News

Cincinnati, Ohio – February 28, 2022. Cincinnati-based Standard Bariatrics, Inc., an emerging leader in the bariatric surgery medical device field, today announced completion of a $35 million Series B round ahead of schedule. The successful launch of the Titan SGS^® surgical stapler completed the final milestones needed to realize the second of two tranches. The company received the remaining $9 million in funds to accelerate commercialization efforts.

“Standard Bariatrics’ performance continues to impress with their execution of key objectives including achievement of their milestones to release tranche two from the Series B raise of $35 million,” said Casey Tansey, general partner at U.S. Venture Partners and Series B investor. “The feedback from our Titan SGS users validates the company’s clinical focus for consistent, repeatable clinic outcomes for bariatric surgeons and their patients. We anticipate the company will scale rapidly in 2022, building off their early Titan SGS launch success,” he added.

The Titan SGS first-of-its-kind surgical stapler design received clearance from the U.S. Food and Drug Administration1 in April 2021, allowing it to be used in bariatric surgery requiring the creation of sleeve pouch anatomy (sleeve gastrectomy). The completion of a successful 62-patient study supported the submission.

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 Following FDA clearance, it was first used clinically in August 2021 and sales recently reached approximately $3 million.

Since then, Titan SGS has been used in over 1600 clinical cases performed in more than 35 hospital facilities across 12 states. The community of bariatric surgeons using Titan SGS is growing as they share their clinical experiences with the device.

Accomplished bariatric surgeon John Oldham, MD, Medical Director of Bariatrics for Baptist Health in Louisville, KY reached a milestone of over 250 sleeve gastrectomy procedures performed with the Titan SGS stapler. “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!” he said.

Renowned bariatric surgeon Alex Gandsas, MD, Director of the Anne Arundel Medical Center (AAMC) Weight Loss and Metabolic Surgery Program in Annapolis recently completed the first 10 sleeve gastrectomy cases in Maryland using the Titian SGS stapler. “This is the first time in 20 years of practicing bariatric surgery that I am able to reproduce the same operation without variability, which is extremely important when it comes to accurately assessing outcomes,” he said.

Throughout the controlled launch, clinical results are positive and efficacy data continues to build. Benefits of the Titan SGS stapler include:

⦁ A stronger staple line that is more resistant to leaks ³
⦁ Staples better match patients’ native anatomy ⁴
⦁ Potential improvement in resolution of GERD and nausea ⁵
⦁ Improved procedure time and operational efficiencies ²
⦁ One (1) firing to complete the sleeve pouch anatomy ²
⦁ 88% less bleeding at the staple line ⁶
⦁ 82% fewer malformed staples ⁷

Standard Bariatrics CFO Peter Donato said, “We are pleased to announce completion of our series B funding. This will allow us to further accelerate what has already been an amazing launch with unprecedented traction even with difficult COVID-19 pandemic headwinds. I look forward to our post-COVID-19 2022 results.”

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, Series A lead investors RiverVest®, Hatteras Venture Partners and Emergent Medical Partners, and 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. Salyer, C. E., Thompson, J., Hoffman, A., Burstein, M. D., Enochs, P., Watkins, B. M., Kuethe, J., & Goodman, M. D. (2022). Multisite Study of Titan SGS Stapler in longitudinal gastric resection. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09051-x
3. Hoffman, A., Thompson, J., Hanseman, DJ. (2019). Gastric tissue stapler comparison study. Identification No. NCT04086433. Retrieved from https://clinicaltrials.gov/ct2/show/results/NCT04086433
4. Salyer, C., Spuzzillo, A., Wakefield, D., Gomaa, D., Thompson, J., & Goodman, M. (2021 July). Assessment of a novel stapler performance for laparoscopic sleeve gastrectomy. Surgical Endoscopy, 35(7), 4016–4021. https://doi.org/10.1007/s00464-020-07858-0
5. Thompson, J., Dhar, V., Hanseman, D., Watkins, B., Morton, J., & Diwan, T. (2017). Anatomy-based laparoscopic sleeve gastrectomy reduces gastroesophageal reflux disease compared to laparoscopic sleeve gastrectomy with bougie. Surgery for Obesity and Related Diseases, 13(10). https://doi.org/10.1016/j.soard.2017.09.242
6. Standard Bariatrics, Inc. 2020. Comparison of Titan SGS to Ethicon Endo-Surgery ECHELON FLEX™ GST tests on porcine model. Acute Hemostasis Report QT-0367. Internal data on file.
7. Standard Bariatrics, Inc. (2020 June) Comparison of Titan SGS to Ethicon Endo-Surgery ECHELON FLEX™ GST. Gastric Tissue Stapler Comparison Study QT-0372. Identification No. NCT04086433. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04086433

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

Cincinnati, Ohio – January 19, 2022

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 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 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. Salyer, C. E., Thompson, J., Hoffman, A., Burstein, M. D., Enochs, P., Watkins, B. M., Kuethe, J., & Goodman, M. D. (2022). Multisite Study of Titan SGS Stapler in longitudinal gastric resection. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09051-x
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

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