SMSbiotech specializes in the development of small, mobile stem cells (SMS cells) with unique features such as rapid motility and resilience, offering potential therapeutic applications for tissue repair, inflammation control, and immune system modulation.
SMS cell therapy was discovered and named by you. How does it differ from other stem cell therapies and what is its promise?
SMS cells—small mobile stem cells—stand apart because of two key traits: their tiny size and high motility. These features allow them to reach virtually any part of the body. A cell carrying a message to damaged tissue needs to be small, agile, and fast. SMS cells are also remarkably resilient. Even under hostile conditions —abnormal temperatures, acidity, or damaging chemicals—they survive where others fail.
That resilience is critical, since these cells must reach compromised areas under assault from tissue damage, much like first responders entering a danger zone. They deliver signals to local cells, altering gene expression to promote regeneration and repair, while reducing damage caused by bacteria, abnormal cell behavior, or chronic inflammation. In short, they orchestrate control, attach to target cells, and guide the system toward healing.
When we last spoke, SMSbiotech was focused on chronic obstructive pulmonary disease. What could SMS cell therapy mean for the COPD population in the U.S.?
COPD has two main components: chronic bronchitis, or inflammation of the upper airways, and emphysema, the destruction of alveoli. Alveoli are where oxygen passes into the blood; without them, you cannot breathe. COPD progressively destroys these structures, most often through chronic inflammation from smoking or other exposure in the workplace or environment. Patients from stage one to stage four as disease progresses and worsens quality of life, with the most severe experience debilitation and often require supplemental oxygen just to survive.
Our research shows SMS cells bind to alveolar type 2 cells—progenitors capable of repair and immune regulation. By altering their genetic activity, SMS cells reduce inflammation and restore function. A breakthrough is that they can be nebulized—patients inhale them directly into the lungs, something no other cells survive. They also interact with endothelial cells in blood vessels, further aiding restoration. Unlike CAR-T therapies, which focus on killing, our task is building tissue, activating multiple pathways like a coordinated construction crew. That is why the therapy has such promise. Regenerative medicine could transform chronic disease management and prevention. Every day we receive pleas from patients with severe chronic lung disease, COPD, pulmonary fibrosis, pulmonary hypertension, and others, to see whether they can have early access to try for their benefit.
What was the defining moment in scaling SMS cell therapy?
Securing intellectual property was foundational, but the turning point was discovering SMS cells could rescue lungs during COVID. The pandemic, while devastating, had one unifying effect: it captured the world’s full attention. Global behavior shifted, pollution fell, and environmental data improved almost overnight.
Our work on COVID then transitioned to COPD, which is urgent in this vulnerable population. Every year COPD kills 3 million people—about the same toll COVID took over two or three years. Yet while COVID transformed behavior and galvanized action, COPD continues to be largely unaddressed. People remain exposed to smoking, pollution, and the scale of the crisis is alarming.
What kinds of regulatory changes would most help accelerate the safe development and adoption of stem-cell based therapies?
US academic institutions were never intended to be a clinical development environment, rather a system that seeds research. Currently the pathway to regulatory approval in the US is via very expensive trials in academic medical centers that take far too long to conclude. The answer is not cutting funding, but smarter funding—grants that target big problems and reviews that are more aligned with market demand. Reform is essential, even in top institutions, but resources must continue to flow in order to spark true innovation.
Extreme regulatory burdens are also a barrier. Some countries regulate excessively, others too little. Each new indication for SMS cells poses a repeated burden. In the US there is an opportunity for us to have access to the best available options faster than anywhere around the globe. The high costs of healthcare delivery, which is over inflated with limited availability, exaggerates the expenses associated with establishing therapies. We have turned to Latin America, where regulations are more permissive. There, we can obtain earlier adoption and at lower cost, allowing commercial validation. This produces meaningful insights that may help shorten timelines or allow pathways for early access and compassionate use in adjacent markets.
If every therapeutic innovation costs billions, healthcare will never be sustainable. We need intelligent rules that reduce burden without sacrificing safety.
Your decision to conduct patient trials in Mexico is like moves by other U.S. companies in Southeast Asia. What other favourable trial locations are on your map?
Australia is well known for its practical early clinical programs. It is not just cost; the regulations are simpler, and the U.S. regulatory authorities recognize Australian phase one trials as valid. If those results are scientifically acceptable here, why not adopt the same flexibility at home?
What do you think the answer is?
The U.S. is highly litigious. Regulators fear that easing rules could lead to lawsuits from patients or companies. Bureaucracy is also risk-averse—no one wants to make a mistake that costs them their job. But safety and innovation do not always align. At the frontier of science, risk is inevitable. Innovation is rare precisely because it demands understanding the balance between the risk and the benefits.
Are you hopeful that the U.S. political, corporate and academic systems have the collaborative will and scope to enact a healthcare reform that puts the patient at the center?
Reform is needed—no question. But to achieve it, you need the most capable people at the table, including entrepreneurs. Not only big players like Pfizer or Eli Lilly, but also startups like ours that push boundaries. Big pharma often buys small companies for their breakthroughs, yet regulators rarely ask startups what we need to innovate more effectively.
We are the innovators, but our influence compared to large corporations is minimal. That is why opportunities like this interview matter—someone asking what we need to succeed. But solving these challenges requires more than government action. It needs individuals, academics, advocates, companies, and patients working together. The U.S. healthcare system is unsustainable as it stands. Without broad collaboration, we risk reactionary fixes that cause more harm. The better path is cooperative problem-solving or convening top independent experts, as NASA did after the Challenger disaster, to find solutions.
You are saying we need an impartial non-state, non-corporate body to reshape the U.S. system. What could that look like?
The idea is not to create another institution, but to assemble a coalition of credible, independent thinkers—seasoned scientists, retired industry leaders, and experienced policymakers—who are beyond personal or institutional agendas. Such a body could provide impartial oversight and vision, bridging the gap between scientific progress, public trust, and equitable access. While China’s rapid innovation underscores the urgency, we remain optimistic: our $10 million raised is multiplied many times over by the value of volunteer expertise and goodwill driving this effort. Our mission and vision is to transform healthcare into wellbeing through a smart regenerative therapeutic platform that is broadly available and accessible to all.
