Nutra Pharma Corp., a biotechnology holding company that owns rights to intellectual property related to the development of drugs for HIV and Multiple Sclerosis, has announced that its holding, Infectech, Inc. has engaged Lake Erie Research Institute, Inc. (LERI) to assist in all FDA device and 510K submissions required for the company to begin commercializing its Identikit technology. The Company anticipates filing their first documentation before the end of the year.
The Lake Erie Research Institute provides wrap-around research services, such as protocol development, statistical analysis, grant writing, business plan development, technology transfer, and other needed expertise. They are being contracted by Infectech to make the proper submissions to the Food and Drug Administration (FDA) for the regulatory approval of the Identikit technology. A successful submission will allow the products to be distributed in the United States.
"I look forward to working with Infectech," stated Phyllis Kuhn, PhD., President and CEO of LERI. "The request for assistance aligns with the mission of the Lake Erie Research Institute, which is to promote high quality medical research and medical product development. I look forward to their achieving great success in this endeavor," she added.
"Dr. Kuhn's assistance with FDA submissions will be an invaluable resource to Infectech," stated Dr. Mitchell Felder, Infectech's CEO. "Dr. Kuhn will help Infectech prepare for registration and commercialization of its technologies," he added.
Infectech owns 29 issued patents related to the rapid isolation, growth, identification and antibiotic sensitivity of disease-causing bacteria. Infectech's researchers discovered that certain grades of paraffin wax, when used in conjunction with a microscope slide, and combined with a nutrient broth, provides for the rapid isolation, growth and identification of various disease-causing bacteria. Infectech has developed a diagnostic test kit based on this technology. The basic test kit consists of a glass slide coated with paraffin, which is used as a carbon (food) source by certain pathogenic bacterial species such as TB. The slides are incubated in a sample of almost any bodily fluid (a non-invasive sample of saliva is preferred) within a nutrient broth. This creates a semi-solid growth medium for the bacteria, which imitates its natural environment within a human or animal host. The bacteria collect on the paraffin slide in 4-8 days. Testing can then be done to identify the species of bacteria. This testing can be done via acid-fast staining or through PCR gene amplification. Additionally, the bacteria can be cultured with antibiotics to test for specific sensitivities. Through the choice of different nutrient broths, each kit can be tailored to encourage the growth of a specific bacterium. The test kits are being designed to work on a class of bacteria that includes TB, MAC, Para-tuberculosis, Pseudomonas and Nocardia.
"We are very excited about the progress that Infectech has made," said Rik J. Deitsch, Nutra Pharma's Chief Executive Officer. "Gaining regulatory approval from the FDA is the next big step for the company. This will allow for the marketing and distribution of the Identikits and the realization of revenues in the near future," he concluded.
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). Engaging Lake Erie Research for FDA device and 510k submissions should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.