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
ANPD001 and ClearPoint. 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.
ANPD001 FDA Regulatory Events
ANPD001 is a drug developed by ClearPoint Neuro for the following indication: An autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe PD.
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:
- ANPD001
- Announced Date:
- July 31, 2026
- Indication:
- An autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe PD.
Announcement
ClearPoint Neuro, Inc. today congratulated its partner Aspen Neuroscience, Inc. on receiving Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for sasineprocel (ANPD001), Aspen’s investigational autologous dopaminergic neuron cell replacement therapy for Parkinson’s disease.
AI Summary
ClearPoint Neuro congratulated its partner Aspen Neuroscience on receiving Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for sasineprocel (ANPD001). The investigational treatment is an autologous cell replacement therapy being developed for people with moderate to severe Parkinson’s disease. RMAT designation may support more frequent communication with the FDA and an expedited development and review process for therapies that address serious conditions and unmet medical needs.
Aspen’s ASPIRO clinical trial is evaluating sasineprocel, which is made from a patient’s own cells. Cells collected through a small skin biopsy are reprogrammed and developed into dopamine-producing nerve cells, then delivered to the brain’s putamen, where dopamine signaling is disrupted in Parkinson’s disease. ClearPoint’s Navigation System, used with its SmartFlow Cannula, supports accurate, minimally invasive delivery to the intended target. Because the therapy uses a patient’s own cells, it is designed to avoid the need for immunosuppressive drugs.
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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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