Relay Medical and Fio Corporation Announces High-Volume Manufacturing Partner for its COVID-19 Mobile Testing Device, Fionet, to Support Scaled-Up Production

Rhea-AI Summary

Relay Medical Corp. (RYMDF) and Fio Corporation have partnered to produce high-volume COVID-19 mobile testing devices with KeyTronic, a renowned FDA-approved contract manufacturer. The assembly line for these devices is expected to start in October, with an initial run of 165 units. Meanwhile, Fionet has been deployed in 10 clinics in Kenya, and FRR is pursuing regulatory approval from Health Canada, the US, and the EU. This initiative aims to facilitate community-based testing amid the anticipated second wave of COVID-19.

Positive

• Engaged KeyTronic for high-volume production of COVID-19 testing devices, ensuring rapid manufacturing.
• Deployment of Fionet software in 10 clinics in Kenya signifies operational progress.
• New research pilot agreement with a large European medtech network could lead to broader deployments.
• FRR is pursuing expedited regulatory access in Canada and the US, which may facilitate quicker market entry.

Negative

• None.

• Relay & Fio announces engagement with contact manufacturer KeyTronic for high-volume production of its COVID-19 mobile testing device, which enables rapid COVID-19 testing & tracking in community-based settings
  
• KeyTronic is a world class, US-based and FDA-approved medical device contract manufacturer, recently selected as a Top 10 Contract Manufacturing Service Provider for 2020¹
• Recently announced delivery of COVID-19 software in Kenya has been deployed to first 10 clinics in Meru County
• Signed new agreement for a research pilot with a large, European multinational medtech network
• Fionet has been submitted to Health Canada for expedited access to address community-based testing and tracking. FRR is simultaneously working towards Fionet regulatory approval in the US and EU.

TORONTO, Oct. 02, 2020 (GLOBE NEWSWIRE) -- Relay Medical Corp. (“Relay” or the “Company”) (CSE: RELA, OTC: RYMDF, Frankfurt: EIY2), and Fio Corporation (“Fio”), together Fionet Rapid Response Group (“FRR”), announce that its Fionet pandemic response devices will be produced by US-based, FDA-approved, high-volume contract manufacturer, KeyTronic, which is now creating a Fionet device assembly line. KeyTronic (NASDAQ: KTCC) offers turnkey services and global reach and is already producing other COVID-related medical devices.

FRR has approximately 1000 devices being prepared for manufacture, with initial runs of the assembly line expected in October. The company has paid for the manufacturing line set ups and 50% of the cost of the first batch of 165 units and will pay the balance upon completion within 6 to 8 weeks.

“In August, we focused on implementing our vision for adapting Fionet to COVID. In September, we focused on bringing this vision to the market, which resulted in agreements for initial deployment we are signing. We now moved to engage a high-quality, high-volume manufacturer to fulfill orders,” said Dr Michael Greenberg, CEO of FRR and of Fio Corporation.

In early September, FRR announced the first delivery of the COVID-19 workflow software and the Company has since signed additional agreements for trial deployments with other organizations including a subsidiary of a large European diagnostics company which, upon successful completion a feasibility pilot, could result in volume deployments in multiple countries in Africa.

Trial or pilot deployments are designed to enable FRR and clients to customize Fionet for region-based workflows, including safe-return-to-work protocols, community-based COVID-19 testing protocols, and for field stress-testing.

In mid-August Relay Medical and Fio Corp. formed Fionet Rapid Response Group to rapidly adapt the Fionet platform for testing and tracking of COVID-19 to provide a solution that allows for management of mass community-based testing, triage, and contact tracing of the disease. The platform has been successfully deployed in over a dozen countries, where it has performed with excellent results for 1 million tests of high-consequence infectious diseases, including HIV, Ebola, malaria, dengue fever, and others.

Relay Medical and Fio Corporation executed this agreement for COVID based on the anticipation that: (1) for the first wave, all attention would go to personal protective equipment, tests, treatments, and vaccines - which a multitude of other companies would vie to provide; (2) the second wave will be a major threat; (3) by that time, sweeping measures would be needed to protect national and personal economies worn down by the first wave; and, (4) this would drive attention to implementing controlled, mass, community-based testing and triage coupled to real-time data circulation between frontline action and remote decision-making - which FRR can uniquely provide.

“The FRR team is working in unison with client teams to serve a great need and to intercept the opportunity anticipated in the second wave of COVID. Governments and the private sector are moving strongly towards taking the fight against COVID to mass, community-based settings, where people work, live, study, and travel so that they can continue to work, live, study, and travel.” said Yoav Raiter, CEO of Relay Medical Corp.

Fionet has been submitted to Health Canada for expedited access to address community-based testing and tracking. FRR is simultaneously working towards Fionet regulatory approval in the US and EU.

**The Companies are not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

About Fio Corporation

Fio Corporation, privately held and headquartered in Toronto, developed and markets the world’s first integrated guidance & tracking IT platform for decentralized healthcare settings, a new category of solution that raises healthcare quality and lowers healthcare costs. The platform enables average healthcare workers in clinics to deliver a new level of quality-controlled diagnostic testing and case management. Simultaneously, as an automated by-product of its clinical use, the platform captures and provides unprecedented frontline data to remote supervisors and stakeholders, enabling real-time remote tracking, insight distribution, and intervention. Fio operates globally in partnership with local distribution, service, and support organizations and also partners with other companies that license its technologies.

Website: www.fio.com

About Relay Medical Corp.

Relay Medical is a MedTech innovation Company headquartered in Toronto, Canada focused on the development of novel technologies in the diagnostics and AI data science sectors.

Website: www.relaymedical.com

Contact:
W. Clark Kent
President
Relay Medical Corp.
Office. 647-872-9982 ext. 2
TF. 1-844-247-6633 ext. 2
investor.relations@relaymedical.com

Bernhard Langer
EU Investor Relations
Office. +49 (0) 177 774 2314
Email: blanger@relaymedical.com

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the commercialization plans for the Company’s technologies described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management's estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which filings are available at www.sedar.com

¹ https://www.globenewswire.com/news-release/2020/07/14/2062245/0/en/Keytronic-Selected-as-a-Top-10-Contract-Manufacturing-Service-Provider-for-2020.html

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c73e26ec-59f6-4967-825e-53d60a7386d5

FAQ

What is Relay Medical Corp.'s recent announcement regarding COVID-19 testing devices?

Relay Medical Corp. announced a partnership with Fio Corporation and KeyTronic for the production of high-volume COVID-19 mobile testing devices to enhance community-based testing.

How many COVID-19 testing devices is Relay Medical Corp. planning to manufacture?

Relay Medical Corp. is preparing approximately 1,000 devices for manufacture, with an initial run of 165 units expected to be completed in 6 to 8 weeks.

What are the regulatory efforts of Relay Medical Corp. regarding their COVID-19 testing devices?

Relay Medical Corp. is working towards obtaining expedited regulatory approval for its Fionet platform from Health Canada, the US, and the EU.

What recent deployment has Relay Medical Corp. completed in Africa?

The Fionet COVID-19 software has been successfully deployed in 10 clinics located in Meru County, Kenya.

What is the significance of KeyTronic in Relay Medical Corp.'s COVID-19 response?

KeyTronic is a high-volume, FDA-approved contract manufacturer selected by Relay Medical Corp. to produce their COVID-19 mobile testing devices, ensuring rapid production capabilities.