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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, Inc. (Nasdaq: CLPT) reported a record Q1 2022 revenue of $5.0 million, marking a 25% year-over-year increase. The growth was driven by a 30% rise in biologics and drug delivery revenue to $2.2 million. The company expanded its global presence with four additional sites and partnered with Philips for advanced operating room technology. Full-year revenue is now projected between $21.0 million and $22.0 million, translating to a 30-35% growth compared to 2021. Operating expenses rose to $7.1 million, influenced by increased headcount and development costs.
ClearPoint Neuro (CLPT) announces a collaboration with Higgs Boson Health to develop the MyClearPoint™ digital health app. This app aims to enhance drug delivery to the brain and spine and support brain-computer interface surgeries. It will provide patients with essential services, including education and recovery tracking. The partnership leverages Higgs Boson’s proven ManageMySurgery platform, which has shown to improve surgical outcomes and reduce cancellations. This initiative is poised to reduce healthcare resource utilization and improve patient satisfaction.
ClearPoint Neuro has received FDA clearance for version 1.1 of its SmartFrame Array Neuro Navigation System, designed to improve procedures in MRI suites and operating rooms. The system, in limited market release since May 2021, has been utilized in over 50 procedures across 10 clinical sites. The new version includes a pre-planning module to enhance workflow and reduce procedure time. The company's mission focuses on enabling therapies for complex neurological disorders. The SmartFrame Array's enhanced features aim to streamline clinical trial processes.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced an expansion of its licensing agreement with Philips to incorporate Computed Tomography (CT) into its surgical navigation system. This aims to enhance surgical procedures in the Operating Room (OR), utilizing the ClearPoint Maestro™ Brain Model for improved accuracy. The integration will facilitate the training of surgeons and allow workflows to mirror those used in MRI environments. ClearPoint's navigation system has FDA clearance and is operational in around 60 sites globally, supporting various neurological treatments.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced it will release its financial results for Q1 2022 on May 11, 2022, post-market. Investors can join a live review at 4:30 p.m. ET the same day via a conference call or online. The company focuses on enabling therapies for complex neurological disorders and has FDA clearance for its ClearPoint® Neuro Navigation System, operational in approximately 60 sites across the US, Canada, and Europe. ClearPoint is also engaged with about 40 biologics/pharmaceutical firms for CNS therapeutic delivery.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its participation in the B. Riley Securities Disruptive Biotech Enabling Technologies Mini Conference on April 7, 2022, at 2:30 p.m. Eastern Time. The company specializes in navigating and delivering therapies to treat complex neurological disorders with precision. Its FDA-cleared ClearPoint® Neuro Navigation System is in around 60 active sites across North America and Europe. Currently, ClearPoint is collaborating with approximately 40 pharmaceutical firms and has supported over 5,000 clinical cases globally.
ClearPoint Neuro reported record revenues for Q4 2021, achieving $4.3 million, a 15% increase from Q4 2020. For the full year, revenue reached $16.3 million, marking a 27% growth over 2020. The firm highlighted a robust 31% rise in biologics and drug delivery revenue, totaling $6.8 million. Despite challenges from COVID-19, ClearPoint supported 929 cases in 2021 and ended the year with $54.1 million in cash. The company anticipates revenue between $20 to $22 million for 2022, fueled by strategic expansions and FDA clearances.
ClearPoint Neuro announced preliminary financial results for Q4 and full year 2021. Q4 revenue reached $4.3 million, up 15% year-over-year, driven by a 37% increase in neurosurgery products to $2.1 million. Full year revenue hit $16.3 million, a 27% rise, supported by a record 929 cases handled. The company projects 2022 revenue of $20.0-$22.0 million, marking a 23%-35% growth. However, COVID-19's impact on elective procedures remains a key risk. The earnings call is scheduled for March 1, 2022, after market close.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its participation in the H.C. Wainwright BIOCONNECT Virtual Conference on January 10, 2022. A pre-recorded presentation will be available from 7 a.m. ET. The company focuses on enhancing treatment for complex neurological disorders through its FDA-cleared ClearPoint Neuro Navigation System, operational at over 60 sites across the U.S., Canada, and Europe. ClearPoint has partnered with around 40 companies and has supported over 5,000 clinical cases, providing precise delivery of therapies and innovations in the field.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) congratulates Blackrock Neurotech for its FDA Breakthrough Device designation for the MoveAgain Brain Computer Interface (BCI) system. This system aims to assist the 5.35 million people suffering from paralysis in the U.S. by translating brain signals into commands for devices like wheelchairs. ClearPoint is leveraging its expertise in neuro-navigation to help develop a surgical solution for BCI implantation. The partnership aims to enhance quality of life for patients with severe neurological disorders.
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