ECM represents a platform technology that addresses unmet clinical needs in a number of markets that either have no effective therapy or only marginally effective therapy. Extensive bench-top laboratory work, preclinical animal studies, human clinical experience with alternative forms of ECM-based surgical mesh materials, scientific publications, and an extensive patent portfolio have positioned the company to develop products to address these needs.

Pipeline

Discovery Pre-Clinical Data Phase I Phase II FDA Approval Market Entry
Esophageal Disease Products
EsophaGard™
EsophaLift™
EsophaGel™
CNS Applications
Stroke
Glioblastoma
Traumatic Brain Injury
Ocular Applications
Retinal Disease
Optic Nerve Trauma
Corneal Ulcers
Musculoskeletal Applications
Ventral Hernia
Tendon Repair
Volumetric Muscle Loss
Arthritis
Topical Wound
Diabetic Ulcers
Venous Statis Ulcers
Decubiti (Bed Sores)
Burns

EsophaGel™

For Esophageal Repair

An ECM hydrogel that can halt, and possibly reverse, the progression of esophageal cancer and its precursor stages that result from gastric reflux. Esophageal cancer has a rate of growth during the past 30 years that exceeds that of any other type of cancer worldwide.

Current therapeutic options have very high morbidity and a mortality rate of 80% within 5 years regardless of treatment. ECM Therapeutics' product line consists of formulations that could be delivered by minimally invasive endoscopy or by oral administration.

Barrett’s Esophagus Clinical Need

Barrett's esophagus is a precancerous condition with no adequate treatment options.

Esophageal adenocarcinoma incidence is rising faster than any other cancer type.

[1] El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut 2014;63:871-80.
[2] Rossi, M., et al., Efficacy of Nissen fundoplication versus medical therapy in the regression of low-grade dysplasia in patients with Barrett esophagus: a prospective study. Ann Surg, 2006. 243(1): p. 58-63.
[3] O'Connor JB, Falk GW, Richter JE. The incidence of adenocarcinoma and dysplasia in Barrett's esophagus: report on the Cleveland Clinic Barrett's Esophagus Registry. The American journal of gastroenterology 1999;94:2037-42.
[4] Soni A, Sampliner RE, Sonnenberg A. Screening for high-grade dysplasia in gastroesophageal reflux disease: is it cost-effective? The American journal of gastroenterology 2000;95:2086-93.
[5] Pohl, H., B. Sirovich, and H.G. Welch, Esophageal adenocarcinoma incidence: are we reaching the peak? Cancer Epidemiol Biomarkers Prev, 2010. 19(6): p. 1468-70.
[6] Galmiche JP, Zerbib F, des Varannes SB. Treatment of GORD: Three decades of progress and disappointments. United European Gastroenterol J 2013;1:140-50.
[7] Wang KK, Sampliner RE, Practice Parameters Committee of the American College of G. Updated guidelines 2008 for the diagnosis, surveillance and therapy of Barrett's esophagus. The American journal of gastroenterology 2008;103:788-97.

Market for Esophageal Applications

Esophageal cancer affects approximately 17,000 new patients each year in the U.S. alone. Four out of five patients diagnosed with esophageal cancer die within 5 years in spite of current best current treatment options.

3-4x more common among men than women

50% more common in African Americans than Caucasians

5 year survival is only 20%