VANCOUVER, British Columbia and LOS ANGELES, CA, Sept 4, 2024 - (NewMediaWire) - Femto Technologies Inc., formerly known as BYND Cannasoft Enterprises Inc. (Nasdaq: BCAN) (“Femto” or the “Company”), a leading innovator in the FemTech industry, acts to summarize commercial conditions with an FDA-registered facility to produce 510(k) lubricants, integral to Femto’s flagship product, soon to be launched in the US.
This collaboration is part of the company's agenda to upgrade its flagship product to a medical device 510(k) FDA approved.
The 510(k) Premarket Notification, as mandated by the Food, Drug, and Cosmetic Act, requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This process allows the FDA to determine whether the device is equivalent to an existing device in one of the three classification categories. Manufacturers must submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or significantly modify an existing device in a way that could affect its safety or effectiveness.
Femto intends to submit all relevant documents to obtain the approval. After the release of the recreational version of the product to the market, the engagement with the facility will constitute an important layer in arranging the necessary approvals for the product as a medical device.
“We have identified an outstanding professional FDA-approved partner that aligns with Femto’s innovative DNA and vision to enhance women’s wellness globally,” explained Yftah Ben Yaackov, CEO of Femto. “All of Femto’s lubricants will meet the 510(k) requirements. Meeting these high standards is the first milestone in regulating our flagship product as a medical device, this partnership ensures that our products meet the highest standards of safety and efficacy, allowing us to deliver unparalleled value to our customers.”
The chosen facility also holds certifications from the International Compliance Association (ICA), California Department of Public Health, Women Business Enterprise (WBENC), and CCOF (Organic), among others.
Femto has rapidly emerged as a pioneer in the FemTech sector, dedicated to addressing the unique health and wellness needs of women through innovative and scientifically backed solutions. The introduction of its flagship product marks a significant milestone in the company’s journey to empower women and improve their quality of life.
Key highlights of Femto’s flagship product include:
Advanced Technology: Integrating the latest in FemTech innovation to provide superior wellness support.
User-Centric Design: Engineered to cater to the specific needs and preferences of women.
Holistic Wellness: Promoting overall physical and emotional wellbeing through comprehensive care solutions.
For more information, visit www.femtocorp.com.
About Femto Technologies Inc.
Femto, previously known as BYND Cannasoft Enterprises Inc., aims to become a leader of transformative change in the sphere of female health and wellness. Through proprietary Smart Release Technology and a dedication to creating smart, women-centric products, Femto is establishing new benchmarks in the wellness industry.
Femto is a British Columbia integrated software company based in Israel. Femto owns and markets "Benefit CRM", a proprietary customer relationship management (CRM) software product enabling small and medium-sized businesses to optimize their day-to-day business activities such as sales management, personnel management, marketing, call center activities, and asset management.
Femto owns the patent-pending intellectual property for the EZ-G device. This therapeutic device uses proprietary software to regulate the flow of low concentrations of CBD oil, hemp seed oil, and other natural oils into the soft tissues of the female reproductive system to potentially treat a wide variety of women's health issues. The EZ-G device includes technological advancements as a sex toy with a more realistic experience and the prototype utilizes sensors to determine what enhances the user’s pleasure. The user can control the device through a Bluetooth app installed on a smartphone or other portable device. The data will be transmitted and received from the device to and from the secure cloud using artificial intelligence (AI). The data is combined with other antonymic user preferences to improve its operation by increasing sexual satisfaction. Commercialization of the EZ-G device is subject to regulatory approvals.
The devices described in this news release are concept devices that are in the first stage of development and will be subject to testing, experiments and regulatory approvals and therefore there is no certainty that they will eventually be marketed.
For further information please refer to the Company’s new website: www.femtocorp.com and on SEDAR+: www.sedarplus.ca.
Gabi Kabazo Chief Financial Officer Tel: (604) 833-6820 e-mail: ir@femtocorp.com
Cautionary Note Regarding Forward-Looking Statements
This press release includes certain statements that may be deemed “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended and under Canadian securities laws. When used in this press release, the words “may”, “would”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, and actual circumstances, events or results may differ materially from those projected in such forward-looking statements.
Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual events or developments may differ materially from those in forward-looking statements. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause the Company’s actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Such statements reflect the Company's current views with respect to future events and are subject to such risks and uncertainties. Many factors could cause actual results to differ materially from the statements made, including future financial performance, unanticipated regulatory requests and delays, final patents approval, and those factors discussed in filings made by the company with the Canadian securities regulatory authorities, including (without limitation) in the company's management's discussion and analysis for the year ended December 31, 2023 and annual information form dated April 2, 2024, which are available under the company's profile at www.sedarplus.ca, and in the Company’s Annual Report on Form 20-F for the year then ended that was filed with the U.S. Securities and Exchange Commission on April 3, 2024. Should one or more of these factors occur, or should assumptions underlying the forward-looking statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, or expected. We do not intend and do not assume any obligation to update these forward-looking statements, except as required by law. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. Shareholders are cautioned not to put undue reliance on such forwardâ€?looking statements.
Topic: Press release summary
Source: Femto Technologies Inc
Sectors: Healthcare & Pharm, Cannabis
https://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|