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. (NASDAQ: CLPT) is a leader in MRI-guided neurosurgical navigation systems and targeted therapeutic delivery solutions for neurological disorders. This page serves as the definitive source for official company announcements, regulatory updates, and strategic developments in precision neurosurgery and cell/gene therapy delivery.
Access real-time updates on CLPT's innovative medical devices, including the SmartFlow® Cannula and Prism® Laser Therapy System. Stay informed about FDA clearances, biopharma partnerships, clinical trial milestones, and financial disclosures that demonstrate the company's progress in advancing minimally invasive neurological treatments.
Key updates include earnings reports, product launch announcements, research collaborations with academic institutions, and expansion of global clinical sites. Our curated news collection enables investors and healthcare professionals to track CLPT's role in enabling next-generation therapies for Parkinson's disease, brain tumors, and rare genetic conditions.
Bookmark this page for streamlined access to ClearPoint Neuro's latest achievements in neurosurgical navigation technology and therapeutic delivery systems. Check regularly for verified updates on regulatory approvals, intellectual property developments, and strategic initiatives shaping the future of precision neurology.
ClearPoint Neuro (Nasdaq:CLPT) has received FDA De Novo marketing authorization for its SmartFlow Neuro Cannula, marking the first-ever FDA approval for a device delivering gene therapy directly to the brain. The device is specifically approved for intraputaminal administration of PTC Therapeutics' gene therapy KEBILIDI™ to treat aromatic L-amino acid decarboxylase (AADC) deficiency. This milestone represents the first commercially available neuro gene therapy in the United States. The company offers comprehensive medical device solutions for pharma partners, including surgical strategy, testing, clinical trial support, and navigation systems.
ClearPoint Neuro (CLPT) reported strong Q3 2024 results with record revenue of $8.1 million, representing 41% year-over-year growth. The company saw significant expansion in navigation and device revenue, reaching $2.9 million (53% increase), while overall product revenue more than doubled to $5.5 million. Notable achievements include activating five new global centers, reducing quarterly operational cash burn to $1.2 million, and fully repaying a $10 million convertible note. The company maintains its 2024 revenue guidance of $30.0-$33.0 million and reported cash and cash equivalents of $21.6 million as of September 30, 2024.
ClearPoint Neuro (NASDAQ:CLPT), a global device, cell, and gene therapy-enabling company focused on brain and spine navigation, has announced its participation in several major healthcare conferences during Q4 2024. The company's management will attend five significant events, including the UBS Global Healthcare Conference, Stifel Healthcare Conference, Canaccord Genuity Forum, Piper Sandler Healthcare Conference, and Stifel MedTech Madness West Coast Bus Tour. Additionally, President and CEO Joe Burnett's interview is featured on the Bloomberg Intelligence Vanguards of Healthcare Podcast, released on October 31, 2024.
ClearPoint Neuro, Inc. (NASDAQ: CLPT), a global device, cell, and gene therapy-enabling company focused on precise navigation to the brain and spine, has announced its plans to release financial results for the third quarter of 2024 on Thursday, November 7th, after market close. The company will host a live broadcast review of the Q3 2024 results on the same day at 4:30 p.m. Eastern time.
Investors and analysts can participate in the conference call via telephone or listen to the live broadcast online. For those unable to attend the live event, a replay will be available until December 7, 2024. An online archive of the broadcast will also be accessible on the company's Investor website.
ClearPoint Neuro (Nasdaq: CLPT) has announced the early repayment of a $10 million convertible note held by PTC Therapeutics Inc., originally due in January 2025. This strategic move, completed on August 23, 2024, demonstrates the company's financial strength and commitment to reducing debt without diluting shareholder value. Joe Burnett, President and CEO of ClearPoint Neuro, emphasized the importance of this repayment in removing all debt from the balance sheet while maintaining a strong partnership with PTC Therapeutics.
ClearPoint Neuro continues to support PTC's Biologics License Application submission to the FDA for Upstaza™, an investigational treatment for AADC Deficiency currently under priority review. The company reaffirms its position as a global device, cell, and gene therapy-enabling company, offering precise navigation solutions for the brain and spine.
ClearPoint Neuro (Nasdaq: CLPT) reported record Q2 2024 revenue of $7.9 million, a 32% year-over-year increase. Key highlights include:
- Product revenue across all segments more than doubled, growing 112% to $4.9 million
- Biologics and Drug Delivery revenue increased 28% to $4.3 million
- Navigation and device revenue grew 34% to $2.6 million
- Gross margin improved to 63% from 53% in Q2 2023
- Operating cash burn reduced by 47% to $2.7 million
- Cash and cash equivalents totaled $32.8 million as of June 30, 2024
The company raised its full-year 2024 revenue guidance to $30.0-$33.0 million. ClearPoint Neuro continues to expand its biologics and drug delivery services, add strategic agreements with pharmaceutical partners, and grow its installed base of navigation and therapy systems globally.
ClearPoint Neuro (NASDAQ: CLPT), a global device, cell, and gene therapy-enabling company, has announced it will release its 2024 second quarter financial results on August 7, 2024, after market close. The company will host a live broadcast review of the results at 4:30 p.m. Eastern time on the same day.
Investors and analysts can participate in the conference call via telephone or listen to the live broadcast online. For those unable to attend the live event, a replay will be available until September 7, 2024. An online archive of the broadcast will also be accessible on the company's Investor website.
ClearPoint Neuro announces the use of its ClearPoint® Navigation System in Aspen Neuroscience's ASPIRO clinical trial for Parkinson's Disease (PD). The trial, aimed at assessing the safety and tolerability of ANPD001, uses intraoperative MRI to guide the precise implantation of autologous replacement neurons in patients.
Dr. Paul Larson, a pioneer in MRI-guided stereotactic neurosurgery, developed the surgical approach. The trial involves patients aged 50-70 with moderate to severe PD and excludes those with cognitive impairment and other comorbidities.
Primary endpoints focus on safety and tolerability, while secondary endpoints include symptom control and quality of life improvements. The ClearPoint Navigation System, in conjunction with the SmartFlow® Cannula, allows for minimally invasive delivery of therapeutic agents.
Aspen Neuroscience announced the use of the ClearPoint Navigation System in their ASPIRO Phase 1/2a clinical trial for patients with Parkinson’s Disease (PD). The trial aims to assess the safety and tolerability of ANPD001, an autologous dopaminergic neuron cell replacement therapy. Utilizing intraoperative MRI guidance, the ClearPoint system allows precise transplantation of dopaminergic neuron precursor cells (DANPCs) to the putamen, a brain region critical for motor function. The surgical approach, developed by Dr. Paul Larson, aims to restore lost neurons and improve motor and neurological function in PD patients. ClearPoint Neuro’s system is being used in over 80 centers worldwide, supporting various gene and cell therapy trials. This collaboration marks the first multi-center trial for autologous neuron replacement in PD, showcasing a promising personalized medical approach for neurodegenerative conditions.
ClearPoint Neuro announced the full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 ASSFN meeting in Nashville from June 1-4.
The SmartFrame OR aims to expand Deep Brain Stimulation (DBS) to more hospitals, making it accessible to more patients. Dr. Kim Burchiel noted that DBS is effective for Parkinson's Disease, Essential Tremor, and Dystonia, but only 5% of eligible patients receive treatment due to access.
ClearPoint's new platform promises precision and efficiency in DBS procedures, according to Dr. Andrew Conner. CEO Joe Burnett highlighted the company's innovation, emphasizing the benefits for surgical customers and patients.
The new products will be featured in various sessions during the ASSFN meeting, showcasing their potential to improve neurosurgical practices.
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