Montana goes beyond federal right-to-try by dropping the life-threatening-disease requirement and lifting the ban on profit. Is a passed phase 1 trial enough protection against snake oil, how is paying a patient to access an unapproved treatment different from paying a research participant to accept risk, and can the data this generates might count as real evidence, or would it be just used as an excuse to skip the FDA process?

Watch on YouTube

More about Holly Fernandez Lynch’s work:

• Holly on LinkedIn

September went by fast, and most of it happened in Montana.

Two foundations are now covering the license fee for the first clinics that join Montana’s experimental treatment pathway, and in October we’re taking the conversation to Billings and New York.

We also have two new podcast episodes on why healthcare is built the way it is, and what it could look like instead.

So follow along to learn more about ↓

$50,000 in Grants for Montana’s First Treatment Centers

Under Montana’s SB535, clinics and hospitals can become Experimental Treatment Centers (ETCs). That means they can offer patients treatments that have completed Phase 1 trials but aren’t FDA-approved yet.

To get licensed, a clinic has to pay a $10,000 application fee to the state. For a small clinic or community hospital, that may be a lot to pay before the program has proven itself.

So the Sijbrandij Foundation and the Musella Foundation are helping these biotechs to cover it. Together they committed $50,000 to pay the full fee for the first five approved clinics!

Are you a doctor or do you run a clinic? Write to stephen@infinita.co to apply.

Read the announcement →

How Does Montana’s Pathway Actually Work?

We get this question a lot, so we put together a 3-minute explainer.

What’s new in Montana is that all patients are eligible, not only the terminally ill, and biotechs can now charge for treatments instead of only covering costs. But it’s not a free-for-all. Every treatment follows the same path:

1. The treatment has to be eligible, which includes completing Phase 1.

2. An independent Experimental Treatment Review Board (ETRB) reviews the protocol, the safety evidence, and informed consent.

3. A clinic licensed by the state handles the actual care and monitoring.

4. The patient and their doctor make the final decision together.

Infinita helps biotechs through the process, the ETRB reviews independently, and the clinics take care of patients.

Read Here →

The Montana ETRB Issues Its First Guidance

Can a safety study conducted outside the U.S. qualify a treatment for Montana, even if it was never called “Phase 1”?

The Montana ETRB’s first Guidance Letter says yes. The Board will evaluate studies by their design, oversight, and safety evidence, not their label. A qualifying study needs systematic safety monitoring and appropriate oversight, but not randomization, placebo controls, proof of efficacy, or a minimum number of participants.

Read the full guidance →

Highlights From This Month’s Podcast Episode

In Episode 117, John Cochrane, economist at Stanford and the Hoover Institution, joins Niklas to take apart the three arguments usually used to justify heavy regulation: that the poor need protection, that patients can’t make informed choices, and that nobody can shop around in a health crisis. His answer is that private certifiers, insurance, and competition could keep patients safe while giving them better options, the same way they already do in airlines and retail.

Listen to Episode 117 →

In Episode 116, cardiologist Dr. Anish Koka and neurosurgeon Dr. Anthony DiGiorgio, co-hosts of The Doctor’s Lounge, explain why the US system keeps favoring large hospitals over independent doctors. They get into rules like Stark Law, and Certificate of Need laws, which in more than 35 states require government approval to open a new facility. They also look at Montana’s rollback of Certificate of Need as a possible blueprint for other states.

Listen to Episode 116 →

And that’s all for September!

Before you go, here’s what’s coming up.

Your next best chance to meet us:

• Montana SB535 for Biotech & Healthcare, Billings Meetup, Thursday, October 8, with Rep. Curtis Schomer. A casual evening on what SB535 means for Montana’s biotech and healthcare scene.

• Biotech Federalism, Montana SB535 & Regulatory Entrepreneurship, Tuesday, October 20, with Bradley Tusk, Uber’s first political advisor.

Both require approval, so request your spot early!

Also worth your time:

• Future Neuro Founders Program, October 9, 16, and 23. A free, virtual program by PsyMed Ventures and KdT Ventures for scientists ready to go from academia to building companies in neuro.

• Take VitaDAO’s Experimental Longevity Drug Survey

Must reads this month:

• A Pilot Is Not Enough to Beat China in Clinical Trials

• A Healthcare Revolution Under Big Sky Country

Follow along

X · YouTube · LinkedIn

See you in Billings or New York,
Nelsi ;)

They’ve spent years developing a treatment and have finally tested it in humans. The early safety data is there, and now they need to answer the bigger questions: How well does it work? For which patients? At what dose? What should the next trial look like?

Answering those questions takes more clinical data. And generating that data gets expensive very quickly.

Phase 2 studies typically involve more patients and start looking for preliminary evidence of effectiveness, alongside continued safety monitoring. One analysis of industry-sponsored U.S. trials estimated average Phase 2 costs ranging from $15 million to $40 million, depending on the therapeutic area.[1]

For a small biotech, that usually means raising another round of capital. But the conversations with investors often come back to the same thing: show us more evidence.

And there’s the Catch-22.

You need capital to generate better clinical evidence, but better clinical evidence is often what makes it easier to raise that capital in the first place.

This matters because early-stage biotech development makes no revenue. It only has a cost for its research & development. It therefore depends on outside capital. This is a highly limiting model compared to any other industry, where it’s expected you show real customer demand and revenue.

What if treating patients could also help generate data?

Earlier clinical access introduces another possibility: an eligible post-Phase 1 treatment can be used in medical practice while the company continues its broader development path. If that clinical experience is collected systematically, it can generate additional data on patient selection, dosing, safety signals, treatment protocols, and outcomes, while also generating revenue from providing the treatment.

That changes the economics. Patient access, evidence generation, and revenue can happen alongside one another. The resulting data doesn’t replace controlled trials or automatically satisfy FDA requirements, but it can give the biotech additional evidence to work with as it designs those trials and continues development.

What changes in practice?

Let’s go back to that small biotech coming out of Phase 1.

The traditional development path is still there. The company may still need to raise capital, run Phase 2 and Phase 3 trials, and ultimately meet the FDA’s requirements for approval.

What changes is what can happen in the meantime.

Instead of waiting for the next financing round before generating more clinical evidence, earlier access creates another setting where eligible treatments can reach patients, generate data, and potentially generate revenue while development continues.

That’s the opportunity behind Montana’s model: not replacing the traditional clinical development pathway, but creating another way to keep generating evidence while a treatment is still moving through it.

See the Pathway in Practice

The Montana ETRB has already completed its first treatment protocol review under SB535.

Read About the First ETRB Approval →

Sources

[1] Sertkaya et al. (2016), Key Cost Drivers of Pharmaceutical Clinical Trials in the United States — ⁠PubMed

Watch On YouTube

More about John Cochrane’s work:

• After the ACA: Freeing the Market for Health Care

• “Free Market Vaccines” on Cochrane’s blog

• John on X

The FDA is aware of the gap, which is why it just proposed a pilot program meant to speed up how fast new drugs can start human testing.

The role model for the proposal is Australia. Australia has been running the Clinical Trial Notification (CTN) scheme since 1991. Instead of waiting for regulatory approval before a trial can begin, sponsors simply notify the regulator of their intent, and an independent ethics board reviews the study design. The regulator only steps in when something looks wrong, which rarely happens. Twenty-five years later, the model has held up well. New Zealand, Singapore, and parts of the EU have adopted similar versions.

What does the FDA implementation look like? First of all, it’s not adopting Australia’s best practice. It starts with a “pilot” of 8-10 companies. That’s not enough urgency.

Second, it introduces “QRIs,” outside institutions that would help review submissions alongside the FDA. But the goal for them is not to become like Australia’s ethics boards, trusted reviewers, but FDA highlights that FDA still has to review everything itself. Fine, the regulator retains that authority too in Australia - but the point is that the approval by the ethics board leads to acceptance. That should be the outcome FDA cares about, to review less.

By making QRIs explicitly “advisory only”, it obfuscates the goal and the mechanism that makes Australia successful. The more direct path is to adopt the notification system outright, let QRIs earn trust through published track records instead of credentials. Currently, QRIs are basically the same old “expensive consultants”.

It seems that one more time, the FDA does not understand what is really causing the problem: the agency is inefficient at serving smaller biotechs over big pharma. It takes months to get a meeting with the FDA. A big company can wait for that, a smaller biotech runs out of runway.

Will the pilot even test for that, or will the QRIs and sponsors be again the better-funded, established ones that don’t have that problem to begin with? We’ll see.

It is laudable that the FDA tackles the right issues. But more urgency is needed. A program built to compete with China does not need another multi-year pilot to test a 25-year-old proven model.

Read full comment to the FDA →

What’s new about it?

For the first time, all patients are eligible - not just the terminally ill. And biotechs can charge money for it, where they could only cover costs before.

But Montana is not a free-for-all. It offers significantly more liberties, but comes with a tightly regulated pathway with licensing, oversight and reporting requirements.

Here is how it works.

In 2025, Montana passed Senate Bill 535, creating a framework for experimental treatments to move from biotech developers into clinical use through licensed Experimental Treatment Centers, or ETCs.

At a high level, the pathway looks like this:

1. The treatment has to be eligible.

Montana’s framework covers investigational drugs, biologics, medical devices, and other treatments that meet the requirements set out in the law.

Completing Phase 1 is an important part of that, but it’s not the only requirement. There are additional criteria around the treatment’s investigational status and safety evidence.

2. The treatment protocol goes through independent review.

Before an Experimental Treatment Center (ETC) can offer a treatment protocol, it has to go through an Experimental Treatment Review Board (ETRB).

The ETRB reviews the safety evidence behind the treatment, the proposed protocol, informed consent, monitoring plans, and other safeguards.

The important distinction here is that ETRB approval is not FDA approval, and it isn’t a determination that a treatment works. The Board’s role is to independently review whether the protocol meets the safety, informed-consent, and other requirements of Montana’s framework.

3. Treatment happens through a licensed ETC.

The ETRB reviews treatment protocols. It doesn’t treat patients.

That happens through an Experimental Treatment Center, a healthcare facility licensed by Montana’s Department of Public Health and Human Services (DPHHS).

The ETC is where the clinical side comes in: medical oversight, patient care, administration of the treatment, monitoring, and reporting.

