Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 12

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 12
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 observations (all animals were 100% normal). At one week and at four weeks the animals were sacrificed. AppTec pathologists
evaluated knee joint histology. The reported cartilage surfaces of the femoral and tibia condyles and the menisci were grossly and histologically
100% normal for all animals and test sites. The test particles were found in all of the injection sites.

The
test particle did not cause changes in the articular cartilage of the femur or tibia when injected into the stifle joint of rabbits.
The test article and control rabbit knees were not different for either 1 or 4-week time points for all histological measurements. In
conclusion, the particles do not cause inflammation or damage to knee joint and will stick to exposed tissues and biologically integrate
with those tissues. The particles were not found to stick to articular cartilage in any sample.

Regenerative
Characteristics

The
particle devices for joint injections have been extensively studied for a broad range of applications including the treatment of wrinkles
as dermal filler. Here is an overview of the pre-clinical and clinical studies completed for CosmetaLife, which is the name used for
the particle device when it was used as a dermal filler.

CosmetaLife
is an easy-to-inject, water-protein-based dermal filler that not only fills nasolabial wrinkle depressions but also helps rejuvenate
the dermal tissues, counteracting damage that causes wrinkles. The dermal cells are attracted to the CosmetaLife gel-particles, attach
to them, and then slowly replace them with natural dermal material (extracellular matrix). The natural biological replacement process
of CosmetaLife to collagen is estimated to take 6-12 months. CosmetaLife clinical trial on nasolabial folds supports this estimate.

CosmetaLife
injections allow the body to create a more natural dermal structure in and around every particle. Enhancing the natural process of dermal
tissue construction with CosmetaLife allows for long-term dermal contouring, corrections, and rejuvenation with little to no adverse
side effects noted in clinical trials.

Particle
Device Clinical Studies

The
Company has conducted several biocompatibility animal studies. In the implantation study, no abnormal clinical signs were noted for any
of the rabbits. The results of the sensitization study in guinea pigs showed a sensitization response equivalent to the negative controls.

A
Food and Drug Administration (FDA