ClearPoint Neuro, Inc.

ClearPoint Neuro announces FDA De Novo Marketing Authorization of SmartFlow Cannula for direct delivery of gene therapy to the brain. SmartFlow is the only device approved to deliver the first disease-modifying treatment for AADC Deficiency in the United States. "Today is one of the most important strategic milestones in the history of our company," commented Joe Burnett, President and CEO at ClearPoint Neuro. "FDA's granting of this De Novo classification is the culmination of years of disciplined co-development, creative problem solving, and tireless efforts. We could not be prouder of the PTC and ClearPoint Teams and how we have worked together. Most importantly, we are thrilled and humbled that children with this terrible disease will now be treated with the first-ever neuro gene therapy available commercially in the United States." #CLPT #genetherapy #CED #Smartflow #Nsgy PTC Therapeutics, Inc. https://lnkd.in/gKkpGKCB

For November’s employee highlight, we’re celebrating Northeast US-based Senior Clinical Specialist, David Shoshan! David has the distinction of providing onsite support for procedures not only in the US, but also for gene therapy procedures in Brazil since he is fluent in Portuguese. We’re grateful to have such an experienced and committed #ClinicalSpecialist on the #ClearPoint team. #CLPT #Nsgy #EmployeeHighlight

It’s been a great couple of days at #SNO2024 sharing #ClearPoint’s laser and MRI-guided navigation capabilities for Neuro-Oncology! Join us at Booth 309 before this Sunday to learn more and meet the team. #CLPT #LITT #PrismLaser

Congratulations to our partner uniQure on the successful dosing of the first patient in the GenTLE Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy (MTLE). #CLPT #genetherapy #epilepsy

We are delighted to exhibit at the Society for Neuro-Oncology #SNO2024 meeting starting tomorrow in Houston. Please stop by Booth 309 to see the #ClearPoint Prism® Neuro Laser Therapy System featuring our next-generation laser applicator technology eliminating the need for external cooling. #CLPT #LITT #PrismLaser

We're #hiring a new Field Service Engineer in Carlsbad, California. Apply today or share this post with your network.

Today we approved an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. https://lnkd.in/er5tacke

ClearPoint Neuro reports third quarter 2024 results. Achieved record revenue and growth of 41%; operational cash burn reduced to $1.2 million #CLPT #earnings https://lnkd.in/gVGsTSK3

Don’t miss last week’s Bloomberg Intelligence - Vanguards of Health Care podcast featuring President and CEO, Joe Burnett. In this episode Joe explains how ClearPoint Neuro is transforming brain surgery by developing a suite of new magnetic resonance (MR) navigation technology that aids minimally invasive procedures including direct infusion of gene and cell therapies to targets in the brain: https://loom.ly/JdZ7xIA #CLPT #BloombergIntelligence #VanguardsOfHealthcare #VHC #neurosurgery #DBS #GeneAndCellTherapy #Nsgy

ClearPoint to participate in multiple investor conferences and interview formats including Bloomberg Intelligence Vanguards of Healthcare Podcast series published today found here: https://lnkd.in/gdMJmzKQ https://lnkd.in/g6A9MEtK #CLPT