THE TREATMENT PROCEDURE

Gorham’s non-invasive technology creates an artificial bezoar by having the patient swallow small caplets similar in size to a Vitamin pill. Each caplet contains two magnetic cubes, encapsulated in a material that is impervious to stomach fluid.

The physician initiates treatment in the office, where the patient drinks a protein shake that causes the pylorus to close temporarily. The patient then spends a few minutes under physician supervision ingesting a number of caplets, creating an initial agglomeration that is too large to transit the pyloric outlet.

Following the initial caplet ingestion, the patient will take three caplets three times a day over 15 weeks. Peristalsis forms the cubes into a bezoar that conforms to the shape of the stomach and reduces the stomach lumen. The physician will determine the total number of caplets required for each patient depending upon the size of the patient’s stomach.

ADVANTAGES

• Gradual creation of the engineered bezoar causes no discomfort: only reduced appetite

• The bezoar shape allows natural hormone secretion and other stomach functions

• The engineered bezoar reduces stomach capacity up to 80%

• The treatment can be tailored to the patients’ individual needs.

• The bezoar is biologically inert

• Painless treatment in the privacy of the patients’ home

• Reversible and re-treatable

REVERSABILITY

• A degaussing machine de-magnetizes magnets in the stomach

• Peristalsis breaks up demagnetized artificial bezoar

• De-magnetized caplets pass through intestines and are defecated

PROOF-OF-SAFETY STUDIES

A series of animal studies were conducted at Washington State University College of Veterinary Medicine and at Bayside Medical Center in Springfield, Massachusetts.

Animal testing, over a two-year period, has shown the product is safe and non-debilitating.

• The histological study of each of the animal’s tissue indicated that there was no damage to the stomach or intestinal lining.

• B-Caplet passed through the stomach and intestines without damage, validating that there were no adverse effects from the caplets passing through the entire digestive system.

• B-Caplet when de-magnetized passed freely through the intestines and were defecated, caused no occlusion, obstruction or fistula.

FDA STATUS

A pre-submission IDE was submitted to the FDA. Their feedback has been received. A program to fulfill their requirements is in place.