New Space Offers Advanced Development Capabilities for the PREVA (TM) Clot Removal Device for Ischemic Stroke Treatment
Toronto, Ontario--(Newsfile Corp. - March 8, 2023) - Investor partner Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and investor in a range of leading edge, proprietarydiagnostic and medical device technologies, is pleased to provide an update on its partnership with Inretio Inc. ("Inretio"), a leading Israeli medical device startup and developer of PREVA™ a novel clot removal device for ischemic stroke treatment. Inretio announced earlier this week it is moving into a new facility of its own in Sapirim Industrial Park, Israel, which is a hub for major technology and medical devices companies in Israel and home for several FDA approved facilities.
The new development site will feature a large manufacturing floor and a cleanroom, which will allow the Company to design, develop and manufacture its groundbreaking PREVA™ stroke treatment. The facility spans 10,700 square feet and features state-of-the-art equipment and dedicated spaces specific for research and development, manufacturing, and quality control. In fact, Inretio's new facility is designed to scale production of the PREVA™ device up to 5,000 units per month, whereas the former space had a maximum production capability of 500 units per month. Overall, the new location allows the Company to meet demand for the growing global ischemic stroke treatment market. On average, the current clot retrievers from top competitors sell for between $6200 to $7000 USD per unit. These current competitive ischemic stroke treatment solutions are single use only, much like the PREVA™ device will be a single use solution.
"We are excited to move into our new facility at Sapirim Industrial Park and to have a dedicated space that is tailored to our needs," shared Raviv Vine, CEO of Inretio. "Having our own manufacturing facility is a game-changer for us. It will enable us to produce our PREVA device at scale, which is critical as we move towards clinical trials and potential commercialization."
"This expansion into a new space with the right equipment to bring this innovative, leading-edge ischemic stroke solution to market faster is fully supported by Therma Bright," shared Rob Fia, CEO of Therma Bright, who has invested in Inretio and the PREVA™ clot removal device. "With initial tests wrapping up and preparation for human trial approval and clinical study, the new site offers the right environment for the Inretio team's success."
Inretio's move to Sapirim Industrial Park comes at a time of significant growth. The Company has been making significant strides in the development of the PREVA™ clot removal device, and has demonstrated promising results from a Good Laboratory Practice (GLP) animal study, at the Shamir Medical Center's Research Unit. The GLP animal study is expected to be completed in second quarter of 2023. Inretio then plans to submit the study's data, as well as mechanical verification and validation (V&V) testing data, to the Israeli Ministry of Health for Clinical Trial clearance in humans, which will be a significant milestone towards commercialization. Furthermore, as recently announced, Inretio has received funding and support from various investors and organizations, including a non-dilutive investment from the Israel Innovation Authority.
Further to the Company's news release of January 19, 2023, in which it announced its acquisition of up to 25% in Inretio, at the request of the TSX Venture Exchange ("TSXV"), the Company clarifies that with respect to the portion of the purchase price that is comprised of US$500,000 in Therma Bright shares, the number of shares to be issued will be calculated based on the 5 day VWAP prior to the date of issue of the shares, subject to a minimum price per share equal to yesterday's closing market price (being CAD$0.10).
Similarly, further to the Company's news release of February 16, 2023, in which it announced the signing of an exclusive license agreement with AI4LYF, the Company clarifies that US$420,000 of the cash consideration payable to AI4LYF may be issued in Therma Bright shares if certain funding is not achieved by June 30, 2023. In such event, the price per share will be determined based on the share price on closing on June 30, 2023, subject to a minimum price per share equal to yesterday's closing market price (being CAD$0.10).
About Inretio
Inretio was born out of the need for improving stroke care and reducing thrombectomy complications. Inretio has set itself the goal of reducing stroke's burden and patients' suffering, by being a leader in the neurovascular field, and bringing value to physicians with simple, yet innovative solutions. For further information, go to http://www.inretio.co.il.
About Therma Bright Inc.
Therma Bright, is a developer and partner in a range of leading edge, proprietarydiagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright is the developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test, currently undergoing regulatory review. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation. as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.
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