Information Regarding CapNostics & the EsophaCap® (Sponge on a String)
2021 Fiscal: Year NIH Cancer Research Grant: Awarded to Boston University Medical Campus for: "Development of diagnostic and prognostic tests for esophageal adenocarcinoma" which will utilize the EsophaCap Devices.
May 04, 2021: CapNostics receives FDA 510(k) Clearance for the EsophaCap device. 510(k) numbers is K203450. This 510(k) clears sizes ranging from 20mm to 35mm in diameter, the use of vegetable-based capsule material and device being provided non-sterile.
April 2021: Published in Gastrointestinal Endoscopy: "Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study". This study used the EsophaCaps to collect samples from their patients.
August 01, 2020: The American Journal of Gastroenterology: August 2020 - Volume 115 - Issue 8 - p 1201-1209: "Accurate Non-endoscopic Detection of Barrett’s Esophagus by Methylated DNA Markers: A Multisite Case-Control Study."
October 2016 - American Journal of Gastroenterology: Volume 111 - Issue - p S229: "Assessment of Sponge-on-String Device Parameters for the Non-endoscopic Detection of Barrett's Esophagus: Results from a Randomized Trial: 2016 ACG Presidential Poster Award 506". This abstract describes an evaluation of the EsophaCap versions 25mm/10ppi and 25mm/20ppi foam Sphere configurations.
September - October 2016: Journal of the American Society of Cytopathology: "Combined EsophaCap Cytology with MUC2 Immunohistochemistry for Screening Barrett’s Esophagus and Diagnosing Esophageal Dysplasia and Carcinoma".
April 26, 2016 the United States Patent and Trademark Office Registered "EsophaCap®."
November 26, 2015 The EsophaCap™ is now CE-Marked! It is a Class I, non-sterile device.
November 02, 2015: The Ontario Institute for Cancer Research presented at the NCRI Cancer Conference: "New screening method for patients at high risk of esophageal adenocarcinoma using encapsulated sponge (EsophaCap™)."
October 05, 2015: MAYO CLINIC begins a human clinical trial: "Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma." This study will evaluate if the capsule sponge device ( EsophaCap™) can detect the presence of Barrett's Esophagus. Official Title: "Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device."
Fiscal 2015, NIH, National Cancer Institute, Division of Cancer Prevention awarded a grant to Boston University Medical Campus titled: " Feasibility of Molecular Cytology for the Management of Barrett's Esophagus." This study will evaluate the EsophaCap™ with targeted, next-generation sequencing of a panel of ~100 genes known to be drivers of EAC development.
June 17, 2015: CapNostics signs a letter of support with Johns Hopkins University to collaborate with a grant application that would use the EsophaCap™ together with their proprietary epigenetic biomarker to develop a test strategy to detect patients with Adenocarcinomas of the colorectum and esophagus.
November 18, 2014: CapNostics enters into a non-exclusive License Agreement with a major mid-western USA Cancer Research Institution for their use of the EsophaCap™ with their epigenetic biomarkers for detection of Barrett's Esophagus, Esophageal Dysplasia and Carcinoma, Eosinophilic Esophagitis.
October 19, 2014: Society for Medical Decision Making: "DEVELOPMENT AND VALIDATION OF A MICROSIMULATION MODEL TO EVALUATE THE COST-EFFECTIVENESS OF INNOVATIVE SCREENING AND SURVEILLANCE FOR EARLY DETECTION OF ESOPHAGEAL ADENOCARCINOMA."
July 14, 2014: Health Canada grants CapNostics "Investigational Testing Authorization - Class II" pursuant to a "Early detection of patients at high risk of Esophageal Adenocarcinoma" protocol. Number of subject authorized is 250.
February 28, 2014: CapNostics enters into a shareholders agreement with London, UK based venture capital group that secured a 5% interest along with an exclusive Supply Agreement for the EsophaCap™ to be used with their non-genetic, non-epigenetic test kits for the detection of cancer in the upper gastic tract via the detection of a protein marker which is raised in all types of oesophageal cancer. This exclusivity is limited to the territory of the European Economic Area (EEA).
December 13, 2013: CapNostics signs a letter of support with Johns Hopkins University to collaborate with a grant application that would use the EsophaCap™ together with their proprietary biomarkers to "Improve the early detection of esophageal cancer in the African-American community".
December 13, 2013: CapNostics signs a letter of support with Johns Hopkins University to collaborate with a grant application that would use the EsophaCap™ together with their proprietary biomarkers to improve "Point-of-Care screening for esophageal cancer".
December 01, 2013: CapNostics enters into a Funding and License Agreement with a large Canadian Cancer Research Institution. This grants institution exclusive access of the EsophaCap™ for use with their genetic biomarker test kit to determine simple somatic mutations for cancer progression risk in esophageal tissue samples.
October 28, 2013: Martin von Dyck signs a letter of support with Boston University Medical Center, Department of Surgery for their grant application. “Feasibility of Molecular Cytology for the Management of Barrett’s Esophagus.“ NIH, National Cancer Institute grants the award in 2015.
October 28, 2013: Martin von Dyck signs a letter of support with Boston University Medical Center, Department of Surgery for their grant application. “Evaluating the Feasibility of a Molecular Cytology Approach for Management of Patients with Barrett’s Esophagus.” The DeGregorio Family Foundation awarded a $225,000 grant.