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Izotropic Reacts to Supply Chain Disruptions and Updates IzoView Engineering Timelines

Izotropic Reacts to Supply Chain Disruptions and Updates IzoView Engineering Timelines

Izotroy对供应链中断做出反应并更新IzoView工程时间表
newsfile ·  2022/06/29 09:05

Vancouver, British Columbia--(Newsfile Corp. - June 29, 2022) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a company commercializing a dedicated breast CT (computed tomography) imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers, announces timeline updates for the initial IzoView commercial prototype build.

温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2022年6月29日)-Izotrotic公司(CSE:以藏)(OTCQB:IZOZF)(FSE:1R3) ("各向同性“或”公司),一家商业化专用乳腺CT(计算机断层扫描)成像平台IzoView的公司,用于更准确地检测和诊断乳腺癌,宣布了最初IzoView商业原型构建的时间表更新。

  • Supply chain issues and unforeseen impacts on engineering work have resulted in an estimated delay of up to 3 quarters to the Company's previously projected 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.
  • 供应链问题和对工程工作的不可预见的影响导致公司先前预计的时间表估计推迟了3个季度。
  • 工程团队正在修改IzoView的各个方面,并在关键组件中构建冗余,以减轻对供应链的进一步中断。
  • 临床研究的设计正在修改,以允许更大的患者招募池,因此更快的整体临床研究时间和更高的市场接受度。

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.

本公司一直在应对因新冠肺炎而影响全球供应链的众所周知的涓滴效应并制定战略。由于供应商组件交付期的波动,IzoView所需组件的供应商时间表一直在快速变化,并多次推迟。为了应对这种不稳定性,Izotroy的工程团队重新设计了内部方面,使IzoView成为一台更灵活的机器。这将降低工程风险,以更好地保持性能,并减少进一步的延误和对特定组件或供应商的依赖。

In addition, the Company experienced unforeseen delays in transitioning from its previous third-party engineering firm, StarFish Medical, to its in-house engineering and development team, now based in Sacramento, CA. With the engineering transition, there were delays that included changing custom components towards more modular subsystem parts that now allow for increased device flexibility, modular testing, and future expandability of the IzoView platform. The Company is now in complete control of the final development of IzoView with a strong engineering group and a mandate to continue to simplify and streamline all aspects of development for flexibility and ease of manufacturing.

此外,该公司在从之前的第三方工程公司海星医疗过渡到其内部工程和开发团队(目前总部设在加利福尼亚州萨克拉门托)的过程中遇到了意想不到的延误。随着工程过渡,出现了一些延迟,包括将定制组件改为更模块化的子系统部件,从而提高了设备灵活性、模块化测试和IzoView平台的未来可扩展性。该公司现在完全控制了IzoView的最终开发,拥有一支强大的工程团队,并受命继续简化和精简开发的所有方面,以实现灵活性和制造便利性。

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 clinical prototype unit for its clinical study out to Q1 2023. Updates on execution points will be regularly disclosed to shareholders going forward.

该公司现在估计,供应链问题和其他事项将先前预计的时间表推迟了2至3个季度,将其临床研究的第一个临床原型装置发货所需的验证、认证和测试推迟到2023年第一季度。未来将定期向股东披露执行点的最新情况。

To further mitigate the impact of delays, the Company has taken advantage of panel discussions with EXCITE International to modify its clinical study design to expand the comparator group. This will allow for faster participant recruitment by expanding the number of eligible patients for the study, which in turn is expected to decrease the overall length of the clinical study time. This proposed change is also aimed at increasing market adoption of the device following market authorization and assisting in recapturing the aforementioned time delays associated with IzoView's overall commercialization plan.

为了进一步减轻延迟的影响,该公司利用与Excite International的小组讨论修改了其临床研究设计,以扩大比较组。这将允许通过扩大研究的合格患者数量来更快地招募参与者,这反过来预计将减少临床研究的总体时间长度。这项拟议的改革还旨在根据市场授权增加该设备的市场采用率,并帮助重新获得与IzoView整体商业化计划相关的上述时间延迟。

Izotropic continues its ongoing dialogue with the US FDA to obtain feedback on proposed modifications to the trial design as well as providing additional details on study plans prior to an Investigational Device Exemption submission required to initiate the clinical study.

