For Healthcare Professionals only | This website contains clinical and regulatory information about a certified (EU MDR) medical device for Depression and Parkinson's Disease.

For Healthcare Professionals only | This website contains clinical and regulatory information about a certified (EU MDR) medical device for Depression and Parkinson's Disease.

Sub-threshold TMS (T-PEMF) -
Electrode-Free Brain Stimulation

Clinic‑grade TMS outcomes. At home.

The only EU MDR certified home neurostimulation with proven efficacy in TRD - even after ECT failure.

Clinic-grade TMS outcomes at home

EU MDR certified sub-threshold TMS (T-PEMF) with sham-controlled remission in TRD.

~70%

Remission at 8 weeks in a dose-response RCT in TRD (Straasø 2014)

34% / 61% / NNT 3.4

Sham-controlled remission / response / number needed to treat for remission at 5 weeks in TRD (Martiny 2010)

29%

Remission in ECT non-responders (Larsen 2020)

20,000+

Sessions in 10+ years. Zero serious adverse events

Depression

Key results in treatment resistant depression:

~70% remission at 8 weeks in dose-response RCT

34% remission / 61% response (sham-controlled)

29% remission in ECT non-responders



50% decrease in patients reporting side effects from concurrent medication - 75% among remitters

85% treatment compliance across studies

0 serious adverse events across 20,000+ sessions

Parkinson's Disease

Key results in Parkinson’s:

Improved mobility and ADL scores (PDQ-39)

19% improvement in sit-to-stand speed at 26 weeks

CSF erythropoietin elevation (p=0.012)

98% treatment compliance over 26 weeks

12-month sham-controlled RCT ongoing

Results with perspective

What is sub-threshold TMS?

Functional and biomarker findings supports the neurobiological effects of sub-threshold TMS (T-PEMF) in patients with Parkinson's Disease.

Why sit-to-stand matters in Parkinson's
First evidence of a neurobiological activation
Ongoing: 12-Month sham-controlled RCT in Parkinson's

Peer-reviewed clinical evidence

Backed by science

6+

Peer-reviewed clinical publications - including sham-controlled RCTs, dose-response studies, independent multicenter trials, and real-world outcomes data

34% / 61%

Sham-controlled remission / response in strictly defined TRD (≥2 failed antidepressant courses) in a 5-week treatment protocol, n=50 (Martiny 2010)

~70%

Remission in an 8-week treatment protocol in a dose-response RCT in TRD, n=65 (Straasø 2014)

Zero

Serious Adverse Events in 20,000+ sessions (CER)

29%

Remission in patients who did not respond to ECT, n=19

(Larsen 2020)

100%

Remission in relapsed remitters at 2-year follow-up, n=13 (Bech 2015)

Clinically differentiated by design

Unique patented technology, engineered for efficacy and safety, validated through trials, and positioned against established treatment benchmarks.

ECT Non-Responder Efficacy

29% remission in patients who failed ECT - the only home neurostimulation with published efficacy in this hardest-to-treat population.

Efficacy comparable to TMS. At home.

34% sham-controlled remission in TRD - comparable to clinic-based TMS benchmarks but delivered at home. 61% of patients achieved significant response (>50% reduction in symptom score)

34%

Sham-controlled remission in TRD

Efficacy comparable to TMS. At home.

34% sham-controlled remission in TRD - comparable to clinic-based TMS benchmarks but delivered at home. 61% of patients achieved significant response (>50% reduction in symptom score)

34%

Sham-controlled remission in TRD

Engineered for Safety

Electrode-free, sub-threshold TMS (T-PEMF) penetrates tissue without direct skin contact or scalp preparation. No burns or itching. No pads. Zero serious adverse events in 20,000+ sessions.

20,000+

Sessions with zero serious adverse events

Engineered for Safety

Electrode-free, sub-threshold TMS (T-PEMF) penetrates tissue without direct skin contact or scalp preparation. No burns or itching. No pads. Zero serious adverse events in 20,000+ sessions.

20,000+

Sessions with zero serious adverse events

85-98% Compliance

Consistently high compliance rates across all studies. No electrode placement complexity, no scalp tingling, imperceptible treatment.

Sustained Effect

2-year follow-up shows 55% sustained remission. 100% of relapsed patients achieved remission again with re-treatment.

Side Effect Reduction

50% decrease in patients reporting side effects from concurrent medication - 75% among remitters (PRISE). The only home neurostimulation with published data on medication side-effect reduction.

