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Altamira Medica obtains extended ISO 13485 certification

Published 09/27/2024, 09:04 AM
CYTO
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HAMILTON, Bermuda - Altamira Therapeutics Ltd. (NASDAQ:CYTO) announced today that its associate company, Altamira Medica Ltd., has achieved an extension to its ISO 13485 certification for its quality management system to now include the production process. This certification confirms that the entire cycle of design, development, production, and distribution of Altamira Medica's Bentrio nasal spray adheres to international standards.

The ISO 13485 standard is a globally recognized benchmark for quality management systems in the medical device industry, ensuring that products consistently meet customer and regulatory requirements throughout their life cycle. The extended certification follows a comprehensive audit by an independent and accredited organization.

Thomas Meyer, Chairman and CEO of Altamira Medica, expressed pride in meeting the stringent requirements set by the ISO 13485 standard. He emphasized the significance of the extended certification in supporting the company's growth strategy for Bentrio, which involves collaboration with a strategic contract manufacturer and an expanding network of international distributors.

Bentrio is marketed as a drug-free, over-the-counter nasal spray that forms a protective gel layer on the nasal mucosa upon application. It is designed to help shield against airborne allergens and, where approved, airborne viruses. The product's efficacy and safety have been demonstrated in four clinical trials, including the NASAR study, which showed a statistically significant reduction in symptoms and an improvement in the quality of life for patients with seasonal allergic rhinitis compared to a saline nasal spray.

Altamira Therapeutics, the parent company of Altamira Medica, focuses on developing and supplying nanoparticle technologies for RNA delivery and holds a 49% stake in Altamira Medica AG. The company is also in the process of partnering or divesting its legacy assets related to inner ear conditions.

The information in this article is based on a press release statement from Altamira Therapeutics Ltd. It is important to note that forward-looking statements in the press release involve risks and uncertainties that could cause actual results to differ materially from those projected.

In other recent news, Altamira Therapeutics reported significant developments in its RNA delivery technologies during its first-half 2024 earnings call. The company's advancements in cancer and rheumatoid arthritis treatments through their OligoPhore and SemaPhore platforms were highlighted. Altamira is preparing for FDA investigational new drug approval submissions for its AM-401 and AM-411 programs by 2026.

The company raised $4 million in a public offering, with an additional $8 million possible through future milestones. Altamira also announced the expansion of its Bentrio nasal spray in Asia and Scandinavia, with a market launch expected in Mainland China in 2025. Financially, Altamira reported a reduced net loss from the previous year, indicating a shift towards a less capital-intensive business model.

These recent developments signal Altamira's strategic shift towards RNA delivery technologies, reflecting the acquisition of Tracer Therapeutics in 2021. The company's focus on cardiac regeneration and mRNA vaccines, along with the divestment of legacy assets, is also noteworthy. Despite a reported net loss of $4.3 million for the first half of 2024, the firm's restructuring efforts and expansion of distribution agreements for Bentrio suggest potential for significant revenue growth.

InvestingPro Insights

While Altamira Therapeutics Ltd. (NASDAQ:CYTO) celebrates the extension of its ISO 13485 certification, a closer look at the company's financial metrics reveals some challenges. According to InvestingPro data, CYTO's market capitalization stands at a modest $2.26 million, reflecting its current position as a small-cap biotech company.

The company's financial performance has been under pressure, as evidenced by several InvestingPro Tips. CYTO is not profitable over the last twelve months, with an adjusted operating income of -$6.85 million. This aligns with the InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.

The stock's recent performance has been particularly concerning. CYTO has experienced significant price declines across various timeframes, with a one-year price total return of -86.01% and a year-to-date return of -80.92%. These figures underscore the InvestingPro Tip that the stock has fared poorly over the last month and is trading near its 52-week low.

Despite these challenges, CYTO is trading at a low Price / Book multiple of 0.36, which could potentially interest value investors looking for undervalued assets in the biotech sector. However, this should be weighed against the company's weak gross profit margins and the fact that short-term obligations exceed liquid assets, as highlighted by additional InvestingPro Tips.

For investors seeking a more comprehensive analysis, InvestingPro offers 14 additional tips for CYTO, providing a deeper understanding of the company's financial health and market position. These insights could be particularly valuable given the volatile nature of biotech stocks and the specific challenges faced by Altamira Therapeutics.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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