MindMaze Therapeutics: Consolidating a Global Approach to Reimbursement for Next-Generation Therapeutics

Rhea-AI Summary

MindMaze Therapeutics (OTC:RLFTF) outlined a coordinated global reimbursement strategy on December 23, 2025 to scale access for its AI-driven digital neurorehabilitation. Key elements include a U.S. CMS Category III (CAT III) code enabling reimbursed home-based, clinician-supervised high-intensity therapy; a CHF 11.2 million Innosuisse-backed Swiss flagship program (SwissNeuroRehab) for national evidence generation; and guideline-aligned engagement with NICE in the UK. The company cites 27+ completed clinical studies, 11 regulatory clearances, and a data engine processing 1.2 billion data points/month as foundations for long-term, scalable reimbursement and patient access.

Positive

• CMS Category III code established for home-based digital neurorehabilitation
• CHF 11.2M Innosuisse-backed SwissNeuroRehab national consortium participation
• 27+ completed clinical studies supporting evidence base
• 11 regulatory clearances across major markets
• Data engine processing 1.2 billion data points per month

Negative

• Current U.S. reimbursement is CAT III (temporary pathway) not CAT I
• CAT III deployment requires ongoing utilization and outcomes evaluation for durability

Key Figures

Innosuisse flagship budget CHF 11.2 million SwissNeuroRehab national consortium backing

Completed clinical studies 27+ studies Clinical evidence base for AI-powered neurorehabilitation

Regulatory clearances 11 clearances Across major markets for MindMaze neurorehabilitation solutions

Data engine scale 1.2 billion data points per month AI data processing volume for neurorehabilitation platform

New ordinary shares issued 140,000,000 shares Share exchange for NeuroX business combination (Dec 15, 2025)

Total shares outstanding 152,602,044 shares Post-combination share count, excluding treasury shares

Relief valuation CHF 100 million Valuation in proposed NeuroX combination (Jul 29, 2025)

NeuroX valuation CHF 1 billion Valuation in proposed business combination (Jul 29, 2025)

Market Reality Check

$3.85 Last Close

Volume Volume 2,036 shares vs 20-day average of 4,796 suggests limited participation ahead of this news. low

Technical Price at 2.93 is trading below the 200-day MA of 3.23, indicating a still-weak longer-term trend pre-announcement.

Peers on Argus

Peers show mixed moves: key peer RLFTY is up 23.47%, while others range from slightly negative to modest gains, indicating stock-specific rather than broad sector momentum for RLFTF/MMTX around this update.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 15	Business combination close	Positive	-57.5%	Completion of NeuroX combination and start of trading as MindMaze Therapeutics.
Nov 14	Shareholder approval	Positive	+0.5%	Shareholders approve NeuroX combination and related capital increase, plus name change.
Aug 14	Half-year report	Positive	+27.0%	Half-year report with pipeline progress, designations, and extended cash runway.
Aug 11	Report timing update	Neutral	+4.8%	Company advances publication date of 2025 half-year report ahead of prior schedule.
Jul 29	Proposed combination	Positive	-6.5%	Announcement of proposed NeuroX business combination and valuation terms for both parties.

Pattern Detected

News tied to the NeuroX/MindMaze combination has produced mixed reactions: some strategic and pipeline updates were followed by gains, while major combination milestones saw sharp declines, indicating inconsistent alignment between positive news and price.

Recent Company History

Over the last six months, the company moved from announcing a proposed business combination with NeuroX on Jul 29, through shareholder approval on Nov 14, to completion of the deal and formation of MindMaze Therapeutics on Dec 15. Earlier, a 2025 half-year report on Aug 14 highlighted pipeline progress and cash runway. Today’s reimbursement-focused update builds on this transition toward an AI-driven, digital neurotherapeutics platform.

Market Pulse Summary

This announcement details MindMaze Therapeutics’ coordinated reimbursement strategy, combining CMS Category III coverage in the U.S., a CHF 11.2 million Innosuisse-backed SwissNeuroRehab program, and NICE-aligned work in the UK. With 27+ clinical studies, 11 regulatory clearances, and a data engine processing 1.2 billion points monthly, it builds on recent business-combination milestones. Investors may watch future reimbursement upgrades, additional clinical data, and real-world utilization metrics.

