Early Clinical Access

Bridging the Gap from Biotech to Clinic.

Infinita helps biotechs navigate
emerging clinical access pathways.

Supporting clinical access through Montana's SB535 Experimental
Treatment Center Law and other emerging pathways.
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Emerging clinical access pathways are creating new routes from breakthrough science to patient care.
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Infinita helps treatment developers navigate those pathways responsibly.
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Explore Pathways

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Every treatment is different.
Explore the pathway that's right for yours.

The Bottleneck

Promising Therapies
Get Stuck.

+68%

of Phase 1 therapies fail for commercial,
not scientific reasons.

The Consequence

Patients Die
While Waiting.

~0.02%

of eligible patients gain access
to experimental treatments.

Toward Clinical Trial Abundance.

Emerging Pathways

Clinical Early Access Pathways.

Explore real options for clinical early access across emerging regulatory pathways.

Montana.

PTH-001

Pathway Overview.

Montana established one of the most advanced frameworks for clinical early access. Eligible treatments are independently reviewed by an Experimental Treatment Review Board (ETRB) and administered through licensed Experimental Treatment Centers (ETCs).

Technical Profile.

Status:

Active 

Jurisdiction:

State of Montana,
United States of America

Legal Basis:

Senate Bill 535
acrhive.legmt.gov ↗

Phase Eligibility:

Post-Phase 1

Patient Eligibility:

All Patients

Access Process:

Independent ETRB Review
montanaetrb.org ↗

New Hampshire.

PTH-002

Pathway Overview.

New Hampshire established a Right-to-Try framework for patients with life-threatening conditions. The law strengthens legal protections for clinicians while reducing barriers to experimental treatment access.

Technical Profile.

Status:

Active 

Jurisdiction:

State of New Hampshire,
United States of America

Legal Basis:

House Bill 701-FN
gc.nh.gov ↗

Phase Eligibility:

All Phases

Patient Eligibility:

Life-Threatening Conditions

Access Process:

Treating Physician

Prospera.

PTH-003

Pathway Overview.

Próspera operates under a special legal framework that supports alternative regulatory approaches to clinical research and healthcare innovation. Its governing system enables flexible pathways for treatment development and clinical access.

Technical Profile.

Status:

Active 

Jurisdiction:

Prospera ZEDE, Roatán,
Republic of Honduras

Legal Basis:

Ley Orgánica de las Zonas de Empleo y Desarrollo Económico
tsc.gob.hn ↗

Phase Eligibility:

Flexible

Patient Eligibility:

Determined by Applicable Framework

Access Process:

Regulatory Registration

Bahamas.

PTH-004

Pathway Overview.

The Bahamas is developing a regulatory framework for longevity and regenerative medicine intended to expand opportunities for innovative therapies while establishing oversight through dedicated legislation.

Technical Profile.

Status:

Pending 

Jurisdiction:

Commonwealth
of The Bahamas

Legal Basis:

Longevity and Regenerative Therapies Bill, 2024
bahamas.gov.bs ↗

Phase Eligibility:

Flexible

Patient Eligibility:

Flexible

Access Process:

LARTA Approval
larta.health ↗

PTH-001 Feature

Montana SB535.

A pathway for eligible post-Phase 1 experimental treatments.

01—

Independent Review.

Treatment submissions are independently reviewed by the Montana ETRB under the requirements of SB535.

02—

Clinical Administration.

Connect with participating clinics and physicians prepared to administer eligible treatments within Montana's framework.

03—

Evidence Generation.

Coordinat, manufacturing logistics, and clinical outcomes data collection throughout the access program.

Board Members:
Matt Kaeberlein
Jessica Flanigan
Jamie N. Justice
James Burke
Felipe Sierra

PTH-001 FEATURE

Montana ETRB.

Independent scientific and ethical review under the requirements of SB535.

Get Review Submission Guide

evidence

Public Signals.

Industry leaders, researchers, and policy makers discussing emerging clinical access.

Alex Tabarrok 
@ATabarrok

Montana’s SB535, signed into law in May 2025, is the most important regulatory innovation in drug approval in my lifetime.

The law lets drugs be prescribed and sold in experimental treatment centers once they have passed Phase I trials.

A very big deal.

9:12 am · 16 Jun 2026 · 60.4K Views

Adam Gries 
@adamgries

Prospera built a new governance zone in Honduras.

Regulatory innovation for biotech and beyond. @erickbrimen on what's possible with transformative governance.

7:20 pm · 15 Jan 2026 · 273 Views

Center for Modern Health 
@centermodhealth

HB 701 was signed into law today!

‍New Hampshire already has a RTT, but this new law expands protection from civil liability and allows patients to use telehealth for remote screening and signing of consent forms.

Thank you NH Gov. @KellyAyotte

7:20 pm · 15 Jan 2026 · 273 Views

Steve Martin 
@RighttoTryGuy

Why You Can't Use Your "Right to Try".

You can access unapproved treatments through federal laws like the 2018 Right to Try bill, or through FDA pathways like “Expanded Access”.
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That’s why despite there being somewhere in the neighborhood of 13,000,000 Americans with terminal or serious illness, the FDA only grants about 2,000 Expanded Access requests per year, even though they approve 99% of all requests, typically within 24 hours.

