Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 88

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 88
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 manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of noncompliance could have a material adverse impact on our business prospects.

The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of our products or affect our ability to manufacture, market, or distribute our products after approval. Moreover, increased attention to the containment of healthcare costs in the United States and in foreign markets could result in new government regulations that could have a material adverse effect on our business. Our failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for our future products could diminish any revenues we may be able to generate. Our ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers, and other third-party payors. European Union and U.S. government and other third-party payors increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of reimbursement for new drugs. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the United States or abroad.

Our activities also may be subject to state laws and regulations that affect our ability to develop and sell our products. We are also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on our business prospects.

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Nano-Mupirocin - Regulatory Evaluation

Nano-mupirocin is a liposomal formulation of the antibiotic mupirocin. Mupirocin is currently approved and used as a topical antibiotic under the brand name Bactroban. It has a unique mode of action and has been found effective against bacteria listed as urgent and serious threats by the CDC. However, due to its rapid metabolism and high protein binding, its efficacy is limited to topical administration.

By encapsulating mupirocin in nano-liposomes, the drug is protected in the bloodstream, allowing it to remain active when administered by injection. Therefore, nano-mupirocin may be considered a new mode of action antibiotic for parenteral use. With the growing challenge