No therapeutic claim for Oxycyte gel
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Oxygen Biotherapeutics, a developer of biotechnology products, has announced that the company will move ahead with a line of gels based on Oxycyte.
The first and most basic gel based on Oxycyte will be formulated to enhance its topical cosmetic properties. Oxycyte is the company’s perfluorocarbon (PFC) therapeutic oxygen carrier.
The company intends to market the first Oxycyte gel as a cosmetic which provides a moist, oxygen-rich environment for the skin. No therapeutic claim for healing will be made for this baseline, cosmetically-formulated Oxycyte gel, said Oxygen Biotherapeutics.
Simultaneously, the company is pushing development of the second over-the-counter product, which will be designated as a topical, therapeutic, non-prescription drug intended to provide a moist, oxygen-rich environment to promote healing of minor skin wounds.
While it will require safety and clinical testing, the pre-IND (investigational new drug) process has already been initiated, and a detailed critical path will be decided after the pre-IND exchange with the FDA, the company said.
Chris Stern, chairman and CEO of Oxygen Biotherapeutics, said: Our first product is now very close to market readiness. The regulatory process for such products is uncomplicated and straightforward. Laboratory testing of the cosmetic formulation should be completed in the second quarter along with the packaging design.
We are now ready to start the processes of identifying and signing license and distribution partners. The progress we’re making with the topical gel should give us good momentum to launch our more complex over-the-counter product initiatives.
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