4. The patient and treating provider make the individual decision.

An approved protocol doesn’t mean a patient is automatically cleared to receive it.

The treating provider still has to determine that the individual patient meets the requirements, recommend the treatment, and go through the informed-consent process with them.

So, stripped down to the basic map:

Eligible treatment → ETRB review → Licensed ETC → Patient access

What Does Infinita Do?

Infinita is building a network of biotechs and clinics to use SB535, and it formed an independent ETRB.

The roles remain separate: Infinita helps biotechs navigate the process, the ETRB independently reviews treatment protocols, and licensed ETCs and treating providers are responsible for clinical care.

Get the Review Submission Guide →

They break down specific rules working against independent practice, like Stark Law, which bars doctors from referring patients to equipment they own while hospitals face no such restriction, and Certificate of Need laws in over 35 states, which require government approval to open a new healthcare facility, often granted by boards run by existing competitors.

The conversation traces how these incentives, not bad intentions, produced the consolidation defining American healthcare today, and looks at early state-level experiments, including Montana’s rollback of Certificate of Need, as a possible blueprint for reform.

Watch on YouTube

→ Listen to their podcast episode with Niklas on The Doctor’s Lounge

More about Anish Koka’s work:

• Anish on X

• Anish’s Substack

More about Anthony DiGiorgio’s work:

• Anthony on X

• Anthony’s website

The foundations have tapped Infinita to oversee the initiative, including screening applicants for eligibility and potential impact. Infinita is facilitating biotechs & clinics use of SB535, and has formed the first ETRB (experimental treatment review board) called Montana ETRB.

Under Montana’s SB535 legal framework, licensed ETCs can offer eligible patients access to investigational treatments that have completed Phase 1 clinical trials.

The license application fee, set by statute at $10,000 (MCA 50-5-250(3)(a)), is a meaningful barrier for independent clinics and community hospitals considering the pathway.

This program removes that barrier for the first five approved applicants.

↗ Montana DPHHS ETC Reimbursement Grant

How It Works

1. Interested clinics and hospitals contact Infinita, which screens applicants for eligibility.

2. Eligible applicants submit their ETC license application to the Montana Department of Public Health and Human Services (DPHHS).

3. When DPHHS issues the license, the applicant receives a $10,000 grant covering the full application fee.

Grants are available for up to five clinics based on the Sijbrandij Foundation’s impact goals.

“SB 535 will make Montana a world-leading destination for access to cutting-edge treatments, and we’re deeply optimistic about where the program is headed. Biotech interest has been strong from the start, with a robust pipeline of sponsors ready to bring treatments to Montana. The harder challenge has been the brick-and-mortar side: for many clinics, a $10,000 application fee before the program had proven demand was a real deterrent. Support from patient-centered organizations like the Sijbrandij and Musella Foundations is a powerful validation of what this program can do for patients. With this initiative, we’re confident we can jump-start the SB 535 ecosystem.”

Stephen Martin, US Lead, Infinita

Interested Doctors, Clinics, and Hospitals Should Contact: stephen@infinita.co

infinita.co

The summer days are starting to wind down and your chance to participate in Investor Demo Day is less than a week away. We are coming together in Próspera for a full week of conversations, workshops, and building.

Meanwhile, our work on biotech acceleration continues beyond Roatán. This month, we’re looking at Montana’s new pathway for experimental treatments and asking what it would take to develop vaccines faster and at a lower cost.

Here’s everything from this month 🌴

🚀 Infinita Startup Week Is Finally Here

After months of talking about it, Infinita Startup Week starts this Monday, August 31.

We’re bringing founders, investors, policymakers, and builders together in Próspera for a full week focused on one thing: how to build and grow startups faster.

The week starts with a community welcome dinner, followed by:

• Regulatory Innovation Day: Workshops on regulatory strategy and how founders can use it.

• Startup Builder Day: Conversations on product, growth, and fundraising.

• Ecosystem Exploration Day: Behind-the-scenes visits to clinics, a robotics factory, and new developments around Próspera.

• Free Cities Conference: Two days with founders, investors, and policymakers working on new models of governance.

• Investor Demo Day: A chance for founders to pitch their companies and meet investors.

See you very soon in Roatán!!

See the full schedule →

🎤 Pitch Your Startup at Demo Day

Startup Week will close out with Demo Day on September 6, where founders building in healthcare, biotech, and frontier tech will pitch their companies to a room of investors in Próspera.

Over the past few years, we’ve supported more than 150 startups through our accelerator programs and helped them raise over $20 million. Demo Day continues that work by giving founders a room to share what they’re building, connect with investors, and find opportunities to take their startups to the next stage.

🎧 The Ultimate Guide to Montana’s New Biotech Pathway

Montana has opened a new pathway for experimental treatments through SB 535. But what does that actually mean for biotech companies, physicians, and patients?

In Episode 114, Niklas sits down with Infinita’s US lead, Steve Martin, to walk through how the law works, what they learned from more than three years of building in Próspera, and how companies can start using the Montana pathway.

The conversation gets practical: how treatment protocols are reviewed, how companies can gather real-world evidence, and why this could help promising treatments reach patients earlier while generating the data needed for future trials.

Listen here →

🧬 Is It Possible To Make Vaccines Faster and Cheaper?

In our latest conversation, Cremieux and PopVax founder Soham Sankaran join our podcast studio to talk about why vaccines are one of the greatest medical advances we’ve ever had, and why we’re still moving so slowly when it comes to developing new ones.

They get into how India and China approach clinical trials differently, why randomized controlled trials aren’t the right tool for every situation, and what personalized cancer immunotherapy using AI and mRNA could look like within the next few years.

Listen to the episode →

And that’s a wrap on August! 🏄‍♀️

Before you go, here are three things worth your time ;)

Month’s highlights:

• 🔗 What is Montana ETRB

• 🎧 The Doctor Lounge Podcast — Right to Try 2.0

• 🔗 See how one of our community members is building a new ecosystem for builders inside Próspera

Follow along 👀

Instagram · X · YouTube

Talk soon 👋,

Nelsi 🌊

Crémieux is a pseudonymous writer and researcher known for data-driven essays on genetics, drug regulation, and biotech policy.

In this episode, we break down how vaccines actually work, why they may be one of the most powerful longevity medical interventions ever created, and how new approaches could prevent not just infections — but cancer, neurodegeneration, and chronic disease.

We also explore why biotech innovation is shifting toward countries like China and India, how regulatory systems slow down progress, and what it would take to radically accelerate drug development worldwide.

This is a conversation about science, institutions, and the future of human health.

Watch on YouTube

More about Soham’s work:

• PopVax

• Soham on X

More about Crémieux’s work:

• Cremieux Substack

• Crémieux on X

The rapidly changing landscape of gene therapies offers countless opportunities to create long lasting, single dose interventions that could replace current small molecule alternatives.

Currently most gene therapies are still too expensive a treatment option for most conditions, but that’s because the approval process is so expensive. In Próspera it makes a lot more fiscal sense to do phase-1 trials , for under $50,000 while still operating within established legal and ethical frameworks.

So far multiple companies have decided to sell the same 2 or 3 gene therapies in Próspera. They’re missing out on a vast number of available opportunities!

The following 100 entries represent opportunities across longevity, metabolic enhancement, peptide replacements, rare diseases, and monoclonal antibody alternatives. Each entry details the target condition, a rough gene therapy proposal, and the legacy biopharma market it disrupts.

All of these (surprisingly) have some form of animal validation, but some novel tweaks, delivery methods, etc., have been added here and there. More engineering and safety testing might make a few of these into gems, but there is always another way to tackle the same problem. The list, if anything, is meant to highlight market opportunities over specific methods.

I. Longevity, Cellular Rejuvenation & Metabolic Optimization

1. Gray Hair Reversal

• Gene Therapy Proposal: Up-regulating the KITLG (Kit Ligand) / c-KIT and EDN3 / EDNRB (Endothelin receptor B) pathways via local gene delivery to force stem cells migration into the hair matrix. Will it cause hyper pigmentation?

• Replaces & Revenue: Anti-aging hair market is $8.4 billion..

2. Systemic NAD+ Depletion

• Gene Therapy Proposal: AAV-mediated liver delivery of Nicotinamide Phosphoribosyltransferase (NAMPT) to upregulate the rate-limiting enzyme in the NAD+ salvage pathway, restoring youthful cellular energetics and mitochondrial function.

• Replaces & Revenue: Replaces daily oral NAD+ precursors (NR/NMN) and expensive weekly NAD+ IV infusions. The global longevity supplement market is valued at over $24 billion.

3. Epigenetic Aging & Cellular Senescence

• Gene Therapy Proposal: An inducible minicircle vector delivering an optimized cassette of Yamanaka factors (OSK: Oct4, Sox2, Klf4) utilizing a doxycycline-regulated switch to safely reset cellular methylation age without inducing pluripotency or teratomas. Many are exploring this with their own twists. Maybe you have your own variation?

• Replaces & Revenue: No direct clinical pharmaceutical equivalent exists; competes with boutique anti-aging wellness clinics and longevity therapeutic startups currently raising billions globally.

4. Visceral Adiposity & Metabolic Slowdown

• Gene Therapy Proposal: Adipose-targeted delivery of a transgene encoding Uncoupling Protein 1 (UCP1) to transdifferentiate white adipose tissue into metabolically active brown adipose tissue, accelerating basal metabolic rate. Heat management and hyperthermia will be a hurdle here, requiring brilliant design of thermal feedback loop switching which will have applications well beyond obesity..

• Replaces & Revenue: Replaces chronic GLP-1 agonist injections and surgical liposuction. The current anti-obesity medication market exceeds $36 billion and is climbing rapidly.

5. Inducible Mitophagy Acceleration Vector (IMAV)

• Gene Therapy Proposal: Systemic delivery of a non-viral, transient minicircle vector encoding an optimized FUNDC1/Nix dual-expression cassette under a Doxycycline-inducible (Tet-On) promoter. This architecture restores cellular bioenergetic efficiency by aggressively clearing damaged, ROS-leaking mitochondria before they trigger the NLRP3 inflammasome, effectively reversing systemic inflammaging.

