ONWARD Reports Interim Clinical Outcomes for Implantable ARC Therapy Demonstrating Potential to Improve Blood Pressure Regulation after Spinal Cord Injury

Low blood pressure is a major issue for people with spinal cord injury that impacts
cardiovascular health and quality of life
ARC Therapy resulted in immediate improvement in blood pressure regulation in
all study participants
EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA—December
8, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating
innovative therapies to restore movement, independence, and health in people with spinal cord
injury (SCI), today reported interim clinical outcomes from the first ten1 people treated to regulate
blood pressure with implantable ARC Therapy, ONWARD’s targeted spinal cord stimulation
technique. ARC Therapy immediately improved blood pressure levels for all participants; this
benefit has been sustained for the duration of the current follow-up period. Participants have also
reported improved quality of life, increased energy and vitality, and reduced dizziness.
Aaron Phillips, PhD, Associate Professor, Physiology and Pharmacology, Biomedical
Engineering, Cardiac Sciences, Clinical Neurosciences, Cumming School of Medicine, University
of Calgary, and the Principal Investigator of the HEMO study, said: “Low blood pressure has long
been a hidden complication of spinal cord injury that often goes unrecognized and leaves people
feeling unwell. It also potentially predisposes them to cardiovascular disease. The results reported
today with ARC Therapy are compelling and may open a new avenue to help people with spinal
cord injury truly feel better, while also addressing heart health.”
The interim outcomes reported today are from ten people with spinal cord injury who were treated
at clinical centers in Canada and Switzerland. In addition to a sustained increase in blood pressure
levels, participants who were taking an anti-hypotension drug prior to entering the study were able
to significantly reduce or discontinue their medication. Participants also reported improved
general well-being: Participants reported a reduction in orthostatic hypotension, including reduced
dizziness and improved energy, and those prone to fainting or light-headedness prior to implant
indicated that such incidents declined dramatically following treatment with ARC Therapy.
Participants continue to be followed, in one case for as long as three years, and the therapy
remains beneficial in all cases.
Dave Marver, CEO of ONWARD, said: “We are excited by these highly promising outcomes,
which reinforce our plan to further develop and bring ARC-IM to the market for this important
indication. Today, there are limited and ineffective options for treating people with low blood
pressure after spinal cord injury, and our therapy has the potential to address an issue that
significantly impacts their quality of life.”
1 A total of 10 people have received ARC Therapy across three studies: STIMO-HEMO, HEMO, and HemON, as well
as a clinical proof-of-concept, published in Nature in January 2021
2
Over 40% of people with spinal cord injury, or approximately 262,000 people in the U.S. and
Europe2
, are estimated to experience hypotension, or low blood pressure. Hypotension may limit
active participation in physical rehabilitation programs and facilitate the deterioration effects of
immobilization and development of undesirable secondary medical complications.
Based on the promising interim outcomes from these feasibility studies, ONWARD is preparing
to initiate further clinical trials to include U.S. participants in 2023.
About Spinal Cord Injury
Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure.
Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S.
and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of
sensation, issues with blood pressure control and trunk stability, increased potential for infection,
incontinence, and loss of sexual function. Assistance is required for daily living activities. And SCI
is costly, with the average lifetime cost for paraplegia (paralysis of the legs) of $2.5 million and $5
million for tetraplegia (paralysis of all four limbs). Treatments are urgently needed to restore
movement and improve quality of life.
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement,
independence, and health in people with spinal cord injuries. ONWARD’s work builds on more
than a decade of basic science and preclinical research conducted at the world’s leading
neuroscience laboratories. ONWARD’s 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 five Breakthrough Device Designations from the U.S. FDA encompassing
both ARC-IMand ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable
stimulator and wireless programmer. Positive top-line data were reported in September 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 U.S. and Europe. ARC-IM consists of an implantable
pulse generator and lead that is placed near the spinal cord. The company completed its first-inhuman use of the ARC-IM neurostimulator in May 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 the Swiss Federal Institute of Technology (EPFL) and Lausanne University Hospital
(CHUV). For additional information about the company, please visit ONWD.com.
2 2020 NSCISC Annual Statistical Report Complete Public Version; company data
3
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