ONWARD Medical Highlights Major Progress in 2024 Financials
ONWARD Medical Reports Significant Progress in 2024
ONWARD Medical N.V. (NASDAQ: ONWD), known for its innovative medical therapies aimed at restoring movement and independence in individuals with spinal cord injuries, has recently announced its Half Year 2024 financial results along with a comprehensive business update. The company revealed key successes in the first half of the year, including strategic advancements and financial growth.
Highlights of the Half-Year Results
The first half of 2024 marked an exceptional period for ONWARD Medical, as they submitted a De Novo application for their investigational ARC-EX System to the FDA, published the results of the pivotal Up-LIFT study in a prominent medical journal, and secured over EUR 52.5 million in growth financing from Runway Growth Capital. CEO Dave Marver expressed his excitement about the progress made, particularly in the brain-computer interface (BCI) field, which aims at developing therapies to restore movement after spinal cord injury.
Clinical and Development Advancements
- In January, the Company expanded its HemON clinical feasibility study, incorporating Sint Maartenskliniek in the Netherlands, emphasizing its preparations for a global pivotal trial called Empower BP focused on improving blood pressure control in SCI patients.
- February saw the awarding of Breakthrough Device Designation from the FDA for the ARC-BCI System, a testament to its innovative use of BCI technology combined with therapeutic solutions.
- By March, ONWARD Medical became one of only two BCI companies admitted into the FDA's Total Product Lifecycle Advisory Program (TAP), aiming to streamline the commercialization of their technologies.
- In April, they took a decisive step by submitting a De Novo application to the FDA to market their non-invasive ARC-EX System, anticipating clearance by late 2024.
- May brought the publication of their Up-LIFT trial results, which demonstrated significant improvements in upper limb function for individuals stationed with chronic tetraplegia.
Science and Intellectual Property Milestones
- During the first half of 2024, ONWARD Medical was granted 30 new patents, raising its total to over 270 patents, reinforcing its leading position in spinal cord injury therapies.
Corporate Strategies and Financial Status
ONWARD Medical completed a €20 million equity financing round in March, further bolstering its cash reserves to finance ongoing product developments and clinical studies. Furthermore, they secured a debt financing agreement for up to EUR 52.5 million, with plans to utilize these funds for upcoming commercial activities and general corporate purposes.
- As of June 30, 2024, the Company reported an operating loss of EUR 18.7 million, consistent with the previous period while maintaining a positive cash position of EUR 32.1 million, an increase from EUR 29.8 million at the end of 2023.
Future Outlook and Anticipated Milestones
Looking ahead, ONWARD Medical is focused on maintaining its trajectory of consistent progress. The company aims to obtain FDA clearance for launching its ARC-EX System in Q4 2024 and is actively forming a dedicated sales and service team to support this launch.
- They also anticipate a peer-reviewed publication on the outcomes of the first ten patients implanted with the ARC-IM Therapy, focusing on blood pressure stability after spinal cord injury.
- Preparations are underway for the international Empower BP trial, linked to the ARC-IM Therapy, with significant milestones expected by late 2024 and early 2025.
- Continued development of the ARC-BCI System is on the agenda, supported by new funding from recognized foundations and significant partnerships.
About ONWARD Medical
Founded on more than a decade of cutting-edge research, ONWARD Medical develops ARC Therapy, which has received multiple Breakthrough Device Designations from the FDA. The therapy utilizes tailored spinal cord stimulation delivered via its ARC-EX and ARC-IM platforms. The results from the Up-LIFT trial highlight the efficacy of ARC-EX Therapy in enhancing upper limb function.
Headquartered in Eindhoven with an office in Boston, ONWARD Medical is dedicated to pushing the boundaries of rehabilitation for spinal cord injury recovery and has plans to expand its clinical studies across various applications, including addressing mobility challenges for different conditions, including Parkinson's disease.
Frequently Asked Questions
What are the key financial results for ONWARD Medical in the first half of 2024?
ONWARD Medical reported an operating loss of EUR 18.7 million while maintaining a positive cash balance of EUR 32.1 million by the end of June 2024.
What advancements did ONWARD Medical make in BCI technology?
They achieved Breakthrough Device Designation for the ARC-BCI System and became a participant in the FDA's TAP program for streamlined commercialization.
What is the relevance of the Up-LIFT study published in Nature Medicine?
The Up-LIFT study reported significant improvements in upper limb function for patients with chronic tetraplegia, marking a significant milestone for ONWARD Medical.
How much funding has ONWARD Medical secured recently?
The company secured EUR 52.5 million in growth financing from Runway Growth Capital along with a €20 million equity financing round completed earlier in 2024.
What is ONWARD Medical's primary goal for the remainder of 2024?
The primary goal is to obtain FDA clearance for the ARC-EX System and prepare for its commercial launch while continuing to develop their innovative therapies.
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