4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

4 - ClearPoint Neuro, Inc. (0001285550) (Issuer)

Aspen Neuroscience Announces MRI-Guided Transplantation Approach for ASPIRO Clinical Trial with the ClearPoint® Navigation System

ClearPoint Neuro (NASDAQ:CLPT) reported quarterly losses of $(0.16) per share which beat the analyst consensus estimate of $(0.19) by 15.79 percent. This is a 30.43 percent increase over losses of $(0.23) per share from the same period last year. The company reported quarterly sales of $7.639 million which beat the analyst consensus estimate of $6.994 million by 9.23 percent. This is a 40.60 percent increase over sales of $5.433 million the same period last year.

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 congratulates its partner AviadoBio on treating its first patient in the ASPIRE-FTD Phase 1/2 clinical trial evaluating its investigational gene therapy AVB-101 in people with frontotemporal dementia (FTD) with progranulin (GRN) mutations. "FTD is an important cause of dementia in people under 65 and has a devastating impact on patients and families. The importance of accurately delivering this one-time gene therapy to the thalamus, while minimizing systemic exposure, is the precise use case of ClearPoint's minimally invasive

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 congratulates its partner PTC Therapeutics on completion of its BLA submission to the U.S. Food and Drug Administration (FDA) for the approval of Upstaza™ (eladocagene exuparvovec), an investigational treatment for AADC Deficiency. If approved, Upstaza™would become the first therapy to treat AADC Deficiency in the United States. "AADC Deficiency is a devastating rare pediatric movement disorder that causes significant developmental delays and autonomic symptoms starting from birth. Patients with AADC deficiency are at a high

Stifel analyst Mathew Blackman reiterates ClearPoint Neuro (NASDAQ:CLPT) with a Buy and raises the price target from $8 to $9.

ClearPoint Neuro (NASDAQ:CLPT) reported its Q4 earnings results on Tuesday, March 12, 2024 at 04:05 PM. Here's what investors need to know about the announcement. Earnings ClearPoint Neuro beat estimated earnings by 5.0%, reporting an EPS of $-0.19 versus an estimate of $-0.2. Revenue was up $1.64 million from the same period last year. Past Earnings Performance Last quarter the company beat on EPS by $0.05 which was followed by a 18.0% drop in the share price the next day. Here's a look at ClearPoint Neuro's past performance: Quarter Q3 2023 Q2 2023 Q1 2023 Q4 2022 EPS Estimate -0.25 -0.19 -0.18 -0.20 EPS Actual -0.20 -0.29 -0.23 -0.18 Revenue Estimate 6.80M 5.90M 5.10M 5.19M R

SOLANA BEACH, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- 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 2024 third quarter on Thursday, November 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 third quarter on Thursday, November 7th at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or a

SOLANA BEACH, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- 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 2024 second quarter on Wednesday, August 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 second quarter on Wednesday, August 7th at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or

SOLANA BEACH, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- 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 2024 first quarter on Tuesday, May 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 first quarter on Tuesday, May 7th, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201

SOLANA BEACH, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- 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 2023 fourth quarter and full year on Tuesday, March 12th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2023 fourth quarter and full year results on Tuesday, March 12th, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telep

SOLANA BEACH, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its third quarter ended September 30, 2023. Third Quarter Highlights Reported quarterly revenue of $5.8 million, a 12% year-over-year increase;Increased biologics and drug delivery revenue to $3.5 million, a 55% year-over-year increase;Operational cash burn of $1.8 million, the lowest quarterly burn since 2020;Entered into new strategic biologics and drug delivery agreements, including additional milestone-based agreement;Submitted three new stereotacti

SOLANA BEACH, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that it will release financial results for its 2023 third quarter on Thursday, November 9, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2023 third quarter on Thursday, November 9, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (800) 715-9871, or at (646) 307-196

SOLANA BEACH, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its second quarter ended June 30, 2023. Second Quarter Highlights Reported record quarterly revenue of $6.0 million, a 14% year-over-year increase;Increased biologics and drug delivery revenue to $3.4 million, a 40% year-over-year increase;Announced an example of a milestone-based biologics and drug delivery agreement whereby ClearPoint would earn cash compensation based on the successful progression of a drug candidate through the clinical and regulato