Key Terms

cms category iii regulatory

"This multi-year body of real-world evidence supported the establishment of a CMS Category III"

A CMS Category III code is a temporary medical billing code used by U.S. public insurers to identify and track new or experimental procedures, devices, and tests that do not yet have established, widespread reimbursement. For investors, the code signals that a technology is gaining clinical attention and can affect revenue prospects and adoption timelines — think of it as a temporary barcode that lets hospitals bill and monitor a new product while payers decide whether to create permanent coverage.

cat iii reimbursement regulatory

"CAT III reimbursement enables continued real-world deployment while utilization, outcomes"

Category III (Cat III) reimbursement denotes payment and tracking tied to temporary CPT codes used by U.S. payers to monitor new medical tests, procedures, or technologies while data on clinical benefit and utilization are collected. For investors, Cat III status signals early-stage market access—like a provisional store listing for a new product—meaning payments are limited and uncertain, so long-term revenue depends on whether the service gains sufficient evidence and permanent coverage.

digital neurorehabilitation medical

"U.S. reimbursement pathways for digital neurorehabilitation in 2020, recognizing that long-term"

Digital neurorehabilitation uses software, mobile apps, wearable sensors and virtual-reality tools to deliver or support therapy that helps people recover nervous-system function after stroke, brain or spinal injury, or neurological disease. It matters to investors because these solutions can scale like other digital products, create recurring revenue streams and lower long-term care costs, while adoption depends on clinical evidence, regulatory approval and payer willingness to cover the service.

ai-driven personalization technical

"Recognizes AI-driven personalization and remote supervision as integral to care delivery"

AI-driven personalization uses computer programs that learn from customer data to tailor products, marketing, pricing, or content for individual users—think of it like a digital personal shopper that notices preferences and adjusts offerings automatically. For investors, it matters because better personalization can increase sales, customer loyalty and marketing efficiency, while reducing churn and acquisition costs; however it also carries technology, data privacy and implementation risks that can affect profit and reputation.

AI-generated analysis. Not financial advice.

GENEVA, SWITZERLAND / ACCESS Newswire / December 23, 2025 / MindMaze Therapeutics Holding SA (SIX:MMTX ) (MindMaze Therapeutics or the Company), a commercial-stage company delivering evidence-based, precision digital treatments for neurological diseases, today outlined the evolution of its global reimbursement strategy to enable scalable patient access and sustainable commercial growth for next-generation neurotherapeutics.

Building on a decade of clinical development and five years of focused reimbursement engagement, the Company's approach integrates reimbursed deployment in the United States, national evidence-generation programs in Switzerland, and guideline-aligned engagement in the United Kingdom, creating a coordinated framework for long-term reimbursement durability across major healthcare systems.

Reimbursement Journey: From Vision to Scalable Reality

The MindMaze platform began actively evaluating and engaging with U.S. reimbursement pathways for digital neurorehabilitation in 2020, recognizing that long-term scale in healthcare innovation requires formal reimbursement alignment.

Over the subsequent five years, the MindMaze platform worked closely with clinical partners, payers, and policymakers to demonstrate real-world feasibility and utilization of technology-enabled care. This effort began with early clinic-to-home deployments at Vibra Healthcare hospitals, where MindMaze solutions were used to extend supervised neurorehabilitation beyond inpatient settings into the home, enabling patients to continue high-frequency therapy after discharge and generating real-world utilization and outcomes data that informed reimbursement discussions.

This multi-year body of real-world evidence supported the establishment of a CMS Category III (CAT III) reimbursement code for home-based digital neurorehabilitation-one of the first reimbursement pathways designed to recognize high-intensity neurotherapeutic care delivered outside traditional clinical environments. CAT III reimbursement enables continued real-world deployment while utilization, outcomes, and payer engagement are further evaluated and documented.

What CAT III Reimbursement Covers

The CAT III code enables reimbursement for:

• Technology-enabled, clinician-supervised digital neurorehabilitation

• High-frequency, high-intensity therapy delivered at patients' homes

• Remote monitoring, therapy adaptation, and patient engagement tools

• Data-driven personalization and outcome tracking

Rather than reimbursing hardware alone, CAT III supports a service-based care model, aligning reimbursement with patient usage, therapy intensity, and clinical oversight. This framework allows providers to extend therapy duration and reach more patients without proportional increases in staffing or infrastructure.

Why This Is First of Its Kind

MindMaze Therapeutics' reimbursement framework is considered first-of-its-kind because it:

• Supports high-dose digital neurorehabilitation as a reimbursable clinical service

• Enables home-based therapy at scale, not as an exception

• Recognizes AI-driven personalization and remote supervision as integral to care delivery

• Aligns reimbursement with real-world usage, not rare and episodic clinic visits

This represents a fundamental shift from episodic rehabilitation models toward continuous, data-driven neurological care.

Geography-Specific Reimbursement Strategy

United States (US): Reimbursed Scale Through CMS Category III

In the U.S., CAT III reimbursement provides the foundation for near-term commercial scale. It enables providers to deploy MindMaze Therapeutics' solutions across post-acute, outpatient, and home-based settings, driving increased patient onboarding, longer therapy duration, and recurring utilization. It also serves as a strategic foundation toward potential Category I (CAT I) reimbursement in the future. Real-world evidence from national programs such as SwissNeuroRehab, and multi-site deployments with hospital partners are designed to support this progression.

