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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對供應鏈中斷做出反應並更新IzoView工程時間表
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.

温哥華,不列顛哥倫比亞省-(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),一家商業化專用乳腺CT(計算機斷層掃描)成像平臺IzoView的公司,用於更準確地檢測和診斷乳腺癌,宣佈了最初IzoView商業原型構建的時間表更新。

  • 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.
  • 供應鏈問題和對工程工作的不可預見的影響導致公司先前預計的時間表估計推遲了3個季度。
  • 工程團隊正在修改IzoView的各個方面,並在關鍵組件中構建宂餘,以減輕對供應鏈的進一步中斷。
  • 臨牀研究的設計正在修改,以允許更大的患者招募池,因此更快的整體臨牀研究時間和更高的市場接受度。

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.

本公司一直在應對因新冠肺炎而影響全球供應鏈的眾所周知的涓滴效應並制定戰略。由於供應商組件交付期的波動,IzoView所需組件的供應商時間表一直在快速變化,並多次推遲。為了應對這種不穩定性,Izotroy的工程團隊重新設計了內部方面,使IzoView成為一臺更靈活的機器。這將降低工程風險,以更好地保持性能,並減少進一步的延誤和對特定組件或供應商的依賴。

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,該公司在從之前的第三方工程公司海星醫療過渡到其內部工程和開發團隊(目前總部設在加利福尼亞州薩克拉門託)的過程中遇到了意想不到的延誤。隨着工程過渡,出現了一些延遲,包括將定製組件改為更模塊化的子系統部件,從而提高了設備靈活性、模塊化測試和IzoView平臺的未來可擴展性。該公司現在完全控制了IzoView的最終開發,擁有一支強大的工程團隊,並受命繼續簡化和精簡開發的所有方面,以實現靈活性和製造便利性。

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.

該公司現在估計,供應鏈問題和其他事項將先前預計的時間表推遲了2至3個季度,將其臨牀研究的第一個臨牀原型裝置發貨所需的驗證、認證和測試推遲到2023年第一季度。未來將定期向股東披露執行點的最新情況。

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.

為了進一步減輕延遲的影響,該公司利用與Excite International的小組討論修改了其臨牀研究設計,以擴大比較組。這將允許通過擴大研究的合格患者數量來更快地招募參與者,這反過來預計將減少臨牀研究的總體時間長度。這項擬議的改革還旨在根據市場授權增加該設備的市場採用率,並幫助重新獲得與IzoView整體商業化計劃相關的上述時間延遲。

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繼續與美國FDA進行對話,以獲得對試驗設計擬議修改的反饋,並在啟動臨牀研究所需的研究設備豁免提交之前提供有關研究計劃的更多細節。

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正在與美國知名領先醫院就參與臨牀研究進行深入討論,重點放在每天有大量患者進行乳腺癌診斷成像的地點。這些引人入勝的討論也為未來的機會和新的乳房CT產品的應用和適應症提供了投入。作為與這些主要醫院最終敲定協議的關鍵途徑的一部分,該公司將最終敲定其擬議的臨牀研究修訂,獲得倫理批准,並通過在每個地點簽訂合同來開展工作。

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.

該公司正在聘請一個獨立的臨牀研究組織(CRO)來管理這項臨牀研究,並幫助促進這些活動。在對幾家專業和著名的全球CRO進行了大量盡職調查之後,該公司預計將在7月初敲定並宣佈一項全面的協議。

ON BEHALF OF THE BOARD
Dr. John McGraw, CEO

我代表董事會
首席執行官約翰·麥格勞博士

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

投資者關係聯繫人:
詹姆斯·貝拉德
電子郵件:jberard@izocorp.com
電話:778-228-2314
免費電話:1-833-IZOCORP分機1

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

媒體問詢聯繫人:
雅克林·塔斯特
電子郵件:Jaclyn@izocorp.com
免費電話:1-833-IZOCORP轉3

About Izotropic Corporation

關於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公司是唯一一家將專門的乳腺CT成像平臺IzoView商業化的上市公司,該平臺用於更準確地檢測和診斷乳腺癌。為了加快患者和供應商使用IzoView的速度,Izotroy的初步臨牀研究打算證明診斷性乳房CT成像比診斷性乳房X光檢查程序具有更好的性能。在後續的臨牀研究中,Izotroy公司打算驗證平臺應用,包括放射學中的乳房篩查、外科腫瘤學中的治療計劃和監測,以及整形和重建外科中的乳房重建和植入監測。

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

欲瞭解有關Izotroy公司的更多信息,請訪問公司網站:izocorp.com,或查看公司在SEDAR上的簡介:sedar.com。

Forward-Looking Statements

前瞻性陳述

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.

本文檔可能包含“前瞻性陳述”,這些陳述基於對公司管理層、業務的當前估計、假設、預測和預期,以及對公司運營所處的相關市場和經濟環境的瞭解。在可能的情況下,本公司已嘗試通過使用下列詞語來識別此類信息和陳述:“預期”、“相信”、“設想”、“估計”、“預期”、“打算”、“可能”、“計劃”、“預測”、“項目”、“目標”、“潛在”、“將”、“將”、“可能”、“可能”、“應該”、“繼續,關於未來事件、趨勢或前景或未來經營或財務業績的任何討論,“考慮”及其他類似表述及其派生,儘管並不是所有前瞻性表述都包含這些識別詞語。這些陳述不是對業績的保證,涉及難以控制或預測的風險和不確定因素,因此,它們可能導致公司未來活動的結果與此類陳述的內容和影響大不相同。前瞻性陳述僅在作出之日起具有相關性,公司沒有義務更新或修改任何前瞻性陳述,以反映新的信息或未來事件或情況的發生,除非法律另有要求。本公司及其股東、高級管理人員和顧問均不對任何人根據本文所含信息採取的任何行動以及任何行動的結果負責,包括但不限於購買或出售公司證券。本文檔中的任何內容都不應被視為任何類型的醫療或其他建議。所有圖片僅用於説明目的。IzoView尚未獲準出售。

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