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THE PERIODONTAL MEDICAL DEVICE AS A STAND-ALONE DEVICE HAS FDA CLEARANCE. HOWEVER, THE CANDIDATE PRODUCT PERIOCIN, AS A COMBINATION PRODUCT, HAS NOT YET BEEN APPROVED BY FDA AND IS NOT AVAILABLE IN THE UNITED STATES FOR SALE

Minocycline Microspheres

THE PERIODONTAL MEDICAL DEVICE (PerioER) HAS FDA CLEARANCE AS A STAND-ALONE DEVICE. HOWEVER, THE CANDIDATE PRODUCT PerioER, AS A COMBINATION PRODUCT, HAS NOT YET BEEN APPROVED BY THE FDA AND IS NOT AVAILABLE FOR SALE IN THE UNITED STATES

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IMPORTANT SAFETY INFORMATION
  • THE PerioER™ PERIODONTAL MEDICAL DEVICE HAS FDA CLEARANCE AS A STAND-ALONE DEVICE. HOWEVER, THE PerioER™ COMBINATION PRODUCT HAS NOT YET RECEIVED FDA APPROVAL AND IS NOT CURRENTLY AVAILABLE FOR SALE IN THE UNITED STATES

  • Do not take micocycline if you are allergic to minocycline or tetracyclines. Ask your dentist or pharmacist for a list of these drugs if you are not sure. Swelling of the face, itching of the skin, fever and enlarged lymph nodes have been reported with the use of Minocycline on periodontal pockets. Some of these reactions were serious. Tell your dentist right away if you have any signs of allergic reaction, such as skin reactions or trouble breathing, or if you have an exaggerated sunburn reaction.

  • THE USE OF TETRACYCLINE CLASS DRUGS, INCLUDING ORAL AND TOPICAL MINOCYCLINE, DURING TOOTH DEVELOPMENT MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH, AND THEREFORE SHOULD NOT BE USED IN CHILDREN OR IN PREGNANT OR NURSING WOMEN.

  • Administration of sutained release MINOCYCLINE into periodontal pockets has not been studied in patients with weakened immune systems (such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation). Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndrome with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness. Tell your doctor about any health problems you have, including whether you have had oral candidiasis (“thrush”) in the past, and about all medications you are taking.

  • In clinical studies, using minocycline microspheres, the most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.

THIS WEBSITE MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY.  THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT.  WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS.  INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE.  THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

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