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 ...

"By the time of diagnosis, it is common for people with Parkinson's to have lost the majority of dopaminergic neurons, leading to progressive loss of motor and neurological function," explained Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience. "To replace these lost cells, we must target a very specific area of the brain with a high degree of surgical precision. Utilizing the latest advances in intraoperative MRI guided techniques provided by the ClearPoint system, the patient's new ce ...

ClearPoint Neuro (CLPT) recently announced the full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System. The newly launched technologies are likely to be on display at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Jun 1 to Jun 4 in Nashville. These meaningful innovations are likely to ultimately benefit ClearPoint's surgical customers and many new patients around the world. Price Performance For the past six months ...

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 ...

Core Viewpoint - ClearPoint Neuro, Inc. (CLPT) shows significant upside potential with a mean price target of $10, indicating an 81.5% increase from the current price of $5.51 [1] Price Targets and Analyst Estimates - The mean estimate consists of three short-term price targets with a standard deviation of $1, where the lowest estimate of $9 suggests a 63.3% increase, and the highest estimate of $11 indicates a 99.6% surge [2] - A low standard deviation among price targets reflects a high degree of agreement among analysts regarding the stock's price movement [8] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about CLPT's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [10] - The Zacks Consensus Estimate for the current year has risen by 16% over the past month, with two estimates increasing and no negative revisions [11] - CLPT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential for upside [12]

ClearPoint Neuro, Inc. (CLPT) closed the last trading session at $5.86, gaining 0.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $10 indicates a 70.7% upside potential. The average comprises three short-term price targets ranging from a low of $9 to a high of $11, with a standard deviation of $1. While the lowest estimate indicates an increase of 53.6% from the current price le ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2024 was $7.6 million, representing a 41% increase from $5.4 million in Q1 2023 [8] - Gross margin remained consistent at 59% for both Q1 2024 and Q1 2023 [12] - Cash and cash equivalents increased to $35.4 million from $23.1 million at the end of 2023, primarily due to a public offering that generated net proceeds of $16.2 million [15][31] - Cash burn in Q1 2024 was $3.8 million, down 32% from the previous year [16] Business Line Data and Key Metrics Changes - Biologics and drug delivery revenue grew 61% to $4.3 million in Q1 2024, up from $2.7 million in Q1 2023 [9] - Functional neurosurgery navigation therapy revenue declined 18% to $1.9 million, attributed to lower service revenue [10] - Capital equipment and software revenue surged 255% to $1.4 million from $0.4 million in the same period last year [11] Market Data and Key Metrics Changes - The company added eight new customers in Q1 2024, a significant increase compared to seven new customers added throughout 2023 [48] - The demand for traditional MRI-guided systems reached an all-time high, contributing to the record capital revenue [48] Company Strategy and Development Direction - The company is focused on a four-pillar growth strategy: biologics and drug delivery, functional neurosurgery navigation, therapy and access products, and achieving global scale [6] - Plans to expand into the operating room and laser therapy, as well as enhance preclinical and clinical trial services [6][30] - The company aims to achieve revenue between $28 million and $32 million for the year, with expectations of double-digit growth across all segments [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in 2024, citing significant progress in financial and strategic goals [19] - The market for neuro biotechnology is showing signs of recovery, with increased capital investment in the sector [25] - The company is well-positioned to benefit from the growing demand for its products and services in neurosurgery [26] Other Important Information - The company achieved FDA clearance for the SmartFrame OR solution, allowing for expanded use of ClearPoint products in operating rooms [27] - The introduction of new software features is expected to enhance the functionality of existing products and support future growth [49] Q&A Session Summary Question: Regarding guidance and strong start to the year - Management indicated that it is too early to change guidance despite a strong Q1, as growth was partly driven by non-recurring capital sales [55] Question: Scale-up process for new customers - Management noted that revenue from new placements is expected to ramp up in Q2, with a potential shift from initial case orders to stocking levels [57] Question: Expansion of product offerings for new customers - It was highlighted that new customers often start with one product but typically expand into additional services and products over time [39][61]

Company Overview - ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine[9] - The company leverages live MR imaging for precise guidance with sub-millimetric accuracy[11] - ClearPoint Neuro has over 50 biotech and pharma partners, with an established quality system and custom device development[10] - The company estimates a total addressable market (TAM) of over $12 billion across 35+ indications and 50+ partners[10] Products and Services - ClearPoint Neuro offers translational pre-clinical, clinical trial, and regulatory services[6] - The company has an FDA-cleared second-generation laser therapy system[6] - The ClearPoint Neuro Navigation System has been used in over 7,000 procedures[6, 51] Financials and Growth - The company's revenue guidance for 2024 is $28.0 - $32.0 million[34] - The company is expanding its global footprint, aiming for 100+ centers[42, 50] Strategic Focus - The company's strategy includes expanding into the operating room with ClearPoint OR and showing compatibility with existing third-party navigation systems[43] - ClearPoint Neuro aims to expand neuro pre-clinical CRO services and capacity, including GLP capability[43] - The company is developing a pipeline for drug infusion monitoring/modeling, intracranial cell therapy, and spinal routes of administration[43]

þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 FORM 10-Q Or Commission file number: 001-34822 Delaware 58-2394628 (State or Other Jurisdiction (IRS Employer of Incorporation or Organization) Identification Number) (888) 287-9109 (Registrant's Telephone Number, Including Area Code) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 par value per share CLPT Nasdaq Capital M ...

SOLANA BEACH, CA, May 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 first quarter ended March 31, 2024. | --- | --- | |-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...