Regulatory Disclosures

1. Scope of This Page

This Regulatory Disclosures page provides important information about the development stage and regulatory status of the Portable Hormone Analyser (including its PCOS biosensing kit) and the research described on yohafly.com, operated by Yohafly Technologies Private Limited ("Yohafly", "we", "us", "our"), CIN U26600TN2026PTC189481. It should be read together with our Terms of Use.

2. Development Status

The Portable Hormone Analyser is an early-stage research and development project, currently in Phase I (completed, bench-validation) with Phase II (AI/ML model development and integration) planned for July–September 2026.

The underlying research has been supported by a grant from the Science and Engineering Research Board (SERB) under its POWER scheme, now administered under the Anusandhan National Research Foundation ("ANRF") — Grant No. SPG/2022/000681. The grantee and host institution for this research grant is Kongunadu College of Engineering and Technology ("KNCET"); Yohafly Technologies Private Limited is the company working to translate this research into a manufacturable product for commercialisation.

[REVIEW] The specific terms of any technology-transfer or licensing arrangement between KNCET and Yohafly are to be documented and referenced by qualified personnel.

3. Not a Cleared Medical Device

The Portable Hormone Analyser has not been reviewed, cleared, approved, registered, or certified by the Central Drugs Standard Control Organisation (CDSCO) or by any other medical device regulator, in India or elsewhere.

We are pursuing classification as a Class B medical device under India's Medical Device Rules, 2017, and intend to seek the relevant CDSCO registration in due course as development progresses. [REVIEW] No CDSCO application has been filed as of the date of publication; the classification, requirements, and timeline remain subject to confirmation.

4. Not for Sale, Clinical, or Diagnostic Use

The device described on this Site is a prototype under active development. It is not available for sale, lease, or distribution, and must not be used for clinical use, diagnostic use, patient monitoring, or to make any decision regarding the diagnosis, treatment, mitigation, or prevention of any disease or condition. Nothing on this Site is, or should be construed as, an offer, advertisement, or solicitation for a medical device available for clinical use.

5. Research Results & Performance Data

Where this Site refers to bench-validation results for hormone parameters — including AMH (1.82 ng/mL), FSH (3.11 mIU/mL), and LH (1.23 mIU/mL) measured against a Roche reference platform — these figures represent preliminary, Phase I bench-level testing under controlled laboratory conditions only. They do not represent clinical trial results, clinical validation, or evidence reviewed by any regulatory authority, and agreement with a reference platform on the bench is not equivalent to, and must not be interpreted as, clinical or diagnostic accuracy.

Where this Site refers to machine-learning or AI-based risk-prediction performance, those figures are derived from a simulated dataset used for early-stage model development and exploration. The Phase II AI/ML model (planned for July–September 2026) has not yet been built, trained, or validated on real-world clinical data.

6. Ethics & Data

Research activities associated with this project have been conducted under the ethical clearance obtained for the relevant research study. [REVIEW] The specific ethics committee name, approval number, and approved scope are to be confirmed and referenced by qualified personnel before publication.

7. Forward-Looking Statements

Statements on this Site regarding future development phases (including Phase II, planned for July–September 2026), regulatory submissions or certifications (including DPIIT recognition and CDSCO registration), patent filings, scientific publication, and commercial launch are forward-looking and reflect current intentions only. They are subject to change, delay, or revision based on research outcomes, funding availability, regulatory feedback, and other factors beyond our control.

As of the date of publication: DPIIT recognition has been applied for but not yet granted; patent applications are in preparation and have not yet been filed; no CDSCO registration has been sought; and no peer-reviewed publication of clinical results has occurred.

8. No Guarantee of Regulatory Outcome or Timeline

Yohafly makes no representation or warranty, express or implied, that the Portable Hormone Analyser will receive any particular regulatory clearance, registration, or certification, or that any such outcome will be achieved within any particular timeframe, or at all. Regulatory classification, requirements, and outcomes are determined solely by the relevant authorities and may differ from current expectations.

9. Contact for Regulatory Queries

For questions regarding the development or regulatory status of our products or research, contact us at ceo@yohafly.com.