• Replaces & Revenue: Replaces the need for daily, low-potency small-molecule mitochondrial support (like Urolithin A) and nonspecific antioxidant supplementation. The broader mitochondrial disease and longevity therapeutics market is rapidly expanding, with the mitochondrial-based therapeutics segment alone projected to reach over $1 billion by 2035.

6. Age-Related Thymic Involution

• Gene Therapy Proposal: Localized delivery to the thymic remnant encoding Keratinocyte Growth Factor (KGF) or FOXN1 to stimulate thymic epithelial cell regeneration, restoring T-cell maturation and reversing immune system senescence.

• Replaces & Revenue: Replaces experimental peptide protocols and intravenous immunoglobulin (IVIG) therapies. The IVIG market generates over $11 billion annually.

7. Chronic Cellular Inflammation (”Inflammaging”)

• Gene Therapy Proposal: Systemic minicircle delivery of an engineered IL-10 or IL-1 Receptor Antagonist (IL-1Ra) variant with a constitutive promoter to maintain a youthful, balanced anti-inflammatory cytokine profile.

• Replaces & Revenue: Replaces chronic NSAID use, corticosteroids, and off-label biologic use. The global anti-inflammatory biologics market exceeds $120 billion.

8. Telomere Attrition in High-Turnover Tissues

• Gene Therapy Proposal: A transient, non-integrating minicircle vector encoding human Telomerase Reverse Transcriptase (hTERT) to safely extend telomeres in hematopoietic stem cells and dermal fibroblasts. Can an inducible construct create a solution without oncogenic risk?

• Replaces & Revenue: Replaces unverified nutraceutical telomerase activators and high-end wellness supplements, capturing a multi-million dollar direct-to-consumer longevity market.

9. Osteoarthritis & Articular Cartilage Degradation

• Gene Therapy Proposal: Intra-articular injection of a minicircle vector encoding Transforming Growth Factor-beta (TGF-beta) or IL-1Ra directly into the joint space to arrest cartilage catabolism and stimulate chondrocyte repair.

• Replaces & Revenue: Replaces recurring hyaluronic acid injections, corticosteroid shots, and total joint replacements. Joint replacement surgeries represent a $20 billion global footprint.

10. Cognitive Decline & Synaptic Loss

• Gene Therapy Proposal: Intrathecal or intranasal AAV-mediated delivery of Brain-Derived Neurotrophic Factor (BDNF) or Nerve Growth Factor (NGF) to preserve neuronal plasticity, protect dendritic spine density, and slow age-related memory deterioration.

• Replaces & Revenue: Replaces cholinesterase inhibitors and off-label nootropics. The global dementia treatment market represents over $17 billion annually.

11. Hypercholesterolemia & LDL Accumulation

• Gene Therapy Proposal: Hepatic delivery of a CRISPR-Cas9 or base-editing minicircle construct targeting and silencing the PCSK9 gene to permanently upregulate LDL receptor availability on hepatocytes.

• Replaces & Revenue: Replaces monthly PCSK9 inhibitor monoclonal antibodies (e.g., Repatha) and daily statins. Repatha alone generates over $1.6 billion annually.

12. Hypertriglyceridemia & Cardiovascular Risk

• Gene Therapy Proposal: AAV or minicircle delivery targeting the liver to overexpress Lipoprotein Lipase (LPL) or knock down Angiopoietin-like 3 (ANGPTL3), significantly lowering circulating very-low-density lipoproteins.

• Replaces & Revenue: Replaces high-dose prescription omega-3 fatty acids and fibrates. The global lipid-lowering drug market generates over $20 billion annually.

13. Systemic Fibrosis (Liver, Kidney, and Heart)

• Gene Therapy Proposal: Vector-mediated delivery of an engineered Decorin gene or matrix metalloproteinase (MMP-1/MMP-8) to actively degrade excess extracellular matrix and halt fibrotic remodeling in chronic disease.

• Replaces & Revenue: Replaces pirfenidone and nintedanib. The anti-fibrotic therapy market is currently valued at over $4.5 billion.

14. Mitochondrial Myopathy & Metabolic Inefficiency

• Gene Therapy Proposal: Minicircle-mediated delivery of Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-Alpha (PGC-1-alpha) to muscle tissue to stimulate mitochondrial biogenesis and enhance oxidative phosphorylation.

• Replaces & Revenue: Replaces high-dose CoQ10, L-carnitine cocktails, and experimental metabolic orphan drugs.

15. Bone Density Loss (Osteopenia/Osteoporosis)

• Gene Therapy Proposal: Systemic minicircle delivery encoding an osteoprotegerin (OPG) Fc-fusion protein to neutralize RANKL, mimicking the mechanism of denosumab to continuously inhibit bone resorption.

• Replaces & Revenue: Replaces twice-yearly denosumab (Prolia) injections and daily bisphosphonates. Prolia generates over $4 billion annually.

16. Cellular Accumulation of Advanced Glycation End-products (AGEs)

• Gene Therapy Proposal: Genetic delivery of a soluble variant of the Receptor for Advanced Glycation End-products (sRAGE) into circulation to act as a decoy receptor, neutralizing circulating AGEs and reducing vascular cross-linking.

• Replaces & Revenue: Replaces various metabolic supplements and anti-glycation cosmetics; opens up a completely novel therapeutic vertical in preventative longevity medicine.

17. Hypochlorhydria & Digestive Decline

• Gene Therapy Proposal: Localized delivery to gastric parietal cells encoding an optimized proton pump gene or gastrin receptor variant to restore optimal stomach acid pH and improve nutrient absorption in older adults..

• Replaces & Revenue: Replaces chronic use of over-the-counter betaine HCl supplements and addresses the long-term side effects of widespread proton pump inhibitor (PPI) abuse.

18. Dermal Atrophy & Skin Elastin Loss

• Gene Therapy Proposal: Subcutaneous injection of a minicircle vector encoding human Tropoelastin and Type I Collagen under a fibroblast-specific promoter to permanently restore skin elasticity and thickness.

• Replaces & Revenue: Replaces repetitive hyaluronic acid dermal fillers, botulinum toxin injections, and high-end laser resurfacing. The aesthetic dermatology market is valued at over $15 billion.

19. Hepatic Steatosis (Fatty Liver Disease)

• Gene Therapy Proposal: Liver-targeted delivery of a transgene encoding Fibroblast Growth Factor 21 (FGF21) to enhance hepatic fatty acid oxidation, reduce lipotoxicity, and reverse early-stage non-alcoholic steatohepatitis (NASH).

• Replaces & Revenue: Replaces experimental metabolic drugs and complex lifestyle interventions. The NASH therapeutics market is projected to surpass $10 billion.

20. Chronic Fatigue Syndrome, Cellular Energy Deficits & So Much More

• Gene Therapy Proposal: Minicircle vector delivery encoding an engineered human NNMT (Nicotinamide N-methyltransferase) inhibitor peptide or antisense sequence to preserve cellular SAM and NAD+ pools, maximizing ATP output. The massive fat loss from inhibiting NNMT alone could be enough to surpass GLP-1 products. RNA products to inhibit NNMT are already in phase 1. NNMT also has interesting uses in oncology. As a master switch, controlling this will likely involve tight and precise inducible switching. A fortune awaits the engineer that cracks this.

• Replaces & Revenue: Replaces off-label stimulant prescriptions, adaptogens, and expensive chronic fatigue protocol supplements.

II. Chronic Medical Conditions & Autoimmune Disorders

21. Type 2 Diabetes (Insulin Resistance)

• Gene Therapy Proposal: Skeletal muscle-targeted minicircle delivery of a modified, uniquely inducible GLUT4 transporter to enable insulin-independent glucose uptake into muscle tissue. The lethal hypoglycemic risks are real, but perhaps you have a solution?

• Replaces & Revenue: Replaces daily metformin, SGLT2 inhibitors, and exogenous insulin regimens. The global diabetes care market generates over $65 billion annually.

22. Rheumatoid Arthritis (RA)

• Gene Therapy Proposal: Intra-articular or systemic delivery of a minicircle vector encoding a high-affinity TNF-alpha decoy receptor (similar to etanercept) or a continuous IL-1 antagonist construct.

• Replaces & Revenue: Replaces weekly anti-TNF injections like Humira and Enbrel. Humira historically peaked at over $20 billion in annual revenue before biosimilar entry.

Rheumatoid arthritis, Wikicommons

23. Psoriasis & Psoriatic Arthritis

• Gene Therapy Proposal: Intradermal or systemic delivery of a genetic construct producing an anti-IL-23 or anti-IL-17 monoclonal antibody directly from the host’s muscle tissue.

• Replaces & Revenue: Replaces regular injections of Skyrizi and Cosentyx. Skyrizi alone pulled in $11.7 billion in 2024 sales.

24. Crohn’s Disease & Ulcerative Colitis (IBD)

• Gene Therapy Proposal: Targeted enteric delivery via specialized oral capsular vectors or localized injection of an IL-10 or anti-alpha4beta7 integrin expression cassette to suppress localized mucosal inflammation.

• Replaces & Revenue: Replaces intravenous infusions of Entyvio, Stelara, and Remicade. Stelara generates over $10 billion annually.

25. Chronic Kidney Disease (CKD) Anemia

• Gene Therapy Proposal: A hypoxia-inducible minicircle vector delivering the Erythropoietin (EPO) gene to skeletal muscle, ensuring that EPO is synthesized only when systemic oxygen levels drop below a healthy threshold. Also a nice little performance enhancer for athletes (though performance enhancement would be better with a small-molecule switch over a hypoxia-inducible one), but the polycythemia risk & hematocrit capping needs to be carefully managed.

• Replaces & Revenue: Replaces regular injections of recombinant human erythropoietin (Epogen/Procrit). The global EPO market exceeds $8 billion annually.

26. Hypertension (Chronic High Blood Pressure)

• Gene Therapy Proposal: Endothelial or hepatic gene delivery of human Atrial Natriuretic Peptide (ANP) or endothelial Nitric Oxide Synthase (eNOS) to maintain continuous, baseline vasodilation. ANP is probably better, but you need to figure out a way around the priapism and hypotension risks.

• Replaces & Revenue: Replaces daily oral ACE inhibitors, ARBs, and calcium channel blockers. The global antihypertensive market is worth over $30 billion.

