Roadmap & GLP Validation

Module 03. Roadmap and GLP Validation

The value

inflection point.

1st half — preclinical validation under Good Laboratory Practice (GLP). Building a body of scientific evidence with regulatory validity, aligned with international standards (FDA / EU MDR).

Current round

Closing in progress

Funds the GLP program, ISO 14801 fatigue testing, and regulatory preparation under Tier-1 diligence standards (amount not published on the site). Experimental execution of the program is conditional on closing this round.

Milestones completed

3/5

Industrial design · RMS bench testing · PCT applications.

Target acquirer

Tier-1 MedTech

Manufacturers in the dental and implantology sector.

2nd half

GLP protocol with

AnaPath (Switzerland)

GLP preclinical program with AnaPath Services GmbH (Liestal, Switzerland), an independent CRO certified under Good Laboratory Practice.

See full experimental protocol

Preclinical validation program under Good Laboratory Practice (GLP) — AnaPath Institute, Switzerland. Preclinical protocol designed according to GLP guidelines and ISO 17025 accreditation.

Independent research organization certified under Good Laboratory Practice (GLP), aimed at generating regulatory-grade data to support whichever regulatory strategy is ultimately defined for the European Union and the United States. Scientific direction led by Dr. Benjamin Pippenger.

Experimental model: canine model, split-mouth protocol, within-subject evaluation in a compromised/atrophic bone bed, ensuring rigorous statistical control.

Primary Validation Endpoints

EP·01

Histomorphometry and bone-implant contact (BIC)

At 3 and 6 weeks.

EP·02

Immediate functional loading

Biomechanical monitoring of bicortical anchorage under occlusal load.

EP·03

Stabilization of the regenerative complex (single-stage GBR)

Simultaneous fixation of the implant and the graft, assessing micromotion and the stability of the regenerative complex during consolidation.

EP·04

Soft-tissue seal

Verification of the biologic width around the implant collar.

Execution roadmap

Project timeline

2020–2024

Foundation and engineering

Functional prototypes, static stiffness validation at RMS Foundation, first PCT application.

Completed

2025–2026

GLP preclinical phase

Definition of the experimental protocol and engagement of AnaPath, in preparation for ISO 14801 testing and the second PCT application (Unified Guide). Funding round closing in progress — experimental execution begins once the round is closed.

In design

2027

Regulatory phase

Opening of the regulatory process in the European Union and the United States, with classification and pathway subject to whichever regulatory strategy is defined, plus usability studies with key opinion leaders.

Planned

2028

Technology transfer

Licensing negotiation or strategic acquisition with Tier-1 medical technology manufacturers.

Planned