CLINICAL OUTCOMES

The Pose® procedure has been studied extensively worldwide since 2010. USGI Medical has sponsored multiple clinical studies examining weight-loss effectiveness, mechanism of action and safety.

OUS Clinical Data

USGI Medical multiple clinical studies

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Clinical StudiesLocationTypeNumber EnrolledRetention RateMean % EWLMean % TBWLSerious Adverse Events*
MILEPOST1 (2014-15) Spain
Austria
Netherlands		 Prospective
Multicenter
Control		 44 88%
12 months		 43.7% / 18%
Active/ Control		 12.6% / 5.3%
Active/ Control		 1
MOTIVATE2 (2012-13) Spain Prospective
Single Site		 18 83%
15 months		 63.7% 19.1% 0
ULTIMATE3 (2012-13) Spain Prospective
Single Site		 10 90%
12 months		 65.5% 17.8% 0
AI4 (2013) Spain Prospective
Single Site		 9 89%
12 months		 42% 13.0% 0

* 2% SAE rate (2 of 81) One patient experienced an extra gastric bleed which resolved within one week. No long term sequelae. One patient experienced an intra gastric bleed which required one additional night stay in the hospital. No long-term sequelae.

Satiety Test Data

Mean caloric intake required to reach maximum satiation before the Pose procedure and at 2 and 6 months post-procedure.2

OUS Commercial Data

Commercial weight-loss data demonstrates excellent weight-loss results in a real world clinical setting.

U.S. Clinical Outcomes

The ESSENTIALTM Trial demonstrated statistically significant weight loss and low to moderate risk safety profile of the Pose® procedure. It was the largest blinded endolumenal obesity study ever conducted, with the longest reported follow-up to-date.

SAFE

The procedure is a safe minimally invasive obesity procedure with one of the lowest serious adverse event (SAE) rates of any endolumenal obesity study. There were no device removals and no device failures.9

EFFECTIVE

People experienced 4x greater weight loss compared to people following a diet and exercise program alone.9 In studies in Europe, on average, over 15% of patients' total body weight was lost after 12 months. This represented 45% of their excess weight.10

SUSTAINABLE

Patients maintained 76% of their 12-month weight loss through 24 months (the longest reported follow-up to date among endolumenal obesity studies).11

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** USGI Medical has a CE Mark Indication that states: "The design, development and manufacture of preloaded, synthetic, non-absorbable suture delivery catheters (g-Cath) and single use, surgically invasive, flexible endotherapy grasping forceps (g-Lix) used for approximation of soft tissue in minimally invasive gastroenterology procedures, including use in obesity intervention for BMI 30-40.

Those aspects of design, development and manufacture related to securing and mantaining the sterility of non-surgically invasive, multichannel endotherapy guides (Transport) and non-surgically invasive flexible endotherapy grasping forceps (g-Prox)."

Results and patient experience may vary. Travel and accommodations for the video shoot provided by USGI Medical.

  • Greve J et al A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity (Pose) vs. Diet-Exercise alone: The MILEPOST Study Obesity Surgery (2015) Volume 25, Supplement 0.232.
  • J. Espinos, S. Delgado-Aros et al Primary Obesity Surgery Endolumenal (POSE) Effects on Satiation, Gastric Emptying and Hunger/Satiation Peptides. Predictive Factors of Weight Loss after POSE in a Prospective Cohort of Obese Patients Obesity Surgery (2013) 23:1028 0.038.
  • USGI Medical (2013) Ultimate Anchor Study. Unpublished raw data.
  • USGI Medical (2014) Alternate Indications Study. Unpublished raw data.
  • Presented by Turro, et al, (Twelve month weight loss results of patients undergoing the pose procedure for primary obesity), at Flexible Endoscopic Surgery, 2016 in Miami, Florida.
  • Presented by del Pozo Garcia, et al, (One year weight loss results across Spain using an incisionless surgery for primary obesity: The pose procedure), at SEED, 2014 in Seville, Spain.
  • Lopez-Nava, G. et al The Primary Obesity Surgery Endolumenal (POSE) procedure: one-year patient weight loss and safety outcomes SOARD (2015) 11: 861-865.
  • Presented by Lopez-Nava, G. - "The Primary Obesity Surgery Endolumenal (POSE) procedure: two-year patient weight loss outcomes", at IFSO-LAC, 2015, San Jose del Cabo.
  • 12 Month Randomized Sham Controlled Trial Evaluating the Safety and Efficacy of Targeted Use of Endoscopic Suture Anchors for Primary Obesity: The ESSENTIAL Study. Sullivan, Shelby et al. Gastroenterology, Volume 150, Issue 4, S25 - S26.
  • Gontrand López-Nava, M.D., Inmaculada Bautista-Castaño, M.D., Ph.D., Amaya Jimenez, M.D., Teresa de Grado, M.D., Juan Pedro Fernandez-Corbelle, M.D. The Primary Obesity Surgery Endolumenal (POSE) procedure: one-year patient weight loss and safety outcomes. Surgery for Obesity and Related Diseases. July-August, 2015 Volume 11, Issue 4, 861-865.
  • Data on file