RESTON, Va., Nov. 29, 2007 (PRIME NEWSWIRE) -- TenthGate International, Inc. www.TenthGate.biz (Pink Sheets:TGTI) ("TenthGate"), an innovative medical holding company focusing on healthcare related life-changing technologies, submits comments on the FDA's new sunscreen proposals.
The Food and Drug Administration (FDA) proposed new rules in August 2007 covering the ingredients, labeling and testing of sunscreens that boast of protecting against both the sun's ultraviolet B rays, which cause sunburn, and the ultraviolet A rays associated with more serious and longer-term damage. The FDA called for public comments to make revisions as necessary and then publish a final rule. That rule, once it appears, is expected to take effect sometime in 2009 at the the earliest.
Sunscreen Rule Proposal
Department of Health and Human Services, Food and Drug Administration, 21 CFR Parts 347 and 352, Docket No 1978N-0038; Sunscreen Drug Products for Over-the-Counter Humans Use; Proposed Amendment of Final Monograph.
Per Tim Novak, Chairman and Chief Executive Officer of TenthGate; "We believe our innovative science and testing methodologies for sunscreen efficacy will ultimately become an integral part of the current movement to improve public safety and disclosures concerning sun exposure. On November 23, 2007, TenthGate formally submitted specific comments and recommendations for the FDA's consideration to enhance the efficacy of the new proposed rules. In addition, we have introduced our emerging technology research to the FDA, which may provide the missing specific endpoints sought in sunscreen efficacy testing," says Novak.
http://www.fda.gov/ohrms/dockets/dailys/07/nov07/112307/112307.htm
TenthGate has acquired a suite of technology licenses from STC.UNM (http://stc.unm.edu/) that were developed at the University of New Mexico School of Pharmacy by Dr. Graham Timmins. Dr. Timmins' research and technology patents focus on understanding specific causation factors of melanoma skin cancer, using Electron Paramagnetic Resonance (EPR) as the diagnostics medium at the cellular level. TenthGate is pending trademark approval for 'MPF' or 'Melanocyte Protective Factor', which they will use to quantitatively describe the new protective efficacy scale in a standard fashion.
Per Dr. Graham Timmins, "This testing takes place at the melanin free radical level and is the basis for the creation of several melanoma prevention and intervention strategies."
Graham Timmins, UNM professor of medicinal chemistry and toxicology, developed the technology using an "electron paramagnetic resonance" (EPR) device. Timmins' invention, called the Melanoscan, uses magnetic waves to detect cancerous or precancerous moles on the human body.
"It's like a small MRI machine to measure free radicals that affect melanin, or pigment, in skin," Timmins says. "Optical, or light-based, devices can only get about one-tenth of an inch into the skin, which is not enough to image melanoma. We can go much deeper to actually measure and image the free radicals that mutate the cells. By measuring the level of free radicals in cells, the technology can set a new standard for determining how effective sunscreens and other cosmetics are in protecting against ultra-violet rays."
TenthGate looks to provide sunscreen manufacturers and retailers a more exact description of the UVA/UVB protective qualities of sunscreens and other cosmetic products as well as assist in the development of new, more effective formulations. This technology serves to provide consumers more accurate information with which to make better informed decisions on responsible sun exposure protective measures. This goal aligns with the recent FDA proposal.
Description of TenthGate's EPR Technology Applications: http://www.tenthgate.biz/mDP.html
About TenthGate
TenthGate International, Inc. is focused on the acquisition and development of life changing, health related technologies. The range of acquired technologies includes biotech/life sciences, diagnostic and unique medical devices. The Company has acquired several intellectual properties and licenses to dates, two of which have obtained FDA approval and are currently selling commercially. The Company has obtained exclusive license for an emerging melanoma diagnostic and prevention technology utilizing Electron Paramagnetic Resonance (EPR) technology. TenthGate has identified several additional technologies for acquisition.
The TenthGate International, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3179
Safe Harbor Disclaimer
Except for the historical information contained herein, the matters discussed in this press release may include forward-looking statements or information. All statements, other than statements of historical fact, including, without limitation, those with respect to the objectives, plans and strategies of TenthGate International, Inc., and its affiliates, set forth herein and those preceded by or that include the words "believes," "expects," "given," "targets," "intends," "anticipates," "plans," "projects", "forecasts" or similar expressions, are forward-looking statements. Although the Company's management believes that such forward-looking statements are reasonable, it cannot guarantee that such expectations are, or will be, correct. These forward-looking statements involve a number of risks and uncertainties which could cause the Company's future results to differ materially from those anticipated. The Company assumes no obligation to update any of the information contained or referenced in this press release.