27. Gout & Hyperuricemia

• Gene Therapy Proposal: Hepatic delivery of a functional Urate Oxidase (Uricase) gene variant, allowing humans to metabolize insoluble uric acid into highly soluble allantoin, preventing crystal deposition. Must include a C-terminal peroxisomal targeting signal (such as a PTS1 tripeptide sequence) to safely route the expressed protein into the peroxisomes. Hydrogen peroxide is not our friend.

• Replaces & Revenue: Replaces daily oral allopurinol or painful, immunogenic Pegloticase (Krystexxa) infusions. Krystexxa generates over $1 billion annually.

28. Severe Asthma & Eosinophilic Airway Inflammation

• Gene Therapy Proposal: Inhaled aerosolized or systemic delivery of an expression cassette encoding an anti-IL-5 or anti-IgE antibody segment to permanently blunt airway hypersensitivity.

• Replaces & Revenue: Replaces regular biologic injections like Xolair and Nucala, alongside daily steroid inhalers. Xolair sales exceed $4 billion annually.

29. Systemic Lupus Erythematosus (SLE)

• Gene Therapy Proposal: Vector-mediated delivery of a B-cell Activating Factor (BAFF) inhibitor or anti-CD20 single-chain variable fragment (scFv) to safely downregulate autoantibody production.

• Replaces & Revenue: Replaces Benlysta infusions and toxic immunosuppressive drugs like mycophenolate mofetil. Benlysta generates over $1.3 billion annually.

30. Multiple Sclerosis (MS) Neuroinflammation

• Gene Therapy Proposal: Central nervous system (intrathecal) delivery of a vector encoding Interleukin-4 (IL-4) or Interleukin-10 (IL-10) under an astrocyte-specific promoter to skew the microenvironment away from demyelinating auto-immunity.

• Replaces & Revenue: Replaces Ocrevus infusions and interferon injections. Ocrevus generates over $6.5 billion in annual revenue.

31. Atherosclerosis (Arterial Plaque Build-up)

• Gene Therapy Proposal: Hepatic or vascular delivery of Apolipoprotein A-1 Milano (ApoA-1M), facilitating ultra-efficient reverse cholesterol transport to rapidly shrink unstable arterial plaques.

• Replaces & Revenue: No current direct pharmaceutical equivalent exists on the market; replaces lifetime statin maintenance and invasive coronary stenting procedures.

32. Atopic Dermatitis (Severe Eczema)

• Gene Therapy Proposal: Subcutaneous or localized intradermal delivery of an expression construct for an anti-IL-4 receptor alpha monoclonal antibody (functional equivalent to dupilumab).

• Replaces & Revenue: Replaces bi-weekly Dupixent injections. Dupixent generates over $11 billion in annual sales.

33. Chronic Insomnia & Circadian Dysregulation

• Gene Therapy Proposal: Intranasal or targeted neural delivery of an orexin receptor antagonist peptide or an RNAi knockdown, a native circadian rhythm promoter (Bmal1 or Per2), and/or perhaps another construct utilizing a light-sensitive or time-inducible promoter switch to restore deep sleep architecture and regular wake cycles.

• Replaces & Revenue: Replaces chronic use of addictive benzodiazepines, Z-drugs (ambien), and over-the-counter melatonin supplements.

34. Non-Alcoholic Cirrhosis & Hepatic Fibrosis

• Gene Therapy Proposal: Hepatic targeting of a minicircle vector delivering human Hepatocyte Growth Factor (HGF) to promote parenchymal regeneration and halt progressive liver failure.

• Replaces & Revenue: Replaces generic palliative management and liver transplantation listing. Liver transplants cost upwards of $800,000 per procedure.

35. Gastroesophageal Reflux Disease (GERD)

• Gene Therapy Proposal: Localized delivery to the lower esophageal sphincter muscle encoding a gene to increase baseline muscle tone or tissue density, permanently preventing acid reflux mechanically.

• Replaces & Revenue: Replaces lifetime reliance on daily Proton Pump Inhibitors (Nexium, Prilosec), which are associated with long-term bone density and nutritional deficits.

36. Chronic Migraine Headaches

• Gene Therapy Proposal: Skeletal muscle or hepatic delivery of a vector encoding an anti-Calcitonin Gene-Related Peptide (CGRP) monoclonal antibody fragment for continuous, preventive neural desensitization.

• Replaces & Revenue: Replaces monthly preventative injections like Aimovig, Emgality, or Ajovy. The preventative CGRP class accounts for over $3 billion annually.

37. Chronic Obstructive Pulmonary Disease (COPD) Emphysema

• Gene Therapy Proposal: Inhaled delivery of a functional Alpha-1 Antitrypsin (AAT) gene cassette into alveolar macrophages or epithelial cells to arrest progressive tissue destruction by elastases.

• Replaces & Revenue: Replaces weekly, highly expensive intravenous AAT augmentation therapies (e.g., Aralast, Prolastin), which cost up to $100,000 per patient annually.

38. Celiac Disease & Gluten Autoimmunity

• Gene Therapy Proposal: Hepatic or intestinal mucosal delivery of an immunodominant gluten peptide sequence engineered to induce peripheral immune tolerance through regulatory T-cell induction.

• Replaces & Revenue: Replaces strict lifelong gluten-free dietary restrictions and experimental enzyme supplement therapies.

39. Chronic Pain & Neuropathic Hyperalgesia

• Gene Therapy Proposal: Intrathecal or dorsal root ganglion delivery of a vector encoding human Preproenkephalin or an engineered Nav1.7 sodium channel blocker peptide to continuously suppress chronic pain signals at the spinal level.

• Replaces & Revenue: Replaces addictive opioid prescriptions, gabapentinoids, and invasive spinal cord stimulator implants. The global chronic pain market exceeds $70 billion.

40. Benign Prostatic Hyperplasia (BPH)

• Gene Therapy Proposal: Intraprostatic delivery of an inducible 5-alpha reductase type 2 antisense sequence or a localized pro-apoptotic peptide to reduce prostate volume and relieve urinary obstruction.

• Replaces & Revenue: Replaces daily oral finasteride/tamsulosin cocktails and invasive transurethral resection (TURP) surgeries.

By Unknown author - National Cancer Institute, AV Number: CDR462221, Public Domain, https://commons.wikimedia.org/w/index.php?curid=5581217

III. Peptide Replacements & Endocrine Optimization

41. Chronic Growth Hormone Deficiency & Lean Mass Loss

• Gene Therapy Proposal: An inducible minicircle vector delivering Growth Hormone Releasing Hormone (GHRH) or Growth Hormone (GH) controlled by a secure oral small-molecule switch.

• Replaces & Revenue: Replaces expensive, daily subcutaneous recombinant human growth hormone injections.

42. Obesity & Chronic Appetite Suppression

• Gene Therapy Proposal: Hepatic or muscle delivery of a long-acting, optimized GLP-1/GIP co-agonist peptide sequence for continuous, single-injection weight management and blood sugar stabilization. I mean, as long as it has a kill switch, it’s a better option than weekly injections for a medication that doctors are currently recommending for lifelong use. Watch out for permanent gastroparesis.

• Replaces & Revenue: Replaces weekly injections of blockbuster medications like Ozempic, Wegovy, Mounjaro, and Zepbound. The combined market for these therapies reached $36.5 billion for Eli Lilly alone in 2025.

43. Secondary Hypogonadism & Low Testosterone

• Gene Therapy Proposal: Muscular delivery of a genetic sequence encoding Kisspeptin-10 or Gonadotropin-Releasing Hormone (GnRH) under a pulse-mimicking promoter to restore natural, endogenous luteinizing hormone and testosterone production.

• Replaces & Revenue: Replaces lifetime exogenous testosterone injections, gels, and pellets, bypassing the side effect of testicular atrophy. The global TRT market exceeds $4 billion.

44. Central Diabetes Insipidus

• Gene Therapy Proposal: Long-term intramuscular minicircle delivery of a modified Arginine Vasopressin (AVP) transgene to restore systemic fluid regulation and stop chronic polyuria.

• Replaces & Revenue: Replaces daily desmopressin nasal sprays or oral tablets.

45. Primary Adrenal Insufficiency (Addison’s Disease)

• Gene Therapy Proposal: An ACTH-responsive, multi-cistronic vector system delivered to the adrenal cortex or an engineered subcutaneous cellular depot containing the steroidogenic enzymes necessary to restore physiologic cortisol synthesis.

• Replaces & Revenue: Replaces lifetime oral hydrocortisone and fludrocortisone replacement therapy.

46. Post-Menopausal Osteoporosis & Vasomotor Symptoms

• Gene Therapy Proposal: A liver-targeted or muscle-targeted delivery platform utilizing a weak estrogen-receptor alpha agonist peptide construct to safely maintain bone density and prevent hot flashes without stimulating breast or uterine tissue proliferation.

• Replaces & Revenue: Replaces conventional hormone replacement therapy (HRT) and denosumab injections.

47. Hypoparathyroidism

• Gene Therapy Proposal: Continuous muscular or subcutaneous tissue production of full-length human Parathyroid Hormone (PTH 1-84) via minicircle DNA to maintain normal calcium homeostasis without daily injections.

• Replaces & Revenue: Replaces daily subcutaneous Natpara or high-dose calcium/calcitriol regimens. Natpara historically cost over $100,000 annually.

48. Severe Leptin Deficiency & Congenital Morbid Obesity

• Gene Therapy Proposal: Systemic delivery of a human Leptin gene cassette to adipose or muscle tissue, restoring central satiety signaling and normalizing metabolic rate.

• Replaces & Revenue: Replaces daily subcutaneous metreleptin (Myalept) injections, which cost upwards of $500,000 per year per patient. So yeah, this one has the potential for nice margins.

49. Chronic Hypoglycemia & Glycogen Storage Disease

• Gene Therapy Proposal: A glucose-sensitive minicircle vector encoding human Glucagon, engineered to express and secrete only when blood glucose levels fall below 70 mg/dL.

• Replaces & Revenue: Replaces emergency glucagon rescue kits and round-the-clock dietary cornstarch regimens.

