This section highlights FDA-related milestones and regulatory updates for drugs developed by ClearPoint Neuro (CLPT).
Over the past two years, ClearPoint Neuro has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ClearPoint, ClearPoint, SmartFrame, and AVB-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ClearPoint Prism Neuro Laser Therapy System FDA Regulatory Events
ClearPoint Prism Neuro Laser Therapy System is a drug developed by ClearPoint Neuro for the following indication: Brain Tumor Laser Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ClearPoint Prism Neuro Laser Therapy System
- Announced Date:
- October 7, 2025
- Indication:
- Brain Tumor Laser Therapy
Announcement
ClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospital in Lund, Sweden evaluating the ClearPoint Prism Neuro Laser Therapy System's safety, feasibility, and efficacy..
AI Summary
ClearPoint Neuro, Inc. shared Phase I-II study results from Skåne University Hospital in Lund, Sweden. This trial tested the ClearPoint Prism Neuro Laser Therapy System for safety, feasibility, and effectiveness in 14 patients with primary or recurrent glioblastoma or grade 4 astrocytoma.
The findings showed improved survival compared to matched open‐surgery controls, with no device‐related events or complications. The workflow proved safe, feasible, and reproducible, and the median time to ablate each tumor was just 6.5 minutes.
Chris Osswald, PhD, said these results show potential for minimally invasive neuro‐oncology treatment. He added that the system’s fast, simple, and predictable workflow can improve patient care and support future cell and gene therapy applications.
The ClearPoint Prism Neuro Laser Therapy System will be featured at the 75th Annual Congress of Neurological Surgeons in Los Angeles on October 13–15, 2025.
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ClearPoint Neuro Navigation software. FDA Regulatory Events
ClearPoint Neuro Navigation software. is a drug developed by ClearPoint Neuro for the following indication: Software Version 2.1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ClearPoint Neuro Navigation software.
- Announced Date:
- June 20, 2024
- Indication:
- Software Version 2.1
Announcement
ClearPoint Neuro, congratulates its partner Aspen Neuroscience, Inc. on use of the ClearPoint Neuro Navigation System to transplant dopaminergic neuron precursor cells (DANPCs) for all enrolled patients with Parkinson's Disease (PD) in its recently launched ASPIRO Phase 1/2a clinical trial.
AI Summary
ClearPoint Neuro recently congratulated its partner, Aspen Neuroscience, Inc., for successfully using the ClearPoint Neuro Navigation System in its ASPIRO Phase 1/2a clinical trial for Parkinson’s Disease. In this trial, all enrolled patients receive a transplant of dopaminergic neuron precursor cells (DANPCs) into the putamen, a key brain structure affected by the disease. This innovative approach uses MRI guidance, the SmartFlow® Cannula, and the Aspen Metered Delivery Syringe (AMDS) during a single surgical procedure.
The streamlined process, developed under the expertise of leading neurosurgeon Dr. Paul Larson, aims to reduce surgical variability and boost safety, which is essential for assessing both safety and tolerability of the therapy. This milestone reflects a promising step forward in regenerative treatment options for patients with moderate to severe Parkinson’s Disease.
Read Announcement- Drug:
- ClearPoint Neuro Navigation software.
- Announced Date:
- June 1, 2024
- Estimated Event Date Range:
- June 4, 2024 - June 4, 2024
- Target Action Date:
- June 04, 2024
- Indication:
- Software Version 2.1
Announcement
ClearPoint Neuro, Inc. announces full market release of its SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery from Saturday, June 1st – Tuesday, June 4th in Nashville.
AI Summary
ClearPoint Neuro, Inc. has announced the full market release of its innovative SmartFrame OR platform and ClearPoint Prism Neuro Laser Therapy System. The launch was showcased at the 2024 Biennial Meeting of the American Society of Stereotactic and Functional Neurosurgery held in Nashville from June 1 to June 4. These new products are designed to improve precision in brain and spine navigation during neurosurgical procedures, particularly for deep brain stimulation (DBS), a treatment for conditions such as Parkinson’s Disease, Essential Tremor, and Dystonia.
The SmartFrame OR platform offers stereotactic precision in an efficient and reliable framework, making advanced neurosurgical techniques more accessible in a variety of hospitals. This milestone highlights ClearPoint Neuro’s commitment to innovation, aiming to expand the availability of critical treatments to a broader range of patients globally.
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SmartFrame OR™ FDA Regulatory Events
SmartFrame OR™ is a drug developed by ClearPoint Neuro for the following indication: to provide stereotactic guidance.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SmartFrame OR™
- Announced Date:
- April 24, 2024
- Indication:
- to provide stereotactic guidance
Announcement
ClearPoint Neuro announced it has initiated the Limited Market Release for its SmartFrame OR™ Stereotactic System.
AI Summary
ClearPoint Neuro has started a Limited Market Release for its new SmartFrame OR™ Stereotactic System, marking a major step forward for the company. This new product is designed to perform complete neurosurgical procedures in the operating room, offering a “plug-and-play” solution that works with existing imaging equipment. The system consists of two main components: the SmartFrame OR and the ClearPointer™ Optical Navigation Wand, which help guide procedures like biopsies, electrode placements, and more, even in cases where MRI guidance isn’t possible.
In its first month, over ten cases have been completed, with active sites already reordering or scheduling further patient treatments. This early success suggests that the SmartFrame OR could significantly increase the annual clinical procedure volume for ClearPoint Neuro, opening up new market opportunities and expanding their reach into more hospitals.
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AVB-101 FDA Regulatory Events
AVB-101 is a drug developed by ClearPoint Neuro for the following indication: for Frontotemporal Dementia with GRN Mutations.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AVB-101
- Announced Date:
- April 16, 2024
- Indication:
- for Frontotemporal Dementia with GRN Mutations
Announcement
ClearPoint Neuro, Inc. today congratulates its partner AviadoBio on treating its first patient in the ASPIRE-FTD Phase 1/2 clinical trial evaluating its investigational gene therapy AVB-101 in people with frontotemporal dementia (FTD) with progranulin (GRN) mutations.
AI Summary
ClearPoint Neuro, Inc. has congratulated its partner AviadoBio on treating the first patient in the ASPIRE-FTD Phase 1/2 clinical trial. This study is evaluating the investigational gene therapy AVB-101, which is designed to help people suffering from frontotemporal dementia (FTD) caused by progranulin (GRN) mutations. FTD is a severe form of early-onset dementia that often affects individuals under the age of 65, leading to serious personality changes and cognitive decline.
Jeremy Stigall, Chief Business Officer at ClearPoint Neuro, explained that the therapy needs to be delivered precisely into the thalamus to reduce the risk of side effects. ClearPoint Neuro’s minimally invasive platform is ideally suited for this critical task. The trial is set to expand to other clinical sites in Europe and the United States, marking a significant step forward in the fight against FTD.
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