BPI-001 (Libracaine)

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.

(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.

(10) “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

(11) “Effectiveness of Buffered and Non-Buffered Local Anesthetic in Inferior Alveolar Nerve Block: A Randomised Study”, M Bala, A.O. Taiwo, A.A. Ibikunle, H.O. Olasoji, A.O. Sulaiman, B.C. Chukwuma, R.O. Braimah, B.O. Ileogedengbe, Published in the British Journal of Oral and Maxillofacial Surgery, April 21, 2023;  https://www.bjoms.com/article/S0266-4356(23)00108-0/fulltext 

(12) Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD, “Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine”, J Am Acad Dermatol. 2006 Jan;54(1):128-31

(13) Richard F. H. Catchlove, “The Influence of CO₂ and pH on Local Anesthetic Action“, Journal of Pharmacology and Experimental Therapeutics May 1972, 181 (2) 298-309