Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 13

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 13
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) IDE approved pivotal human clinical trial began with CosmetaLife late in 2006. The clinical trial
was a randomized, double-blind, parallel assignment, multi-center comparison of the safety and efficacy of CosmetaLife versus Restylane®
(Control) for the correction of nasolabial folds. One hundred seventy-one patients were skin tested and 145 were treated at six trial
sites. The number of study exits after treatment totaled four subjects. This clinical trial was reported and published at www.clinicaltrials.gov
(NCT00414544).

The
feedback from physician investigators has been positive with respect to CosmetaLife injection qualities, cosmetic appearance, and its
feel to the touch. During the first three to four months of the study, CosmetaLife showed no decrease in efficacy, as compared to Restylane
which showed an 11 percent decrease in efficacy. The FDA/IDE approved human clinical trial for the CosmetaLife product through twelve
months was found to be the same as compared to control hyaluronic acid product, Restylane (for each interval the consensus of the blinded
subjects tested preferred CosmetaLife or showed no preference at 3, 6, 9 and 12 months).

10

We
use existing, scalable processes to reduce the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality
product while being responsive to volume requirements. We are able to scale the manufacturing process having made batches in up to 2.0-kilogram
quantities to near GMP (Good Manufacturing Practices) standards.

Particles
Safety Study

Patients
injected with CosmetaLife were found to have no or mild inflammatory, irritation, or immunogenic responses. These results suggest the
particles are biocompatible because it closely matches the skin structure, composition, and moisture content. The no-to-low immunogenic
responses are attributed to the tight cross-linking of the CosmetaLife matrix, which prevents immunogenic progenitor cells from producing
antibodies to the matrix.

In
the clinical trial, the incidence of possible reaction to a skin test was 2.55 percent, with only one subject showing a reaction to a
second test or 0.6%, (1 out of 171). We also have a study report by AppTec, Inc., our Contract Research Organization, that CosmetaLife
did not produce an antibody response during the clinical trial further supporting our belief that it is safe to use.

CosmetaLife
is composed of materials