ProArc Medical

Company overview

ProArc Medical is an Israeli medical device company developing treatments for lower urinary tract symptoms associated with benign prostatic hyperplasia, or BPH. Founded in 2010, it is led by CEO Gilad Hizkiyahu.

Its current Omega system is designed to open the prostatic urethra through a combination of tissue incision and mechanical retraction. A self-embedding implant is intended to hold back obstructing prostate tissue while leaving a channel for urine flow.

Omega remains in clinical development. ProArc describes an ongoing multicenter international clinical programme and plans for a U.S. and Canadian pivotal study in 2027. Earlier company research and EU funding used the ClearRing name; those historical projects should be distinguished from the current Omega programme.

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Products & regulatory status How does MedTechIndex get this information?

Summary

ProArc describes Omega as a clinical-stage system and reports an ongoing multicenter global trial. Its U.S. and Canadian pivotal trial is planned for 2027; this is a future development milestone rather than a marketing authorization. ^[3]

The earlier EU-funded ClearRing project supported development and clinical validation of an implant-based BPH treatment. Its funding objectives and historical product descriptions do not establish current authorization of Omega. ^[1][3]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-04.

Scope: selected product families.

Commercial portfolio snapshot

No commercially marketed product portfolio has been established in the reviewed material.

Commercial development

Implant-based BPH treatment system

Omega ↗

Investigational system combining tissue incision with mechanical retraction through a self-embedding implant, designed to relieve prostatic urethral obstruction. ^[3]

Clinical development