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ClearPoint Neuro, Inc. operates as a medical device company primarily in the United States. The company develops and commercializes platforms for performing minimally invasive surgical procedures in the brain under direct, and intra-procedural magnetic resonance imaging (MRI) guidance. It offers ClearPoint system for the insertion of deep brain stimulation electrodes and biopsy needles, and the infusion of pharmaceuticals and laser catheters into the brain; and ClearPoint Neuro Navigation System, an MRI suite. It has license and collaboration agreements with Boston Scientific Corporation, The Johns Hopkins University, Clinical Laserthermia Systems Americas Inc, Koninklijke Philips N.V., Blackrock Neurotech, and University of California and San Francisco. The company was formerly known as MRI Interventions, Inc. and changed its name to ClearPoint Neuro, Inc. in February 2020. ClearPoint Neuro, Inc. was incorporated in 1998 and is headquartered in Solana Beach, California.

ClearPoint Neuro, Inc.

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SITE READINESS CONTINUES FOR SPECIALIZED TREATMENT CENTERS ENVISIONED TO SUPPORT A GROWING NUMBER OF CELL AND GENE THERAPY TRIAL PATIENTS AND LATER COMMERCIALIZATION SOLANA BEACH, CA / ACCESS NEWSWIRE / NOVEMBER 6, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED FINANCIAL RESULTS FOR ITS THIRD QUARTER ENDED SEPTEMBER 30, 2025. THIRD QUARTER HIGHLIGHTS CONTINUED TO PROVIDE SUPPLY, DEVELOPMENT, AND STRATEGIC SUPPORT TO MORE THAN 60 ACTIVE BIOPHARMA PARTNERS, INCLUDING NINE PARTNER PROGRAMS ACCEPTED FOR FDA EXPEDITED REVIEW, WITH MANY PARTNERS SHARING UPDATES ON THEIR SCIENTIFIC AND REGULATORY PROGRESS AT THE 2025 ESGCT ANNUAL CONGRESS IN SEVILLE, SPAIN; COMPLETED TRANSITION TO THE NEW PRE-CLINICAL CRO FACILITY NAMED CLEARPOINT ADVANCED LABORATORIES (CAL) LOCATED IN TORREY PINES, CALIFORNIA, WHICH BECAME OPERATIONAL AND ALREADY BEGAN RUNNING PRECLINICAL STUDIES EARLY IN Q4 2025; ANNOUNCED THE DEVELOPMENT AND DEMONSTRATION OF THE COMPANY'S PROTOTYPE ROBOTIC NEURO-NAVIGATION SYSTEM, WHICH IS BEING DESIGNED TO ENABLE THE CLEARPOINT NEURO NAVIGATION SOFTWARE TO OPERATE THE KUKA LBR MED ROBOTIC ARM TO SUPPORT ALL MINIMALLY INVASIVE CRANIAL SURGICAL PROCEDURES INCLUDING CELL AND GENE THERAPY INFUSIONS, LASER CATHETER PLACEMENT, BIOPSY WORKFLOWS, DEEP BRAIN STIMULATION, AND STEREOTACTIC EEG LEAD PLACEMENTS; RECEIVED FDA 510(K) CLEARANCE EXPANDING COMPATIBILITY OF THE CLEARPOINT PRISM LASER THERAPY SYSTEM WITH 1.5T MRI GUIDANCE IN ADDITION TO THE PREVIOUSLY CLEARED 3T MRI GUIDANCE, OPENING UP MORE THAN 50% OF THE EXISTING MARKET FOR NEURO LITT; ANNOUNCED SEVERAL EXPANDED REGULATORY APPROVALS FOR PRODUCT USE IN CANADA, HONG KONG, AND TAIWAN, BRINGING THE TOTAL NUMBER OF INTERNATIONAL CLEARANCES FOR KEY THERAPY DELIVERY PRODUCTS TO 34 COUNTRIES WORLDWIDE; ANNOUNCED A SIGNED AGREEMENT FOR THE ACQUISITION OF IRRAS HOLDINGS, INC., WHICH WILL EXPA

