InOut stands alone as a non-invasive ingestible capsule used to sample localized gastrointestinal microbiota and content for medical diagnostics, treatment, research, and precision medicine.
The InOut immediate action or delayed action ingestible capsule is designed to be used at home or clinic. The patient consumes the capsule, recovers it from the stool, places it in the protective container, and sends or takes it to an attending lab, clinic, doctor, or researcher for analysis.
Endoscopic sampling methods require anesthesia, risk, recovery, and high costs in a clinic or hospital setting. Even then, the most remote areas of the small intestine cannot be reached.
Fecal samples from stool are a complicated amalgamation of the total digestive processes and thwarts advances toward understanding the microbiome and its role in life, health, and disease.
InOut non-invasive methods captures localized upstream microbiota and content from the chyme instead of feces and can be repeated at will with one or more capsules at a time.
InOut Capsules can be used to determine microbiota communities and bodily fluid content before and after diets, during and after medical treatments, and its simplicity makes it a boon to the DNA and microflora testing industry.
InOut is an unparalleled tool for medical diagnostics, treatment, research and individualized medicine. Consider immediate and differing delayed action capsules used alone or in series with one individual or any number of individuals repeatable at home or clinic. Obtain otherwise unavailable samples of microbe stains within their environment; sample virus mRNA before it degrades in the upper intestines. Shotgun metagenomics and high-throughput sequencing techniques can finally be used on localized material.
The idea for InOut was fostered by my wish to sample microbes and bodily fluid located in the small intestine and finding there was no practical way to do it. Present practice and methods are invasive and incomplete. No method exists for non-invasive localized gastrointestinal sampling. Incredibly the medical, clinical, and research professions are limited to samples provided by mouth swabs, anal swabs or stool, and endoscopic procedures,
The need is verified by market reports, research and medical publications, a Texas Tech University Technology Assessment Report, and National Science Foundation I-Corp market studies.
Assembling the puzzle to achieve commercial production of the InOut capsule nears completion. Three of the 4 key key pieces are in place:
1. All US Patent Claims have been allowed, a CIP is pending, and the patent is on the International patent prosecution highway.
2. Proof of Concept results charts, and metagenomic sequencing Advanced Analysis Reports are available.
3. USA companies have submitted costs and time frame bids to gain registration as a Class l or Class II medical device, micro mold and assemble the InOut capsules, and build a scalable custom robotic manufacturing facility.
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