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Bridging the Gap
from Biotech to Clinic.

Infinita facilitates access to faster regulatory pathways for novel treatments.
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Promising Treatments Get Stuck.

2/3 of post-phase-1 treatments fail not for demonstrated lack of safety or efficacy, but for lack of data.

13m American patients per year don’t receive life-saving treatments on-time.
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Montana Experimental
Treatment Pathway.

Montana Senate Bill 535 creates a pathway for patients to access any post-phase-1 treatments, under regulated oversight by medical experts.

More info ↗
Benefits for Biotechs:
• US-regulated jurisdiction compliant with FDA
• Early commercialization and outcome data

Benefits for Patients:
• Flexible and fast access post-phase-1

Eligible
Treatments

Post-Phase 1 therapies and select pre-Phase 1 programs with supporting data get access.

Real-World
Evidence

Generate treatment experience and patient data outside traditional trial pathways.

Commercial Opportunity

Generate revenue through structured treatment deployment and licensing arrangements.

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for Review

Start Here

What Infinita Does.

Infinita is service provider to biotechs to access faster regulatory pathways compliantly.

We are a partner to clinics, scientific experts and patients to foster medical excellence.

Submit For Review.

A legally required ETRB will review your treatment, and approve/deny according to requirements.

Find A Clinic.

Clinics, doctors and hospital are ready to administer treatments in Montana - check from our list.

Monitor.

Treatment administration by medical professionals, meeting manufacturing needs, outcome data collection etc.

Apply for Review.

Partnering
Organizations.

Infinita works with organizations across the treatment access ecosystem to help coordinate emerging pathways.
Marian L Tupy
@Marian_L_Tupy

Montana passed a groundbreaking law (SB535) that allows companies to sell experimental drugs to patients as soon as they pass initial safety tests (Phase I), skipping years of traditional FDA waiting.

5:30 am · 16 Jun 2026 · 392 Views
CXCarroll
@CXCarroll

Montana has passed SB535, which allows patients to try experimental drugs that have passed a Phase 1 trial. This is one of the most interesting pieces of legislation I've seen passed in a while.

7:22 pm · 15 May 2025 · 3,040 Views
The Alliance for Longevity Initiatives (A4LI)
@theA4LI

SB535 is a critical step forward in building upon the Right to Try Act, offering clearer guidance on provider and patient access to experimental treatments.

4:53 pm · 7 Apr 2025 · 742 Views
Eleanor Davies
@gwei_sha

Montana's new SB535 law enables patients to access experimental therapeutics after Phase 1 safety trials, accelerating traditional timelines for FDA approval

1:23 pm · 30 Jun 2025 · 2,101 Views
Patri Friedman 🌆
@patrissimo

SB535 creates a regulatory framework for Montana physicians to prescribe experimental treatments that have passed FDA Phase 1 safety trials. State-level experimentation can help accelerate innovation.

10:57 am · 18 May 2025 · 14.1K Views
Frederic Scheer
@frederic-scheer

SB535 creates something no other state has: a parallel pathway from Phase 1 to patient. It is built to generate real-world evidence for the FDA, not bypass it

06:50 am · 30 May 2026 · 280 Views
VCBeat Health
@vcbeathealth

Montana's groundbreaking SB535 bill is one of two major experiments accelerating patient access to innovative therapies still in development.

11:34 am · 29 Nov 2025 · 303 Views
Michael Brotherton
@michael-brotherton

SB535 offers a unique environment to commercialize earlier, learn faster, and de-risk later-stage investment. Teams that treat Montana as a proving ground for responsible innovation stand to gain a strategic edge.

03:25 pm · 30 Jun 2025 · 108 Views

Public Perspectives on SB535.

Public voices highlighting the importance and potential of
Montana Senate Bill 535.
Infinita works across the operational layers required to move therapies from eligibility assessment to real-world deployment.

Infinita Coordinates Emerging Paths for Biotech Deployment.

Our role is not to develop therapies or approve treatments, but to help coordinate the systems, stakeholders, and processes that make deployment possible.

Emerging
Pathway Expertise

Deep familiarity with emerging treatment access frameworks and the requirements needed to navigate them.

Operational Coordination

Experience coordinating across review, licensing, clinical, and deployment stakeholders within a single process.

Integrated Infrastructure

Access to a growing network of partners involved in treatment review, licensing, and delivery.

Execution
Focus

A practical approach centered on real-world deployment, evidence generation, and operational outcomes.

Treatment
Review.

Apply to be eligibile for clinical use under Montana right to try
Apply for Review
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