CLEARPOINT NEURO REPORTS THIRD QUARTER 2025 RESULTS

ACQUISITION WILL FURTHER EXPAND THE POTENTIAL OF CLEARPOINT NEURO'S DRUG DELIVERY PORTFOLIO WHILE IMMEDIATELY ADDING NEW INDICATIONS AND COMMERCIAL SCALE ACROSS A $0.5 BILLION MARKET FOR THE TREATMENT OF INTRACRANIAL BLEEDING SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / NOVEMBER 6, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED THE ACQUISITION OF SAN DIEGO BASED, IRRAS HOLDINGS, INC., A MEDICAL TECHNOLOGY COMPANY FOCUSED ON NEUROCRITICAL CARE, WITH AN EMPHASIS ON TREATMENTS FOR INTRACEREBRAL HEMORRHAGE, CHRONIC SUBDURAL HEMATOMA, AND OTHER CONDITIONS REQUIRING INTRACRANIAL FLUID MANAGEMENT. ITS CORNERSTONE PRODUCT IS THE IRRAFLOW  SYSTEM, AN FDA-CLEARED AND CE-MARKED PLATFORM WHICH INTEGRATES CONTINUOUS IRRIGATION, ASPIRATION, AND REAL-TIME INTRACRANIAL PRESSURE MONITORING.

CLEARPOINT NEURO ANNOUNCES AGREEMENT TO ACQUIRE IRRAS

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / NOVEMBER 5, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED IT WILL PARTICIPATE IN THE FOLLOWING INVESTOR CONFERENCES: 2025 UBS GLOBAL HEALTHCARE CONFERENCE - PALM BEACH GARDENS, FL PRESENTING ON MONDAY, NOVEMBER 10, 2025 2025 STIFEL HEALTHCARE CONFERENCE - NEW YORK, NY PRESENTING ON THURSDAY, NOVEMBER 13, 2025 37TH ANNUAL PIPER SANDLER HEALTHCARE CONFERENCE - NEW YORK, NY PRESENTING ON WEDNESDAY, DECEMBER 3, 2025 MEMBERS OF THE CLEARPOINT NEURO MANAGEMENT TEAM WILL BE ONSITE AND AVAILABLE FOR IN-PERSON INVESTOR MEETINGS WHO ARE REGISTERED TO ATTEND THE VARIOUS CONFERENCES. ABOUT CLEARPOINT NEURO CLEARPOINT NEURO IS A DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE.

CLEARPOINT NEURO TO PARTICIPATE IN MULTIPLE GLOBAL HEALTHCARE CONFERENCES IN THE FOURTH QUARTER OF 2025

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / OCTOBER 7, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED RESULTS FROM A PHASE I-II CLINICAL STUDY AT SKNE UNIVERSITY HOSPITAL IN LUND, SWEDEN EVALUATING THE CLEARPOINT PRISM NEURO LASER THERAPY SYSTEM'S SAFETY, FEASIBILITY, AND EFFICACY. THE STUDY COHORT COMPRISED FOURTEEN PATIENTS AGES 18-80YEARS WITH PRIMARY AND RECURRENT GLIOBLASTOMA AND GRADE 4 ASTROCYTOMA, TUMORS WHICH ARE AMONG THE MOST CHALLENGING TO TREAT.

CLEARPOINT NEURO ANNOUNCES PROMISING RESULTS FROM BRAIN TUMOR LASER THERAPY STUDY TO BE PRESENTED AT THE CNS ANNUAL MEETING IN LOS ANGELES

THE CLEARLY ESTABLISHED HISTORY ACROSS GLOBAL REGULATORY BODIES IS EXPECTED TO DE-RISK BIOPHARMA PARTNERS' PATHWAYS TOWARDS ACHIEVING GLOBAL SCALE AND STANDARDIZATION. SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / OCTOBER 6, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED SEVERAL EXPANDED REGULATORY APPROVALS FOR PRODUCT USE IN CANADA, HONG KONG, AND TAIWAN.