3:36 AM · May 9, 2026 · 25K Views

Aubrey de Grey 
@aubreydegrey

With the guidance of our friends at A4LI, Montana has led the way in giving access TO EVERYONE (terminal illness or not) to anything that has cleared Phase 1.

9:30 am · 17 Jul 2023 · 1,147 Views

Adam Sexton 
@AdamSextonWMUR

Gov. @KellyAyotte tells reporters she is supportive of bills moving forward in the legislature to expand right-to-try & expanded experimental access in New Hampshire.

Supporters contend these bills could provide a biotech economic boost for the state. #NHPolitics #WMUR

9:12 am · 16 Jun 2026 · 60.4K Views

CXCarroll 
@CXCarroll

This is one of the most interesting pieces of legislation I've seen passed in a while: Montana passed SB 535 which basically allows for patients to try any experimental drug that has passed a Phase 1 trial.

7:22 pm · 15 May 2025 · 3,040 Views

Eleanor Davies 
@gwei_sha

IMO regulatory change is a key part of DeSci in biotech. Recently, Montana passed the new SB535 law.

It enables patients to access experimental therapeutics after Phase 1 safety trials, accelerating timelines for FDA approval.

A true frontier state - this could change the state of medical access

1:23 pm · 30 Jun 2025 · 2,101 Views

Patri Friedman 🌆 
@patrissimo

Congrats to everyone for passing #SB535, which creates a regulatory framework for Montana physicians to prescribe experimental treatments which have passed FDA Phase 1 (safety) trials.

IMO the United States & EU are victims of their own success after having scaled to such massive sizes. They get economies of scale in production and trade thanks to huge internal markets, while suffering from the diseconomies of scale that come along.

10:57 am · 18 May 2025 · 14.1K Views

Frederic Scheer 
@frederic-scheer

Last night at the Montana High Tech Reception, I had the chance to speak directly with Governor Gianforte about SB 535 and what Montana is building.

He gets it!

His support for Montana's Experimental Treatment Center framework is not abstract. It is operational.

06:50 am · 30 May 2026 · 280 Views

Ian Huyett 
@IanHuyett

A bill by @LisaMazurNH would give dying people access to experimental treatments in New Hampshire.

Patients & families support HB 701, but the Senate is under massive, hostile pressure from the wealthy plaintiffs' lawyers' lobby.

5:53 PM · May 6, 2025 · 6.3K Views

drMAWZ 
@TheDrMAWZ

Ever since The Bahamas signed the Longevity and Regenerative Therapies Act, 2024 (LARTA), tons of new therapies have been finding a home there

I know @join_velocity and @DrDeepMD had one of the Bahamas clinic on their podcast

4:27 PM · Feb 5, 2026 · 14.1K Views

Alex Tabarrok 
@ATabarrok

The single most important graph in all of social science.

8:11 am · 7 May 2024 · 59.1K Views

Alliance for Longevity 
@theA4LI

We're excited to announce that Governor Greg Gianforte has signed Montana Senate Bill 535 into law.

This is a step forward in accelerating access to next-gen therapies and setting a national model for responsible biotech policy.

4:53 pm · 7 Apr 2025 · 742 Views

VCBeat Health 
@vcbeathealth

Two parallel experiments in the U.S. and China are accelerating #PatientAccess to innovative drugs still in development.

Our latest article provides an in-depth examination of China's Boao Lecheng pilot zone, including its policies, real-world cases, and field research, alongside a detailed analysis of Montana's groundbreaking SB535 bill.

11:34 am · 29 Nov 2025 · 303 Views

Michael Brotherton 
@michael-brotherton

Montana has quietly enacted senate Bill 535 (SB‑535), creating a regulatory lane that allows licensed Montana “experimental treatment centers” to dispense investigational drugs once they have completed a Phase I safety study—years before FDA approval.

Companies will be able to establish or partner with Montana‑based manufacturing and clinical sites to offer their assets to paying patients after Phase I. This could create a Phase I‑plus market that can generate cash flow and validate unmet‑need demand before traditional commercialization.

Each licensed center effectively becomes a node in a distributed, real‑world study network. Digital health tools (ePROs, wearables, telehealth) can capture longitudinal outcomes, safety events, and quality‑of‑life data that complement formal trials and support future label expansion. Proper data tracking could allow for patient stratification for future clinical development.

03:25 pm · 30 Jun 2025 · 108 Views

evidence

Media Journal.

Reporting, analysis, and commentary on emerging clinical access pathways.

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Montana’s plan to become an experimental medical hub.
By: Jessica Hamzelou. July 30, 2026.

technologyreview.com

Montana’s Right-to-Try Law Enters a New Phase.
By: Arkadi Mazin. July 28, 2026.‍

Montana's Push to Become a Hub for Experimental Treatments.
By: Alex Janin. August 3, 2025.‍

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Montana's Right to Try law explores new ground.
By: Bowen West. June 5, 2025.‍

Right–to-Try Does Not Undermine Clinical Trials.
By: Niklas Anzinger. June 9, 2026.‍

Montana Set to Become a "Wild West" for Experimental Treatments.
By: Vicki G. Norton. May 22, 2025.‍

duanemorris.com