#Canada #Vancouver #Zero Candida #FemTech #ZC-1-A

Zero Candida Plans for FDA Submission by 2025

Zero Candida Technologies, Inc., an Israeli FemTech company, has announced its ambitious plans to complete preclinical studies aimed at submitting to the FDA by the third quarter of 2025. This company, known for its innovative approach to women's health, focuses on a groundbreaking medical device designed to tackle a common yet often overlooked issue: Vulvo-Vaginal Candidiasis (VVC), commonly referred to as yeast infections.

With the statistics revealing that 75% of women experience vulvo-vaginal candidiasis in their lifetime, the need for effective treatment options has never been more critical. Zero Candida’s device, the ZC-1-A, utilizes a therapeutic blue light technology specifically calibrated to eliminate the Candida fungus, achieving an impressive 99.999% success rate in Point of Care (POC) settings. Unlike traditional treatments that often involve medications with potential side effects, this non-pharmaceutical approach offers a safe and fast-acting alternative.

As part of the preparation for their FDA submission, Zero Candida has initiated extensive preclinical studies. The company recently completed a small pilot trial involving two sheep. During this trial, both sheep were subjected to a three-hour treatment involving the ZC-1-A device, which resulted in no adverse effects, confirming the device's safety for human use. This crucial milestone paves the way for more extensive testing which will involve additional subjects to validate the device's efficacy and safety further.

Eli Ben Haroosh, the CEO and Founder of Zero Candida, expressed confidence in the upcoming studies. He stated, "Zero Candida is poised to revolutionize women's health with our innovative approach. By 2025, we aim to have successfully navigated the preclinical phase with our device, which we believe will significantly impact countless women around the world."

Dr. Asher Holzer, the company's Chief Technology Officer, emphasized the importance of their technology in the realm of hybrid medicine. He noted that the data collected from treatments using the ZC-1-A device is transmitted in real time to healthcare professionals, allowing for personalized treatment consultations. This feature adds a layer of convenience and effectiveness, particularly for women who may not have easy access to traditional gynecological services.

What sets the ZC-1-A apart is its design—a tampon-like device that integrates cutting-edge technology to deliver treatment without the side effects commonly associated with pharmaceutical options. This thoughtful design supports a growing demand among women for holistic and chemical-free health solutions. Additionally, by embracing telemedicine functionalities, Zero Candida aims to reach underserved populations, including those in developing countries, where such health technologies are often unavailable.

With its dedicated research team and ongoing development efforts, Zero Candida is on track to reshape the treatment landscape for women suffering from VVC. The company has secured collaborations with esteemed hospitals in Israel and Europe for its upcoming clinical trials, reflecting its commitment to improving women's health worldwide.

As the deadline for FDA submission approaches, the team remains optimistic about the potential of their product. With continued support and collaboration, Zero Candida is not just aiming to comply with regulatory standards; they're looking to transform the healthcare industry for women. The success of their innovative device could lead to improved health outcomes for millions, marking a significant step forward in the evolution of gynecological care.

For more information about Zero Candida and their pioneering work in women's health, visit www.zero-candida.com.