Investigational robotic HIFU system
LOTUS-1 ↗
Externally delivered, ultrasound-guided transperineal HIFU platform under clinical evaluation. [10]
Investigational / in developmentInvestigational only; not commercially available.
Companies / NINA Medical
Medical device company profile
NINA Medical
Investigational robotic ultrasound technology for externally delivered treatment of benign prostatic hyperplasia.
Medical Device DeveloperUrology & Renal CareUrologyClinical development
Company overview
NINA Medical is developing LOTUS-1, an extracorporeal robotic high-intensity focused ultrasound system for benign prostatic hyperplasia. Its approach uses transperineal ultrasound imaging and energy delivery from outside the body.
The company reports that its first patient was treated at Rambam Medical Center on February 17, 2026 as part of a first-in-human study. This is a clinical-development milestone, not marketing authorization or proof of established clinical effectiveness.
Co-founder Shmuel Ben-Ezra leads the company, with John Linn overseeing U.S. operations. NINA identifies the technology and LOTUS-1 system as investigational and unavailable for commercial sale; clinical evidence generation and regulatory development remain central to its path forward.
Leadership
5 peopleShmuel Ben-EzraCo-Founder, CEO & Board Member [8]
Alex VolovickCo-Founder & Chief Scientific Officer [8]
David TimorChief Operating Officer [8]
Ketty ShkolnikChief Clinical and Regulatory Officer [8]
John W. LinnPresident, U.S. Operations [8]
Products & regulatory status How does MedTechIndex get this information?
Summary
LOTUS-1 and NINA technology are investigational and not available for commercial sale. [8][10][9][7][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [5][3]
Regulatory snapshot How to read this snapshot
U.S. FDA- 0
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
No routinely marketed devices established in the reviewed scope.
Commercial development
Clinical-stage investigational device. First-in-human treatment does not establish marketing authorization. [8][10][9]
Activity & Milestones
1 events2026-02-17 · Clinical
First patient treated in first-in-human study
Company reports treatment at Rambam Medical Center on February 17; announcement published March 12, 2026. [9]
10 Cited Sources
Accessed 10/20/2026
10 Cited Sources
Accessed 10/20/2026
[1] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[2] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[3] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[4] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[5] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[6] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[7] Hiring source review ↗NINA Medical · company website
[8] Technology, leadership and investigational status ↗NINA Medical · company website
[9] First-in-human treatment announcement ↗NINA Medical · company website
[10] LOTUS-1 solution ↗NINA Medical · company website