(via TheNewswire)
Supply chain issues and unforeseen impacts on engineering work have resulted in an estimated delay of up to 3 quarters to the Company’s previouslyprojected timelines
Engineering teams are revising aspects of IzoView and building redundancy into critical components to mitigate further disruptions to the supply chain.
The clinical study design is being modified to allow for a larger patient recruitment pool, consequently faster overall clinical study time and enhanced market acceptance.
The Company has been reacting and strategizing around well-known trickle-down effects impacting global supply chains because of Covid-19. Supplier timelines for components necessary for IzoView have been rapidly changing and pushed back multiple times due to fluctuations in the supplier's component lead times. In reaction to the instability, Izotropic’s engineering teams have redesigned internal aspects to make IzoView a more flexible machine. This will reduce engineering risks to better maintain performance and mitigate further delays and dependence on specific components or suppliers.
In addition, the Company experienced unforeseen delays in transitioning from its previous third-party engineering firm, StarFishMedical, to its in-house engineering and development team, now based in
The Company now estimates that supply chain issues and other matters have set back previously projected timelines by 2 to 3 quarters, putting validation, certification, and testing required for shipping of the first clinicalprototype unit for its clinical study out to Q1 2023. Updates on execution points will be regularly disclosed to shareholders going forward.
To further mitigate the impact of delays, the Company has taken advantage of panel discussionswith
The Company is engaging an independent Clinical Research Organization (CRO) to manage the clinical study and help facilitate these activities. After considerable due diligence on several specialty and prominent global CROs's the Company expects to finalize and announce a comprehensive agreement in early July.
ON BEHALF OF THE BOARD
Dr.
Investor Relations Contact:
Email:jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1
Media Inquiries Contact:
Email:jaclyn@izocorp.com
Toll Free: 1-833-IZOCORP ext.3
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This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. These statements are not guarantees of performance and involve risks and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposesonly. IzoView is not yet approved for sale.
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