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MedMira Reports First Quarter Results FY2024Corporate update During Q1 FY2024, MedMira continued its focus on its regulatory and clinical trial work for a number of products, while increasing its sales and marketing activities. Throughout the reporting period, the Company achieved significant milestones in its pursuit of FDA and Health Canada approvals for a range of products. Subsequent to Q1 FY2024, the Company received the US FDA 510(k) clearance for the HIV-2 claim on the Reveal G4 Rapid HIV 1/2 antibody test in the United States. This achievement marks a significant milestone for MedMira, positioning the company as a key player in the HIV testing landscape and addressing the demand for comprehensive HIV screening mandated by various State laws across the nation. It further allows the Company to significantly grow its market share and revenue in the United States, while re-confirming its quality for its upcoming Clinical Laboratory Improvement Amendments (CLIA) waiver. This latest approval enables the Company to offer the fastest high quality HIV rapid test which can be sold to CLIA laboratories, clinics and hospitals. In anticipation of the high demand, the Company increased its Business Development unit to assist its existing distribution partners with the product launch and any sales and marketing efforts. Furthermore, Company was able to discuss its pending and future submissions with Health Canada's In Vitro Diagnostic Division, Medical Device Directorate. The Company had a positive dialogue with key staff and is confident to satisfy all regulatory requirements set forward by Health Canada. In addition, the division has provided clear guidance and answers to any open questions to move forward with its pending and subsequent submissions. The Company will provide an Update in January 2024. Profit and Loss Highlights
Balance Sheet Highlights
The Company's financial statements and management's discussion and analysis are available on the Company's profile on SEDAR at www.sedar.com. For matters of going concern, reference is made to the Auditor's Emphasis of Matter statement in the fiscal year ended 2023 Auditors Report and note 2b in the audited financial statements which are also available on SEDAR. About MedMira MedMira is the developer and owner of Rapid Vertical Flow (RVF) Technology. The Company's rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company's tests are sold under the Reveal , Multiplo and Miriad brands in global markets. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada and the Company has a sales and customer service office located in the United States. For more information visit medmira.com. Follow us on Twitter and LinkedIn. This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events including statements regarding possible approval and launch of new products, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. MedMira Contacts: Markus Meile, CFO SOURCE: MedMira, Inc. View the original press release on accesswire.com
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