This section highlights FDA-related milestones and regulatory updates for drugs developed by EDAP TMS (EDAP).
Over the past two years, EDAP TMS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Focal and High. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Focal One - FDA Regulatory Timeline and Events
Focal One is a drug developed by EDAP TMS for the following indication: For the Treatment of Benign Prostatic Hyperplasia (BPH).
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:
- Focal One
- Announced Date:
- November 22, 2024
- Indication:
- For the Treatment of Benign Prostatic Hyperplasia (BPH)
Announcement
EDAP TMS SA announced a scientific presentation which demonstrated the technical feasibility of performing non-thermal histotripsy energy delivery and generating histotripsy lesions in biological tissues ex vivo using the Company's Focal One® Robotic HIFU technology.
AI Summary
EDAP TMS SA recently announced promising early feasibility work using its Focal One® Robotic HIFU technology. In a scientific presentation, the company demonstrated that their system can perform non-thermal histotripsy energy delivery and create histotripsy lesions in biological tissues outside the body. Histotripsy uses controlled ultrasound pulses to generate microcavitation, which mechanically destroys tissue without using heat. The study’s results, shown at the 187th Acoustical Society of America meeting, support the idea that this technology could someday offer a noninvasive way to treat conditions like cancer and other benign diseases. EDAP TMS SA continues to invest in innovative approaches to focal therapy and energy-based treatments, reinforcing its role as a global leader in minimally invasive medical technology.
Read Announcement- Drug:
- Focal One
- Announced Date:
- October 1, 2024
- Indication:
- For the Treatment of Benign Prostatic Hyperplasia (BPH)
Announcement
EDAP TMS SA y announced that the first patients have been treated in a Phase I/II study evaluating the Company's proprietary Focal One® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH).
AI Summary
EDAP TMS SA has begun treating the first patients in a Phase I/II study to evaluate its Focal One® robotic high-intensity focused ultrasound (HIFU) technology for benign prostatic hyperplasia (BPH). This clinical trial, led by experienced urologists including Dr. Harry Toledano from Martigues Hospital, aims to determine the best treatment settings that effectively relieve BPH symptoms with minimal side effects. Using Focal One®, already well-known for its success in treating prostate cancer, the study hopes to offer a less invasive option that protects important structures like the urethra while allowing patients a quick return to normal activities.
The two-part study will first confirm optimal parameters at leading academic centers in France, and then it will expand to further validate the safety and effectiveness of this new treatment method. Researchers are optimistic that this approach could benefit millions of men suffering from BPH, with plans to initiate a similar study in the United States next year.
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High Intensity Focused Ultrasound - FDA Regulatory Timeline and Events
High Intensity Focused Ultrasound is a drug developed by EDAP TMS for the following indication: For the treatment of pancreatic tumors.
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:
- High Intensity Focused Ultrasound
- Announced Date:
- January 8, 2025
- Indication:
- For the treatment of pancreatic tumors.
Announcement
EDAP TMS SA announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors.
AI Summary
EDAP TMS SA announced a significant milestone as the first patient was treated in the phase I/II PULS Trial. Sponsored by the Centre Léon Bérard in Lyon, France, the trial is testing a proprietary High Intensity Focused Ultrasound (HIFU) technology designed for treating pancreatic tumors. The initial procedure was completed successfully, with the patient discharged without any complications.
The trial focuses on patients with locally advanced and unresectable pancreatic cancer—a group that currently has limited treatment options beyond chemotherapy and radiotherapy. The phase I portion will assess the safety and tolerance of HIFU on pancreatic lesions, while phase II will focus on evaluating its early effectiveness. This innovative approach offers new hope for patients facing a difficult-to-treat disease and underscores the collaborative effort among EDAP TMS SA’s product, clinical development teams, and research partners in advancing pancreatic cancer therapy.
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