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ClearPoint Neuro, Inc. develops and commercializes medical-device and therapy-enabling systems for precise navigation to the brain and spine. Its recurring news includes updates on the FDA-cleared and CE-marked ClearPoint Neuro Navigation System, SmartFrame navigation platform, SmartFlow Neuro Cannula, Velocity Alpha MR High Speed Surgical Drill System, and services that support controlled CNS delivery for cell and gene therapy programs.
Company announcements also cover financial results, product clearances and international regulatory approvals, preclinical development services, biopharma and academic partnerships, and integration of the completed IRRAS Holdings acquisition, which expanded the portfolio into neurocritical care and IRRAflow-related products.
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.
ClearPoint Neuro, Inc. reported a 41% year-over-year increase in revenue for the first quarter of 2024, reaching $7.6 million. The company saw significant growth in biologics and drug delivery revenue, partnered with PTC Therapeutics for a neuro gene therapy BLA submission, and achieved 510(k) clearance for a new system. They activated eight new hospital customers, reduced operational cash burn by 32%, completed a public offering resulting in $16.2 million in net proceeds, and ended the quarter with $35.4 million in cash and cash equivalents. The company reaffirmed its full-year revenue outlook of $28.0 to $32.0 million for 2024.
ClearPoint Neuro, Inc. (Nasdaq: CLPT) will present novel research and exhibit at the 27th American Society of Gene & Cell Therapy Annual Meeting. The Company offers navigation to the brain and spine, showcasing abstracts and technology collaborations. The ASGCT Annual Meeting serves as a platform for networking and attracting new customers. ClearPoint Neuro provides clinical products and pre-clinical development services for controlled drug and device delivery, with a global presence in healthcare and research centers.
ClearPoint Neuro, Inc. announced FDA clearance for its Prism Bone Anchor Accessory, supporting the ClearPoint Prism Neuro Laser Therapy System, expanding into the operating room. The accessory will enable precise navigation for laser therapy in the brain and spine, with a market release in Q2 2024 and full market release in the second half of the year.
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