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 (NASDAQ: CLPT) announced a multi-year licensing deal with UCSF to develop a radial cellular delivery device for brain therapies. This device aims to enhance the precision of delivering biologics, such as stem cells and gene therapy, to specific brain locations using real-time imaging. Dr. Daniel Lim from UCSF highlighted its potential impact on treating neurological disorders like Parkinson's disease. The agreement allows ClearPoint to commercialize the device, which is expected to improve cell therapy trials plagued by technical limitations. ClearPoint's system is already in over 65 sites globally, enhancing the delivery of various therapeutic agents.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) reported record revenues for the year ended December 31, 2022. The company achieved $20.6 million in total revenue, representing a 26% increase from 2021, marking the eighth consecutive year of growth. Q4 revenue was $5.2 million, a 21% year-over-year increase. Biologics and drug delivery revenue increased by 34% to $9.1 million for the full year. However, while gross margin was 66%, it decreased from 68% in 2021 due to rising indirect labor costs. The company ended 2022 with $37.5 million in cash and short-term investments. ClearPoint expects continued growth of 20% in 2023.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced plans to release its financial results for the fourth quarter and full year of 2022 on March 1, 2023, after market close. Investors and analysts can join a live broadcast at 4:30 p.m. ET to discuss these results. The call will be accessible via telephone and an online archive will be available on the Company’s Investor website. ClearPoint Neuro aims to enhance treatment for neurological disorders through its Neuro Navigation System, which has FDA clearance and is utilized in over 65 sites globally. The Company emphasizes its partnerships and the importance of its innovative therapies for complex neurological conditions.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its preliminary financial results for Q4 and full year 2022. Q4 revenue reached $5.2 million, a 21% increase year-over-year, while full-year revenue was $20.6 million, up 26%. Cash burn for Q4 was approximately $3.0 million, with cash reserves of $37.5 million at year-end. The company forecasts 2023 revenue between $25.0 million and $27.0 million, citing growth driven by new clinical trials and product developments. CEO Joe Burnett noted a record backlog of orders for a promising 2023.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) has initiated a clinical trial for Glioblastoma, enrolling its first patient at Skåne University Hospital in Lund, Sweden. This trial assesses the safety and feasibility of the ClearPoint Prism™ Neuro Laser Therapy System for tumor ablation in five patients. The system combines navigation and laser technology for minimally invasive procedures. Following FDA clearance received in September, data from this trial will also assist in obtaining CE Mark in Europe. ClearPoint aims to improve treatment options for neurological disorders.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced its participation in upcoming investor conferences. Management will present at the 2022 Stifel Healthcare Conference on November 15, 2022, at 10:55 a.m. ET in New York, and at the 34th Annual Piper Sandler Healthcare Conference on November 29, 2022, at 11:50 a.m. ET, also in New York. ClearPoint Neuro focuses on enabling therapies for complex neurological disorders, with its navigation system having FDA clearance and operational at over 60 sites globally.
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.
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