Munich Startup: What does your startup do? What problem do you solve?
Prof. Dr. Marie-Nicole Theodoraki, Founder and CEO of Bioexotec: Imagine if cancer could be detected before it becomes dangerous – even before symptoms appear. That is exactly what Bioexotect Possible: with a new test that detects cancer in its very early stages, when the chance of cure is still over 90 percent. Today, cancer is usually only discovered in stage 4, where the survival rate drops to only 50 percent.
The basis of our test are so-called exosomes: tiny particles released by every cell in our body. They transport information about what's happening in tissues or tumors, like a kind of body-internal intelligence service. Our team has developed a method to analyze these exosomes from blood or saliva and use them to obtain early indications of tumors.
The test is not only limited to early detection, but can also help replace biopsy operations and improve aftercare in the future: fast, inexpensive, painless and highly precise. Bioexotec close a gap that classic biomarkers have not been able to fill so far: a test for reliable early detection and the least possible burden for patients.
Goal: Stage 1 cancer detection
Munich Startup: But that's been around for a long time!
Prof. Dr. Marie Nicole TheodorakiNot quite. Cancer research has been working on so-called "liquid biopsies" for several years – tests designed to detect cancer from blood samples. However, most of these approaches focus on tumor DNA (ctDNA) circulating freely in the blood or isolated tumor cells (CTCs). The catch: These procedures usually only detect cancer when the tumor is already at an advanced stage. And they don't work reliably for all types of cancer.
Our approach starts much earlier. We analyze so-called exosomes – tiny particles that even the smallest tumors release into the blood or saliva in the early stages. They contain not only DNA, but also proteins, RNA, and other biomolecules that provide us with a much more complete picture.
This allows us to detect cancer much earlier and more precisely, often as early as stage 1. For many patients, this means a much better chance of recovery and significantly less stressful treatments. We are thus closing a key diagnostic gap that other procedures have not been able to fill so far.
Munich Startup: What is your founding story?
Prof. Dr. Marie Nicole Theodoraki: Sometimes an idea begins in the lab and becomes a life's work through a personal experience. That's what happened to me: During my postdoc period in Pittsburgh (USA), I first encountered a topic that was barely researched at the time: exosomes. I was immediately fascinated by their potential for medicine.
At the same time, my grandfather was diagnosed with cancer – unfortunately, too late. He died from the disease. The question of whether the cancer could have been detected earlier never left me. Back in Germany, I resolved to make just that possible: to find a way to detect cancer as early as possible.
In 2019, Linda joined the team as a doctoral student, and the project gained momentum. Together, we developed a patented exosomal signature, a molecular pattern that forms the core of today's diagnostic platform. Tobias was on board from the beginning to guide the path to clinical application and through regulatory hurdles. Gaby, an experienced entrepreneur who contributes commercial know-how, rounded out the team.
Today, the Bioexotec team combines medical, scientific and entrepreneurial expertise with a common goal: to detect cancer early enough to make it curable.
Biggest challenge: Path to approval
Munich Startup: What have been your biggest challenges so far?
Prof. Dr. Marie Nicole Theodoraki: As is often the case in medical technology, the biggest hurdle for the Bioexotec team wasn't the technology itself, but the path to approval. Failure to consider the appropriate regulatory steps from the outset when developing a medical diagnostic test risks massive delays, sometimes lasting several years.
Especially at the beginning, it was difficult to navigate the complex web of approval requirements, clinical validation, and reimbursement rules. Who is responsible for what? Which documents are needed and when? And how do you plan so that the test can ultimately be covered by health insurance companies?
This process took approximately two years. During this time, the team not only advanced the medical idea, but also simultaneously built a network of experienced regulatory experts and partners. Today, this strategic foundation is a key building block for market access.
A particularly significant milestone: Eight German university hospitals have already committed in writing to use the test in routine clinical practice. A vote of confidence—and an important step toward improved care.
Munich Startup: Where would you like to be in one year, where in five years?
Prof. Dr. Marie Nicole Theodoraki: Today, our test for head and neck cancer is already running in a clinical laboratory. In one year, our cancer screening test will be simplified and standardized to the point where it can be reliably used in any commercial laboratory.
At the same time, we are evaluating data from a large clinical trial involving over 700 patients—a key milestone for clinical validation and subsequent approval. We are also working on expanding the trial to include four additional cancer types.
In five years, we aim to be established on the market with an approved test for head and neck cancer and a pipeline of additional tests for other tumor types. Our long-term goal: to detect cancer early enough to ensure it remains curable. This includes our saliva test, which will be available for use directly in the doctor's office: fast, easy, and close to the patient. The first clinical trial for this has already been completed.
We want to bring early cancer detection from the laboratory closer to people's real lives: fast, precise, cost-effective and accessible.
Munich as a catalyst for innovation
Munich Startup: How have you experienced Munich as a startup location so far?
Prof. Dr. Marie Nicole Theodoraki: For us, Munich is more than just a nice place to work. It's a true catalyst for innovation. This is where cutting-edge research meets entrepreneurial spirit, and that's exactly what helped us tremendously in founding Bioexotec.
The proximity to leading university hospitals, the excellent research landscape, and access to investors, biotech startups, and established companies provide an ideal environment for developing marketable products from scientific ideas. Support from programs such as Baystartup, the TU Munich and the UnternehmerTUM: here the entrepreneurial spirit is not only encouraged, but actively lived.
What makes Munich special is that everything is close by. You can spontaneously meet important contacts for coffee, build personal relationships, and discuss issues directly, without hours of train travel or endless Zoom calls. This density and openness of Munich's startup scene is a real advantage of the location that should not be underestimated.
“In medicine, if you want to make a difference, you need patience.”
Munich Startup: Quick exit or long breath?
Prof. Dr. Marie Nicole Theodoraki: In medicine, if you want to make a difference, you need patience – and that's exactly what we bring. A quick exit isn't our priority. We've been working on exosome research for almost ten years and know that true innovation in diagnostics requires time, validation, and diligence.
Our goal is to establish a sustainable, clinically anchored solution for early cancer detection – not just for today, but for the long term. We want our test to become an integral part of medical care and truly impact patients. We are prepared to take the long road to achieve this – even though regulatory processes in diagnostics often take years.
But: We're not concerned with the principle, but with the result. If an early exit (for example, to a large pharmaceutical company) ensures that our test becomes available worldwide more quickly, we would consider that option. What's crucial for us is that the test doesn't end up in a drawer, but rather saves lives. We'll do whatever it takes to achieve that.