SOLANA BEACH, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that it will release financial results for its 2023 second quarter on Tuesday, August 8, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2023 second quarter on Tuesday, August 8, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 437-3179, or at (862) 298-0702 if

SOLANA BEACH, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its first quarter ended March 31, 2023. First Quarter Highlights Reported quarterly revenue of $5.4 million, a 8% year-over-year increase;Increased biologics and drug delivery revenue to $2.7 million, a 24% year-over-year increase;Announced exclusive multi-year licensing agreement with UCSF for Innovative Intra-Cerebral Cellular Delivery Platform;Added multiple new biologics and drug delivery partners in the quarter to bring the total to more than 50;Ins

SOLANA BEACH, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that it will release financial results for its 2023 first quarter on Thursday, May 11, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2023 first quarter on Thursday, May 11, 2023, at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or at (862) 298-0702 if ca

Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United StatesSOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro Cannula is intended for intraputaminal administration of PTC Therapeutics' gene therapy KEBILIDI™ (eladocagene exuparvovec-tneq) for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency. This signifies th

Achieved Record Revenue and Growth of 41%; Operational Cash Burn Reduced to $1.2 Million SOLANA BEACH, CA / ACCESSWIRE / November 7, 2024 / 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, 2024.Third Quarter HighlightsReported quarterly revenue of $8.1 million, a 41% year-over-year increase;Accelerated growth of SmartFrame OR™ platform and ClearPoint Prism® Laser Therapy System, contributing to record navigation and device revenue of $2.9 million, a 53% year-over-year increase;Overall product revenue, inc

President and CEO Joe Burnett Interview Highlighted on Bloomberg Intelligence Vanguards of Healthcare Podcast TodaySOLANA BEACH, CA / ACCESSWIRE / October 31, 2024 / 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 participation in multiple investor conferences and interview formats including Bloomberg Intelligence Vanguards of Healthcare Podcast series published today. The link to the interview published this morning on Bloomberg can be found HERE.Healthcare Conferences with Participation of ClearPoint Neuro Management Include:UBS Global Healthcare Conference in

SOLANA BEACH, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- 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 2024 third quarter on Thursday, November 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 third quarter on Thursday, November 7th at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or a

SOLANA BEACH, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- 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 on August 23, 2024, it provided for the full early repayment of the principal amount and interest on a $10 million convertible note held by PTC Therapeutics Inc., which would have matured in January 2025 according to its terms. The convertible note was issued by the Company pursuant to a financing transaction which was completed in January 2020. "PTC has been and continues to be a strong partner of ClearPoint Neuro. The early repayment of our convertibl

SOLANA BEACH, Aug. 07, 2024 (GLOBE NEWSWIRE) -- 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, 2024. Second Quarter Highlights Reported quarterly revenue of $7.9 million, a 32% year-over-year increase;Product revenue across all segments more than doubled, and grew 112% to $4.9 million;Increased Biologics and Drug Delivery revenue to $4.3 million, a 28% year-over-year increase;Full market release of SmartFrame OR™ platform and ClearPoint Prism® Laser Therapy System contributing to record navigation and d

SOLANA BEACH, Calif., July 17, 2024 (GLOBE NEWSWIRE) -- 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 2024 second quarter on Wednesday, August 7th, after the market close. Investors and analysts are invited to listen to the live broadcast review of the Company's 2024 second quarter on Wednesday, August 7th at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here. Investors and analysts who would like to participate in the conference call via telephone may do so at (888) 428-7458, or

SOLANA BEACH, Calif., June 20, 2024 (GLOBE NEWSWIRE) -- 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 congratulates its partner Aspen Neuroscience, Inc. on use of the ClearPoint Neuro Navigation System to transplant dopaminergic neuron precursor cells (DANPCs) for all enrolled patients with Parkinson's Disease (PD) in its recently launched ASPIRO Phase 1/2a clinical trial. ASPIRO is an open label trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe PD. The DANPCs

Aspen Neuroscience Announces MRI-Guided Transplantation Approach for ASPIRO Clinical Trial with the ClearPoint® Navigation System SAN DIEGO, June 20, 2024 /PRNewswire/ -- Aspen Neuroscience, Inc. announced today that it is utilizing the MRI-guided ClearPoint® Navigation System for all patients enrolled in the recently launched ASPIRO Phase 1/2a clinical trial for transplantation of dopaminergic neuron precursor cells (DANPCs) in patients with Parkinson's Disease (PD). ASPIRO is an open label trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe PD.