50. Erectile Dysfunction (ED) & Nitric Oxide Insufficiency

• Gene Therapy Proposal: Intracavernosal pelvic delivery of a minicircle vector encoding human Endothelial Nitric Oxide Synthase (eNOS) to permanently restore localized vascular responsiveness and erectile capacity. Another novel idea might be the use of an optogenetic switch coupled with tiny, injectable, passively powered NIR LEDs for instant erectile control, bypassing refractory periods at the push of a button. These injectable implants are already manufactured, so that is less on your plate. It crosses into the medical device realm in most jurisdictions, but not in Próspera!

• Replaces & Revenue: Replaces oral PDE5 inhibitors like Viagra and Cialis or painful alprostadil penile injections. The global ED drug market exceeds $4.5 billion.

51. Muscle Atrophy via Anabolic Resistance

• Gene Therapy Proposal: Continuous systemic secretion of a high-potency, stable Mechano-Growth Factor (MGF) peptide variant to bypass age-related anabolic blunting and accelerate injury recovery.

• Replaces & Revenue: Replaces off-label body-building peptides (BPC-157, TB-500) and underground anabolic androgenic steroid use.

52. Chronic Anorexia Cachexia (Cancer/HIV Induced)

• Gene Therapy Proposal: Muscle delivery of a genetic construct producing Ghrelin or a high-affinity Ghrelin receptor agonist to continuously stimulate appetite and preserve lean mass during wasting states.

• Replaces & Revenue: Replaces synthetic cannabinoids, megestrol acetate, and intravenous nutritional formulas.

53. Sleep Apnea & Upper Airway Muscle Laxity

• Gene Therapy Proposal: Localized delivery to the hypoglossal nerve and surrounding musculature encoding a neurotrophic factor or muscle-stabilizing peptide to enhance baseline muscle tone during sleep.

• Replaces & Revenue: Replaces cumbersome CPAP machines and invasive surgical airway reconstructions. The global CPAP market exceeds $4 billion.

54. Anemia of Chronic Disease (ACD)

• Gene Therapy Proposal: Systemic or hepatic delivery of a vector encoding an antisense sequence against Hepcidin or an engineered Ferroportin stabilizer to unlock trapped intracellular iron stores and normalize hemoglobin synthesis.

• Replaces & Revenue: Replaces repetitive intravenous iron infusions and expensive erythropoietin-stimulating agents.

55. Hypothyroidism (Refractory Levothyroxine Malabsorption)

• Gene Therapy Proposal: Intramuscular or subcutaneous delivery of a multi-cistronic construct containing thyroid peroxidase and thyroglobulin elements to establish a functional, hormone-producing thyroid micro-tissue depot. This also assumes you have the entire machinery setup: NIS for basal uptake, Pendrin for apical transport, and a hydrogen peroxide generation system (such as DUOX2 and DUOXA2) to drive the TPO-mediated iodination of thyroglobulin. Furthermore, without an organized follicular architecture to store colloid, the system isn’t going to function autonomously. Infinitia believes in you!

• Replaces & Revenue: Replaces daily lifelong oral levothyroxine (Synthroid), one of the most widely prescribed drugs in the world.

56. Age-Related Dehydroepiandrosterone (DHEA) Decline

• Gene Therapy Proposal: Adipose or muscle-targeted delivery of a transgene encoding the rate-limiting steroidogenic enzyme CYP17A1 to boost endogenous DHEA production back to peak youthful levels.

• Replaces & Revenue: Replaces over-the-counter oral DHEA supplementation and anti-aging compound therapies.

57. Short Bowel Syndrome & Malabsorption

• Gene Therapy Proposal: Intestinal or intramuscular production of a long-acting Teduglutide (GLP-2 analog) sequence via minicircle DNA to promote mucosal hypertrophy and structural adaptation of the remaining gut tissue.

• Replaces & Revenue: Replaces daily subcutaneous Gattex injections, which cost over $400,000 annually per patient.

58. Refractory Vitamin D-Dependent Rickets

• Gene Therapy Proposal: Hepatic delivery of a functional 25-Hydroxyvitamin D3 1-Alpha-Hydroxylase gene to permanently restore endogenous synthesis of active Calcitriol.

• Replaces & Revenue: Replaces high-dose lifelong active vitamin D metabolite supplementation and frequent monitoring protocols.

59. Idiopathic Short Stature

• Gene Therapy Proposal: Growth plate-targeted delivery of an Insulin-like Growth Factor 1 (IGF-1) construct under a highly localized, self-limiting developmental promoter to optimize long bone growth in pediatric patients.

• Replaces & Revenue: Replaces daily recombinant hGH or Increlex injections, costing up to $60,000 annually.

60. Severe Exocrine Pancreatic Insufficiency

• Gene Therapy Proposal: Duct-targeted or local parenchymal delivery of pancreatic lipase, amylase, and protease genes into the upper intestinal tissue, transforming mucosal cells into functional digestive enzyme producers.

• Replaces & Revenue: Replaces the need to take dozens of daily oral porcine pancreatic enzyme replacement therapy (PERT) capsules (Creon) with every meal. Creon generates over $1.2 billion annually.

IV. Monoclonal Antibody Substitutes (In Vivo Bioreactors)

Note: All of these (and others in the list) assume an engineered immune tolerance and mitigation of anti-drug antibodies (ADAs).

61. Advanced Colorectal and Lung Cancer (VEGF Inhibition)

• Gene Therapy Proposal: Muscle delivery of a minicircle vector encoding a soluble VEGF trap or a full anti-VEGF single-chain antibody variant (scFv) to maintain a constant anti-angiogenic barrier around solid tumors.

• Replaces & Revenue: Replaces monthly intravenous infusions of Bevacizumab (Avastin). Avastin historically generated over $7 billion annually.

62. Advanced Melanoma, NSCLC, and Renal Carcinoma (PD-1 Blockade)

• Gene Therapy Proposal: Intramuscular or peritumoral delivery of an expression construct producing an anti-PD-1 monoclonal antibody fragment to provide sustained, baseline checkpoint inhibition.

• Replaces & Revenue: Replaces recurring Keytruda or Opdivo infusions. Keytruda is the world’s best-selling drug, generating over $29.5 billion in 2024 alone.

63. Her2-Positive Breast Cancer

• Gene Therapy Proposal: Long-term skeletal muscle secretion of a full-length anti-HER2 monoclonal antibody sequence, maintaining therapeutic serum levels to neutralize circulating tumor cells and micro-metastases.

• Replaces & Revenue: Replaces regular intravenous infusions of Herceptin (Trastuzumab). Herceptin historically generated over $6 billion in peak annual sales.

64. Severe Asthmatic Hypereosinophilia (IL-5 Inhibition)

• Gene Therapy Proposal: A minicircle DNA vector delivered intramuscularly to continuously secrete an anti-IL-5 antibody fragment, blunting eosinophil activation and preventing severe airway constriction.

• Replaces & Revenue: Replaces regular subcutaneous injections of Nucala (Mepolizumab). Nucala generates over $1.8 billion annually.

65. Wet Age-Related Macular Degeneration (AMD)

• Gene Therapy Proposal: A single intraocular (intravitreal) injection of an AAV or minicircle vector encoding an anti-VEGF scFv, transforming retinal pigmented epithelial cells into factory lines for anti-VEGF production.

• Replaces & Revenue: Replaces painful, recurring monthly eye injections of Eylea or Lucentis. Eylea generates over $9 billion globally per year.

66. Severe Hypercholesterolemia (PCSK9 Monoclonal Equivalent)

• Gene Therapy Proposal: Sustained muscle production of an anti-PCSK9 single-chain variable fragment (scFv) to block circulating PCSK9 and maximize hepatic LDL clearance without requiring gene editing.

• Replaces & Revenue: Replaces monthly Repatha or Praluent monoclonal antibody injections.

67. Osteoporosis (Sclerostin Inhibition)

• Gene Therapy Proposal: Long-term vector production of an anti-Sclerostin monoclonal antibody fragment, mimicking the action of romosozumab to decouple bone formation and resorption for rapid skeleton reconstruction.

• Replaces & Revenue: Replaces monthly subcutaneous injections of Evenity, which costs roughly $2,000 per month.

68. Advanced Bladder and Urothelial Carcinoma (PD-L1 Inhibition)

• Gene Therapy Proposal: Muscular or regional peritumoral production of an anti-PD-L1 single-chain antibody, keeping immune checkpoints open to allow local T-cell clearance of malignant cells.

• Replaces & Revenue: Replaces regular intravenous infusions of Tecentriq, which generates over $2.5 billion annually.

69. Paroxysmal Nocturnal Hemoglobinuria (PNH) & Macular Degeneration (C5 Complement Inhibition)

• Gene Therapy Proposal: Hepatic delivery of a genetic construct secreting a high-affinity anti-C5 complement monoclonal antibody or decoy molecule to protect red blood cells from intravascular hemolysis.

• Replaces & Revenue: Replaces lifelong, ultra-expensive Soliris or Ultomiris infusions. Soliris costs up to $500,000 per patient annually and generates over $4 billion globally.

70. Moderate-to-Severe Hidradenitis Suppurativa & Crohn’s (IL-17/23 Inhibition)

• Gene Therapy Proposal: Muscle-mediated minicircle delivery encoding an anti-IL-17 or anti-IL-23 antibody fragment to maintain strict, localized cutaneous or mucosal cytokine suppression.

• Replaces & Revenue: Replaces bi-weekly injections of Cosentyx or Bimzelx. Cosentyx generates over $5 billion annually.

71. Recurrent Clostridioides difficile Infection (Toxin B Neutralization)

• Gene Therapy Proposal: Expression of an anti-C. difficile Toxin B neutralizing monoclonal antibody fragment in the gut lumen (apically-secreting epithelial vectors or an engineered probiotic chassis?), providing long-term mucosal defense against recurrent toxic megacolon. Every nurse’s favorite infection, neutralized.

• Replaces & Revenue: Replaces single-dose Bezlotoxumab (Zinplava) infusions, which cost over $4,000 per dose.

72. Severe Chronic Urticaria (Hives)

• Gene Therapy Proposal: Intramuscular production of an anti-IgE monoclonal antibody snippet, mirroring omalizumab’s mechanism to prevent mast cell and basophil degranulation safely.

• Replaces & Revenue: Replaces monthly Xolair injections for refractory dermatological patients.

