Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 75

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 75
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 also referred
to as nanomedicines or nano delivery systems, are employed to serve as means of diagnostic tools or to deliver therapeutic agents to
specific targeted sites in a controlled manner. Nanotechnology offers multiple benefits in treating chronic human diseases by site-specific,
and target-oriented delivery of precise medicines. These systems enable site-specific, controlled delivery of pharmaceutical agents—including
chemotherapeutic, biological, and immunotherapeutic compounds—with what we believe to be improved safety and efficacy profiles..

Liposomal and lipid-based nanoparticles are
designed to improve the therapeutic index of both novel and existing drugs by modifying pharmacokinetics, enhancing absorption, reducing
metabolism, extending biological half-life, and reducing toxicity [2]. These nanostructures circulate in the bloodstream for extended
periods and enable controlled drug release, thereby minimizing plasma fluctuations and associated adverse effects. Due to their nanoscale
size and ability to be functionalized with targeting ligands, they can preferentially accumulate in tumor or inflamed tissues via the
enhanced permeability and retention (EPR) effect and improve cellular uptake. Studies have shown that nanoparticles (<200 nm) achieve
significantly greater cellular internalization than microparticles (>1 µm), resulting in more effective targeting with reduced
off-target toxicity [3].

The advantages of liposomes as drug carriers
are well recognized. Over 20 liposomal and lipid-based formulations have received approval from the FDA and EMA, with many others in
clinical and preclinical development stages [4]. One of the earliest and most significant approvals was Doxil™, a liposomal formulation
of doxorubicin co-invented by Prof. Chezy Barenholz, and the first FDA-approved nano-drug.

More recently, lipid nanoparticles (LNPs)
have emerged as the leading non-viral delivery systems for nucleic acid-based therapeutics, including RNA interference (RNAi) and in
vitro transcribed (IVT) mRNA. Their role was central in the development and success of mRNA vaccines during the COVID-19 pandemic:

| ● | Pfizer-BioNTech                                                                              
 (Comirnaty): Used LNPs to encapsulate and deliver mRNA encoding the SARS-CoV-2 spike protein 
 [5].                                                                                         |

| ● | Moderna                                                                                 
 (Spikevax): Similarly relied on LNP technology for mRNA stabilization and delivery [6]. |

| ● | Arcturus:                                                                                 
 Developed an mRNA vaccine platform using LNPs, demonstrating the broader trend toward