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dMD-002, Control

Phase 1

Prostate Cancer | Unknown | Oncology |BrainsWay Ltd.|Last Updated: May 15, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

dMD-002, Control · 1 trial · 1 indication

Phase 1 1
NCT07564102dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical ProstatectomyProstate Cancer
NOT YET_RECRUITING30 Analytics
PHASE1NOT YET_RECRUITING
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean IIEF-EF scores
6 months postoperatively

Secondary Endpoints

Mean EHS score
Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
Mean SHIM score
Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
24-hour pad weight test
Screening, 6 weeks, and 3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment groupEXPERIMENTAL -
Control groupSHAM_COMPARATOR -

Interventions

NameTypeDescription
dMD-002DEVICEThe 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.
ControlOTHERProstatectomy without dMD-002
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Eligibility Criteria

Age Range40 Years to 74 Years
SexMALE
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about dMD-002, Control

What is dMD-002 used for in prostate cancer?

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.

Who makes dMD-002?

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.

What phase is dMD-002 in?

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.

What clinical trials is dMD-002 in?

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.

Is dMD-002 a randomized controlled trial?

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.

Does the dMD-002 trial use a biomarker?

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.