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Eindhoven, Sept. 19, 2023 (GLOBE NEWSWIRE) -- THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

US commercialization of ARC-EX™ expected 2H 2024 with USD 30,000 anticipated price

Clinical study initiated pairing ARC Therapy™ with a brain-computer interface to restore use of legs and upper extremities

ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced its first 2023 half results and provided a Business Update.

“During the first half of 2023 we delivered several significant milestones, including revealing additional positive data from our Up-LIFT pivotal study and initiating a groundbreaking clinical feasibility study that includes first-in-human use of an investigational implanted brain-computer interface (BCI) in combination with our ARC-IM™ Therapy to restore thought-driven movement after SCI,” said Dave Marver, CEO of ONWARD. “We have also taken the difficult but correct decision to update the ARC-EX system circuit board assembly. While we share the disappointment of the SCI community that this decision will impact launch timing, now expected in 2H 2024, our cash guidance remains unchanged. We are also increasingly well prepared for launch after recent agreements with a third-party logistics partner that provides rapid access to US government procurement vehicles.”

1H Operating and Financial Results

Clinical and Development

• In April 2023, at the American Academy of Neurology Annual Meeting, Dr. James Guest, Professor of Neurological Surgery at the University of Miami and the Miami Project to Cure Paralysis, shared additional results from the Up-LIFT pivotal study that investigated ARC-EX Therapy for improving upper extremity strength and function after SCI. In addition to meeting all primary safety and effectiveness endpoints, the study demonstrated that 72% of participants responded to ARC-EX Therapy¹, showing improvement in both strength and function.
• In May, the Company announced its ARC Therapy was paired with an investigational implanted wireless BCI, resulting in an individual gaining thought-driven augmented control over when and how he moved his paralyzed legs. This breakthrough was published in the journal Nature and highlighted in major media outlets around the globe.
• Also in May, the Company announced the successful first-in-human use of its investigational ARC-IM Lead to deliver targeted electrical pulses to the spinal cord. The ARC-IM Lead is a key component of the ONWARD ARC-IM system, engineered to address multiple indications by precisely delivering ARC Therapy. The ARC-IM Lead is designed to be used with the ARC-IM Neurostimulator (IPG) and is purpose-built for placement along the spinal cord to restore movement and function in people with SCI.
• The Company announced four new Breakthrough Device Designations (BDD) from the US Food and Drug Administration (FDA) in the first half of 2023. These include BDDs for the use of its ARC-EX platform for bladder control (awarded late 2022), alleviation of spasticity, and blood pressure regulation in people with SCI. In addition, the Company received an additional BDD for its ARC-IM platform for spasticity in people with SCI. The Company now has a total of nine BDDs, which affords it priority FDA review and the opportunity to interact with FDA experts throughout the pre-market review phase as the technology moves toward commercialization.

Science and Intellectual Property

• The Company was issued 39 new patents in H1, bringing its total number of pending or issued patents to more than 360. Of these, more than 200 are issued patents, further reinforcing the Company’s first-mover advantage.

Corporate

• In January, the Company strengthened its leadership team, appointing Erika Ross Ellison as Vice President, Global Clinical, Regulatory, and Quality and Sarah Moore as Vice President, Global Marketing. Erika came to ONWARD from Abbott Neuromodulation, where she was Director, Global Clinical & Applied Research. Previously, Erika was Neuroscience Director at Cala Health, a non-invasive neuromodulation company. She also served as Deputy Director, Medical Device Innovation Accelerator, Department of Surgery and Assistant Professor, Department of Neurologic Surgery at the Mayo Clinic. Sarah came to ONWARD from Nevro, an implantable neuromodulation company, and has more than 20 years of experience in new product development and commercial marketing in the medical device industry, including at Johnson & Johnson.
• In May, Bryan, Garnier & Co, a leading investment bank focused on growth companies, reinitiated research coverage on the Company with a Buy rating. The Company is also covered by equity research at Degroof Petercam and Kepler Cheuvreux.

Financial

• ONWARD reported an operating loss of EUR 18.8 million for the first six months of 2023 compared to EUR 15.1 million in the same period of 2022.
• The Company ended the six-month period with a positive cash balance of EUR 43.8 million (31 December 2022: EUR 61.8 million). The decrease in cash of EUR 18 million compared to 31 December 2021 is due to cash outflows for operating activities.

