TB or Not TB: An Innovative Gastric Collection Device for Improving Pediatric Tuberculosis Diagnosis

(mid-tempo music) - TB or Not TB? That is the question unknown to many of the million citizens of South Africa, where tuberculosis is the leading cause of death. - With antibiotic treatment, the survival rate is 93%, but effective treatment is dependent on accurate diagnosis. Indiscriminate administration of these antibiotics is not a feasible solution, as it can lead to dangerous, drug-resistant strains. Preventative vaccines remain only 40% effective. - Given a viable bacterial sample, diagnosis can be made using light microscopy or a gene expert device. However, children pose a unique challenge, as they lack the necessary muscle strength to cough up the essential bacterial sample. The procedures seen here, sputum induction and gastric lavage, are the current best in class methods for diagnosing children, but for the 80,000 children infected with the disease each year, these solutions are not good enough. They're invasive, painful, and distressing, and additionally average around $81 per procedure.

Both gastric lavage and sputum induction can result aerosolization of tuberculosis particles, require a steady source of electricity and a trained clinician to administer. - The difference is in our approach. We aim to work with, rather than against the body, by condensing the gastric lavage process into a self-sealing smart pill that collects a bacterial sample in the stomach. The device is played in the upper esophagus using a specially designed delivery tool. A lubricant coating facilitates passage of the device into the stomach, where the acidic environment dissolves the basic contents of the device. This allows the internal spring to expand and suction tuberculosis-laden gastric acid into the internal compartment of the device. A tethered plug then seals off the collected sample, preventing the bacteria loss and enzyme entry in the intestinal tract.

Once excreted, the sample can be easily recovered for diagnosis using a disposable syringe. Bench testing has demonstrated that all materials used are both bowel-compatible and acid-resistant. On average, just one of these pills has been found to collect over 20 times the number of bacteria required for light microscopy diagnosis. Bench testing has also demonstrated that each pill requires an average of just 17 seconds to collect the sample, and a simulated use test has demonstrated these bacteria are easily recoverable using a disposable syringe. Furthermore, public testing has demonstrated that the device is completely sealed after sample collection and a cost analysis has found a tenfold reduction in cost materials compared to gastric lavage, the next least expensive alternative. - We believe these tests demonstrating safety and efficacy will allow us to pursue animal testing, clinical trials, and eventually regulatory clearance for the sale of our device in South Africa.

- The World Health Organization estimates that the global cost of TB contractivity was $3.1 billion in 2008. About 450,000 South Africans are diagnosed with TB each year. Many more are tested for TB at least once a year. At a retail price of $25 a pill and a market size of well over 450,000 people, TB or Not TB will gross over $11 million a year. Prior to the launch of TB or Not TB, animal and clinical testing will need to be performed to ensure safety and efficacy.

We are seeking a total of $100,000 in support to manufacture 1,000 pills and to perform animal testing. In exchange for your support, we will give you 10% equity in our company. - We expect the implementation of our device to revolutionize TB diagnosis in the South African pediatric population due to its simplistic and naturally intuitive design, improving and saving the lives of thousands. - TB or Not TB, that is the question that your support can help us answer.