Assertion Supported AI assessment confidence: 85% certainty 4/5 debate potential 2/5

Energize Has Three Clinical Studies and CDSCO Approval for Vagus Nerve Wearable

Dr. Sidhant Bhargav · Inside India’s Next Gen Startups | Nikhil Kamath ft. WTFund C2/24 Founders · Nikhil Kamath · Mar 21, 2025 · at 51:04

Dr. Sidhant Bhargav, co-founder of Energize, pitches their non-invasive vagus nerve stimulation wearable for stress relief on Nikhil Kamath's WTFund podcast.

0:00 / 0:06exact quote · 6.2s

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“And we've got three clinical studies under our belt, one clinical trial where CDSU approved, we're filing for an FDA license.”

quote is from the automated transcript, cleaned for reading: filler sounds and stutters are removed, nothing is rephrased. names can be misheard (the analysis reads context, assessments check outside sources). how →

The claim, plainly

Energize has completed three clinical studies, conducted one clinical trial, received CDSCO regulatory approval in India, and is filing for an FDA license.

a quote alone can be ambiguous, so this restates it with the references and context of the conversation around it resolved. AI-written; the tape below the player is the source.

Assessment

The multi-part claim made by Dr. Siddhant Bhargava regarding InnerGize (developed by Ezymind Healthcare Private Limited) is substantiated across all components. First, regulatory and registry records show that the company registered a double-blind, randomized, sham-controlled clinical trial on the Clinical Trials Registry of India (CTRI/2025/07/091925) alongside conducting pilot evaluations and an overnight sleep laboratory clinical study. Second, public regulatory disclosures confirm that InnerGize Gen 1 received Class B Medical Device certification from India's Central Drugs Standard Control Organisation (CDSCO). Third, company disclosures from 2025 and 2026 confirm ongoing preparation and progression toward a 510(k) premarket notification filing with the U.S. FDA, aligning with the present-continuous statement that the company was 'filing for an FDA license.'

A double-blind, randomized sham-controlled trial evaluating the device was registered under CTRI/2025/07/091925 enrolling 212 participants at Vasundhara Hospital in Jodhpur.
Company documentation and investor materials record multiple pilot studies and an IRB-approved overnight sleep lab evaluation (n=46).
InnerGize Gen 1 obtained Class B Medical Device certification under India's Central Drugs Standard Control Organisation (CDSCO).
Public campaign and corporate disclosures confirm 510(k) premarket notification documentation for the U.S. FDA was in active preparation.

Checked against

[1] zaubacorp.com [2] birac.nic.in [3] businessremedies.com [4] indianstartupnews.com [5] yourstory.com [6] itmatterss.in [7] gizmocrowd.com [8] reddit.com

"Innergize" "Siddhant" "Nikhil Kamath" "Innergize" "Siddhant Bhargava" "Ezymind Healthcare" "Ezymind" CDSCO OR trial OR study "InnerGize" OR "DUSQ" "CTRI" OR "ClinicalTrials.gov" OR "CDSCO" OR "FDA" "CTRI/2025/07/091925" "Innergize" "Siddhant Bhargava" CDSCO "Innergize" "Siddhant Bhargava" "clinical trial" OR CTRI OR FDA "InnerGize" "FDA" "510(k)" OR "clearance" OR "application" "Ezymind Healthcare" "CDSCO" "InnerGize" "Class B" CDSCO

assessed as of 2026-09-05

This assessment is an AI reading of a public statement, made against the cited references with the confidence shown. It can be wrong. The quote, the tape and the references are all on this page; if something is off, use report an error below. full disclaimer →

Mentioned

CDSCO Energize FDA

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More from Dr. Sidhant Bhargav

Assertion Not checkable as stated

Energize Reaches 2,600 Orders and ₹1.5 Crore in Revenue Pipeline

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Dr. Sidhant Bhargav Mar 21, 2025 ▶ 51:48 Inside India’s Next Gen Startups | Nikhil Kamath ft. WTFund C2/24 Founders · Nikhil Kamath

Energize Has Three Clinical Studies and CDSCO Approval for Vagus Nerve Wearable

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