Altamira Therapeutics Expands Quality System Certification for Bentrio
Altamira Therapeutics Achieves Important Quality Certification
Altamira Therapeutics Ltd. (Nasdaq: CYTO) has exciting news to share with the healthcare community. The company recently announced that its affiliate, Altamira Medica Ltd., received an extension of its ISO 13485 certification for its quality management system. This enhancement now includes the production process of Bentrio, a revolutionary nasal spray designed to combat airborne allergens and viruses.
ISO 13485 Certification: A Key Milestone
The ISO 13485 certification is a globally recognized standard that ensures organizations maintain quality management systems specific to the medical device industry. This certification guarantees that Altamira complies with rigorous standards for design, development, production, and distribution. Achieving this certification is a significant milestone for Altamira Medica, signifying its commitment to maintain high-quality standards for its products.
Growth Strategy for Bentrio
Thomas Meyer, Chairman and CEO of Altamira Medica, expressed pride in passing the required audits for this certification. He noted that this certification is not just a formality but a vital component of their growth strategy for Bentrio, which includes partnerships with strategic contract manufacturers and an expanding network of international distributors. This logistical support will be essential for Bentrio's future success as it seeks to enter new markets.
An Overview of Bentrio
Bentrio is marketed as a drug-free nasal spray that protects users from airborne allergens and, in some regions, airborne viruses. Upon application, Bentrio creates a protective gel layer on the nasal mucosa. This gel acts as a barrier, reducing the interaction between harmful particles and nasal cells, and aiding in the removal of such particles from the body. Its efficacy is backed by four clinical trials, with the largest study showcasing significant benefits for users suffering from seasonal allergic rhinitis.
Clinical Trials Affirm Bentrio's Safety
In the notable NASAR study, 100 participants tested either Bentrio or a saline nasal spray over two weeks. The results revealed a significant reduction in nasal symptoms for users of Bentrio compared to those using saline, along with marked improvements in their quality of life—demonstrating both its safety and effectiveness. Users of Bentrio reported fewer days needing relief medication, further underscoring its benefits.
Understanding ISO 13485 Standards
The ISO 13485 standard sets forth specific requirements for quality management systems that organizations in the medical device field must adhere to. This includes ensuring that medical devices satisfy customer and regulatory requirements throughout their lifecycle. Passing an audit by an accredited organization is necessary for certification under this standard, highlighting the stringency of the process.
What Does This Mean for Altamira Therapeutics?
For Altamira Therapeutics, maintaining ISO 13485 certification not only elevates its product offerings but also enhances its credibility within the medical community. As it builds upon its existing technologies, including peptide-based nanoparticle platforms for RNA delivery, Altamira is placing a strong emphasis on quality. Strengthening its operational framework enables the company to explore further innovative therapies and expand its partnerships.
Looking Ahead
As Altamira Therapeutics continually seeks to innovate, the certification extension for Bentrio is a pivotal aspect of its broader objectives. The company is committed to creating effective solutions that enhance health outcomes, and the improved quality management processes stand as a testament to this dedication.
Frequently Asked Questions
1. What is Bentrio?
Bentrio is an over-the-counter, drug-free nasal spray designed for protection against airborne allergens and viruses.
2. What does the ISO 13485 certification entail?
ISO 13485 certification involves adhering to strict quality management standards for medical devices, ensuring quality at every production stage.
3. How has Bentrio been tested for efficacy?
Bentrio's effectiveness has been demonstrated through four clinical trials, with significant improvements shown in patients' symptoms and quality of life.
4. What growth strategies are in place for Bentrio?
Altamira is partnering with strategic manufacturers and expanding its distributor network to promote Bentrio's market growth.
5. How does Altamira Therapeutics ensure product quality?
The company implements a comprehensive quality management system certified by ISO 13485, facilitating high-quality standards for all its products.
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