FDA 510k Cleared and CE Marked device for the gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.
Key Points of Interest:
In the USA, the EsophaCap's are FDA 510k cleared for the gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses. Thus, these can only be sold Physicians and those licensed to write prescriptions.
The EsophaCap's are CE-Marked as a MD Directive Classification class I medical device and can thus be sold as a to any medical professional in the EU and were the CE-Mark is authorized.
Physician Future Plans
We expect to penetrate and convert a substantial portion of endoscopic market currently used for screening patients who have GERDs (est. 30 million in USA.) and other upper GI conditions (est. 50 Million is USA). The second huge market is that of diagnosis of Helicobacter pylori (H. pylori) a Gram‐negative, microaerophilic bacterium found in the stomach. H.pylori is commonly present in patients with chronic gastritis and gastric ulcers. It is also linked to the development of duodenal ulcers and stomach cancer. More than 50% of the world's population harbor H. pylori in their upper gastrointestinal tract. Physicians must be able to diagnose H.pylori in order to prescribe the proper medications.
Medical Cost Savings: The average endoscopic procedure costs $2700 in the USA. Our product together with the Biomarker test kits is a low cost, quick and easy alternative and we hope to have its use become as routine as Pap-smears are today.
With the recent developments in Genome Sequencing, several corporations and medical institutions have developed Biomarker Test Kits to detect diseases of the esophagus without requiring the use of invasive and uncomfortable endoscopic techniques. The problem is that they do not have efficient non-endoscopic (non-invasive) methods of obtaining cellular specimens from patents.
Our initial focus will target Barrett's esophagus which is a disorder in which the lining of the esophagus is damaged by stomach acid and changed to a lining similar to that of the stomach.
Patients with Barrett's esophagus may develop more changes in the esophagus called dysplasia. When dysplasia is present, the risk of getting cancer of the esophagus increases. Early detection and treatment is highly desirable as this is a potentially lethal malignancy.
The EsophaCap swallowable screening device is comprised of a medical grade foam ball that is compressed into a swallowable vegetable capsule which is deployed and withdrawn orally within 5 to 10 minutes. This is a Doctors Office and/or possible home use procedure that will serve to pre-screen patients when used together with our clients Biomarker Test Kits.
The three major cancer research partner/clients based in USA and Canada have already begun advanced human clinical trials using the EsophaCaps with their unique Genetic, Epigenetic, and protein based rapid diagnosis kits. Several other distinquished cancer research institutions are currently applying for research grants to explore the use of the EsophaCap™ with their kits.