(What Is It?)

CapNostics, LLC

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:

  • The EsophaCap® is a Non-endoscopic swallowable screening device that is administered to the patient by a Licensed Physician or licensed medical professional such as a nurse. (Please videos)

  • It is swallowed, much like a vitamin capsule (Smaller than a Gummy Bear) with a string attached.

  • The EsophaCap will remain in the stomach for a minimum of 5 minutes and is then gently withdrawn by the Physician or licensed medical professional.

  • The foam sphere will then be cut from the tether (string) and prepared for shipment to the laboratory for diagnostic tests.

Regulatory Status

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 to Physicians and those licensed to write prescriptions.

FDA Cleared

The EsophaCap's are CE-Marked as an MD Directive Classification class I medical device and can thus be sold as to any medical professional in the EU and where the CE-Mark is authorized.

CapNostics, LLC

For the Physician

The EsophaCap® was developed to provide the physician with a simple method of testing his/her patients, in-office, who present with symptoms of GERDs, difficulty with swallowing and other upper GI related complaints.

The patient is asked to swallow the EsophaCap® under medical supervision and the foam sphere is withdrawn after 5 to 10 minutes.  Once the foam sphere is withdrawn it can be cut and placed into a specimen container and sent to a diagnostics laboratory.

Once the diagnostic results are returned to the physician, her or she can develop the best possible treatment plan.   EsophaCaps can then be used again for post-treatment follow-up.

For the Endoscopist:  It envisioned that as other physicians begin to screen their patients with the EsophaCap they will be referring these patients to Endoscopists for treatment in greater numbers.  This would imply that most of these patients will be high risk and in urgent need of endoscopic treatment.

It is not the intent of the EsophaCap to replace endoscopic screening but rather to increase the number of patients, who are reluctant to participate in endoscopy screening or do not have it readily available with an alternative screening option.  Ultimately, this will help identify a greater population of high risk patients that must be referred for endoscopic treatment.

For Physician - Future Plans

With the recent developments in Genome Sequencing, several corporations and medical institutions are developing Biomarker Tests to detect diseases of the esophagus, such as Barrett's Esophagus.

No less than three major cancer research institutions based in the USA and Canada have already begun advanced human clinical trials using the EsophaCap® with their unique Genetic, Epigenetic, and protein-based rapid diagnosis tests. Several other distinguished cancer research institutions are currently applying for research grants to explore the use of the EsophaCap with their tests.

It is our hope that one or more of these innovative biomarker tests will soon become commercially available and that they will include the EsophaCap as a kit component.

Please refer to this website’s “NEWS” page to learn about this exciting research currently being performed using the EsophaCap.

Final note, CapNostics enjoys collaborating and developing new products.  Should you have ideas please contact us.

Business Focus

We expect to penetrate and expand a substantial portion of the endoscopic market currently used for screening patients who have GERD (est. 30 million in USA.), Barrett's Esophagus other upper GI conditions (est. 50 Million is the 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.

Potential Medical Cost Savings: The average endoscopic screening procedure costs approximately $2700 in the USA. Our EsophaCap product, together with the new Biomarker tests, will be a low-cost, quick and easy alternative, and we hope to have its use become as routine as Pap-smears are today.