First Half 2023 Financial Summary

Business Update: 2H Outlook and Upcoming Milestones

ONWARD expects to continue strong execution of its strategy in the second half of 2023 and beyond.

Clinical and Development

• In August, ONWARD marked the successful first-in-human use of an investigational implanted wireless BCI to help a person with SCI recover use of paralyzed arms and hands with thought-driven movement. The implant was part of a clinical feasibility study with partners at CEA-Clinatec, CHUV, and EPFL that is supported by a grant from the European Innovation Council. BCI-augmented ARC-IM implants will continue throughout 2024 as part of this study.
• ONWARD now expects to launch ARC-EX in the US in the second half of 2024. The new date is driven by our decision to redesign the device’s printed circuit board assembly (PCBA). Once the PCBA redesign and associated testing are completed, the Company plans to submit a de novo application for FDA clearance for the ARC-EX system, which would be the Company’s first commercial offering. The Company does not expect the postponement to negatively impact its cash runway.
• The Company also continues to prepare for its pivotal clinical study, called Empower BP, to evaluate the safety and effectiveness of its implantable ARC-IM system to address blood pressure instability after SCI.

Commercial Update

• ONWARD continues to make robust progress in preparing for launch. In September, it forged an agreement with a US third-party logistics (3PL) provider to manage fulfillment to civilian customers and an agreement with a US Service-Disabled Veteran-Owned Small Business (SDVOSB) to manage fulfillment to the US Veterans Affairs (VA) Health Administration. The latter agreement will provide ONWARD with rapid access to US government purchasing vehicles after FDA clearance.
• Based on positive feedback from potential customers on the value of the ARC-EX system, expected to be the first-ever external spinal cord stimulation therapy to restore hand and arm function after SCI, the Company is anticipating a list price of USD 30,000. In addition, the Company expects to offer tiered service packages.

Corporate

• CFO Lara Smith Weber will step down as Chief Financial Officer at the end of September to pursue a new opportunity in the Boston area. Khaled Bahi will join ONWARD as Interim CFO. Prior to joining ONWARD, Khaled served as CFO of Lausanne-based Symetis, acquired by Boston Scientific in 2017 for USD 435 million, and Paris-based Stilla Technologies. He was also a finance leader with Fresenius Medical Care in Europe, Latin America, Middle East, and Africa. Khaled brings more than 20 years of finance experience in the medtech industry. Early in his career, he was a corporate and investment banker with Crédit Lyonnais and the Industrial Bank of Japan.
• The Company continues to expect its current cash position to fuel operations through the end of 2024. ONWARD plans to explore opportunities to further strengthen its cash position to support future investments in product development, clinical trials, and operational and commercial capabilities.

Conference Call & Webcast

ONWARD will host a conference call with a live webcast today, September 19, 2023, at 2:00 pm CET / 8:00 am ET. The webcast may be accessed on the Financial Information page of the Company’s website. A replay of the webcast also will be available on the ONWARD website. The Half Year Report 2023 is available on the Company’s website in the Investors section. To join the webcast via Zoom, please register using this link.

All ONWARD devices and therapies referenced here, including but not limited to ARC-IM™, ARC-EX™, and ARC Therapy™, are investigational and not available for commercial use.

¹Responder was defined as a participant who met or exceeded the minimally important difference criteria for at least one outcome of the strength domain and at least one outcome of the functional performance domain.

About ONWARD Medical

ONWARD is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the Company has received nine Breakthrough Device Designations from the US Food and Drug Administration for its ARC Therapy™ platform.

ONWARD^® ARC Therapy, which can be delivered by external ARC-EX™ or implantable ARC-IM™ systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing regulatory approval submissions for ARC-EX for the US and Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI).

Headquartered in Eindhoven, the Netherlands, ONWARD has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company also has an academic partnership with. NeuroRestore, a collaboration between the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital (CHUV).

For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.

For Media Enquiries:

Aditi Roy, VP Communications

media@onwd.com

For Investor Enquiries:

Lara Smith Weber, CFO

Khaled Bahi, CFO (as of October 1^st, 2023)

investors@onwd.com

Disclaimer

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s 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. All ONWARD devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.