Hamilton, Bermuda, Sept. 27, 2024 (GLOBE NEWSWIRE) --
- Certification to ISO 13485 extended to also include production process
- Supports Bentrio growth strategy together with strategic contract manufacturer and expanding network of international distributors
Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (CYTO, Financial) today announced that its associate company Altamira Medica Ltd. obtained extended ISO 13485 certification for its quality management system, including henceforth also production activities. With this extension, the quality management system has been certified for the whole design, development, production and distribution cycle for Altamira Medica’s Bentrio® nasal spray.
“We are very proud of passing the required audits for the certification of our quality management system for Bentrio in accordance with the internationally recognized, rigorous ISO 13485 standard,” commented Thomas Meyer, Altamira Medica’s Chairman and CEO. “Our comprehensive and effective quality management system helps to ensure that Bentrio complies with high quality standards and regulatory requirements. Its extension to also include our production processes is an important milestone in our growth strategy for Bentrio, which we are implementing with a strategic contract manufacturer and an expanding network of international distributors.”
About Bentrio
Bentrio is an “over the counter” drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne particles with cells; in addition, the composition serves to bind such particles and help with their discharge. The efficacy and safety of Bentrio has been demonstrated in a total of four clinical trials, of which the largest one (“NASAR” study) enrolled 100 patients suffering from seasonal allergic rhinitis. In NASAR, participants self-administered either Bentrio or saline nasal spray for two weeks 3 times per day. The study showed a statistically significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) for Bentrio compared to saline (p = 0.013), as well as a statistically highly significant improvement in health-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire, p < 0.001) and superior global ratings of efficacy by patients and investigators alike (p < 0.001). In addition, Bentrio showed good safety and tolerability, similar to saline controls, and fewer Bentrio treated patients used relief medication and more of them enjoyed symptom-free days compared to saline treatment. For more information, visit: www.bentrio.com
About ISO 13485
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. Certification is achieved based on passing a thorough and comprehensive audit by an independent, accredited organization. ISO (International Organization for Standardization) is a worldwide federation of more than 160 national standards bodies.
About Altamira Therapeutics
Altamira Therapeutics ( CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in Altamira Medica AG, which holds its commercial-stage legacy asset Bentrio®, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets. Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
Forward-Looking Statements
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