FertiZap™ is a single-use, ultrasound-guided transvaginal RF ablation electrode — treating polycystic ovaries and chocolate cysts with the precision of surgery and none of the incision.
The surgeries meant to restore fertility too often compromise it — costing women healthy ovarian tissue, theatre time, and recovery.
Laparoscopic ovarian drilling and cystectomy demand general anaesthesia and abdominal incisions — with the cost, risk and recovery of the operating theatre.
Even in expert hands, cystectomy can strip away healthy ovarian tissue with the cyst, lowering follicle count and threatening the very fertility it aims to protect.
Existing RF electrodes are engineered for tumour ablation, not delicate transvaginal ovarian access — and remain costly imports with limited availability in India.
FertiZap™ is a single-use, sterile monopolar electrode that reaches the ovary transvaginally under ultrasound guidance and delivers precisely targeted radiofrequency energy — through one slender needle that also suctions and irrigates.
Power delivery, suction and irrigation unified in a single double-lumen electrode.
Thermal and electrical insulation shields surrounding tissue; energy is delivered only at the exposed tip.
Compatible with the IEC 60601-2-2 electrosurgical generators clinics already own.
A ~1.5 mm profile for ultrasound-guided access with the fewest possible punctures.
Every parameter chosen for delicacy and precision.
An outpatient alternative to the operating theatre — in four considered movements.
The ovary and target follicles or cyst are located under transvaginal ultrasound guidance.
The slim insulated electrode is advanced transvaginally to the ovarian cortex — no external incision.
Targeted RF energy at the exposed tip thermally ablates cystic tissue, sparing healthy stroma.
Integrated suction and irrigation manage fluid and debris through the same needle, in one pass.
Developed under an ISO 13485 quality-management framework with a structured design history file, risk management to ISO 14971, and a defined pathway to CDSCO licensure.
Manufacturing test licence obtained from CDSCO; full Class C manufacturing licence (MD-7) application in progress.
Bench and safety testing completed, including electrical insulation breakdown testing.
Clinical trial protocol drafted and reviewed by clinicians.
Device Master File, DHF and risk file maintained throughout development.
Substantial-equivalence positioning against established predicate RF electrodes.
From an IIT Bombay prototype to controlled release.
Developed at BETiC, IIT Bombay.
Bench & electrical safety verified.
Design freeze, DFM & supplier qualification.
Biocompatibility, sterilization, packaging.
PQ/PPQ & release, post CDSCO.
Clinicians, engineers and a proven medtech pathway — aligned.
Clinical vision and deep expertise in fertility and reproductive medicine, championed by Dr. Aniruddha & Dr. Anjali Malpani.
The originating research and prototype, developed under Prof. B. Ravi's biomedical engineering & technology incubation centre.
ISO 13485 product development, design transfer and controlled manufacturing driving prototype-to-production execution.
We're engaging clinical collaborators, investors and distribution partners as we move toward controlled release. We would be glad to tell you more.
ovahealth.m@ifmedtech.com