cartridge staple firings⁴.

"Optimal sleeve pouch anatomy is a function of both surgical technique and equipment utilized," said Jonathan Thompson, MD, FACS, FASMBS, Founder and Chief Medical Officer at Standard Bariatrics.

"We are progressively building our clinical foundation for the Standard Sleeve® with Titan SGS technology. We have been focused on improving sleeve gastrectomy quality and consistency since our first clinical cases with the reusable clamp in 2016. We have worked with a terrific group of forward-thinking surgeons to establish and improve the technique of anatomy-based sleeve design. We continue to add surgeon users and evolve our equipment set to meet their needs," added Dr. Thompson.

Bariatric surgeons across the country including California, Florida, Ohio, Kentucky, Alabama, Michigan, Texas, New Jersey, New York and North Carolina have used the Titan SGS and are gaining confidence in the reproducibility of gastric sleeve anatomy from using it. 

Jon L. Schram, MD, board-certified physician specializing in bariatric surgery and weight loss management from Spectrum Health in Michigan had this to say about the Titan SGS technology: "Every sleeve looks just like the last…perfect! This is so much easier to teach and learn than expected. Because of COVID-19, we have been forced to move more of our sleeves to outpatient. Doing a better sleeve has made this very doable."

Gustavo Bello, MD, FACS from AdventHealth Medical Group Weight Loss and Bariatric Surgery at Orlando recently used the Titan SGS during sleeve gastrectomy cases and said, "The Titan SGS sleeve anatomy now looks exactly like the pictures in the medical textbooks." 

John Oldham, MD, Medical Director of Bariatrics for Baptist Health in Louisville, KY said, "In my 20 plus years of bariatric surgery, the Titan SGS is a game changer. Sleeves are amazing, exactly how you would want them to look." Prior to switching to the Titan SGS stapler, Dr. Oldham utilized the Standard Clamp® technology from Standard Bariatrics.

Less than six months on the market, Titan SGS reached a $1M sales milestone during November 2021. Standard Bariatrics currently has multiple investors with a mix of Series A and Series B funding.

Surgeons interested in learning more about Titan SGS stapling technology or about applying for training and use can contact Ronald Galovich, Chief Commercial Officer of Standard Bariatrics at 513.620.7751 or [email protected].

About Standard Bariatrics®, Inc.

Standard Bariatrics, Inc., is a Cincinnati-based surgical procedure company focused on the innovative development and commercialization of medical devices. Driven by a passionate group of surgical innovators, the company continues to release surgical solutions designed to address significant market opportunities. A seasoned team of medical and management professionals, Standard Bariatrics has more than 175 combined years of experience in developing and commercializing novel medical device technologies with a record of achieving both clinical and economic excellence for patients and providers.

Standard Bariatrics is supported through early investment from Queen City Angels and CincyTech, and Series A lead investors RiverVest®, Hatteras Venture Partners and Emergent Medical Partners and more recently Series B investors U.S. Venture Partners (USVP) and River Cities Capital.

For more information, visit https://www.standardbariatrics.com or call 513.620.7751.

1. U.S. Food and Drug Administration. (2021). Indications for Use. (510(k) No. K210278). Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210278.pdf
2. FDA. (2021, October 7). FDA issues final order and guidance on Surgical Staplers and staples for internal use. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-issues-final-order-and-guidance-surgical-staplers-and-staples-internal-use
3. Goodman. (2020). Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection. Identification No. NCT04347837. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04347837
4. Toro, J., Lin, E., Patel, A., Davis, S., Sanni, A., Urrego, H., Sweeney, J., Srinivasan, J., Small, W., Mittal, P., Sekhar, A., & Moreno, C. (2014 Sept. 1). Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy. Journal of the American College of Surgeons, 219(3), 430–438. https://doi.org/10.1016/j.jamcollsurg.2014.02.036

SOURCE Standard Bariatrics