Hives, photo by Dr. James Heilman

73. Prevention of Respiratory Syncytial Virus (RSV) in High-Risk Adults

• Gene Therapy Proposal: Intramuscular injection of a minicircle vector encoding an anti-RSV fusion protein monoclonal antibody (functional equivalent to palivizumab/nirsevimab) to maintain a persistent protective antibody titer through the winter season.

• Replaces & Revenue: Replaces seasonal prophylactic monoclonal antibody injections (Synagis/Beyfortus). Beyfortus sales have cleared $1 billion seasonally.

74. Alzheimer’s Amyloid-Beta Clearance

• Gene Therapy Proposal: Intrathecal or systemic delivery of an expression construct encoding an anti-amyloid beta monoclonal antibody fragment (similar to lecanemab or donanemab) with enhanced blood-brain barrier transport properties.

• Replaces & Revenue: Replaces regular, side-effect-prone intravenous infusions of Leqembi or Kisunla, which generate billions while requiring intense institutional clinical infrastructure.

75. Advanced Head and Neck Squamous Cell Carcinoma (EGFR Blockade)

• Gene Therapy Proposal: Intramuscular or localized delivery of an expression vector producing an anti-EGFR antibody snippet to starve epithelial tumors of essential replication signals.

• Replaces & Revenue: Replaces intravenous infusions of Cetuximab (Erbitux). Erbitux generates over $1 billion annually.

76. Prevention of Migraine (Sustained CGRP Ligand Neutralization)

• Gene Therapy Proposal: Continuous muscular production of an anti-CGRP ligand antibody fragment (functional analog to galcanezumab), removing the peak-and-trough efficacy degradation seen at the end of every month.

• Replaces & Revenue: Replaces monthly Emgality or Ajovy self-injections.

77. Severe Allergic Keratoconjunctivitis & Dry Eye Syndrome

• Gene Therapy Proposal: Salivary gland or subconjunctival delivery of an expression cassette producing a localized anti-ICAM-1 or anti-TNF single-chain fragment to protect the ocular surface without systemic immunosuppression.

• Replaces & Revenue: Replaces daily lifitegrast (Xiidra) or cyclosporine (Restasis) eye drops. Restasis generates over $1 billion annually.

78. Lupus Nephritis (BLyS/APRIL Dual Inhibition)

• Gene Therapy Proposal: Systemic minicircle-mediated secretion of a dual B-lymphocyte stimulator (BLyS) and APRIL antagonist fusion protein to protect renal tissue from autoantibody attack.

• Replaces & Revenue: Replaces recurring infusions of Benlysta or experimental dual-inhibitor biologics.

79. Systemic Amyloidosis Light Chain (AL) Disease

• Gene Therapy Proposal: Intramuscular production of an amyloid-clearing monoclonal antibody fragment designed to bind to and degrade misfolded light-chain aggregates in organs.

• Replaces & Revenue: Replaces aggressive chemo-immunotherapy combinations and experimental monoclonal therapies.

80. Refractory Eosinophilic Esophagitis

• Gene Therapy Proposal: Local esophageal mucosal or intramuscular delivery of an anti-IL-13 single-chain antibody variant to eliminate painful fibrotic food impactions and strictures.

• Replaces & Revenue: Replaces off-label swallowed steroid slurries and frequent Dupixent injections.

V. Neurological, Sensory, and Rare/Orphan Indications

81. Huntington’s Disease (HTT Triplet Repeat Knockdown)

• Gene Therapy Proposal: Intrathecal AAV-mediated delivery of an artificial microRNA or antisense oligonucleotide construct targeting and silencing the mutant Huntingtin (mHTT) transcript within the striatum.

• Replaces & Revenue: No disease-modifying therapies exist; replaces generic symptomatic treatment with vesicular monoamine transporter 2 (VMAT2) inhibitors like tetrabenazine.

82. Parkinson’s Disease (Dopamine Synthesis Restoration)

• Gene Therapy Proposal: Striatal delivery of an AAV or minicircle construct expressing Aromatic L-Amino Acid Decarboxylase (AADC), transforming remaining striatal cells into highly efficient converters of levodopa into dopamine.

• Replaces & Revenue: Replaces high-dose oral carbidopa/levodopa regimens, which cause severe motor fluctuations over time. The global Parkinson’s market exceeds $5 billion.

83. Amyotrophic Lateral Sclerosis (ALS - SOD1 Mutation)

• Gene Therapy Proposal: Intrathecal delivery of a specialized siRNA or antisense construct designed to knock down expression of the toxic, misfolded Superoxide Dismutase 1 (SOD1) protein in spinal motor neurons.

• Replaces & Revenue: Replaces Qalsody (tofersen) intrathecal injections and oral riluzole. Qalsody is priced at over $300,000 per year.

84. Spinal Muscular Atrophy (Adult-Onset/Milder Phenotypes)

• Gene Therapy Proposal: Systemic or intrathecal delivery of a minicircle vector containing an antisense sequence designed to alter the splicing of the SMN2 gene, maximizing production of functional survival motor neuron protein.

• Replaces & Revenue: Replaces multi-million dollar single-dose treatments like Zolgensma or recurring maintenance intrathecal injections of Spinraza. Spinraza pulls in more than $1.5 billion annually.

85. Alpha-1 Antitrypsin Deficiency Liver Pathogenesis

• Gene Therapy Proposal: Hepatic delivery of a dual-action RNAi and gene replacement construct designed to knock down mutant Z-AAT protein accumulation while simultaneously expressing wild-type, functional AAT protein.

• Replaces & Revenue: Replaces regular lifelong intravenous alpha-1 proteinase inhibitor infusions.

86. Leber Hereditary Optic Neuropathy (LHON - ND4 Mutation)

• Gene Therapy Proposal: Intravitreal injection of an AAV vector containing a functional mitochondrial ND4 gene engineered for allotopic expression, directing the protein directly to retinal ganglion cell mitochondria.

• Replaces & Revenue: No standard approved disease-modifying therapies are available in many Western markets; directly replaces supportive low-vision care.

87. Pompe Disease (Late-Onset Acid Maltase Deficiency)

• Gene Therapy Proposal: Hepatic delivery of a minicircle vector encoding human Acid Alpha-Glucosidase (GAA), optimized for continuous high-level secretion into the bloodstream for widespread skeletal muscle uptake.

• Replaces & Revenue: Replaces bi-weekly enzyme replacement therapy infusions (Lumizyme/Nexviazyme). Nexviazyme therapies cost hundreds of thousands of dollars annually per patient.

88. Fabry Disease (alpha-Galactosidase A Deficiency)

• Gene Therapy Proposal: Liver-targeted delivery of a functional GLA gene cassette, transforming hepatocytes into a continuous, stable source of the alpha-galactosidase A enzyme to clear systemic globotriaosylceramine storage.

• Replaces & Revenue: Replaces lifelong every-two-week infusions of Fabrazyme, which costs up to $300,000 per year.

89. Gaucher Disease Type 1 (Glucocerebrosidase Deficiency)

• Gene Therapy Proposal: Hematopoietic stem cell or liver-directed delivery of the glucocerebrosidase (GBA) gene to permanently clear lipid accumulations in macrophages without regular medical monitoring.

• Replaces & Revenue: Replaces regular lifelong enzyme replacement infusions like Cerezyme or substrate reduction capsules like Cerdelga. Cerezyme generates over $800 million annually.

90. Hereditary Angioedema (HAE - C1 Inhibitor Deficiency)

• Gene Therapy Proposal: Hepatic or muscular production of a functional human C1 Esterase Inhibitor transgene via minicircle DNA to permanently prevent sudden, life-threatening vascular swelling events.

• Replaces & Revenue: Replaces frequent prophylactic injections of Takhzyro or Cinryze. Takhzyro single-source revenue exceeds $1 billion annually.

91. Mucopolysaccharidosis Type I (Hurler/Scheie Syndrome)

• Gene Therapy Proposal: Intrathecal or hepatic delivery of the alpha-L-iduronidase (IDUA) gene to continuously produce the enzyme necessary to clear toxic glycosaminoglycans throughout systemic tissues and the central nervous system.

• Replaces & Revenue: Replaces weekly intravenous Aldurazyme infusions, which cost over $200,000 per year per patient.

92. Hemophilia A (Factor VIII Deficiency)

• Gene Therapy Proposal: Hepatic delivery of an optimized B-domain deleted human Factor VIII gene cassette to restore continuous endogenous blood clotting capabilities.

• Replaces & Revenue: Replaces frequent, emergency or prophylactic infusions of recombinant Factor VIII or Hemlibra. The clotting factor market represents a $10 billion annual global burden.

93. Hemophilia B (Factor IX Deficiency)

• Gene Therapy Proposal: Liver-targeted delivery of the high-activity Factor IX Padua variant, requiring extremely low vector copy numbers to completely normalize blood clotting metrics.

• Replaces & Revenue: Replaces regular Factor IX infusions and Hemgenix, a traditional gene therapy priced commercially at $3.5 million per dose.

94. Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Lung Dysfunction

• Gene Therapy Proposal: Repeated nebulized delivery of a non-integrating, lipid-nanoparticle encapsulated minicircle DNA vector containing the full-length CFTR gene to clear thick, static pulmonary mucus.

• Replaces & Revenue: Replaces lifelong daily oral tri-potentiator pills like Trikafta. Trikafta generated over $9 billion in 2024 for Vertex Pharmaceuticals.

95. Wilson Disease (Copper Accumulation Disorder)

• Gene Therapy Proposal: Hepatic delivery of a functional ATP7B copper transporter gene sequence to restore regular biliary copper excretion and protect patients from acute liver and neurological failure.

• Replaces & Revenue: Replaces continuous, side-effect-heavy oral copper chelators (penicillamine) and strict zinc therapy regimens.

Prominent Kayser-Fleischer ring associated with Wilson Disease.

96. Duchenne Muscular Dystrophy (Becker-like Micro-dystrophin Conversion)

• Gene Therapy Proposal: Systemic or high-dose muscle delivery of a highly functional micro-dystrophin gene under a muscle-specific creatine kinase promoter to halt progressive muscle necrosis. It’s systemic though, so targeted LNPs/VLPs all the way (spleen allowing), unless you have cracked a better solution? This is a legacy target in bioengineering, so a crown comes with the bag.