75%

Of remitting patients were relieved from side effect of their concurrent medication

Side Effect Reduction

50% decrease in patients reporting side effects from concurrent medication - 75% among remitters (PRISE). The only home neurostimulation with published data on medication side-effect reduction.

75%

Of remitting patients were relieved from side effect of their concurrent medication

What is sub-
threshold TMS?

What is sub-threshold TMS?

Sub-threshold TMS is a form of transcranial magnetic stimulation that operates at field intensities below the neuronal action potential threshold, orders of magnitude lower than conventional suprathreshold TMS.

The sub-threshold intensity profile alleviates the risk of scalp pain, muscle contraction, and seizure risk associated with suprathreshold TMS, enabling home-based administration. The stimulation is imperceptible, which substantially strengthens sham-controlled trial integrity and addresses the well-documented blinding challenges in neuromodulation research.

T-PEMF (Transcranial Pulsed Electromagnetic Fields) is the specific sub-threshold TMS protocol delivered by the Re5 Technology, a 7-coil, non-focal configuration delivering 50 Hz bipolar pulses across the cortex. Developed at leading Danish research institutions and university hospitals, T-PEMF has been evaluated in randomised sham-controlled trials and open-label cohort studies, and is in routine clinical use across Danish public psychiatry departments.

Re5® Technology

The five-phase regeneration mechanism

Sub-threshold transcranial magnetic stimulation (T-PEMF) delivered through a structured sequence of biological activation and recovery.

1

Application

A 7-coil electromagnetic headset applied over the scalp. No electrode contact. 30-minute daily sessions at home.

2

Induce

Pulsed electromagnetic fields (50 Hz, 3 ms pulses) induce electric fields (E-fields) in brain tissue - sub-threshold and imperceptible.

3

Activate

E-fields activate intracellular processes, triggering release of neurotransmitters and growth factors that enhance neuroplasticity.

4

Acceleration

Activated cells release signaling molecules to neighboring cells, accelerating biochemical processes throughout neural networks.

5

Regenerates

Cellular structures regenerates over 5-8 weeks - improved neural connectivity, blood flow, and functional recovery measured clinically.

Bring clinic-grade TMS outcomes to your patients home

Partner with Re5 to deliver evidence-backed, electrode-free neuromodulation designed for safety, compliance, and measurable outcomes.

Bring clinic-grade TMS outcomes to your patients home

Partner with Re5 to deliver evidence-backed, electrode-free neuromodulation designed for safety, compliance, and measurable outcomes.

Born at leading Danish research institutions and validated through independent multicenter trials, Re5 has been adopted into routine psychiatric practice within university hospitals, with renewed public-sector contracts reflecting institutional trust in its clinical performance and safety.

References

no.

reference

link

1

Martiny, K., Lunde, M., Bech, P. Biol Psychiatry (2010); 68(2):163–169

2

Straasø, B., Lauritzen, L., Lunde, M. et al. Acta Neuropsychiatr (2014); 26(5):272–279

3

Bech, P., Lunde, M., Straasø, B., Lindberg, L. Acta Neuropsychiatr (2015); 27(2):119–125

4

Larsen, E.R., Licht, R.W., Nielsen, R.E. et al. Eur Psychiatry (2020); 63(1):e18

5

Morberg, B.M., Malling, A.S.B., Jensen, B.R. et al. PLoS ONE (2018); 13(9):e0204478

6

Jensen, B.R., Malling, A.S.B., Morberg, B.M. et al. Parkinsonism Relat Disord (2021); 87:49–55

7

Jensen, H.M. et al. Acta Neuropsychiatr (2025). Aalborg University Hospital

8

Data on file. Re5 ApS CE MDR Clinical Evaluation Report (REP-02-402)

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE

Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE

Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.

COMPANY

Re5 ApS

Niels Ebbesens Vej 31

1911 Frederiksberg C Copenhagen, Denmark

E-mail: info@re5.com

© 2026 Re5 Regeneration. All rights reserved.

REGULATORY AND LEGAL NOTICE

Re5 ApS — Danish medical device manufacturer

CE MDR Class IIa | EU MDR 2017/745 | ISO 13485 | IEC 60601

Re5 is a registered medical device manufacturer in the EU. This website and its content are produced in accordance with EU MDR 2017/745 and applicable Danish medical device advertising regulations. For regulatory enquiries or to request clinical documentation, contact us directly.

This website is intended for healthcare professionals and institutional decision-makers. Some illustrative images are AI-generated. All clinical claims are supported by clinical data, including peer-reviewed scientific literature, as documented in the Clinical Evaluation Report prepared in accordance with EU MDR requirements.