ONWARD Reports Q1 Business Update and Year-To-Date Highlights
16 Maio 2023 - 2:30AM
ONWARD Reports Q1 Business Update and Year-To-Date Highlights
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 first quarter 2023 business update.
“Our team continued to execute at a high level
in Q1, achieving milestones and adding strength across our range of
activities,” said Dave Marver, CEO of ONWARD. “We were especially
pleased to announce that the Up-LIFT pivotal study met all primary
endpoints including a 72% responder rate. We expect to achieve
several important milestones in the months ahead, including FDA
submission of our de novo application for ARC-EX® Therapy and
initiation of a groundbreaking clinical feasibility study that
includes first-in-human use of a brain-computer interface in
combination with ARC-IM™ Therapy to restore hand and arm
function.”
Q1 and Year-To-Date
Highlights:
Clinical and Development
- The Company has been issued 10 new
patents during Q1 2023, bringing the total number of issued or
pending patents to more than 340 and strengthening its first-mover
advantage.
- In April 2023 at the American
Academy of Neurology Annual Meeting, Dr. James Guest, Professor of
Neurological Surgery at the University of Miami and the Miami
Project to Cure Paralysis, shared detailed results from the Up-LIFT
pivotal study that investigated non-invasive neuromodulation for
improving upper extremity strength and function after SCI. In
addition to meeting all primary safety and effectiveness endpoints,
the study demonstrated that 72% of participants responded1 to
ARC-EX Therapy.
- The Company has been awarded
Breakthrough Device Designation (BDD) for ARC-IM Therapy for
spasticity in people with SCI. Breakthrough Device Designation is
an FDA program aimed at helping patients and their clinicians
receive timely access to new treatments. The Company now has a
total of 9 BDDs, which affords it priority FDA review and the
opportunity to interact with FDA experts throughout the pre-market
review phase as the technology moves toward commercialization.
- First-in-human use of the Company’s
ARC-IM Lead, which was used with the investigational implantable
ARC-IM system as part of the ongoing HemON study to evaluate use of
ARC-IM Therapy to better regulate blood pressure after SCI. ONWARD
is developing a portfolio of ARC-IM Leads in a range of sizes,
shapes, and electrode arrays for the many indications the Company
is developing or exploring, such as improved blood pressure
management, mobility, upper extremity function, and bladder
control. The ARC-IM Lead was specifically designed to stimulate the
spinal cord anatomy to restore movement and function in people with
SCI.
Corporate and Financial
- The Company reported cash and cash
equivalents of EUR 53 million as of March 31, 2023 and reiterated
its guidance of expected cash runway through the end of 2024.
- In Q1 2023, ONWARD strengthened its
leadership team, appointing Erika Ross Ellison as Vice President,
Global Clinical & Regulatory, and Sarah Moore as Vice
President, Global Marketing. Erika comes to ONWARD from Abbott
Neuromodulation, where she was Director, Global Clinical &
Applied Research. She also served as Deputy Director, Medical
Device Innovation Accelerator, Department of Surgery and Assistant
Professor, Department of Neurologic Surgery at Mayo Clinic. Sarah
comes to ONWARD from Nevro, an implantable neuromodulation company,
and has more than 20 years of experience in new product development
and commercial marketing in medical devices, including at Johnson
& Johnson.
Outlook:
ONWARD expects to continue steady and consistent
execution of its strategy in 2023 and beyond with the achievement
of the following milestones:
- The Company plans to submit a de
novo application for FDA clearance for the ARC-EX system this year
and aims to submit an application for European authorization in the
same period.
- The Company also plans to begin its
pivotal clinical study in the next year to evaluate the safety and
effectiveness of the implantable ARC-IM system to better regulate
blood pressure after SCI.
- The Company plans to begin clinical
feasibility studies to investigate the ability for a brain-computer
interface (BCI) to communicate with the ARC-IM system to enable a
person with SCI to more naturally control when and how they move.
This program is supported by a grant from the European Innovation
Council.
- The Company plans to continue to build organizational
capabilities in preparation for expected launch of ARC-EX later
this year or early next year, recruiting field sales and service
professionals and adding operational systems that will enable it to
conduct commerce once it receives FDA clearance and CE mark.
- The Company anticipates its current
cash position will fuel operations through the end of 2024. In
2023, it plans to pursue opportunities to further strengthen cash
position to support future investments in product development,
clinical trials, and operational and commercial capabilities.
Conference Call &
Webcast
ONWARD will host a conference call with a live
webcast today, May 16, 2023, at 2:00 pm CET / 8:00am 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 referenced
here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy,
are investigational and not available for commercial use.
1Responder was defined as a participant who met
or exceeded the minimally important difference criteria for at
least one outcome of the strength domain and at least one outcome
of the functional performance domain.
About ONWARD®
Medical
ONWARD is a medical technology company creating
innovative therapies to restore movement, function, and
independence in people with spinal cord injuries. The Company’s
work builds on more than a decade of basic science and preclinical
research conducted at the world’s leading neuroscience
laboratories. ONWARD ARC Therapy™, which can be delivered by
implantable (ARC-IM™) or external (ARC-EX®) systems, is designed to
deliver targeted, programmed spinal cord stimulation to restore
movement and other functions in people with spinal cord injury,
ultimately improving their quality of life.
ONWARD has received nine Breakthrough Device
Designations from the U.S. FDA. ARC-EX is an external, non-invasive
platform consisting of a stimulator and wireless programmer.
Positive top-line data were reported in 2022 from the Company’s
first pivotal study, called Up-LIFT, evaluating the ability of
transcutaneous ARC Therapy to improve upper extremity strength and
function. The Company is now preparing marketing approval
submissions for the US and Europe. ARC-IM consists of an
implantable pulse generator and lead placed near the spinal cord.
The Company completed the first-in-human use of the ARC-IM
neurostimulator and reported positive interim clinical outcomes for
ARC-IM Therapy for improved blood pressure regulation following SCI
in 2022.
ONWARD is headquartered in Eindhoven, the
Netherlands. It maintains a Science and Engineering Center in
Lausanne, Switzerland, and has a growing U.S. presence in Boston,
Massachusetts. The Company has an academic partnership with
.NeuroRestore, a collaboration between EPFL, the Swiss Federal
Institute of Technology in Lausanne, and Lausanne University
Hospital (CHUV). For additional information about the Company,
please visit ONWD.com. To access our 2023 Financial Calendar,
please visit IR.ONWD.com.
For Company
Enquiries:info@onwd.com
For Media Enquiries:Aditi Roy,
VP Communicationsmedia@onwd.com
For Investor Enquiries:Lara
Smith Weber, CFOinvestors@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.
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