CLEARPOINT NEURO ANNOUNCES EXPANDED INTERNATIONAL CLEARANCES FOR KEY THERAPY DELIVERY PRODUCT; NOW TOTALING 34 COUNTRIES WORLDWIDE

NEW PRODUCT CATEGORY WILL ENABLE ADDED FLEXIBILITY TO SUPPORT COMMERCIAL LAUNCHES OF CELL AND GENE THERAPY SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / OCTOBER 1, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY FORMALLY ANNOUNCED THE DEVELOPMENT AND DEMONSTRATION OF THE COMPANY'S PROPRIETARY ROBOTIC NEURO-NAVIGATION SYSTEM. THIS NEW PRODUCT CATEGORY WILL ENABLE THE CLEARPOINT NEURO NAVIGATION SOFTWARE TO OPERATE THE KUKA LBR MED ROBOTIC ARM TO SUPPORT ALL MINIMALLY INVASIVE CRANIAL SURGICAL PROCEDURES INCLUDING CELL AND GENE THERAPY INFUSIONS, LASER CATHETER PLACEMENT, BIOPSY WORKFLOWS AND DEEP BRAIN STIMULATION AND STEREOTACTIC EEG LEAD PLACEMENTS.

CLEARPOINT NEURO ANNOUNCES DEVELOPMENT AND DEMONSTRATION OF THE COMPANY'S PROPRIETARY ROBOTIC NEURO-NAVIGATION SYSTEM

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / SEPTEMBER 25, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED THAT DR. PAUL LARSON WILL BE JOINING THE COMPANY AS CHIEF MEDICAL OFFICER STARTING IN JANUARY 2026. DR. LARSON HAS A LONG HISTORY OF WORKING WITH CLEARPOINT NEURO AS AN ADVISOR, ESPECIALLY SUPPORTING EDUCATION AND PRODUCT DEVELOPMENT EFFORTS RELATED TO CELL AND GENE THERAPY DELIVERY.

CLEARPOINT NEURO ANNOUNCES THE APPOINTMENT OF DR. PAUL LARSON AS CHIEF MEDICAL OFFICER

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / SEPTEMBER 4, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED THAT THE CLEARPOINT PRISM NEURO LASER THERAPY SYSTEM ("CLEARPOINT PRISM") RECEIVED 510(K) CLEARANCE FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO INCLUDE 1.5T MRI GUIDANCE IN ADDITION TO THE PREVIOUSLY CLEARED 3T MRI GUIDANCE. THIS EXPANDED LABELING COULD SIGNIFICANTLY INCREASE CLEARPOINT PRISM'S MARKET OPPORTUNITY WITHIN THE UNITED STATES, WHERE 1.5T MRI SYSTEMS ACCOUNT FOR APPROXIMATELY 60% OF CLINICAL USE.1 AS THE COMPANY CONSIDERS FUTURE DEVELOPMENT WITHIN KEY MARKETS, 1.5T SYSTEMS REPRESENT OVER 70% OF THE GLOBAL INSTALLED MRI BASE,2 WELL-POSITIONING CLEARPOINT PRISM FOR FUTURE GROWTH AS THE COMPANY CONTINUES TO EXPAND INTERNATIONALLY.

CLEARPOINT NEURO ANNOUNCES FDA CLEARANCE EXPANDING COMPATIBILITY OF THE CLEARPOINT PRISM NEURO LASER THERAPY SYSTEM WITH 1.5T MRI SCANNERS

RECORD REVENUE AND SUBSTANTIAL CASH INFUSION HIGHLIGHT THE COMPANY'S FAST. FORWARD.' STRATEGY SOLANA BEACH, CA / ACCESS NEWSWIRE / AUGUST 12, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED FINANCIAL RESULTS FOR ITS SECOND QUARTER ENDED JUNE 30, 2025.