• Replaces & Revenue: Replaces multi-million dollar traditional single-dose AAV alternatives (Elevidys) and chronic corticosteroid therapies.

97. Achromatopsia (CNGB3/CNGA3 Blindness)

• Gene Therapy Proposal: Subretinal injection of an AAV vector delivering a functional copy of the CNGB3 or CNGA3 gene directly to cone photoreceptors, restoring daytime color vision and visual acuity.

• Replaces & Revenue: No existing pharmaceutical options are available; directly replaces lifelong low-vision accommodation and occupational therapy infrastructure.

98. Chronic Tinnitus & Auditory Synaptic Loss

• Gene Therapy Proposal: Localized inner-ear (intracochlear) delivery of Neurotrophin-3 (NT-3) or Atonal (ATOH1) expression constructs to stimulate spiral ganglion neuron neurite outgrowth and repair damaged auditory synapses.

• Replaces & Revenue: Replaces ineffective sound-masking devices and white noise generators; opens a completely unaddressed multi-billion dollar audiology sector.

99. Severe Refractory Hyperoxaluria Type 1

• Gene Therapy Proposal: Liver-targeted delivery of a functional alanine-glyoxylate aminotransferase (AGXT) gene or an RNAi construct targeting glycolate oxidase to completely stop the production of toxic, stone-forming oxalate.

• Replaces & Revenue: Replaces continuous monthly Oxlumo subcutaneous injections, which cost upwards of $400,000 per year per patient.

100. Advanced Epithelial Ovarian Cancer (Folate Receptor Alpha Targeting)

• Gene Therapy Proposal: Muscle or intraperitoneal delivery of a vector encoding an anti-Folate Receptor Alpha single-chain variable fragment (scFv) conjugated to a potent cytotoxic or immune-recruiting peptide to constantly target and eliminate ovarian tumor cell lines.

• Replaces & Revenue: Replaces recurring intravenous infusions of Elahere, a newly approved antibody-drug conjugate generating hundreds of millions in early market adoption.

This list represents over $725 billion in annual healthcare spending that is just waiting to be disrupted. But this is just the tip of the iceberg, as hundreds or thousands of other targets exist.

In the right regulatory environments, biotech and biopharma are revealed to be absolute goldmines, as well as a noble quest to improve quality of life for people worldwide.

Montana SB 535, is a new framework allowing eligible post-Phase 1 experimental treatments to reach patients under regulated oversight with special clinic licenses and an expert review board. Stephen explains why traditional Right-to-Try and expanded access programs have struggled to scale, and how Montana could change the economics by allowing biotechs to generate real-world evidence, treat patients, and create revenue earlier in the development process.

They discuss how the pathway works in practice, who qualifies, opportunities for biotech companies and physicians, the relationship between state and federal regulation, the FDA’s role, and whether Montana could ultimately provide a blueprint for accelerating drug development across the United States.

Watch on YouTube

More on this topic:

• Scott Alexander on the Aduhelm Approval

• Jared Rhoads on X

At Infinita, we love showcasing the incredible innovators in our ecosystem. Today, we’re excited to share the story of Anna and Ivan, the founders behind Unlimited Bio.

In less than 2 years, they’ve launched a company, treated patients, generated revenue, secured funding from Infinita VC, and begun preparing one of the boldest experiments in longevity science: a combination gene therapy trial in healthy individuals.

Here’s how they did it — and why they believe regulatory innovation may be just as important as scientific innovation.

The Bottleneck No One Talks About

Both Anna and Ivan come from deep biotech backgrounds.

Anna holds a PhD in bioengineering and previously built multiple biotech companies developing vaccines and age-related diseases. Ivan spent years working on rejuvenation technologies that, despite promising science, were still stuck in preclinical stages.

The contrast became impossible to ignore.

“In the traditional system,” Ivan explains, “you can spend years preparing, testing, filing paperwork — and still be far from injecting the first patient.”

Anna had seen the same pattern. One of the biggest structural challenges is that aging itself isn’t recognized as a treatable condition in most regulatory frameworks. Instead, companies must pursue narrow disease indications rather than targeting the biological drivers of aging directly.

Large pharmaceutical companies often avoid this space entirely. As a result, much of the progress in longevity science comes from small biotech startups and academic labs navigating rigid regulatory constraints.

Even when science moves quickly, infrastructure can slow everything down.

Anna experienced this firsthand when her team developed a COVID vaccine and completed Phase II trials within two years — a remarkable pace by biotech standards. But despite strong safety and efficacy data, the program stalled due to manufacturing limitations and licensing requirements.

“Science can move fast,” Anna says. “Infrastructure and regulation often don’t.”

Discovering a Different Model

Their search for alternatives eventually led them to Prospera, where the first hub of Infinita City is based.

Initially, they planned only a short visit during one of the early pop-up city gatherings. What they found surprised them.

“The depth of expertise was incredible,” Ivan recalls. “You could walk up to almost anyone and get serious feedback — investors, operators, scientists.”

Within two weeks, they had connected with advisors, investors, and collaborators. One of the gene therapy patients they met there later became an investor in the company.

When an accelerator program launched in March, they decided to stay longer — and see how fast they could actually build.

The “MVP” Therapy

Their approach was simple but clever: repurpose an existing gene therapy that Anna knew about.

The therapy had already been approved in Russia in 2011 for patients with lower limb ischemia — a condition where poor blood supply threatens tissue death and amputation. The treatment works by stimulating the growth of new capillaries.

Anna saw another possible use.

“As we age, our microvasculature deteriorates,” she explains. “Capillary density declines. Blood flow becomes less efficient. Why wait until someone is in critical condition?”

Their hypothesis: repurpose the therapy for preventive use — improving muscle oxygenation, aerobic capacity, and vascular health in healthy individuals over 50.

It was a calculated move.

The therapy’s safety profile was already well understood. The mechanism of action was clear. And most importantly, it allowed them to test Prospera’s regulatory framework without spending years on early-stage R&D.

“It was our MVP,” Ivan says. “Not just of the therapy — but of the regulatory system itself.”

The results surprised even them.

It took about nine months to treat their first patient.

Less than a year later, they had generated their first revenue.

For founders coming from systems where first-in-human trials can take many years, that timeline felt revolutionary.

Expanding the Pipeline

Once revenue began, the team moved quickly.

They expanded their pipeline and introduced a second, more advanced gene therapy program, building on the infrastructure and experience they had developed.

But experimentation remains core to their philosophy.

Recently, while attending the Infinite Games, Ivan began running a controlled experiment on himself using one of their gene therapies aimed at hair regeneration.

Half of his scalp received the treatment.
The other half received a placebo.

He doesn’t know which side is which.

Hair growth takes time to evaluate — peak results may appear between six and twelve months — but the experiment reflects how the team thinks about science.

“We don’t just want anecdotes,” Ivan explains. “We want data. Even negative results teach us something.”

Failed hypotheses aren’t losses. They’re information. In science, learning what doesn’t work is just as important as discovering what does.

The Next Big Experiment

Now, the team is preparing something even more ambitious:

A clinical trial combining two gene therapies in healthy individuals.

If successful, it could open the door to multi-gene combination therapies targeting aging more holistically — potentially dozens of genetic interventions working together to address multiple aging pathways at once.

The pieces are already coming together.

Manufacturing is complete. Permissions are in place. The infrastructure is ready.

“We’re almost there,” Ivan says. “Now we’re testing whether we can smoothly run a combo gene therapy trial.”

If it works, it won’t just be a milestone for UnlimitedBio.

It could become a proof of concept for a faster, more adaptive model of developing longevity therapies — one where scientific progress isn’t held back by systems built for a different era of medicine.

July just moved fast here!

Two big events are coming up: Freedom Summit in New Hampshire on August 20-21 and Infinita Startup Week right here in Próspera from August 31 to September 7 🥳

Each a great opportunity to learn about biotech federalism, free cities and special pro-tech jurisdictions.

We also have new podcast episodes, three new partnerships and a new referral program in the Infinita Wallet.

So if this tastes like your cup of tea, keep reading 🍵

🚀 Infinita Startup Week Is Getting Close!

From August 31 to September 7, founders, investors, researchers, and builders will gather in Próspera, Roatán for Infinita Startup Week.

You’ll spend your days collaborating with people building across biotech, AI, crypto, governance, and other frontier technologies.

The week culminates alongside the Free Cities Conference, where you’ll meet the key leaders in the “industry”, and have the opportunity to pitch your startup during Demo Day.

🔗 Get Your Tickets

🧬 Our Next Stop before Roatán: Freedom Summit

Freedom Summit is happening Aug 20-21, 2026 in Manchester, New Hampshire.

New Hampshire is pushing for one of the most ambitious biotech laws in the U.S. right now, and there’s a whole coalition of founders, investors, scientists, and techno-optimists trying to make the state a serious hub for frontier tech.

Register Here

🎁 You Can Now Refer Friends To The Infinita Wallet!

Share your link and earn 2.5% in HIVE on everything they spend in their first month. The more friends you bring in, the more you can earn.

And if you have your Premium Node ID, you get 5% in HIVE on every referral.

Plus this subscription gives you access to all our partner discounts and perks like the ones we’ve been announcing every month. Grow the community, grow your wallet!

Open Your Wallet

🧪 Meet Panacea

A company fresh out of YC is working on something very relevant for our biotech community.

Panacea combines AI with regulatory specialists to help life sciences companies move faster through FDA approval.

They made $500k in bookings in 2 months during YC, and their work feels highly complementary with what we’re building at Infinita: better infrastructure for people trying to bring medical products, diagnostics, therapeutics, and health technologies into the world.

We think they’re a great fit for what we’re building here and we’re looking for Infinitians who want to be early users. If that’s you, get a call with them and mention Infinita.

Book a call →

🔬 Applications Open for the Reactorfield Fellowship

Reactorfield is a free 4-week fellowship backed by Anthropic and Nvidia that helps scientists and deep tech teams embed AI into their existing workflows. The team are YC alumni and have invested in 150+ companies.

They were announced on July 28th and got over 150k views in 24 hours, mentioned by the likes of Peter Diamandis and Derya Unutmaz. And since it’s philanthropically funded, there’s no cost to participants.

