Outstanding Bioscience

Standard Bariatrics® Titan SGS Stapling Technology for Sleeve Gastrectomy Receives FDA Clearance

Cincinnati, Ohio – May 4, 2021 – Standard Bariatrics® announced today that its novel Titan SGS™ stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the US Food and Drug Administration (FDA).1 The Titan SGS™ first-of-its-kind design offers surgeons performing sleeve gastrectomy procedures the industry’s longest continuous staple cutline of 23 centimeters.2

“This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes,” said Jonathan Thompson, MD, Founder and Chief Medical Officer of Standard Bariatrics®. “The Titan SGS™ stapling technology is the natural evolution of the Standard Clamp™ anatomy-based approach to sleeve gastrectomy, which has been successfully used in more than 10,000 procedures.”

With a purposeful design, driven by the needs of today’s bariatric surgeon performing sleeve gastrectomy, Titan SGS™ provides real-time audio and visual feedback, graduated staple height formation, tissue-sensing technology and a firing cycle optimized particularly for the patient’s gastric tissue during gastrectomy pouch creation.1,3,4 While every patient’s anatomy is different, the Titan SGS™ long staple line enables surgeons to plan and place staples in one firing, minimizing variations often associated with the current use of multiple overlapping short-cartridge staple firings.5  

The design ensures more consistent staple formation across the entire 23-centimeter cutline for improved staple-line strength and fewer malformed staples than competitive staplers that offer short cartridges for more general surgical use.2,3,4  The Titan SGS™ design may result in a more secure staple line and fewer chances of leaks, as evidenced with higher burst pressures.3 Because Titan SGS™ takes approximately half the time to create the staple line,6,7 it can also potentially improve procedure time and operational efficiencies.2,7

Titan SGS
Titan SGS

Titan SGS™ was cleared after a successful 62-patient multi-center trial in longitudinal gastric stapling.2 The University of Buffalo Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences (UBMD) was the first to use Titan SGS™. Steven Schwaitzberg, MD, professor and chair of surgery in the Jacobs School and president of UBMD Surgery said, “Gastric sleeve is the predominant bariatric procedure in the world today and this key refinement will serve patients well for years to come.”

“We are focused on bringing innovation and breakthroughs in science and surgery to our users,” said Matt Sokany, Chief Executive Officer of Standard Bariatrics®. “We believe Titan SGS™ has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology.”

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 ron@standardbariatrics.com.

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 more recently Series A lead investors RiverVest®, Hatteras Venture Partners and Emergent Medical Partners.

For more information, visit https://www.standardbariatrics.com or call 513-620-7751.

1. Indications for Use, K210278: “The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation.”
2. Goodman, Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection.2020
3. Slayer, Spuzzillo, Wakefield, et al.  Assessment of a novel stapler performance for laparoscopic sleeve gastrectomy.2020
4. Yeo, Thompson, Hanseman, Diwan, Dunki-Jacobs, et al. Increased staple loading pressures and reduced staple heights in laparoscopic sleeve gastrectomy reduce intraoperative bleeding.2020
5. Toro, Lin, Patel, et al. Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy.2014
6. Titan Pre-clinical 510K data on file
7. Varban, Niemann, Stricklen, et al. Far from Standardized. Journal of Laparoendoscopic & Advanced Surgical techniques.2107

Media Contact
Ronald Galovich
Chief Commercial Officer, Standard Bariatrics®
513.620.7751
ron@standardbariatrics.com

Standard Bariatrics receives FDA clearance for the STANDARD CLAMP™

Innovative laparoscopic surgical device offers technical and clinical improvement to #1 bariatric surgical procedure

Cincinnati, Ohio – August 3, 2017 – Standard Bariatrics, Inc., an innovator of bariatric surgical devices, has received U.S. Food and Drug Administration (FDA) clearance for the STANDARD CLAMP™. The first-of-its-kind, disposable laparoscopic surgical clamp can assist surgeons performing laparoscopic sleeve gastrectomy, the most common and effective weight loss surgery. The company has begun commercial distribution of the product in the United States.

“We are extremely excited by the FDA’s clearance of the STANDARD CLAMP™”, said Matt Sokany, President and CEO of Standard Bariatrics. “The sleeve gastrectomy is already the #1 bariatric surgical procedure. As demonstrated over months of clinical use, the STANDARD CLAMP™ solves an unmet clinical need by giving surgeons a tool that helps to enable consistent results while improving patient outcomes.”

More than 60% of patients seeking a surgical solution to weight loss choose the sleeve gastrectomy. During the procedure, surgeons utilize minimally invasive surgical tools and techniques to remove approximately 80% of the stomach, creating a small sleeve or tubular pouch. With the new, reduced stomach pouch patients will more quickly reach satiety, feeling satisfied after eating smaller amounts of food, which is one key component of losing weight and maintaining weight loss.

The STANDARD CLAMP™ is a laparoscopic surgical device designed to clamp the entire length of the stomach enabling surgeons to plan and hold the staple line prior to dividing the stomach during Laparoscopic Sleeve Gastrectomy. Without the STANDARD CLAMP™, surgeons must freehand stapling producing inconsistent results.

“Developing bariatric surgical device innovations that enable surgeons to meet the various surgical needs of their patients is at the core of our culture”, said Jonathan Thompson, MD Founder, and Chief Medical Officer of Standard Bariatrics. “With FDA clearance of the STANDARD CLAMP™, bariatric surgeons now have a device that can help them create more consistent sleeve gastrectomy anatomy, minimizing surgical pouch variations, while improving procedure efficiency and reducing overall cost of the procedure.”

About Standard Bariatrics, Inc.
Standard Bariatrics, Inc., is a Cincinnati based surgical procedure company focused on the innovative development and commercialization of medical devices for the surgical treatment of obesity. Driven by a passionate group of surgical innovators the company will continue to release surgical solutions designed to address the growing global epidemic of obesity. The Standard Bariatrics management team has over 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. For more information visit www.standardbariatrics.com or call 513-620-7751.

Media Contacts:

Matt Sokany
President and CEO
513- 658-0328

Ronald Galovich
VP & General Manager
908-300-4040

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