Breakthrough Clinical Results
ONWARD Medical N.V. announced concurrent publications in Nature and Nature Medicine highlighting the benefits of its investigational ARC-IM System for managing blood pressure instability in people with spinal cord injuries (SCI). Clinical feasibility studies demonstrated immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, leading to improved quality of life. The studies showed that ARC-IM Therapy can improve hemodynamic stability by delivering precise electrical stimulation to the specific region of the spinal cord responsible for blood pressure regulation. The company plans to initiate the Empower BP global pivotal trial later this year.
Key Highlights
- ARC-IM Therapy shows immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms in SCI patients.
- Enhanced hemodynamic stability resulted in improved quality of life and greater engagement in rehabilitation and daily life activities.
- Electrical stimulation targeting the 'Hemodynamic Hotspot' in the spinal cord can safely and precisely regulate blood pressure.
- FDA has approved an investigational device exemption (IDE) for the ARC-IM System, allowing the initiation of Empower BP, a global pivotal study.
Incidence and Prevalence
Global Estimates of Blood Pressure Instability: Incidence and Prevalence
Hypertension (High Blood Pressure)
According to the World Health Organization, 30% of men and 50% of women aged 65 to 75 years are suffering from high blood pressure (2020). The global burden is significant, with projections indicating that the number of hypertensive patients worldwide will reach 1.56 billion people, representing a 60% increase in prevalence (2020).
While high blood pressure traditionally increases with age, current trends show an increasing incidence in young people (2020), suggesting a shifting demographic pattern that may have significant public health implications.
Orthostatic Hypotension
Research on orthostatic hypotension provides some specific prevalence data in certain populations:
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A Swedish study (SCAPIS) examining 5493 individuals aged 50-64 years found manifest orthostatic hypotension in 1.7% of the population (2022)
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In a study of patients with Parkinson's Disease and orthostatic hypotension, 18 were asymptomatic while 8 were symptomatic (2011)
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Among patients with atrial fibrillation and TIA symptoms, the mortality rate for those with orthostatic hypotension was 119.0 deaths per 1000 person years compared to 98.0 for patients without orthostatic hypotension (rate ratio 1.2, p=0.275) (2020)
Rare Conditions Associated with Blood Pressure Instability
The Brain Bank for Aging Research (BBAR) analysis of more than 10,000 autopsy cases revealed that only two cases had a clinical diagnosis of Pure Autonomic Failure (PAF), a condition that presents with orthostatic hypotension (2020).
Approximately one-third of autopsy cases registered to BBAR contained Lewy pathology in the body. Among these cases, 5% had Lewy pathology exclusively in the peripheral autonomic nervous system, which may represent the earliest stage of PAF (2020).
These findings highlight the varying prevalence of different types of blood pressure instability across different populations and clinical contexts, though comprehensive global epidemiological data specifically on blood pressure instability as a unified condition remains limited.
Study Design Parameters
Study Design Parameters and Endpoints in Blood Pressure Instability Trials
Study Designs
- Experimental studies in conscious cats measuring common carotid blood flow (CCBF) during head-up tilts before and after bilateral vestibular neurectomy
- Prospective comparison between patients undergoing eversion CEA (E-CEA) (n=37) and conventional CEA (C-CEA) (n=27)
- Comparative study in Parkinson's Disease patients with orthostatic hypotension (18 asymptomatic; 8 symptomatic)
- Randomized controlled trial comparing labetalol pretreatment (n=15) versus saline control (n=11) during pheochromocytoma surgery
- Retrospective single-center study of 52,919 surgical patients over 4.5 years
- Longitudinal cohort study of 5,488 hypertensive patients from 60 communities with follow-up from 2010 to 2017
- Observational study including 72 participants with tetraplegia, 13 with high thoracic, and 28 with low thoracic injury
- Pilot study evaluating a treadmill aerobic exercise program for Parkinson's disease patients
Key Measurements
- Blood pressure parameters: systolic pressure (SP), diastolic pressure (DP), mean arterial pressure (MAP)
- Hemodynamic measures: cardiac output (CO), total peripheral resistance (TPR), heart rate (HR)
- Cerebral blood flow: middle and posterior cerebral arteries velocity
- Baroreceptor sensitivity (BRS) calculated as cross-correlation between heart rate and beat-to-beat systolic blood pressure
- Blood pressure lability calculated as modulus of percentage change in mean arterial pressure
- Transfer function parameters between pressure and flow-oscillations
- Ambulatory blood pressure monitoring in various studies
Primary Endpoints
- Changes in baseline CCBF after vestibular neurectomy (41±17% higher after first week)
- Intraoperative hypertension episodes and need for sodium nitroprusside administration
- Maintenance of cerebral blood flow during orthostatic challenges
- Baroreceptor sensitivity changes: decreased after E-CEA from 6.33 to 4.71 ms mmHg⁻¹; increased after C-CEA from 4.59 to 6.13 ms mmHg⁻¹
- 30-day mortality in relation to blood pressure lability during surgery
- Incidence of ischemic stroke (358 new cases, incidence density 1,346.27/100,000 person-years)
Key Findings
- Hypertensive subjects demonstrated more lability than normotensive patients (10 vs 8 episodes, p<0.0001)
- Increased lability associated with decreased 30-day mortality (OR 0.95, 95% CI 0.92-0.97)
- Unstable blood pressure control increases risk of ischemic stroke in female hypertensive patients (HR 1.39, 95% CI 1.05-1.85)
- SBP≥150 mmHg associated with increased stroke risk (HR 2.00, 95% CI 1.26-3.17)
- DBP≥95 mmHg associated with increased stroke risk (HR 1.52, 95% CI 1.01-2.64)
- Labetalol pretreatment provided more favorable blood pressure control during pheochromocytoma surgery
- Normal autoregulatory response to downward blood pressure shifts observed in Parkinson's Disease patients
Methodological Approaches
- Cox proportional hazard regression model used to analyze relationships between blood pressure control and stroke risk
- Two-stage sampling method to select hypertensive patients from communities
- Ambulatory monitors used for recording blood pressure three times daily for 30 days
- Treadmill stress tests to determine eligibility for exercise programs
- Randomization of patients to different coronary perfusion pressure sequences
- Passive head-up tilt and baroreceptor stimulation by sinusoidal neck suction
- 24-hour ambulatory Holter-monitoring performed in parallel with clinical blood pressure measurements
Company drugs in pipeline
ONWARD Medical N.V. Pipeline Indications
Based on the available information, I cannot provide specific details about ONWARD Medical N.V.'s drug pipeline or the indications they are targeting. The requested information about ONWARD Medical's treatment pipeline and the medical conditions they are developing therapies for is not available in the reference materials.
For accurate and up-to-date information about ONWARD Medical N.V.'s pipeline, I would recommend:
- Visiting the company's official website
- Reviewing their investor relations materials
- Checking recent press releases or clinical trial registrations
- Consulting financial reports or regulatory filings
These sources would provide the most current information about which indications ONWARD Medical is targeting with their developmental therapies and the current status of their pipeline products.