ONWARD® Reports Q3 Business Update and Year-To-Date Highlights
16 Novembre 2023 - 7:30AM
Completing activities required for ARC-EX® FDA submission
Expanded HemON Study as
precursor to ARC-IM® Empower BP pivotal study
First-in-human use of
ARC-IM BCI for upper limbs
Potential for ARC
Therapy™ to improve mobility after Parkinson’s
disease
published in Nature
Medicine
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
provided a third quarter 2023 business update.
“We remain focused on completing
activities required to submit an FDA de novo application for
clearance of our ARC-EX System in the first half of 2024,” said
Dave Marver, CEO of ONWARD. “In the meantime we achieved several
additional milestones in Q3, including the first-in-human implant
of our ARC-IM Neurostimulator paired with a brain-computer
interface (BCI) to restore thought-driven movement in the fingers,
hands, and arms and the expansion of our HemON clinical feasibility
study. HemON will investigate use of the ARC-IM System to provide
hemodynamic stability after SCI and is a precursor to our planned
global pivotal study called Empower BP, which we expect to commence
in the second half of next year. A recent Nature Medicine
publication revealed the exciting potential to expand ARC-IM
Therapy into the large, adjacent Parkinson’s disease
market.”
Q3 and Year-To-Date
Highlights:
Clinical and
Development
- In August 2023, the Company marked the first-in-human implant
of its ARC-IM Neurostimulator to restore upper extremity function
after SCI. The study participant also received a wireless
brain-computer interface (BCI), designed to initiate thought-driven
movement when paired with ARC-IM. ONWARD ARC-IM delivers targeted,
programmed ARC-IM Therapy to the spinal cord to restore movement
and other functions after SCI. To date, ARC-IM Therapy has been
applied across multiple clinical feasibility studies to restore
mobility or stabilize blood pressure after SCI.
- In September, the Company expanded its HemON clinical
feasibility study to assess the safety and effectiveness of the
ARC-IM System to improve blood pressure regulation after SCI with
the addition of Sint Maartenskliniek in Nijmegen, the Netherlands
as a study site. The first participant at this site was implanted
in September 2023. Expanding this clinical feasibility study
prepares the company for expected 2H 2024 initiation of a global
pivotal trial, called Empower BP, which is being designed to
provide the evidence necessary to submit a pre-market approval
(PMA) application to the US Food and Drug Administration (FDA) and
other global regulatory bodies.
- In November, the Company announced a publication in Nature
Medicine highlighting the potential for ONWARD ARC Therapy to
address gait challenges related to Parkinson’s disease. The study
participant described in the publication has been living with
Parkinson’s disease for nearly three decades. He has a severe gait
disorder that has not responded to conventional therapies. After
the introduction of ARC Therapy and benefitting from several weeks
of rehabilitation, the participant was able to walk without
previously noticeable gait interruptions.
- Also in November, ONWARD research partner .NeuroRestore was
awarded a $1 million grant from The Michael J. Fox Foundation for
Parkinson’s Research (MJFF) to implant the Company’s ARC-IM System
and investigate the effect of ARC Therapy in six additional
participants with Parkinson’s disease. This study will assist
ONWARD in determining whether to conduct additional clinical trials
and potentially commercialize ARC Therapy in the future for those
living with Parkinson’s disease.
- The Company was issued 33 new patents during Q3 2023, bringing
its total number of issued patents to more than 230 and issued or
pending patents to more than 390, further strengthening its
first-mover advantage.
Commercial
- In September, the Company announced a partnership with Lovell
Government Services (Lovell), a Service-Disabled Veteran-Owned
Small Business (SDVOSB). Lovell is a government vendor and
third-party logistics provider partnering with more than one
hundred US healthcare providers. The two-year distribution
agreement provides ONWARD access to the United States Veterans
Health Administration, the world’s largest healthcare system
providing spinal cord injury care, and the US Department of Defense
Military Health System, the world's largest military healthcare
provider.
Corporate and
Financial
- The Company reported cash and cash equivalents of EUR 36.8
million as of September 30, 2023, and reiterated its guidance of
expected cash runway through the end of 2024.
Outlook:
ONWARD expects to continue steady and
consistent execution of its strategy in through 2024 with the
achievement of the following milestones:
- The Company plans to submit a de novo application for FDA
clearance of the ARC-EX System in 2024, with US launch expected in
the second half of next year. This would be the Company’s first
commercial offering.
- 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 anticipates a list price of USD 30,000. In
addition, the Company expects to supplement revenue by offering
tiered service packages.
- The Company also continues to prepare for its global 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. This study is expected to begin
enrollment in the second half of 2024.
- Concurrent with publication in a peer-reviewed journal, the
Company expects to announce more detailed results from its Up-LIFT
pivotal study in 2024. The Company has already announced that the
study met both primary safety and effectiveness endpoints and that
72% of participants responded to ARC-EX. A responder was defined as
meeting or exceeding the minimally important difference criteria
for at least one strength outcome and at least one functional
performance outcome.
- The Company expects to gain additional clinical data and
experience with its implantable ARC-IM System in 2024, with several
implants planned with support from the Michael J. Fox Foundation
for Parkinson’s Research and several implants planned in
combination with an implanted brain-computer interface (BCI) with
support from the European Innovation Council.
- The Company reaffirmed its expected cash runway through the end
of 2024 and will look for efficient ways to further strengthen its
balance sheet in the coming months.
Conference Call &
Webcast
ONWARD will host a conference call
with a live webcast today, November 16, 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.
To join the webcast via Zoom, please
register using this link.
*All ONWARD devices and therapies,
including but not limited to ARC-IM, ARC-EX, and ARC Therapy, alone
or in combination with BCI, are investigational and not available
for commercial use.
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, a component of hemodynamic stability
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:
Khaled Bahi, 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 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.
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