Revita™ DMR

Revita™ DMR

Our lead investigational program, Revita DMR, takes an innovative approach to treating metabolic disease by addressing the root cause of insulin resistance in the intestine.

Revita DMR (duodenal mucosal resurfacing), is a minimally invasive procedural therapy designed to rejuvenate the lining of the duodenum. The procedure uses hydrothermal ablation to safely remove the excessive layer of the duodenal mucosa that develops due to our modern high fat and sugar diets. After applying heat energy, the body heals itself as it regenerates a new, healthy, duodenal lining. We believe that rejuvenating the duodenal lining with hydrothermal ablation has the potential to restore insulin sensitivity and metabolic health to patients.

The Revita System consists of a console and a novel single-use balloon catheter. The console is used to monitor the procedure, while physicians use the catheter to access the duodenum and perform the DMR procedure in an outpatient setting.

To date, we have conducted rigorous clinical testing of our Revita System in patients with a variety of metabolic disorders and varying degrees of insulin resistance, including type 2 diabetes (T2D), nonalcoholic steatohepatitis (NASH), and polycystic ovarian syndrome (PCOS).

Results thus far have demonstrated Revita DMR to be:
  • Well tolerated with a favorable safety profile
    • More than 265 treated patients across multiple studies in the E.U. and South America
  • Insulin sensitizing
    • Potent and durable reductions in insulin resistance (HOMA-IR), blood sugar, and weight, without diet or lifestyle changes
    • Potent and durable improvement in markers of liver resistance and liver fat for NASH
    • Broad metabolic improvements (cardiovascular surrogate biomarkers)
Current Clinical Programs:
  • In Europe, we are currently exploring the safety and efficacy of Revita DMR in patients with type 2 diabetes in our Revita-2 clinical trial. More information on this study can be found here.
  • In the US, we are performing a pilot study in the same patient population. More information on this trial can be found here.
  • And globally, we have multiple trials ongoing investigating the use of Revita DMR in patients with late-stage T2D, NASH and PCOS.
As a follow-on to Revita DMR, we are investigating the possible combination of our Revita DMR procedure with cell and gene therapy to fully restore intestinal health.
Although Revita DMR has received a CE Mark in Europe, it is currently under clinical investigation and is not commercially available.

Our lead investigational program, Revita DMR, takes an innovative approach to treating metabolic disease by addressing the root cause of insulin resistance in the intestine.

Revita DMR is a minimally invasive procedural therapy designed to rejuvenate the lining of the duodenum. The procedure uses hydrothermal ablation to safely remove the excessive layer of the duodenal mucosa that develops due to our modern high fat and sugar diets. After applying heat energy, the body heals itself as it regenerates a new, healthy, duodenal lining. We believe that rejuvenating the duodenal lining with hydrothermal ablation has the potential to restore insulin sensitivity and metabolic health to patients.

The Revita System consists of a console and a novel single-use balloon catheter. The console is used to monitor the procedure, while physicians use the catheter to access the duodenum and perform the DMR procedure in an outpatient setting.

To date, we have conducted rigorous clinical testing of our Revita System in patients with a variety of metabolic disorders and varying degrees of insulin resistance, including type 2 diabetes (T2D), nonalcoholic steatohepatitis (NASH), and polycystic ovarian syndrome (PCOS).
Results thus far have demonstrated Revita DMR to be:
  • Well tolerated with a favorable safety profile
    • More than 265 treated patients across multiple studies in the E.U. and South America
  • Insulin sensitizing
    • Potent and durable reductions in insulin resistance (HOMA-IR), blood sugar, and weight, without diet or lifestyle changes
    • Potent and durable improvement in markers of liver resistance and liver fat for NASH
    • Broad metabolic improvements (cardiovascular surrogate biomarkers)
Current Clinical Programs:
  • In Europe, we are currently exploring the safety and efficacy of Revita DMR in patients with type 2 diabetes in our Revita-2 clinical trial. More information on this study can be found here.
  • In the U.S., we are performing a pilot study in the same patient population. More information on this trial can be found here.
  • And globally, we have multiple trials ongoing investigating the use of Revita DMR in patients with late-stage T2D, NASH, and PCOS.
As a follow-on to Revita DMR, we are investigating the possible combination of our Revita DMR procedure with cell and gene therapy to fully restore intestinal health.
Although Revita DMR has received a CE Mark in Europe, it is currently under clinical investigation and is not commercially available.

2018

Haidry, et al. Digestive Disease Week – Monumental Developments in Science & Medicine (DDW). Washington, DC, USA, June 2018.

Ghosh, et al. 78th Scientific Sessions American Diabetes Association (ADA). Orlando, Florida, USA, June 2018.

van Baar, et al. 78th Scientific Sessions American Diabetes Association (ADA). Orlando, Florida, USA, June 2018.

deGravelle, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

Maggs, et al. 4th Paris Nash Meeting. Paris, France, July 2018.

van Baar, et al. United European Gastroenterology (UEGW). Vienna, Austria, October 2018.

Maggs, et al. American Association for the Study of Liver Diseases (AASLD). San Francisco, Calif., USA, November 2018.

2017

van Baar, et al. Digestive Disease Week (DDW). Chicago, Illinois, USA, May 2017.

Rajagopalan. 3rd Paris Nash Meeting. Paris, France, July 2017.

van Baar, et al. 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD). Lisbon, Portugal, September 2017.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA, October 2017.

Sacks, et al. American Heart Association Meeting (AHA). Anaheim, Calif., USA, November 2017.

2016

Rajagopalan, et al. 9th Diabetes Drug Discovery & Development Conference- GTO Diabetes Summit. Boston, Massachusetts, USA, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Rajagopalan, et al. The International Liver Congress-European Association for the Study of the Liver (EASL). Barcelona, Spain, April 2016.

Galvao Neto, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

Rajagopalan, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016.

van Baar, et al. Digestive Disease Week (DDW). San Diego, Calif, USA, May 2016

Cherrington, et al. 76th American Diabetes Association (ADA). New Orleans, Louisiana, USA, June 2016.

Maggs. The Obesity Society (TOS). New Orleans, LA, USA, October 2016

van Baar, et al. United European Gastroenterology Week (UEGW). Vienna, Austria, October 2016

Rajagopalan, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

van Baar, et al. American Association for the Study of Liver Diseases (AASLD). Boston, Massachusetts, USA, November 2016.

2015

Cherrington, et al. Third World Congress on Interventional Therapies for Type 2 Diabetes (WCITT2D). London, UK, September 2015.

Cherrington, et al. United European Gastroenterology Week (UEGW). Barcelona, Spain, October 2015.

Cherrington, et al. 13th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRS). Los Angeles, Calif., USA, December 2015.

2014

Rajagopalan. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Holleman. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Rubino. 50th Annual Meeting of the European Association for the Study of Diabetes (EASD). Vienna, Austria, September 2014.

Galvao, et al. World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Montreal, Canada, August 2014.