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Two extra Breakthrough Machine Designations granted by U.S. FDA for ARC Remedy
Sturdy monetary place with €70 million in money and money equivalents as of September 30, 2022, anticipated to fund operations by year-end 2024
Convention name and webcast (in English) immediately, November 8th at 2:30 PM CET/8:30 AM ET
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland & BOSTON, November 08, 2022–(BUSINESS WIRE)– ONWARD Medical N.V. (Euronext: ONWD), the medical know-how firm creating modern therapies to revive motion, independence, and well being in individuals with spinal cord injury (SCI), immediately mentioned highlights from the third quarter of 2022 and supplied a enterprise replace.
“We’re extremely inspired to have obtained two extra FDA Breakthrough Machine Designations, validating the pioneering nature of our work and offering a streamlined approval course of for these essential therapies,” mentioned Dave Marver, CEO of ONWARD. “We’re trying ahead to extra upcoming milestones, together with the anticipated launch of interim knowledge from ongoing blood strain feasibility research.”
R&D and operations
As we speak, ONWARD introduced that the Firm has been granted Breakthrough Machine Designation by the U.S. Food and Drug Administration (FDA) for 2 extra indications: (1) to its exterior system ARC-EX for enhancing or restoring decrease extremity sensory and motor perform in individuals with power neurological deficits ensuing from SCI; and (2) to its implantable system ARC-IM for treating neurogenic bladder dysfunction in individuals with SCI. The Firm now has a complete of 5 Breakthrough Machine Designations for ARC Remedy.
Breakthrough Machine Designation is an FDA program designed to assist sufferers and their physicians obtain well timed entry to applied sciences which have the potential to supply more practical therapy or prognosis for debilitating circumstances of nice unmet want, reminiscent of SCI. As a part of this designation, the FDA will present ONWARD with precedence evaluate and the chance to work together with FDA specialists all through the premarket evaluate part because the know-how strikes towards commercialization.
In September 2022, ONWARD reported constructive top-line outcomes from its Up-LIFT pivotal research evaluating transcutaneous stimulation with its exterior ARC Remedy. The research enrolled 65 individuals at 14 main SCI facilities within the U.S., Europe, and Canada, attaining its main effectiveness endpoint of enchancment in higher extremity energy and performance in individuals with SCI.
In October 2022, ONWARD reported topline outcomes from the LIFT Residence research, evaluating the security and feasibility of ARC-EX Remedy when used at house. The research enrolled 17 individuals at 5 main analysis facilities throughout the U.S. Contributors carried out coaching on actions of each day residing involving arm and hand motion thrice per week over a one-month interval. Roughly 97% of those periods have been accomplished with out usability points, supporting the feasibility of home-based therapy.
Company and Monetary
In September 2022, ONWARD appointed Vivian Riefberg, a extremely completed professional in healthcare, authorities, and technique, to the Board of Administrators. In 2020, Ms. Riefberg retired as a senior accomplice with McKinsey & Firm, the place she led the Public Sector Follow for the Americas and co-led the U.S. Health Care apply. She beforehand served on the U.S. Nationwide Institutes of Health (NIH) Medical Middle Board of Governors and on the NIH Advisory Board for Medical Analysis.
ONWARD’s administration expects to proceed the regular and constant execution of its technique by the tip of 2022 and past.
Following constructive top-line knowledge from the Up-LIFT pivotal research, ONWARD expects to submit for regulatory approval within the U.S. and EU in the course of the first half of 2023 to permit the Firm to commercialize ARC-EX for the development of higher extremity energy and performance in sufferers with SCI. If all goes as deliberate, these authorizations are anticipated within the second half of 2023.
Moreover, ONWARD plans to debate the findings from the LIFT Residence research with regulatory authorities to outline the suitable approval pathway for house use, with a purpose to facilitate entry to ARC-EX Remedy at house with out the burden of continued visits to a clinic.
Earlier than year-end 2022, the Firm expects to launch interim knowledge from the STIMO-HEMO and HemON research. Each research are exploring using ARC-IM Remedy to normalize low blood strain in individuals with SCI, which is the primary deliberate indication for ARC-IM. By year-end, ONWARD, subsequently, expects to have launched top-line knowledge from its pivotal research for ARC-EX and interim knowledge from present scientific feasibility research for ARC-IM, offering essential scientific validation of each of its main know-how platforms.
The Firm plans to proceed constructing its group and capabilities in preparation for the anticipated launch of its ARC-EX Remedy within the second half of 2023, each operationally and commercially. Over the subsequent a number of months, ONWARD plans to deal with recruiting for gross sales, advertising and marketing, and area service roles to cowl the U.S. and choose European markets.
With a robust stability sheet, the present money place is predicted to be adequate to finance operations by the tip of 2024 and assist investments in product improvement, scientific trials, operational capabilities, and business launch. ONWARD continues to contemplate alternatives to additional strengthen its money place as fairness capital markets enhance within the U.S. and across the globe.
Convention Name & Webcast
ONWARD will host a convention name with a dwell webcast immediately, November 8, 2022, at 2:30 pm CET / 8:30 am ET. The webcast could also be accessed on the Monetary Data web page of the Firm’s web site. A replay of the webcast additionally will probably be out there on the ONWARD web site.
To affix the webcast by way of Zoom, please register utilizing this hyperlink.
About ONWARD Medical
ONWARD is a medical know-how firm creating modern therapies to revive motion, independence, and well being in individuals with spinal cord accidents. ONWARD’s work builds on greater than a decade of fundamental science and preclinical analysis performed on the world’s main neuroscience laboratories. ONWARD’s ARC Remedy, which might be delivered by implantable (ARC-IM) or exterior (ARC-EX) techniques, is designed to ship focused, programmed spinal cord stimulation to revive motion and different features in individuals with spinal cord injury, in the end enhancing their high quality of life.
ONWARD has obtained 5 Breakthrough Machine Designations from the U.S. FDA encompassing each ARC-IM and ARC-EX. ARC-EX is an exterior, non-invasive platform consisting of a wearable stimulator and wi-fi programmer. Constructive top-line knowledge have been reported in September 2022 from the corporate’s first pivotal research, known as Up-LIFT, evaluating the flexibility of ARC-EX Remedy to enhance higher extremity energy and performance. The corporate is now making ready advertising and marketing approval submissions for the U.S. and Europe. ARC-IM consists of an implantable pulse generator and lead that’s positioned close to the spinal cord. The corporate accomplished its first-in-human use of the ARC-IM neurostimulator in Could 2022.
ONWARD is headquartered in Eindhoven, the Netherlands. It maintains an workplace in Lausanne, Switzerland, and has a rising U.S. presence in Boston, Massachusetts. The corporate has an educational partnership with NeuroRestore, a collaboration between the Swiss Federal Institute of Expertise (EPFL) and Lausanne College Hospital (CHUV). For added details about ONWARD, please go to ONWD.com. To entry our 2022 Monetary Calendar, please go to IR.ONWD.com.
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