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dMD-002, Control · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment group | EXPERIMENTAL | - |
| Control group | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| dMD-002 | DEVICE | The cut dMD-002 is implanted to cover the nerve injury, tear, or defect, and is fixed by suturing to the surrounding tissue in two or more places. |
| Control | OTHER | Prostatectomy without dMD-002 |
Inclusion Criteria: * Patients diagnosed with prostate cancer. * Patients scheduled to undergo a robot-assisted radical prostatectomy (including either bilateral-nerve sparing or unilateral-nerve sparing) for treatment of prostate cancer. etc. Exclusion Criteria: * Patients undergoing pre-surger...
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dMD-002 is an investigational therapy being studied for use in prostate cancer, specifically in patients with cavernous nerve injury following radical prostatectomy. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
dMD-002 is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting a Phase 1 clinical trial to evaluate the therapy in patients with prostate cancer.
dMD-002 is in Phase 1 clinical development. It is an investigational therapy and has not yet been approved for any use. The ongoing Phase 1 trial is designed to study its effects in patients with cavernous nerve injury following radical prostatectomy for prostate cancer.
dMD-002 is being studied in a Phase 1 clinical trial registered as NCT07564102, titled 'dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy.' The trial is not yet recruiting and plans to enroll 30 male patients aged 40 years and older in the United States.
Yes, the Phase 1 clinical trial of dMD-002 is randomized and double-blind, with a sham-controlled design. This means participants are randomly assigned to receive either dMD-002 or a sham treatment, and neither the participants nor the researchers know who receives which treatment during the study.
Yes, the dMD-002 clinical trial is biomarker-selected, meaning that patient enrollment is guided by specific biomarkers. The trial is designed to evaluate the therapy in a targeted patient population with prostate cancer who have experienced cavernous nerve injury following radical prostatectomy.