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Devices Surgery Venture Capital

 News Release - February 28, 2022

After Successful Launch of Titan SGS(R) Surgical Stapler, Standard Bariatrics, Inc. Achieves Final Series B Funding Early

CINCINNATI, Feb. 28, 2022 -- (Healthcare Sales & Marketing Network) -- 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 leaks3
  • Staples better match patients' native anatomy4
  • Potential improvement in resolution of GERD and nausea5
  • Improved procedure time and operational efficiencies2
  • One (1) firing to complete the sleeve pouch anatomy2
  • 88% less bleeding at the staple line 6
  • 82% fewer malformed staples7
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 http://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.

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


Source: Standard Bariatrics

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