ONWARD® Medical Reaffirms Guidance, Shares 2024 Strategic Priorities, and Releases Unaudited Q4 Financial Highlights
15 Marzo 2024 - 12:30AM
ONWARD® Medical Reaffirms Guidance, Shares 2024 Strategic
Priorities, and Releases Unaudited Q4 Financial Highlights
ONWARD Medical N.V. (Euronext: ONWD), the medical technology
company creating innovative spinal cord stimulation therapies to
restore movement, function, and independence in people with spinal
cord injury (SCI), today reaffirms previous cash guidance, shares
its strategic priorities for 2024, and releases its unaudited Q4
financial highlights.
2024 Strategic
Priorities
- ARC-EX commercial launch. The Company expects to launch
its investigational ARC-EX Therapy to improve the strength and
function of the upper extremities after SCI in the US in Q4 2024.
Major associated milestones this year include FDA De Novo
submission, FDA clearance, and first commercial sale.
- ARC-IM pivotal study commencement. The
Company intends to launch its global pivotal study, called Empower
BP, for investigational ARC-IM Therapy to address blood pressure
instability after spinal cord injury. Major associated milestones
this year include FDA IDE submission, FDA IDE approval and first
participant enrollment.
- ARC-BCI therapy advancement. The Company
plans to advance clinical and development activities for its
investigational ARC-BCI System, leveraging grant funding and the
recently announced FDA Breakthrough Device Designation and
acceptance into the FDA’s new TAP program.
Q4 Unaudited Financial
Highlights
- The Company plans to publish its Full Year 2023 financial
statements on April 25, 2024.
- The preliminary unaudited cash and cash equivalent balance on
December 31, 2023 was EUR 29.8 million.
- Net cash outflow in Q4, 2023 was EUR 7.0 million, consistent
with the EUR 7.0M cash burn in Q3, 2023.
- The Company confirms its previous guidance of expected cash
runway through the end of 2024 and will look for efficient ways to
strengthen its balance sheet in the coming months.
“We made robust progress in 2023,
achieving important clinical milestones, spending capital wisely,
and preparing for regulatory submission of our first therapy,” said
Dave Marver, CEO of ONWARD Medical. “In 2024, our focus is
commercialization -- we look forward to bringing the SCI Community
the first-ever therapy that can improve strength and function even
years after a spinal cord injury.”
To learn more about ONWARD Medical’s
commitment to partnering with the SCI Community to develop
innovative solutions for restoring movement, function, and
independence after spinal cord injury, please visit
ONWD.com.
*All ONWARD Medical devices and
therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™,
and ARC Therapy™, alone or in combination with a brain-computer
interface (BCI), are investigational and not available for
commercial use.
About ONWARD
Medical
ONWARD Medical 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 ten 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, a component of hemodynamic instability, following SCI.
Other ongoing studies include combination use of ARC-IM with a
brain-computer interface (BCI) to address multiple symptoms of
SCI.
Headquartered in Eindhoven, the
Netherlands, ONWARD Medical 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).
ONWARD Medical is listed on Euronext
Brussels and Amsterdam (ticker: ONWD).
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:
Khaled Bahi, Interim CFO
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 Medical devices and therapies referenced
here, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™ and
ARC Therapy™, are investigational and not available for commercial
use.
Onward Medical NV (EU:ONWD)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Onward Medical NV (EU:ONWD)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024