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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) will release its financial results for Q4 and the full year 2020 on March 4, 2021, after market close. Investors can join a live call at 4:30 p.m. ET to discuss the results. ClearPoint specializes in neurosurgery navigation and drug delivery systems, currently having FDA clearance for its products, with installations across over 60 sites. The company is engaged with multiple biologics firms, supporting various stages of clinical trials. Forward-looking statements highlight potential impacts, including COVID-19, on future revenues and market acceptance.
ClearPoint Neuro (Nasdaq: CLPT) announced the pricing of a public offering of 1,850,140 shares of common stock at $23.50 per share, with an option for underwriters to purchase an additional 277,520 shares. The offering is set to close on February 23, 2021. Proceeds will fund product development and research, as well as general corporate purposes. B. Riley Securities is leading the offering, following SEC approval on January 29, 2021.
ClearPoint Neuro (Nasdaq: CLPT) has announced a proposed underwritten public offering of its common stock, with all shares being offered by the Company. This offering includes a 30-day option for underwriters to purchase additional shares, totaling up to 15% of the offering size. The offering is subject to market conditions, and there's no guarantee regarding its completion or terms. B. Riley Securities is the book-running manager, while Lake Street Capital Markets acts as the co-manager. The SEC has declared effective a shelf registration statement related to the offering.
ClearPoint Neuro (CLPT) announced a worldwide license and research agreement with Philips to develop the ‘Maestro™’ Brain Model, set for launch in 2022. This collaboration aims to enhance various applications in drug delivery, deep brain stimulation, laser ablation, and biopsies, enabling precise treatment paths and safer procedures. Philips' Brain Model technology, developed over 10 years, offers accurate assessments backed by extensive research. ClearPoint’s products are FDA cleared and used in over 60 clinical sites across the U.S., Canada, and Europe, supporting a diverse range of neurological therapies.
ClearPoint Neuro has announced a partnership with Blackrock Microsystems to develop innovative products in the neurosurgery market. This collaboration is set to tap into a combined addressable market exceeding $100 million. The first product, the Microelectric Recording (MER) platform, is expected to launch in 2023, followed by advanced biopsy needles and other neural electrodes. This strategic alliance combines ClearPoint's navigation expertise and Blackrock's precision electrode technology, aiming to enhance patient outcomes in neurosurgery.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) announced the appointment of R. John Fletcher as Chairman of the Board, succeeding Kimble L. Jenkins, who retired to focus on his CEO role at OrthoSouth. Joe Burnett, CEO of ClearPoint, praised Jenkins for his contributions in growing the company. Fletcher, recognized for his leadership during Spectranetics' acquisition by Philips for $2.2 billion, aims to guide ClearPoint in its next growth phase. The company continues to advance its neurosurgery solutions, including FDA-cleared products for complex neurological disorders.
ClearPoint Neuro (Nasdaq: CLPT) announced the appointment of Ernesto Salegio, PhD, as Vice President, Segment Leader of Translational and Pre-Clinical Research, starting March 1, 2021. Dr. Salegio has over 19 years of experience in translational neuroscience, specializing in gene therapy delivery. He will enhance ClearPoint’s Biologics and Drug Delivery team, established in 2020, aimed at supporting pharmaceutical partners with pre-clinical services. ClearPoint aims to provide comprehensive medical device solutions for gene and stem cell therapies to improve patient care.
ClearPoint Neuro (Nasdaq: CLPT) has successfully implemented its Version 2.0 software along with the ClearPoint Navigation System at Rigshospitalet, Copenhagen, marking the first usage in Europe. This procedure utilized live MRI guidance for laser catheter navigation, showcasing the system's enhanced precision. Dr. Rune Rasmussen emphasized its superior accuracy compared to traditional methods. ClearPoint aims to expand its presence in Europe, attracting more partners for clinical trials and increasing its service reach across the EMEA region.
ClearPoint Neuro (CLPT) reported preliminary unaudited revenue of approximately $3.7 million for Q4 2020, marking a 14% increase year-over-year, while full-year 2020 revenue is estimated at $12.8 million, also a 14% growth. The company supported 175 cases in Q4 amid ongoing COVID-19 disruptions. Cash used in operations was approximately $2.4 million in Q4 and $7.9 million for the full year, with cash and cash equivalents at $20.1 million as of December 31, 2020.
CEO Joe Burnett noted challenges posed by COVID-19, anticipating ongoing pressures on elective procedures into the first half of 2021.
ClearPoint Neuro (Nasdaq: CLPT) announced a $7.5 million strategic investment from Petrichor Healthcare Capital Management, amending their January 2020 financing agreement. The new terms include a conversion price increase from $6.00 to $10.14 per share and a reduced interest rate of 7%, down from 9%. The funds will support global product commercialization, strategic partnerships, and R&D. The company expects to enter 2021 with cash balances exceeding $20 million, positioning itself for growth in next-generation therapies.
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