Izotroy继续与美国FDA进行对话,以获得对试验设计拟议修改的反馈,并在启动临床研究所需的研究设备豁免提交之前提供有关研究计划的更多细节。

Izotropic is in advanced discussions with well-known leading U.S. hospitals regarding clinical study participation, with a focus on sites with a high number of patients seen daily for diagnostic imaging for breast cancer. These engaging discussions have also provided input into future opportunities and new Breast CT product applications and indications. As part of the critical path to finalize agreements with these key hospitals, the Company will finalize its proposed clinical study revisions, obtain ethics approval and work through contracting at each site.

Izotroy正在与美国知名领先医院就参与临床研究进行深入讨论,重点放在每天有大量患者进行乳腺癌诊断成像的地点。这些引人入胜的讨论也为未来的机会和新的乳房CT产品的应用和适应症提供了投入。作为与这些主要医院最终敲定协议的关键途径的一部分,该公司将最终敲定其拟议的临床研究修订,获得伦理批准,并通过在每个地点签订合同来开展工作。

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.

该公司正在聘请一个独立的临床研究组织(CRO)来管理这项临床研究,并帮助促进这些活动。在对几家专业和著名的全球CRO进行了大量尽职调查之后,该公司预计将在7月初敲定并宣布一项全面的协议。

ON BEHALF OF THE BOARD
Dr. John McGraw, CEO

我代表董事会
首席执行官约翰·麦格劳博士

Investor Relations Contact:
James Berard
Email: jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1

投资者关系联系人:
詹姆斯·贝拉德
电子邮件:jberard@izocorp.com
电话:778-228-2314
免费电话:1-833-IZOCORP分机1

Media Inquiries Contact:
Jaclyn Thast
Email: jaclyn@izocorp.com
Toll Free: 1-833-IZOCORP ext.3

媒体问询联系人:
雅克林·塔斯特
电子邮件:Jaclyn@izocorp.com
免费电话:1-833-IZOCORP转3

About Izotropic Corporation

关于Izotroy公司

Izotropic Corporation is the only publicly-traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic's initial clinical study intends to demonstrate superior performance of diagnostic breast CT imaging over diagnostic mammography procedures. In follow-on clinical studies, Izotropic intends to validate platform applications, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery.

Izotroy公司是唯一一家将专门的乳腺CT成像平台IzoView商业化的上市公司,该平台用于更准确地检测和诊断乳腺癌。为了加快患者和供应商使用IzoView的速度,Izotroy的初步临床研究打算证明诊断性乳房CT成像比诊断性乳房X光检查程序具有更好的性能。在后续的临床研究中,Izotroy公司打算验证平台应用,包括放射学中的乳房筛查、外科肿瘤学中的治疗计划和监测,以及整形和重建外科中的乳房重建和植入监测。

More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.

欲了解有关Izotroy公司的更多信息,请访问公司网站:izocorp.com,或查看公司在SEDAR上的简介:sedar.com。

Forward-Looking Statements

前瞻性陈述

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 purposes only. IzoView is not yet approved for sale.

本文档可能包含“前瞻性陈述”,这些陈述基于对公司管理层、业务的当前估计、假设、预测和预期,以及对公司运营所处的相关市场和经济环境的了解。在可能的情况下,本公司已尝试通过使用下列词语来识别此类信息和陈述:“预期”、“相信”、“设想”、“估计”、“预期”、“打算”、“可能”、“计划”、“预测”、“项目”、“目标”、“潜在”、“将”、“将”、“可能”、“可能”、“应该”、“继续,关于未来事件、趋势或前景或未来经营或财务业绩的任何讨论,“考虑”及其他类似表述及其派生,尽管并不是所有前瞻性表述都包含这些识别词语。这些陈述不是对业绩的保证,涉及难以控制或预测的风险和不确定因素,因此,它们可能导致公司未来活动的结果与此类陈述的内容和影响大不相同。前瞻性陈述仅在作出之日起具有相关性,公司没有义务更新或修改任何前瞻性陈述,以反映新的信息或未来事件或情况的发生,除非法律另有要求。本公司及其股东、高级管理人员和顾问均不对任何人根据本文所含信息采取的任何行动以及任何行动的结果负责,包括但不限于购买或出售公司证券。本文档中的任何内容都不应被视为任何类型的医疗或其他建议。所有图片仅用于说明目的。IzoView尚未获准出售。

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