"Reimbursement is what allows innovation to reach patients at scale," said Alexandre Capet, CEO of MindMaze Therapeutics. "Our Category III reimbursement enables expanded patient access and utilization, while our Swiss and international clinical programs generate the evidence required for durable, long-term reimbursement models. Together, these initiatives support our ambition to build a globally scalable, reimbursed neurotherapeutics platform."

Switzerland (CH): National Evidence Generation via Innosuisse

In Switzerland, MindMaze Therapeutics participates in SwissNeuroRehab, a CHF 11.2 million Innosuisse-backed national flagship consortium involving leading Swiss university hospitals and rehabilitation centers.

SwissNeuroRehab is part of Innosuisse's national flagship initiatives designed to accelerate innovation with system-level impact:

• https://www.innosuisse.admin.ch/en/ongoing-flagships

• https://www.swissneurorehab.ch/

As a technology partner, MindMaze Therapeutics supports the deployment and validation of advanced digital neurorehabilitation pathways across institutional and home-based settings, generating high-quality clinical and health-economic evidence aligned with payer and policy expectations.

United Kingdom (UK): Guideline-Driven Market Access

In the UK, MindMaze Therapeutics is aligning its evidence-generation strategy with NICE evaluation frameworks for digital health technologies. Engagement focuses on demonstrating clinical effectiveness, system efficiency, and scalability within the NHS, supporting future reimbursement and adoption discussions.

Positioned for Long-Term Growth

With 27+ completed clinical studies, 11 regulatory clearances across major markets, and a data engine processing more than 1.2 billion data points per month, MindMaze Therapeutics continues to strengthen its position in AI-powered neurorehabilitation.

By aligning reimbursement history, real-world patient usage, and national-scale evidence generation, the Company is building a durable foundation for long-term value creation-expanding patient access today while supporting future reimbursement durability across global markets.

About MindMaze Therapeutics

MindMaze Therapeutics is a Swiss-based, commercial-stage company formed in December 2025 through the business combination of RELIEF THERAPEUTICS Holding SA (Relief) and NeuroX Group SA. The Company develops and commercializes first-of-its-kind digital treatments for neurological diseases and brain disorders. Built on an advanced brain technology platform integrating software, sensors, and telehealth, its solutions are deployed globally across clinics and home settings. MindMaze Therapeutics' clinically validated neurotherapeutics have demonstrated significant medico-economic outcomes across conditions such as stroke, Parkinson's disease, and at-risk aging. The Company continues to expand its R&D pipeline into adjacent neurological indications, including multiple sclerosis, spinal cord injury, traumatic brain injury, and Alzheimer's disease.

The Company also manages Relief's preexisting portfolio of clinical and commercial biopharmaceutical assets focused on rare dermatological, metabolic, and respiratory diseases.

MindMaze Therapeutics is listed on the SIX Swiss Exchange under the ticker MMTX and quoted in the U.S. on OTCQB under RLFTF and RLFTY.

For more information, visit www.mindmazetherapeutics.com.

Disclaimer

This press release contains forward-looking statements, which may be identified by words such as "believe," "assume," "expect," "intend," "may," "could," "will," or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, business, economic, financial, regulatory, and competitive factors, as well as the Company's ability to execute its strategy. This communication is provided as of the date hereof, and MindMaze Therapeutics undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE: Relief Therapeutics Holding SA

View the original press release on ACCESS Newswire

FAQ

What did MindMaze Therapeutics announce about reimbursement on December 23, 2025?

The company described a global reimbursement strategy anchored by a U.S. CMS Category III code, Swiss national evidence generation, and NICE-aligned UK engagement.

What does the CMS Category III code for RLFTF cover?

CAT III reimburses technology-enabled, clinician-supervised home neurorehabilitation, remote monitoring, AI-driven personalization, and outcome tracking.

How much funding supports SwissNeuroRehab and what is MindMaze's role?

SwissNeuroRehab is a CHF 11.2 million Innosuisse flagship consortium; MindMaze is a technology partner deploying and validating digital neurorehabilitation pathways.

How many clinical studies and regulatory clearances does MindMaze Therapeutics report?

The company reports 27+ completed clinical studies and 11 regulatory clearances across major markets.

What does CAT III mean for RLFTF shareholders and patient access in the near term?

CAT III enables near-term reimbursed deployment and scaled patient onboarding, while requiring further evidence for long-term reimbursement durability.

How is MindMaze aligning with UK market access for RLFTF?

MindMaze is aligning evidence-generation with NICE evaluation frameworks to demonstrate clinical effectiveness and system efficiency for NHS adoption.