ENTREPRENEURSHIP

Executive summary

Our entrepreneurship process is built as a lean, evidence-first path from problem discovery to launch. Our steps cover today's stage, with a well-implemented biological system, validating assumptions with dry-/wet-lab proof and modeling, plus a clean plan to grow at scale into a microneedle–microfluidic patch paired with a CRISPR-Cas13a assay and AI signal analysis.We began with primary market research, starting from a clear Business Model Canvas and Pain–Gain work from the customer backwards. Our strategy is defined through PEST and SWOT to highlight regulatory, privacy, supply-chain and risks alongside strong clinical pull and enabling technologies. We map stakeholders by power and interest so regulators, hospital leaders, and frontline teams co-design our first pilots, while payers and patient groups are kept informed. We size and stage growth via TAM/SAM/SOM and a disciplined cash-flow plan. In this way, we create a real vision with clear milestones and measured risks real-time and painless sepsis detection can reach the people who need it most.

Need Statement

Aechmi will be needed both inside and outside the hospital setting. In the field, clinicians rely mostly on clinical judgment and visual signs, while hospitals rely on laboratory and imaging tests that take hours to give results and require a lot of money, workforce and energy. Today's most widely used biomarkers are CRP and Procalsitonin, which are not sepsis-specific and are mensurable in later stages of sepsis. Aechmi on the other hand, is a portable microneedle patch that provides a minimally invasive solution and detects biomarkers in real time. So, through synthetic biology and biosensing, Aechmi provides real-time detection without the need for lab tests.

Business model Canvas

Market Analysis

Stakeholder map

We mapped stakeholders on a power vs. interest grid to see who can really move AECHMI forward and who we must keep in the loop. In our case, the high-power, high-interest corner includes the people who can approve, buy and use the test right away: regulators and health ministries, hospital administrations, ICU/ER clinicians and paramedics, plus large field operators such as WHO missions and MSF. These groups decide whether AECHMI can be piloted and scaled, so we co-design protocols with them, share performance data early, and align on ethics and training.

SWOT Analysis

SWOT is a simple way to look at our project from four angles at once: what we're good at (strengths), where we're fragile (weaknesses), what's opening up around us (opportunities), and what could be used as a political obstacle (threats). We use it to make sure our strategy is reliable and to decide where effort and money should go first.

PEST Analysis

We conducted a PEST to understand the external environment of AECHMI before launch. The analysis evaluates the political/regulatory, economic, social, and technological forces that we cannot control but must plan for. Overall, the picture is encouraging for a rapid, non-invasive sepsis test. However, there are some factors we need to consider to ensure a realistic and well-prepared market entry.

Pain Gain

We use a Pain–Gain diagram to keep our market understanding structured and decision-oriented. It visualizes the relationship between customer jobs, the pains they experience, and the gains they value most. By organizing these insights, we ensure our strategy remains grounded in real user needs rather than assumptions. The diagram also helps align product design, marketing, and communication, linking what we build (products and services) with how it actually creates value (pain relievers and gain creators) adapted to the current market.

TAM SAM SOM

To evaluate the business potential of AECHMI, our CRISPR-based diagnostic system for early sepsis detection, we applied the TAM–SAM–SOM framework. This approach helps us define the total opportunity, our realistic entry markets, and our obtainable share in the short term.

TAM (Total Addressable Market)
The global sepsis diagnostics market is valued at approximately $3.5 billion. This represents the largest potential for AECHMI: all healthcare systems worldwide in need of faster, more accurate sepsis diagnostics. Considering the critical demand for rapid detection technologies that can reduce mortality, morbidity, and healthcare costs, AECHMI addresses one of the most urgent unmet medical needs in intensive care.

SAM (Serviceable Available Market)
Our initial focus is on Europe, where the sepsis diagnostics market is valued at $1.05 billion. Europe represents an accessible entry point due to its harmonized regulatory frameworks (CE marking), well-established clinical networks, and active adoption of innovative diagnostic technologies. By positioning AECHMI within European hospitals and research centers, we can leverage existing collaborations and healthcare infrastructure for faster adoption.

SOM (Serviceable Obtainable Market)
We estimate that AECHMI can realistically capture 10% of the European sepsis diagnostics market, corresponding to $105 million. This projection is supported by:
Our novel use of CRISPR-based recognition of sepsis-specific circulating microRNAs, which ensures precision and sensitivity.
The integration of electrochemical signal detection and amplification, enabling point-of-care use.
The addition of software-driven prognostic insights, a unique differentiator from traditional diagnostics.
Our long-term goal of incorporating AECHMI into a portable microneedle–microfluidic device for real-time patient monitoring.

PAM (Potential Available Market – Expansion)
Beyond sepsis, AECHMI's modular CRISPR-based platform and biomarker detection strategy have the potential to expand into diagnostics for other critical conditions, such as infectious diseases, autoimmune disorders, and oncology biomarkers. This positions AECHMI not only as a breakthrough in sepsis care but also as the foundation for a broader pipeline of rapid diagnostics.

Risk assessment

We use a risk matrix to make trade-offs, scoring each item by its current likelihood and potential impact on the mission. Our approach adapts established risk-management practices to identify hazards, estimate and evaluate risks, implement controls, and monitor their effectiveness. We also weigh demand, public acceptance, and market conditions, practical concerns we expect to face.

Financial Analysis

Our 2025–2028 cash-flow plan funds development through launch while keeping a small positive year-end balance every year (€10k in 2025–26, €20k in 2027, €45k in 2028). Spending is bucketed into salaries, lab/clinical, prototype & capex, software/cloud, QMS & regulatory, marketing, office, and contingencies, with loan repayments starting in 2027; lab/clinical spend moves to COGS in 2028. The financing mix is organized: grants (€250k/€300k/€250k/€100k), founder/seed/bridge capital, and bank loans drawn in 2025–26 and repaid in 2027–28. Sales begin in 2028, with milestones tied to funding tranches and buffers aligned to key risks. More information about our approach can be found on business plan.

Cash Flow

Business Plan

Download our business plan here: Business_Plan.pdf

References

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