SOLANA BEACH, Calif., June 01, 2024 (GLOBE NEWSWIRE) -- 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 announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1st – Tuesday, June 4th in Nashville. "Deep Brain Stimulation (DBS) has been proven to be a safe and effective strategy to manage patients with medically intractable Parkinson's Disease, Essential Tremor, and Dystonia,1" said Dr. Kim Bur

For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. “Clinical advancements in the f

8-K - ClearPoint Neuro, Inc. (0001285550) (Filer)

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10-Q - ClearPoint Neuro, Inc. (0001285550) (Filer)

8-K - ClearPoint Neuro, Inc. (0001285550) (Filer)

8-K - ClearPoint Neuro, Inc. (0001285550) (Filer)

10-Q - ClearPoint Neuro, Inc. (0001285550) (Filer)

8-K - ClearPoint Neuro, Inc. (0001285550) (Filer)

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8-K - ClearPoint Neuro, Inc. (0001285550) (Filer)

10-Q - ClearPoint Neuro, Inc. (0001285550) (Filer)

SOLANA BEACH, Calif., Sept. 20, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that Mazin Sabra will join the Company effective October 10th as Chief Operating Officer. Mr. Sabra will report directly to Joe Burnett, ClearPoint Neuro's Chief Executive Officer, and serve as a member of the Company's senior leadership team. "We are thrilled to have Mazin join our team and bring his valuable and relevant skill set into our organization," commented Joe Burnett, President and CEO at ClearPoint Neuro. "Our pharma and device partners in many ways view ClearP

SOLANA BEACH, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that Mary McNamara-Cullinane has joined the Company as Vice President of Regulatory Affairs. Ms. McNamara-Cullinane will report directly to Joe Burnett, ClearPoint Neuro's Chief Executive Officer, and serve as a member of the Company's senior leadership team. "We are thrilled to welcome Mary to our team as we fully expect her leadership and experience in Regulatory Affairs will contribute immediately to our partners and to patients globally," commented Joe Burnett, Presiden

SOLANA BEACH, Calif., July 15, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, is pleased to announce that Lynnette C. Fallon has been appointed to the Company's Board of Directors effective immediately. Ms. Fallon will also become a member of the Company's Audit Committee. Ms. Fallon is the Executive Vice President, HR/Legal, General Counsel and Secretary of Axcelis Technologies, Inc. (NASDAQ:ACLS), a provider of equipment and service solutions for the semiconductor manufacturing industry, with locations in eight countries. Ms. Fallon has held her current position sin

SOLANA BEACH, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, announced today the upcoming retirement of John N. Spencer, Jr. from its Board of Directors. Mr. Spencer, who has as served as a director since March 2010, is retiring when his current term of office expires effective at ClearPoint's Annual Meeting of Stockholders to be held on June 3, 2021. "Jack has contributed substantially to the growth of our Company and will be missed," commented Joe Burnett, President and CEO of ClearPoint Neuro. "He has been a steady force, helping to navigate this

IRVINE, Calif., March 24, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced that Ellisa Cholapranee will join the Company as General Counsel on April 5, 2021. Ms. Cholapranee will report directly to Joe Burnett, ClearPoint Neuro’s Chief Executive Officer, and serve as a member of the Company’s senior leadership team. “Ellisa is a tremendous addition to our capable and growing leadership team,” commented Joe Burnett, President and CEO of ClearPoint Neuro. “Not only does Ellisa offer the broad experience in compliance, contracting and strategy, but li

IRVINE, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”) today announced that R. John Fletcher has been appointed Chairman of the Company’s Board of Directors. The prior Chairman, Kimble L. Jenkins, retired from the Chairman role, which he has held since 2003, and resigned from the Board of Directors to focus on commitments associated with his role as the Chief Executive Officer of OrthoSouth. “On behalf of our Board and the management team, we thank Kim for his service and longstanding commitment to the Company. We greatly appreciate the leadership, insight, and expertise that Kim has provided, taking us from a pre-regulatory, pre-revenue