Vyome's VT-1953 Announces Phase 2 Efficacy In Malignant Fungating Wounds, Paving Path To Pivotal Trial

• VT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002).
• Patient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002)
• VT-1953 was well-tolerated, with no new safety concerns observed.
• Based on these positive Phase 2 results, the company plans to advance VT-1953 into a pivotal study following discussions with the FDA to seek approval to enter $1B potential addressable market opportunity.

Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND) announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds ("MFW"). VT-1953, a first-in-class immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial, seek FDA approval, and enter the $1B potential addressable market as the only anticipated approved solution for malignant fungating wounds.