CLEARPOINT NEURO REPORTS SECOND QUARTER 2025 RESULTS

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / AUGUST 4, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) ("COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED MULTIPLE KEY MILESTONES DEMONSTRATING THE PROGRESSION OF THE COMPANY'S BIOLOGICS AND DRUG DELIVERY PORTFOLIO INCLUDING FIRST COMMERCIAL INFUSIONS IN THE UNITED STATES, ADDITIONAL PARTNERS ACCEPTED FOR EXPEDITED REVIEW, CREATION OF CELL AND GENE INFUSION ICD-10 CODES, AND RECORD CLINICAL TRIAL PATIENTS TREATED GLOBALLY IN THE MONTH OF JULY. THE FIRST COMMERCIAL TREATMENTS FOR KEBILIDI (ELADOCAGENE EXUPARVOVEC-TNEQ), A GENE THERAPY APPROVED FOR PEDIATRIC AND ADULT PATIENTS WITH AROMATIC L-AMINO ACID DECARBOXYLASE (AADC) DEFICIENCY-A RARE, LIFE-THREATENING NEUROLOGICAL DISORDER, HAVE BEEN PERFORMED IN THE UNITED STATES USING THE COMPANY'S SMARTFLOW NEURO CANNULA.

CLEARPOINT NEURO ANNOUNCES PROGRESSION OF KEY PARTNER MILESTONES THROUGHOUT THE GLOBAL BIOLOGICS AND DRUG DELIVERY PORTFOLIO

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / JULY 23, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED THAT IT WILL RELEASE FINANCIAL RESULTS FOR ITS 2025 SECOND QUARTER ON TUESDAY, AUGUST 12TH, AFTER THE MARKET CLOSE. INVESTORS AND ANALYSTS ARE INVITED TO LISTEN TO THE LIVE BROADCAST REVIEW OF THE COMPANY'S 2025 SECOND QUARTER ON TUESDAY, AUGUST 12TH AT 4:30 P.M.

CLEARPOINT NEURO TO ANNOUNCE SECOND QUARTER 2025 RESULTS AUGUST 12, 2025

RECORD REVENUE HIGHLIGHTED BY 70% GROWTH IN SINGLE-USE NAVIGATION AND THERAPY PRODUCTS SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / MAY 13, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED FINANCIAL RESULTS FOR ITS FIRST QUARTER ENDED MARCH 31, 2025. FIRST QUARTER HIGHLIGHTS REPORTED RECORD QUARTERLY REVENUE OF $8.5 MILLION, AN 11% YEAR-OVER-YEAR INCREASE COMPARED WITH THE FIRST QUARTER OF 2024; GREW TOTAL CONSUMABLE PRODUCT REVENUE BY $2.6 MILLION YEAR-OVER-YEAR, OR 104%, INCLUDING BIOLOGICS AND DRUG DELIVERY CANNULAS, SMARTFRAME FAMILY NAVIGATION DEVICES, AND CLEARPOINT PRISM LASER THERAPY APPLICATORS; RECEIVED FDA CLEARANCE FOR THE CLEARPOINT 3.0 SOFTWARE WHICH INCLUDES BOTH OPERATING ROOM NAVIGATION CAPABILITY AND ENHANCED LASER THERAPY FEATURES.

CLEARPOINT NEURO REPORTS FIRST QUARTER 2025 RESULTS

SOLANA BEACH, CALIFORNIA / ACCESS NEWSWIRE / MAY 12, 2025 / CLEARPOINT NEURO, INC. (NASDAQ:CLPT) (THE "COMPANY"), A GLOBAL DEVICE, CELL, AND GENE THERAPY-ENABLING COMPANY OFFERING PRECISE NAVIGATION TO THE BRAIN AND SPINE, TODAY ANNOUNCED THAT IT HAS ENTERED INTO A NOTE FINANCING ARRANGEMENT WITH OBERLAND CAPITAL MANAGEMENT LLC ("OBERLAND CAPITAL") OF UP TO $105 MILLION, WITH $30.0 MILLION OF GROSS PROCEEDS FUNDED AT CLOSING. ADDITIONAL NOTE FINANCING WILL BE PROVIDED TO THE COMPANY BY OBERLAND CAPITAL UNDER THE FOLLOWING TERMS: AN ADDITIONAL $25.0 MILLION AT THE OPTION OF THE COMPANY ANY TIME PRIOR TO DECEMBER 31, 2026; AND AN ADDITIONAL $50.0 MILLION AT THE OPTION OF THE COMPANY AND OBERLAND CAPITAL ANY TIME PRIOR TO DECEMBER 31, 2026.

ClearPoint Neuro, Inc.

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ClearPoint Neuro, Inc.

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