Rules for SB 535 are now in place, clearing the way for review boards and treatment centers to begin evaluating post-Phase 1 therapies.
After more than a year of anticipation, Montana’s most closely watched longevity law has moved from legislation to implementation.
Montana’s ambitious effort to reshape access to experimental medicine has reached a new milestone. The rules governing Senate Bill 535 have now been formally adopted, allowing the state’s new framework for experimental treatment review boards (ETRBs) and experimental treatment centers (ETCs) to begin operating.
For supporters of the law, this is the moment when months of debate become real-world infrastructure.
“After more than a year of waiting, it’s finally here!” wrote Stephen Martin in a LinkedIn post announcing the adoption of the rules. “No longer will we need to speak about what these laws can do in theory; soon it will be all about optimizing pipelines for patient access.”
Martin said his organization intends to submit its ETRB board members’ credentials immediately, with the goal of beginning protocol reviews as early as next week.
“Personally, it’s exciting to see what we’ve been working on for so long finally coming to fruition,” he wrote. “After months of waiting, speaking with policy makers on the Hill and regulators at the FDA, and sourcing treatment options from biotechs, it’s finally here. A great day for patients’ rights!”
From legislation to implementation
When Governor Greg Gianforte signed SB 535 into law in May, Montana became the first US state to establish a licensing framework allowing healthcare facilities to administer certain experimental therapies that have completed Phase 1 safety testing.
The legislation expanded on Montana’s earlier Right to Try reforms by creating a regulated pathway for specialized clinics to offer treatments before they receive full FDA approval. Rather than simply broadening legal access, the law introduced oversight through licensed facilities, physician involvement, informed consent requirements and independent review boards.
Now that the implementing rules have been adopted, that framework can begin operating in practice. For the longevity sector, passing legislation was only the first step; detailed regulations determine how clinics, physicians and biotech companies can actually participate.
First review board launches
Among the first organizations to move is Infinita, which announced the formation of what it describes as the first registered Montana Experimental Treatment Review Board.
According to founder Niklas Anzinger, the board will review therapies that have successfully completed Phase 1 trials before they are considered for treatment in licensed clinics.
The inaugural board brings together scientists, physicians and bioethicists from across aging research and medicine, including Matt Kaeberlein, Felipe Sierra, Jamie Justice, Jessica Flanigan and James M Burke.
Under Montana’s model, the review board’s legal role is focused on safety. Treatments must demonstrate a safety profile consistent with successful Phase 1 testing, while patients must receive appropriate information about potential risks before making treatment decisions.
Anzinger argues that separating treatment review from traditional federal approval could reduce bottlenecks while maintaining oversight [1].
“That’s smart regulation,” he wrote on X. “Competitive, efficient, with oversight. That’s what American biotech needs.”
A new experiment in biotech regulation
Supporters see Montana’s approach as more than a state healthcare policy. They view it as an experiment in regulatory innovation.
Instead of relying solely on a centralized national approval process, Montana’s system allows licensed review boards to evaluate eligible therapies while the state oversees clinic licensing and reporting.
Advocates believe the model could help patients access promising treatments sooner while also creating new opportunities for biotechnology companies to generate real-world evidence.
Anzinger argues that states can serve as testing grounds for new regulatory ideas, potentially informing future federal reforms.
He also points to growing international competition. Clinical research has become faster and less expensive in countries including Australia and China, while some patients already travel abroad to seek treatments unavailable in the United States.
Whether Montana’s approach can keep more innovation – and patients – at home remains an open question.
A test case for longevity
The adoption of SB 535’s rules marks the beginning, not the conclusion, of Montana’s experiment. The coming months will reveal whether review boards can evaluate therapies responsibly, whether biotech companies embrace the pathway and whether patients gain meaningful access without compromising safety.
For the longevity industry, the significance extends beyond a single state. One of the field’s biggest challenges has long been the gap between scientific discovery and patient access. Even as aging research accelerates, translating promising therapies into clinical care remains slow and expensive.
Montana is now attempting to bridge part of that gap through a new regulatory model. If it succeeds, it could offer an alternative blueprint for how emerging longevity therapies reach patients. If it falls short, it will provide equally valuable lessons for policymakers weighing how innovation and oversight should evolve together.
Either way, the conversation around longevity is no longer confined to laboratories and clinical trials. Increasingly, it is also being shaped in state legislatures, regulatory agencies and healthcare systems – places where the future of patient access may be decided long before a therapy receives its final federal approval.
