Sunday, October 1, 2023

positive cash balance of 43.8 million euros

( — ONWARD Medical NV, the medical technology company specializing in creating innovative therapies to restore movement, function and independence to people with spinal cord injuries (SCI), announces first half results 2023 and takes stock of its activities.

“During the first half of 2023, we achieved several important milestones, including the publication of additional positive data from our pivotal Up-LIFT study and the launch of a groundbreaking clinical feasibility study utilizing the first-in-human experimental implantation of a brain-to-brain interface. computer. in combination with our ARC-IM therapy, with the goal of restoring thought-guided movement after a spinal cord injury,” says Dave Marver, CEO of ONWARD. “We have also made the difficult but correct decision to revise the circuit board assembly of the ARC-EX system. Of course, we share the disappointment of the spinal cord injury community at the delay of the expected commercial launch. take place in the second half of 2024. However, it is worth noting that our cash flow forecasts remain unchanged and that we are increasingly better prepared for the launch thanks to recent agreements with a third-party logistics partner that will provide us with rapid access to U.S. vehicles in public procurement.”

Operating and financial results for the first half

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In April 2023, at the American Academy of Neurology Annual Meeting, Dr. Jim Guest, professor of neurological surgery at the University of Miami and the Miami Project to Cure Paralysis, shared additional results from the pivotal Up-LIFT study that focuses on non-invasive Neuromodulation to improve upper extremity strength and function after SCI. In addition to meeting all primary safety and efficacy endpoints, the study demonstrated that 72% of participants responded positively to ARC-EX therapy, showing improvement in both strength and function.

In May, ONWARD announced that ARC therapy was associated with the experimental implantation of a wireless brain-computer interface (BCI), which allowed an individual to control the moment through thinking and the way they moved their paralyzed legs. This advance was published in the journal Nature and highlighted by major media outlets around the world.

Also in May, the company announced the first successful human experimental use of the ARC-IM Lead to deliver specific electrical pulses to the spinal cord. The ARC-IM cable is a key component of the ONWARD ARC-IM system, designed to address multiple indications through precise delivery of ARC therapy. The ARC-IM lead is designed for use with the ARC-IM neurostimulator (IPG) and is specifically designed to be implanted along the spinal cord to restore movement and function in people with spinal cord injury.

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ONWARD has received four new Breakthrough Device Designations (BDDs) from the US Food and Drug Administration (FDA). They include BDD for the use of its ARC-EX platform for bladder control (received in late 2022), spasticity mitigation, and blood pressure regulation in people with spinal cord injuries. It also secured an additional BDD for its ARC-IM platform aimed at treating spasticity in people with SCI. The company now has a total of 9 BDDs, allowing it to benefit from FDA priority review and interact with FDA experts throughout the pre-market review phase, as the technology moves toward commercialization.
Science and intellectual property

The company was granted 39 new patents in the first half, bringing the total number of patents pending or issued to more than 360. Of these, more than 200 patents are granted, further strengthening the company’s competitive advantage. company, pioneer in its field.

In January, ONWARD strengthened its leadership team by naming Erika Ross Ellison as vice president of global clinical and regulatory and Sarah Moore as vice president of global marketing. Erika joined ONWARD from Abbott Neuromodulation, where she was director of global clinical and applied research, and Cala Health, a non-invasive neuromodulation company, where she was director of neuroscience. She also served as deputy director of the Medical Device Innovation Accelerator in the Department of Surgery and assistant professor in the Department of Neurological Surgery at Mayo Clinic. Sarah joined ONWARD after working for Nevro, a company specializing in implantable neuromodulation. She has more than 20 years of experience in new product development and commercial marketing in the medical device space, including at Johnson & Johnson.
In May, Bryan, Garnier & Co, a leading investment bank focused on growth companies, restored research coverage on ONWARD with a Buy rating. The company is also covered by analysts at Degroof, Petercam and Kepler Cheuvreux.

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ONWARD reported an operating loss of €18.8 million for the first six months of 2023, compared to €15.1 million for the same period in 2022.
The company closed the semester with a positive cash balance of 43.8 million euros (compared to 61.8 million euros as of December 31, 2022).
The cash decrease of 18 million euros compared to December 31, 2022 is due to the financing of operating activities.

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