Cincinnati, OH – April 4, 2019 – Standard Bariatrics is developing products to improve the consistency and clinical outcomes of sleeve gastrectomy, the surgical procedure most commonly used in the United States to treat morbid obesity.
Innovative laparoscopic bariatric device manufacturer announces FDA 510(k) clearance for Sleeve Gastrectomy
Cincinnati, Ohio – October 22, 2018 – Standard Bariatrics, an innovator of surgical devices, has received a sleeve gastrectomy indication from the Food and Drug Administration (FDA) for the STANDARD CLAMP®.1
“Standard Bariatrics is committed to creating superior bariatric surgery outcomes through device innovations. The acceptance of the supplemental data by the FDA to expand the U.S. indications of the STANDARD CLAMP® is another significant milestone for the Company,” said Jonathan Thompson MD, Founder and Chief Medical Officer of Standard Bariatrics. “With the patient’s health top priority, we aimed to standardize an anatomy-based approach to sleeve gastrectomy.”
Current techniques and device usage for laparoscopic sleeve gastrectomy are highly variable, and studies show that freehand sleeve gastrectomy techniques can yield inconsistent pouch anatomy. Because of challenges, bariatric surgeons have been able to achieve the ideal sleeve anatomy less than 40% of the time, resulting in inconsistent outcomes for the patient including reduced weight loss and GERD.2
The STANDARD SLEEVE™ addresses issues of inconsistent surgical anatomy through an anatomy-based approach. Performed with the first-of-its-kind, purpose-built, disposable device, the STANDARD CLAMP® allows fixation of the full cut line across the entire stomach, enabling surgeons to plan and hold the staple line prior to dividing the stomach during sleeve gastrectomy.
“The STANDARD CLAMP® allows planning, visualization and stabilization of the full staple line before staple firing, enabling bariatric surgeons to confidently achieve ideal surgical sleeve anatomy consistently,” said Ronald Galovich, Chief Commercial Officer of Standard Bariatrics. “We are excited about the opportunity to bring the STANDARD CLAMP® to every bariatric surgeon performing the sleeve gastrectomy 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. Driven by a passionate group of surgical innovators, the company will continue to release surgical solutions designed to address significant market opportunities. 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.
Standard Bariatrics is supported through early investment from Queen City Angels and CincyTech, and more recently Series A lead investors RiverVest® and Hatteras Funds. For more information, visit https://www.standardbariatrics.com or call 513-620-7751.
Media contact
Ronald Galovich, Chief Commercial Officer
908-300-4040, ron@standardbariatrics.com
Read the article on EurekaAlert!
1 K181608 The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
2 Toro, JP, et al. (2014). Association of radiographic morphology with early gastroesophageal reflux disease and satiety control after sleeve gastrectomy. Journal of American College of Surgeons. Sep; 219(3):430-8.
Come visit us in Booth #1103 at ObesityWeek 2018 in Nashville, TN from November 11 through 15th.
Learn more about ObesityWeek 2018.
Standard Bariatrics received the 2018 Innovation & Technology Award in the category of Outstanding Bioscience from the Business Courier‘s eighth-annual Innovation & Technology Awards, recognizing companies that are fueling growth through innovative processes and products.
Read the full article on Cincinnati Business Courier.
Standard Bariatrics, Inc., an innovator of bariatric surgical devices, has raised a Series A round of financing. RiverVest Venture Partners led the round with participation from Hatteras Venture Partners, Queen City Angels/QCA First Fund V, Emergent Medical Partners, Accelerant Fund and North Coast Angels. The size of the round is undisclosed.
“This new capital will enable us to complete our product development plans to launch new products for use in gastric procedures,” said Matt Sokany, CEO of Standard Bariatrics.
Read the full article on EurekaAlert!
Thank you for stopping by our booth June 14–16 at ASMBS Weekend 2018 in New York City.
Standard Bariatrics will attend SAGES 2018. Come visit us in Booth #812 at SAGES 2018 in Seattle, WA from April 11 through 14.
Standard Bariatrics is a proud sponsor of the ASMBS Practice Building Networking Reception. Come visit us in Booth #217 at OBESITY WEEK 2017 in Washington D.C. from October 29 through November 2.
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
Please fill out the form below to receive training information.
