Welcome to our dedicated page for Clearpoint Neuro news (Ticker: CLPT), a resource for investors and traders seeking the latest updates and insights on Clearpoint Neuro stock.
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 third-quarter 2022 revenue of $5.1 million, reflecting a 13% year-over-year increase. Key achievements include the European Commission granting full marketing authorization for Upstaza, a gene therapy, and multiple FDA clearances for new products. The company anticipates full-year revenues between $21.0 million and $22.0 million. However, operating expenses rose to $7.5 million, attributed to increased headcount and share-based compensation, leading to a decrease in cash reserves from $54.1 million at the beginning of the year to $40.5 million.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) is set to release its financial results for Q3 2022 on November 8, 2022, after market close. A live broadcast of the results will occur at 4:30 p.m. Eastern time the same day. Investors can access the call online or by phone. ClearPoint's current offerings include advanced navigation and delivery systems for treating neurological disorders, and the company maintains partnerships with over 45 organizations in clinical trials. Investors are reminded of uncertainties affecting future performance, including market acceptance and supply chain issues.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced that its Swedish partner, Clinical Laserthermia Systems (CLS), has received 510(k) clearance for its laser, facilitating the launch of the ClearPoint Prism™ Neuro Laser Therapy System. This system, designed for soft tissue necrosis through MRI-guided thermal therapy, combines the ClearPoint navigation platform and CLS laser technology. Currently, it is in limited market release across select U.S. academic medical centers. ClearPoint aims to enhance treatment accessibility for neurological diseases through this innovative solution.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced the appointment of Mazin Sabra as Chief Operating Officer, effective October 10. Reporting to CEO Joe Burnett, Sabra brings extensive experience in quality, procurement, and supply chain management from Philips and Stryker. His leadership is anticipated to strengthen ClearPoint's operational infrastructure and enhance confidence among pharma and device partners. ClearPoint Neuro is dedicated to delivering therapies for neurological disorders and has a robust product portfolio including the ClearPoint Neuro Navigation System.
ClearPoint Neuro announced 510(k) clearance for version 2.1 of its Neuro Navigation software, enhancing stereotactic guidance for neurological procedures within MRI environments. This update includes improved usability for clinicians, new trajectory planning tools, and enhanced visualization capabilities. Currently in limited market release, the software will first be available to customers in the ClearPoint 'Pathfinder' Program. The company aims to optimize clinical workflows and support future innovations in preoperative planning and medical imaging.
ClearPoint Neuro reported a record quarterly revenue of $5.2 million for Q2 2022, reflecting a 52% year-over-year growth. The company reaffirmed its full-year revenue outlook of $21.0 to $22.0 million. Significant gains were seen in biologics and drug delivery revenue, which rose by 73% to $2.4 million. Operating expenses increased to $7.5 million from $5.7 million due to higher headcount and product development costs. As of June 30, 2022, cash and short-term investments totaled $45.1 million.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) has received 510(k) clearance for its ClearPoint Maestro™ Brain Model, enhancing its portfolio for brain navigation and therapy delivery. The software automates MRI analysis, facilitating the identification and quantification of brain structures. Developed over a decade, it ensures sub-millimeter accuracy and is supported by extensive research. ClearPoint aims to integrate this tool into its navigation system, enhancing functionality for targeted therapies. The product release is expected to contribute significantly to clinical applications in neurosurgery.
ClearPoint Neuro (Nasdaq: CLPT) has appointed Mary McNamara-Cullinane as Vice President of Regulatory Affairs, strengthening its leadership team. With over 25 years in healthcare, she brings expertise in regulatory and clinical affairs critical for the company’s growth strategy involving new product launches and geographic expansion. CEO Joe Burnett expressed confidence in her ability to enhance the company's regulatory strategy, essential for supporting its portfolio of partners. ClearPoint aims to improve patient outcomes by delivering precise therapies for complex neurological disorders.
ClearPoint Neuro, Inc. (CLPT) will release its second-quarter financial results for 2022 on August 9, 2022, post-market close. A live broadcast will follow the announcement at 4:30 p.m. Eastern time. ClearPoint Neuro specializes in enabling therapies for complex neurological disorders. The company's ClearPoint Neuro Navigation System has received FDA clearance and is deployed in over 60 active sites globally. The press release also includes a caution regarding forward-looking statements and potential risks associated with the company's operations influenced by the COVID-19 pandemic and market acceptance.
ClearPoint Neuro has announced a significant milestone as partner PTC Therapeutics receives marketing authorization from the European Commission for Upstaza™, the first gene therapy approved for direct infusion into the brain. This therapy targets aromatic L-amino acid decarboxylase (AADC) deficiency, a severe condition affecting children, and is now authorized for patients aged 18 months and older across the EU and select countries. ClearPoint's SmartFlow® Neuro Cannula will be utilized in administering this therapy, enhancing the treatment landscape for neurological disorders.
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