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ClearPoint Neuro, Inc. (symbol: CLPT) is a leading medical device company based in the United States, specializing in the development and commercialization of innovative platforms designed for performing minimally invasive surgical procedures in both the brain and heart, utilizing magnetic resonance imaging (MRI) guidance. Since its inception in 1998, ClearPoint Neuro has been at the forefront of interventional MRI research and product development.
The company's flagship product, the ClearPoint® System, is currently being used in the United States for minimally invasive brain surgeries. This system allows for precision and real-time visualization during complex neurosurgical procedures, significantly improving patient outcomes. The ClearTrace® System, still under development, aims to bring similar advancements to cardiac surgeries, offering minimally invasive solutions for heart procedures.
ClearPoint Neuro's product portfolio includes the ClearPoint System, ClearPoint Services, and ClearPoint Therapeutic Solutions. Their latest innovation, the Prism Neuro Laser Therapy System, received FDA clearance and has been integrated with the company's SmartFrame Array® 1.2 software, enhancing the practicality and efficiency of neuro laser therapies. This integration allows for combined biopsy and laser therapy procedures to be performed in a single setting, reducing setup times and improving procedural accuracy.
Financially, ClearPoint Neuro has shown robust growth. In the fourth quarter of 2023, the company reported a record revenue of $6.8 million, marking a 30% increase. Their strategic partnerships, including those with clinical and pharmaceutical firms, further bolster their financial stability and market reach. The recent equity offering of approximately $15 million has solidified their balance sheet, reinforcing investor confidence in their continued growth and innovation.
ClearPoint Neuro is also deeply involved in advancing gene and cell therapy. Their SmartFlow® Cannula is a key device used globally for delivering approved gene therapies directly to the brain. This device has been instrumental in numerous clinical trials, including those for treating AADC deficiency and Frontotemporal Dementia (FTD).
Overall, ClearPoint Neuro remains committed to driving innovation in the medical field, with a strong focus on improving surgical outcomes through advanced imaging and precise navigation technologies. For more information, visit their website at www.clearpointneuro.com.
ClearPoint Neuro reported Q1 2021 revenue of $4.0 million, up 29% year-over-year. Biologics and drug delivery revenue surged 61% to $1.7 million. The company added new partnerships, raising its total to approximately 30. Case volume increased to 214, exceeding previous estimates. Following a public offering, net proceeds reached $46.8 million, bolstering cash reserves to nearly $65.0 million. Despite hospital budget constraints, the company anticipates 2021 revenues between $16.0 million and $17.5 million.
ClearPoint Neuro (Nasdaq: CLPT) announced a partnership with D&K Engineering to develop a robotic system for MRI and operating room use. This collaboration aims to streamline neurosurgery, enhancing procedural efficiency and patient interaction. The partnership leverages ClearPoint's existing technology and D&K's expertise in medical devices. The robotic system is expected to see its first clinical application in 2023. ClearPoint Neuro's platform has FDA clearance and is already implemented in over 60 clinical sites across the U.S., Canada, and Europe.
ClearPoint Neuro (Nasdaq: CLPT) announced its Q1 2021 financial results release date set for May 11, 2021, after market close. The live broadcast for the results will occur at 4:30 PM ET on the same day. Interested parties can access the call online or by phone. ClearPoint Neuro focuses on improving patient quality of life through precise therapies for neurological disorders, with FDA-cleared products used in over 60 clinical sites. The company’s partnerships include 25 biologics and drug delivery companies, supporting over 4,000 cases.
ClearPoint Neuro (CLPT) announced its support for Voyager Therapeutics' FDA clearance of the IND application for the gene therapy candidate VY-HTT01, aimed at treating Huntington’s disease, affecting around 30,000 people in the U.S. This gene therapy will undergo a Phase 1/2 clinical trial to assess its safety and tolerability. ClearPoint's navigation and delivery systems play a crucial role in this trial. The company remains committed to innovating and providing clinical services that support complex neurological treatments.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced on April 23, 2021, that its Board of Directors approved the grant of stock options and restricted shares to Mr. Danilo D’Alessandro. The package includes 30,000 restricted shares and a stock option for 75,000 shares at an exercise price of $5.80, with vesting starting September 29, 2021. This grant follows NASDAQ guidelines and aims to facilitate Mr. D’Alessandro's acceptance of employment. The company focuses on enabling advanced therapies for neurological disorders through its FDA-cleared products.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced the upcoming retirement of John N. Spencer, Jr. from its Board of Directors, effective at the Annual Meeting of Stockholders on June 3, 2021. Spencer has served since March 2010 and is credited with substantially contributing to the company's growth. ClearPoint has achieved significant milestones, including nearing its 5,000th case, and holds a preeminent status in the medical device sector. The company provides innovative solutions for neurological disorders.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announces that uniQure N.V. has completed patient enrollment for the first dose cohort of a randomized Phase I/II clinical trial of AMT-130 for early-stage Huntington's disease. Six of ten patients received AMT-130 using ClearPoint's navigation systems. A second cohort with 16 patients is set to enroll in late 2021, along with a Phase Ib/II trial planned in Europe. Huntington's disease affects ~70,000 individuals in the U.S. and Europe, with no approved therapies currently available for its progression.
ClearPoint Neuro (CLPT) announced the appointment of Ellisa Cholapranee as General Counsel, effective April 5, 2021. Reporting to CEO Joe Burnett, Cholapranee brings nearly a decade of legal experience in the life sciences and medical device sectors. Her expertise in compliance, strategy, and partnerships is expected to enhance the company's operations, especially in gene therapy and drug delivery agreements. The company continues to innovate in neurological disorder treatments, with its ClearPoint Neuro Navigation System already installed in over 60 clinical sites.
ClearPoint Neuro reports a 16% revenue increase to $3.7 million in Q4 2020, with full-year revenues totaling $12.8 million, up 14% from 2019. Notably, biologics and drug delivery revenues surged by 109% to $5.0 million, while functional neurosurgery revenues declined by 12% to $6.3 million due to COVID-19 challenges. The company's gross margin improved to 71%, attributed to higher service revenue. Despite a solid year, ClearPoint refrains from forecasting for 2021, citing persistent COVID-related disruptions in elective procedure volumes.
ClearPoint Neuro (Nasdaq: CLPT) has successfully closed a public stock offering, selling 2,127,660 shares, including 1,850,140 at $23.50 each and 277,520 following underwriters' options at $22.09. The net proceeds are approximately $46.8 million, which will support product development, R&D activities, and general corporate purposes. CEO Joe Burnett highlighted the strategic use of this capital to enhance the company’s capabilities in neuro-based therapies. B. Riley Securities managed the offering, with shares sold under an effective SEC registration statement.