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Man & Science logo
Man & Science logo

Clinical-stage neuromodulation for severe headache

Purpose-built.
Smaller.
Smarter.

Purpose-built.
Smaller.
Smarter.

Neuromodulation implants designed for people with cluster headache and disabling migraine, when medicines are no longer enough.

Neuromodulation implants designed for people with cluster headache and disabling migraine, when medicines are no longer enough.

Man outdoors by a lake wearing the external unit behind the ear

Purpose-built.

Designed specifically for chronic cluster headache, a condition patients rate as more painful than childbirth [1].

Smaller.

One integrated implant at the back of the head, with no implanted battery. Power comes from a small unit worn behind the ear.

Smarter.

Designed to let stimulation be adjusted for each patient, with data shared with the care team.

FDA Breakthrough Device Designation for ONSS

FDA Breakthrough Device Designation for ONSS

See our clinical programme

01 · The unmet need

When medicines stop working, options run out.

When medicines stop working, options run out.

When medicines stop working, options run out.

Cluster headache and high-disability migraine are among the most disabling conditions in neurology.

Cluster headache and high-disability migraine are among the most disabling conditions in neurology.

Cluster headache affects around 1 in 1,000 people [2]. Attacks are severe, frequent and often strike at night.

9.7/10

Average pain rating of a cluster headache attack. The same patients rated childbirth 7.2. [1]

Up to 8

attacks a day, each lasting 15 to 180 minutes. [3]

02 · Our technology

Two implants, designed for two needs.

ONSS is designed to prevent attacks in chronic cluster headache. iSPGS is designed to treat migraine attacks on demand, as they start.

Prevention

Investigational

Investigational

Investigational

ONSS

ONSS

Occipital Nerve Stimulation System

ONSS integrated lead-and-receiver implant
ONSS ear-worn unit

Ear-worn unit

Ear-worn unit

ONSS charging case

Charging case

Charging case

For people with refractory chronic cluster headache.

Why a new device?

The approach has been studied. The hardware was built for something else.
Occipital nerve stimulation has been tested in a randomised trial in medically intractable chronic cluster headache [7], using stimulators originally designed for other indications. Long-term studies report further surgery for lead migration and battery depletion [8, 9]. ONSS uses one integrated implant at the back of the head, with no implanted battery.

One integrated lead-and-receiver implant at the back of the head, with no implanted battery. Power comes from a small unit worn behind the ear.

  • Designed without an implanted battery; power is supplied by an external unit worn behind the ear

  • Designed to allow stimulation to be adjusted for each patient

  • Designed to share device data with the care team through a secure cloud platform

  • Currently being evaluated in the ONFIELD study

On-demand treatment

Pre-clinical

Pre-clinical

iSPGS

iSPGS

Injectable Sphenopalatine Ganglion Stimulation

iSPGS miniature stimulator resting on a hand for scale

For people with high-frequency, high-disability migraine.

Why a new device?

The target has been studied. Reaching it has meant an implant placed through the mouth.
Sphenopalatine ganglion stimulation has been studied in a randomised, sham-controlled trial in chronic cluster headache [10] and an open-label study in high-disability migraine [11], using an implant inserted through the mouth. Most adverse events in these studies were related to the implant procedure, most often sensory disturbances [11]. iSPGS is designed to be injected and positioned with image guidance instead.

A miniature stimulator injected next to the sphenopalatine ganglion, placed with a dedicated image-guided navigation system.

  • Miniature stimulator designed to be placed by injection

  • Designed for image-guided placement with a dedicated navigation system

  • Intended to be used on demand when an attack begins

  • Miniature stimulator designed to be placed by injection

  • Designed for image-guided placement with a dedicated navigation system

  • Intended to be used on demand when an attack begins

03 · Clinical programme

Building the evidence in severe headache.

Development pipeline

ONSS

FDA Breakthrough Device

Chronic cluster headache

iSPGS

High-disability migraine

Dark = completed · Green = current stage · Outline = not yet started

ONFIELD

First-in-human study of ONSS

Status

Ongoing

ClinicalTrials.gov NCT07677137

ONFIELD II

Planned pivotal study of ONSS in chronic cluster headache

Status

In planning

Further details will be shared when the study opens.

Patients: for information about our clinical studies, visit ClinicalTrials.gov or speak to your doctor.

Patients: for information about our clinical studies, visit ClinicalTrials.gov or speak to your doctor.

Investigational devices. Not approved or cleared for commercial use in any market.

Man & Science offices at LégiaPark, Liège

04 · Team

The team bringing these implants to patients.

Co-founded by chairman Robert Taub, who previously built Omrix Biopharmaceuticals and Nyxoah, and Prof. Jean-Pierre Van Buyten, an internationally recognised pain specialist, Man & Science brings together neuromodulation engineers, clinical researchers and leading headache specialists.

Backed by Wallonie Entreprendre, Noshaq and private investors.

Leadership

Hugues Wallemacq

Hugues Wallemacq

Chief Executive Officer

Prof. Jean-Pierre Van Buyten

Prof. Jean-Pierre Van Buyten

Co-founder & Chief Medical Officer

Robert Taub

Robert Taub

Founder & Chairman

Scientific advisors: Prof. Erling Tronvik (Norwegian National Headache Centre), Prof. Jean Schoenen (University of Liège), Prof. Koen Paemeleire (Ghent University Hospital), Prof. Konstantin Slavin (University of Illinois at Chicago) and Prof. Leo Kapural (Carolinas Pain Institute).

Careers

Join our team.

Man & Science brings together scientists, engineers, clinical research specialists and experienced MedTech entrepreneurs. We are always interested in talented people in R&D, Clinical and QA/RA.

Send your CV to

References (11)

References [7]–[11] describe studies of other companies’ devices and are cited as scientific rationale only.

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