Investor area · Endocalm SAS

Targeted neuromodulation for pelvic pain: an underserved need, a frugal model

PelviMod™ is a passive endovaginal applicator intended for use with a compatible TENS generator, designed to target chronic pelvic pain and dyspareunia associated with endometriosis. CE marking targeted as Class IIa (Regulation (EU) 2017/745). Seed round of €300k targeted for Q1 2027.

Executive summary

Class IIatargeted, MDR 2017/745
100% passiveno battery, no software
FR 25 09664patent filed, PCT
€300kseed targeted Q1 2027

The opportunity

  • An underserved medical need: endometriosis-related pelvic pain persists in a significant share of patients despite hormonal, analgesic and surgical treatment.
  • Innovation in use, not a technological leap: a proven mechanism (TENS, Gate Control) applied with specific endovaginal anatomical targeting.
  • Device-to-device architecture: a passive applicator that relies on existing TENS generators, within a strict compatibility envelope.

Why now

  • French guidelines (HAS, CNGOF) promote multimodal care that includes drug-free approaches.
  • FemTech and women's health are becoming a priority for public policy and investors.
  • A clinician founder at the heart of the Paris-region endometriosis networks: direct access to prescribers.

Market & competition

TAM~14 M

women in Europe (endometriosis, adenomyosis, pudendal neuralgia)

SAM300–400 k

treatment-refractory patients seeking care in France

SOM€0.5–5 M

initial market: 3,000 to 20,000 patients (1–5% of SAM), excluding consumables

AlternativeLimitationPelviMod™ position
Skin-surface TENSStimulation far from deep structuresEndovaginal anatomical targeting
Vaginal rehabilitation probesDesigned and positioned for the pelvic floor, not for deep painDesigned for deep pelvic pain
Implanted neuromodulationInvasive, costly, limited to expert centresNon-invasive, home use
PharmacologySide effects, loss of efficacy, risk of analgesic escalationComplementary, no systemic effect

To our knowledge, after market and literature review, no endovaginal applicator is currently dedicated to the analgesic indication in endometriosis: the devices identified mainly claim pelvic floor rehabilitation. This appears to be an underserved space.

Regulatory strategy & intellectual property

Class IIa (MDR 2017/745)

A passive applicator with no software and no energy source of its own: a reduced, controlled compliance scope.

Compatibility envelope

Stimulation parameters strictly defined with TENS generators already on the market.

ISO 13485

Design, design-frozen clinical batch and technical file entrusted to Statice, a certified French CDMO.

Patent

French application FR 25 09664 (priority August 2025), international PCT extension procedure.

2026

Industrial and clinical structuring, non-dilutive funding.

2027

Seed round; proof of concept, design freeze and clinical batch manufacturing.

2027–2028

Multicentre clinical investigation in community practices (Paris region) towards CE marking; MDR technical file.

2029

Targeted CE marking and commercial launch in France.

Business model & impact

Frugal and asset-light

  • No heavy industrial assets: outsourced production in France, under ISO 13485.
  • Direct commercialisation in stages: investigating centres, a prescriber network (midwives, pelvic floor physiotherapists, pain centres), then regional networks.
  • Recurring revenue: applicator renewal (every 3 to 6 months) and conductive gel.

Measurable social impact

  • Patient-reported outcomes (EHP-30): a Value-Based Healthcare approach.
  • 10.8 h of productivity lost per week by symptomatic women (Nnoaham et al., 2011): a lever for job retention.
  • Alignment with the CSRD directive (ESRS S1 standard, workforce health).

Fundraising

Seed: €300k, Q1 2027

A round positioned after the technological risk has been lifted by the proof of concept, taking over from the non-dilutive funding requested from the Île-de-France Region and Bpifrance (Innov'up Santé des femmes, application filed in September 2026).

Use of funds

Design freeze and clinical batch manufacturing, clinical investigation towards CE marking, MDR technical file, team building.

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Team

Founder, scientific committee & advisory board

TLThéo Lemouton

Théo Lemouton

Founder & President

Sonographer midwife specialising in endometriosis and adenomyosis, clinical researcher, graduate of the EHESP (French School of Public Health). Board member of Endo IDF, leading the L'Endobus project. Experience in the financial and administrative management of healthcare organisations.

Scientific committee

Ensures the medical and scientific rigour of the project: state of the art, protocol, interpretation of results.

EPDr Erick Petit
Dr Erick PetitMedical validation

Advisory board

Supports strategic choices: regulatory, quality, industrialisation, market access.

QSQuentin de Snoeck
Quentin de SnoeckRegulatory affairs & quality (QARA)

Partners: Statice (CDMO, ISO 13485) · Cabinet Lavoix (intellectual property)