Izotropic Responds to Supply Chain Disruptions and Updates IzoView Engineering Deadlines
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Vancouver, British Columbia–(Newsfile Corp. – June 29, 2022) – Izotropic Corporation (CSE: IAO) (OTCQB: IZOZF) (ESF: 1R3) (“Izotropic“or the”Company“), a Company Marketing a Dedicated Breast Computed Tomography (CT) Imaging Platform, IzoView, for More Accurate Detection and Diagnosis of Breast Cancers, Announces Schedule Updates for Initial Prototype Build commercial IzoView.
- Supply chain issues and unforeseen impacts on engineering work have resulted in an estimated delay of up to 3 quarters from the Company’s previously planned timelines.
- Engineering teams are revising aspects of IzoView and building redundancy into critical components to mitigate additional supply chain disruptions.
- The clinical study design is being modified to allow for a larger patient recruitment pool, therefore faster overall clinical study time and better market acceptance.
The company has responded and strategized around the well known trickle down effects impacting global supply chains due to Covid-19. Supplier lead times for the components needed for IzoView changed rapidly and were repeatedly pushed back due to fluctuating supplier component lead times. In response to the instability, the engineering teams at Izotropic redesigned the internals to make IzoView a more flexible machine. This will reduce engineering risk to better maintain performance and mitigate additional delays and dependency on specific components or vendors.
Additionally, the company experienced unforeseen delays in transitioning from its former third-party engineering company, StarFish Medical, to its in-house engineering and development team, now based in Sacramento, California. Along with the technical transition, there were delays which included the change from custom components to more modular subsystem components which now allow for increased device flexibility, modular testing, and future scalability of the IzoView platform. The company now has full 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 greater flexibility and ease of manufacture.
The company now estimates that supply chain issues and other issues have delayed previously planned timelines by 2-3 quarters, putting the validation, certification and testing required for shipment of the first clinical prototype for its study. clinical until the first quarter of 2023. Updates on execution points will be regularly communicated to shareholders in the future.
To further mitigate the impact of the delays, the Company took advantage of group discussions with EXCITE International to modify the design of its clinical study to enlarge the comparator group. This will allow faster recruitment of participants by increasing the number of patients eligible for the study, which in turn should reduce the overall duration of the clinical study. This proposed change is also intended to increase the adoption of the device in the post-marketing authorization market and help address the aforementioned delays associated with IzoView’s overall commercialization plan.
Izotropic continues its ongoing dialogue with the U.S. FDA to obtain feedback on proposed trial design changes as well as provide additional details on study plans prior to an investigational device exemption submission required to initiate the trial. ‘clinical study.
Izotropic is in advanced discussions with well-known leading US hospitals regarding participation in clinical studies, with an emphasis on sites with a high number of patients seen daily for breast cancer diagnostic imaging. These exciting discussions also provided insight into future opportunities and new applications and indications for breast CT products. As part of the critical path to finalize agreements with these key hospitals, the Company will finalize its proposed clinical study reviews, obtain ethics approval and work through contracts at each site.
The Company engages an independent clinical research organization (CRO) to manage the clinical study and help facilitate these activities. After extensive due diligence on several specialist and leading global CROs, the company expects to finalize and announce a global deal in early July.
ON BEHALF OF COUNCIL
Dr. John McGraw, CEO
Contact with Investor Relations:
E-mail: [email protected]
Toll free: 1-833-IZOCORP ext. 1
Contact for media inquiries:
E-mail: [email protected]
Toll free: 1-833-IZOCORP ext. 3
About Izotropic Corporation
Izotropic Corporation is the only publicly traded company to market a dedicated breast CT imaging platform, IzoView, for more accurate breast cancer detection and diagnosis. To accelerate patient and provider access to IzoView, Izotropic’s initial clinical study aims to demonstrate the superior performance of diagnostic CT imaging of the breast compared to diagnostic mammography procedures. In follow-up clinical studies, Izotropic intends to validate applications of the platform, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in surgery. plastic and reconstructive.
Further information about Izotropic Corporation is available on its website at izocorp.com and by viewing its profile on SEDAR at sedar.com.
This document may contain statements that are “forward-looking statements”, which are based on management’s current estimates, assumptions, projections and expectations of the business and its knowledge of the relevant market and economic environment in which it operates. . The Company has tried, to the extent possible, to identify such information and statements by using words such as “anticipate”, “believe”, “intend”, “estimate”, “expect”, “have the ‘intent to’, ‘may’, ‘plan’, ‘predict’, ‘project’, ‘target’, ‘potential’, ‘shall’, ‘should’, ‘could’, ‘should’, ‘continue’, ‘contemplate’ and other similar expressions and their derivatives in connection with any discussion of future events, trends or prospects or of 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 may cause future results of the Company’s business to differ materially from the contents and implications of these statements. Forward-looking statements speak only as of the date 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 stated. by the law. Neither the Company nor its shareholders, officers and consultants shall be responsible 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 herein should be taken as medical or other advice of any kind. All images are for illustrative purposes only. IzoView is not yet approved for sale.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/129392