Effect of warming and buffering lidocaine on pain during facial anesthesia

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(1) 2018 META-ANALYSIS: SIGNIFICANTLY DECREASED ONSET TIME AND INJECTION PAIN; GUO ET AL FROM UNIVERSITY OF SOUTHERN CALIFORNIA SCHOOL OF DENTISTRY CONCLUDED: “BUFFERED LIDOCAINE SIGNIFICANTLY DECREASED ONSET TIME AND INJECTION PAIN (VAS) COMPARED WITH NON-BUFFERED LIDOCAINE IN INFERIOR ALVEOLAR NERVE BLOCK.”; 2017 CLINICAL STUDY: REDUCES THE PAIN ON INJECTION; PHERO ET AL FROM UNIVERSITY OF NORTH CAROLINA SCHOOL OF DENTISTRY CONCLUDED: “BUFFERED LIDOCAINE REDUCES THE PAIN ON INJECTION WITH A MAXILLARY FIELD BLOCK AND RESULTS IN SIMILAR LENGTHS OF PULPAL ANESTHESIA AS NON-BUFFERED 2% LIDOCAINE.” 2017 CLINICAL STUDY: LOWER PAIN ON INJECTIONS. WARREN ET AL FROM UNIVERSITY OF NORTH CAROLINA SCHOOL OF DENTISTRY CONCLUDED: “AFTER MANDIBULAR NERVE BLOCK, BUFFERED 1% LIDOCAINE CAN PRODUCE SIMILAR DURATION OF PULPAL ANESTHESIA AS NON-BUFFERED 2% LIDOCAINE AND LOWER PAIN ON INJECTIONS.”; 2019 META-ANALYSIS: 2.29 TIMES MORE RELIABLE IN INFLAMED TEETH; KATTAN ET AL FROM UNIVERSITY OF PENNSYLVANIA SCHOOL OF DENTISTRY CONCLUDED: “BUFFERED LOCAL ANESTHETICS HAVE 2.29 TIMES GREATER LIKELIHOOD OF ACHIEVING SUCCESSFUL ANESTHESIA [IN PULPALLY INVOLVED TEETH].”

(2) “DENTISTS REPORT AN INITIAL ANESTHETIC FAILURE RATE OF 20%,” OLSON RESEARCH GROUP, “DENTIST QUANTITATIVE REPORT, CONDUCTED FOR BALANCED PHARMA, AUGUST 13, 2021,” FIELDING: JUNE 18–JULY 19, 2021, TOTAL SAMPLE SIZE: N=181

(3) “58% OF PATIENTS BELIEVE THE INJECTION IS THE WORST PART OF THE DENTAL EXPERIENCE,” OLSON RESEARCH GROUP, “PATIENT DENTAL CARE STUDY QUANTITATIVE REPORT, CONDUCTED FOR BALANCED PHARMA, MAY 7, 2021,” FIELDING: MARCH 30–APRIL 23, 2021, TOTAL SAMPLE SIZE: N=140 (INCLUDES 40 PARENTS/CAREGIVERS)

(3) “OVER 90% OF DENTISTS REPORT A DESIRE FOR CURRENT ANESTHETICS TO BE MORE RELIABLE, LESS PAINFUL, OR FASTER ACTING,” OLSON RESEARCH GROUP, “DENTIST QUANTITATIVE REPORT, CONDUCTED FOR BALANCED PHARMA, AUGUST 13, 2021,” FIELDING: JUNE 18–JULY 19, 2021, TOTAL SAMPLE SIZE: N=181;

(4) “WHAT PATIENTS WANT: A LESS-PAINFUL DENTAL INJECTION: 86%,” OLSON RESEARCH GROUP, “PATIENT DENTAL CARE STUDY QUANTITATIVE REPORT, CONDUCTED FOR BALANCED PHARMA, MAY 7, 2021,” FIELDING: MARCH 30–APRIL 23, 2021, TOTAL SAMPLE SIZE: N=140 (INCLUDES 40 PARENTS/CAREGIVERS)

(5) SDM NORTHCOAST, LLC REPORT, “INJECTABLE CARPULES MARKET SIZE ANALYSIS, UNITED STATES, CANADA, MEXICO, 2019 UNITS”, JULY 15, 2021; KEY-STONE RESEARCH, “EUROPEAN LOCAL ANESTHETICS MARKET SURVEY,” SEPTEMBER 20, 2021; BALANCED PHARMA INTERNAL ESTIMATES

(6) BPI OWNS THE FOLLOWING GRANTED PATENTS AND PENDING PATENT APPLICATIONS: U.S. PATENT NO. 11,305,064 (ISSUED APRIL 19TH, 2022); U.S. APPLICATION NO. 17/722,016; INTERNATIONAL PCT APPLICATION NO. PCT/IB2018/052598; CANADIAN APPLICATION NO. 3,111,347 (CANADIAN NATIONAL PHASE OF PCT/IB2018/052598); EUROPEAN APPLICATION NO. 18897951.2 (EUROPEAN REGIONAL PHASE OF PCT/IB2018/052598); JAPANESE APPLICATION NO. 2020-556351 (JAPANESE NATIONAL PHASE OF PCT/IB2018/052598); KOREAN APPLICATION NO. 10-2020-7021685 (REPUBLIC OF KOREA NATIONAL PHASE OF PCT/IB2018/052598); U.S. APPLICATION NO. 16/655,362; U.S. APPLICATION NO. 63/233,879; BPI ALSO OWNS ONE TRADEMARK APPLICATION, U.S. APPLICATION NO. 88/198,808, PENDING FOR THE LIBRACAINE MARK.

(7) OLSON RESEARCH GROUP, “U.S. DENTIST QUANTITATIVE REPORT, CONDUCTED FOR BALANCED PHARMA, AUGUST 13TH, 2021,” TOTA SAMPLE SIZE: 181 DENTISTS; KEY-STONE RESEARCH, “EUROPEAN LOCAL ANESTHETICS MARKET SURVEY, CONDUCTED FOR BALANCED PHARMA, SEPTEMBER 20, 2021,” TOTAL SAMPLE SIZE: 433 DENTISTS

(8) LIBRACAINE HAS NOT YET BEEN APPROVED BY FDA AND IS NOT AVAILABLE FOR SALE.

(9) BPI HAS NOT YET BEGUN TRIALS TO DETERMINE WHETHER ITS TECHNOLOGY CAN ADAPT TO DERMATOLOGY, PLASTIC SURGERY, EMERGENCY MEDICINE, INTERVENTIONAL RADIOLOGY, AND PODIATRY.