Following positive top-line data from its first pivotal study, Up-LIFT, ONWARD announced plans to submit for regulatory approval in the US and EU late this year or in early 2023 to allow the Company to commercialize ARC-EX for the improvement of upper extremity strength and function in patients with SCI. These authorizations are expected in the second half of 2023.
In the second half of 2022, top-line data from the LIFT Home study are expected. The Company plans to discuss findings from LIFT Home with regulatory authorities to determine the requirements to gain clearance to market ARC-EX for home use, including the design and scope of a potential pivotal study for the home setting, should this be necessary.
Also in the second half of 2022, the Company expects to release combined top-line data from the STIMO-HEMO and HemON studies. Both studies are exploring the use of ARC-IM Therapy to normalize low blood pressure and provide enhanced trunk control in people with SCI, which is the first planned indication for ARC-IM. By year-end, ONWARD therefore expects to have released top-line data from its pivotal study for ARC-EX and top-line data from current clinical feasibility studies for ARC-IM, providing important clinical validation of both of its major technology platforms.
The Company expects to continue building its team and capabilities in preparation for launch of its ARC-EX Therapy in the second half of 2023, both operationally and commercially. In late 2022 or early 2023, ONWARD plans to place even greater focus on recruiting for sales, marketing, and field service roles to cover the US and select European markets.
Organizational enhancements extend to the Company's Board of Directors, which this September added Vivian Riefberg, a highly accomplished expert in healthcare, government, and strategy. In 2020, Ms. Riefberg retired as a senior partner with McKinsey & Company, where she held a variety of senior positions, including leader of the Public Sector Practice for the Americas and co-leader of the U.S. Healthcare practice. She served on McKinsey & Company's global board of directors and on the committee evaluating and developing global partners. Ms. Riefberg is currently Professor of Practice at the University of Virginia Darden School of Business where she holds the David C. Walentas Jefferson Scholars Chair.
With a strong balance sheet, the current cash position is expected to be sufficient to finance operations through the end of 2024 and support investments in product development, clinical trials, operational capabilities, and commercial launch. ONWARD continues to consider opportunities to further strengthen its cash position as equity capital markets improve in the U.S. and around the globe.
Conference Call & Webcast
ONWARD will host a conference call with live webcast today at 4 pm CET / 10 am EDT. The webcast may be accessed on the News and Events page of the Company's website or by clicking here. A replay of the webcast will be available on the ONWARD website.
The Half-Year Report 2022 is available on the Company's website in the Investors section .
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries. ONWARD's work builds on more than a decade of basic science and preclinical research conducted at the world's leading neuroscience laboratories. ONWARD's ARC Therapy, which can be delivered by implantable (ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed spinal-cord stimulation to restore movement and other functions in people with spinal cord injury, ultimately improving their quality of life.
ONWARD has received three Breakthrough Device Designations from the U.S. FDA encompassing both ARC-IM and ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable stimulator and wireless programmer. Positive top-line data were reported in September 2022 from the company's first pivotal study, called Up-LIFT, evaluating the ability of ARC-EX Therapy to improve upper extremity strength and function. The company is now preparing marketing approval submissions for the U.S. and Europe. ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The company completed its first-in-human use of the ARC-IM neurostimulator in May 2022.
ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands. It has substantial operations in Lausanne, Switzerland, and a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com. To access our 2022 Financial Calendar, please visit IR.ONWD.com.
Disclaimer
Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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(END) Dow Jones Newswires
September 27, 2022 01:30 ET (05:30 GMT)