Applications are open until August 15th.

Apply now →

That’s it for July, thanks for reading! 🍧

And don’t miss your chance to visit us on August 31, 2026 in our Startup Week!

Must reads this month:

Here are three articles our CEO recommends on Montana’s latest steps toward expanding access to experimental therapies:

• 🔗 MIT Technology Review — Montana’s experimental medical hub

• 🔗 Longevity Technology — Montana takes next step on experimental therapies

• 🔗 Lifespan.io — Montana’s Right to Try law enters a new phase

Latest podcast episodes:

• 🎧 Ep. 113 — Reason on Clinical Trials

• 🎧 Ep. 112 — Tim Urban on Startup Cities

New partnerships this month:

• 🔗 Shefi

• 🔗 Ascend

• 🔗 RAADfest

Follow along 👀

Instagram · X · YouTube

See you again in August 😉,

Nelsi 🌊

He breaks down why investors backing gene and cell therapies care more about a drug’s earning potential than whether it works, and why treatments already in use could be quietly adding years to human lifespan without anyone confirming it. Drawing on his own experience as a trial participant in Roatán, he also explains why Australia has become a faster, cheaper alternative for clinical trials, and how much of that gap comes down to culture rather than actual safety.

Watch on YouTube

More about Reason’s work:

• Fight Aging!

The review board’s role is oversight for early access to treatments before FDA approval. For a $12.5k fee, you can submit a post-phase-1 therapy to our review board.

Montana ETRB

What is a Montana ETRB?

Montana’s model is a major regulatory innovation. National regulators typically review treatments one by one, which causes years-long bottlenecks.

In Montana, registered ETRBs do treatment reviews, licensed specialized clinics (ETCs) provide treatments. The state receives reporting and can take away licenses.

That’s smart regulation. Competitive, efficient, with oversight. That’s what American biotech needs.

First Montana ETRB Members

We are honored to welcome highly esteemed scientists, physicians and bioethicists on the first Montana ETRB

- Matt Kaeberlein, PhD - a biologist internationally recognized for research on the basic mechanisms of aging and translational interventions to extend healthspan

- Felipe Sierra, PhD - a biochemist that served as Director of the Division of Aging Biology, NIA/NIH, where he developed the concept of Geroscience.

- Jessica Flanigan, PhD - a bioethicist who is is the Richard L. Morrill Chair in Ethics and Democratic Values at the University of Richmond, where she teaches leadership and healthcare ethics

- Jamie Justice, PhD - is Executive Vice President of the Health Domain at XPRIZE and Executive Director of the XPRIZE Healthspan Prize

- James M. Burke, MD - is a hematologist and oncologist with more than three decades of experience in cancer drug development and patient care

Each review submitted will have to pass their judgement on adequate safety characterization.

What will the ETRB look for?

An ETRB’s legal mandate is safety-only.

Risks need to be disclosed to patients for informed consent properly, and treatments need to have a safety profile equivalent to a successful phase-1 trial.

After that it’s up to the doctor and patient to decide.

ETRB will compete for reputation.

They are free to approve or not approve according to their assessment. If they wanted, they could even ask for efficacy data as a basis for approval.

Our Montana ETRB has a set of governance principles that guide its decisions beyond the legally required minimum floor, as a guide for its decisionsmaking.

Congratulations to Montana

Thanks to the leadership of Sen. Kenneth Bogner, Montana now has the most forward looking medical access law in the country in SB 535.

Montana’s department of health and human services (DPHHS) provided a tight and comprehensive set of rules for clinic licenses and review boards.

Montana is becoming a biotech frontier.

Towards Clinical Trial Abundance

The FDA has led the world for decades, gating the largest and most innovative biopharma market in the world. But the US’ competitive advantage is evaporating. Regulators in Australia and China have made clinical trials far more cost- and time-competitive. Patients are going to offshore clinics in Mexico and the Caribbean. High-agency patients like Sid Sijbrandij take matters into their own hands, and use multiple available jurisdictions.

The FDA needs to modernize, and lots of federal efforts to this end are underway. We support federal reforms, however these efforts often fall short or are slow.

Let US states innovate. The states can be as a source of regulatory innovation. In states important learnings can take place, and inform better federal policy.

Montana is leading the charge in biotech. New Hampshire is following suit. Utah, Texas and Florida have opened up to stem cells and many states are improving conditions for individualized treatments.

FDA / HHS should give explicit safe harbor to such responsible state medical access programs, to encourage a regulated market forming vs. gray markets.

How to Get Involved

We’re looking for state and federal policymakers to advance this regulatory innovation, clinicians to be the patient-facing stewards for responsible access, scientific reviewers to partake in ETRB oversight, biotechs to provide their novel treatments to these programs to collect valuable data, and ultimately for patients to benefit from potentially life-saving access.

Get in touch! niklas@infinita.co | stephen@infinita.co | contact@montanaetrb.org

Ascend is a 24/7 travel concierge that books your flights, hotels, and ground transport via WhatsApp.

And if you are planning to come to Infinita Startup Week this August 31 to September 7, 2026, you can use it to get here ;)

As part of this partnership, Infinita Premium Node ID members can now enjoy $500 off an Ascend membership.

To redeem, open the Infinita app, go to Discover → Partners, find Ascend, and you’ll see the steps to claim your discount there.

Get Your Discount

New to Infinita?

The Infinita Node ID is our membership program. Premium members receive access to a growing network of benefits, including discounts at partner events and pop-up cities around the world, special pricing on services and experiences, access to exclusive programs, and other perks across the ecosystem.

Explore more benefits ↗

We love building partnerships like this because they give our community more ways to travel smarter, with the added benefits!

✈️🌴🤝

In this episode, he discusses the Space Race, longevity, AI safety, startup cities, and the social conditions that allow new ideas to survive. Tim explains why some technologies move fast while others stall for decades, why the best communities treat ideas like experiments, and why the future may depend less on prediction and more on building better environments for progress.

Watch on YouTube

More about Tim Urban’s work:

• Tim Urban’s X

• What’s Our Problem?: A Self-Help Book for Societies

SheFi is a global education platform and community helping women learn, connect, and build confidence in crypto, AI, and frontier technology.

Their next Summer Cohort runs from July 21 to August 13, 2026.

As part of this partnership, Infinita Premium Node ID members can now enjoy 15% off SheFi’s Cohort 17.

To redeem, open the Infinita app, go to Discover → Partners, find SheFi, and you’ll see the steps to claim your discount there.

Get Your Discount

New to Infinita?

The Infinita Node ID is our membership program. Premium members receive access to a growing network of benefits, including discounts at partner events and pop-up cities around the world, special pricing on services and experiences, access to exclusive programs, and other perks across the ecosystem.

Explore more benefits ↗

We’re happy to build partnerships like this because they give our community more ways to access world-class education and grow alongside people who are shaping the future of web3.

🌐💜🚀

Over the past two years we’ve been building a community around one simple idea:

If you want to accelerate the future, you need a place where founders, researchers, investors, and builders can actually build together without being bogged down by bureaucracy and politics.

And that’s why we’re very excited to announce your next best chance to visit Próspera at the Infinita Startup Week @ the Free Cities Conference (Aug 31 - Sep 7).

More details below!

Besides that, we’ll look at Tomas Pueyo’s conversation on how new governance models could shape the future of innovation, two new Premium Node ID partner benefits, and what it really looks like to build a life in Roatán.

Let’s get into it! ☀️☕️

🚀 Come To Build: Infinita Startup Week!

Spend a full week between workshops, founder sessions, startup building, ecosystem tours, and community events before flowing directly into the Free Cities Conference!

Whether you’re already building a company, thinking about your next one, investing, or just curious about frontier technology and governance, this is designed to give you a real feel for what it’s like to build inside Infinita and Próspera, and actually get you to launch your project.

Grab Your Ticket

Take a look at the announcement & share it with others who might be interested!

🎧 Could the Next Silicon Valley Be a Country?

It sounds like a metaphor, but it isn’t. That’s literally what Tomas Pueyo – the famous blogger who got more than 50 million views on his pandemic essays – came here to research.

He sat down with us and Próspera’s Trey Goff to dig into how new governance models could unlock entirely new models of human progress. The conversation touches on everything from why biotech became Próspera’s clearest opportunity, to why you still can’t legally sell an anti-aging drug (spoiler: aging isn’t officially a disease ), to what’s actually limiting growth here right now.

Listen Here

🤝 Our New Partnerships

If you have a Premium Node ID and haven’t checked the partners section lately, you are not taking full advantage of your benefits.

This month we added two new ones:

• Noma Collective — a remote work travel community bringing professionals together in amazing destinations. They’re coming to Próspera this July and Premium members get $300 off.

• Edge Esmeralda — a month-long gathering for founders, scientists, and builders from around the world. Premium members get 20% off tickets.

And if you’re still reading this and don’t have your Premium Node ID yet... let’s just say you’re missing out on a lot more than just these two 😉

Check It Out

🌴 What It’s Really Like to Build a Life in Roatán

What does it actually look like to build a life in Roatán?

This month, our ambassador Kiandra shares her own experience of growing up on the island, building a career, and creating opportunities without having to leave home.

Her story is a reminder that Roatán isn’t just a place to visit. For many people, it’s a place to build.

As she says, “The island was never the limit, it was always my starting point.”

Watch her reel here

Thanks for sticking to month’s newsletter ☀️

We have our July community call coming up where Stephen Martin (the “Right To Try Guy”) is going to talk about medical freedom, Right to Try of course, and what’s happening at the frontier of biotech access. Join here

The next chances to visit are:

• Noma Family (Jul 5 – Aug 2, 2026) 🔗 Link
  ($300 off if you’re a Premium Node ID member)

• Infinita Startup Week (Aug 31– Sep 7, 2026) 🔗 Link
  (Stay tuned for member benefits)

Must read this month:

• 🔗 From Brazil to Próspera: How Westy Is Building Bridges for the Next Generation of Entrepreneurs

• 🔗 The story of Octavio Sanchez and the long fight to create zones of governance experimentation in Honduras.

Follow along 👀

Instagram · X · YouTube

See you next month 😊,

Nelsi 🌊