Entrepreneurship

Introduction

At ALSense, entrepreneurship is more than a business pathway—it is our way of turning science into tangible impact. As the first team from UIC Barcelona to participate in iGEM, we embraced the challenge of transforming a student-led research project into a solution with real-world potential. From the very beginning, we understood that science alone is not enough—true impact comes when research is paired with strategy, vision, and collaboration.

ALSense is the outcome of this mindset. By working hand in hand with clinicians, patient associations, regulatory experts, and IP advisors, we have been able to design our project with stronger criteria and clearer direction, laying the foundations to eventually evolve into a startup aimed at addressing one of the most urgent needs in neurodegenerative disease: earlier and more accessible ALS detection.

In this section, we present how our business model, development roadmap, and partnerships align to create a credible path forward. This is not just a story of entrepreneurship, it is a story of designing solutions, earning the trust of our ecosystem, and placing entrepreneurship at the service of patients and families who cannot afford to wait.

iGEM Entrepreneurship Criteria

1) Business Plan

The ALSense Business Plan offers a comprehensive look at how our project moves from scientific innovation to real-world application. It begins by addressing the unmet medical need in ALS diagnostics and then lays out our path forward—covering who our potential users and customers are, what value we deliver, how our business model is structured, and the challenges we must overcome.

We also detail our go-to-market strategy, including partnerships, risk management, and the resources and team required to bring ALSense from proof of concept to impact in clinical practice.

Far from being just a technical requirement, this plan acts as a roadmap that bridges our scientific ambitions with a sustainable strategy capable of delivering tangible benefits to patients, families, and society at large.

We strongly encourage readers to explore this section in full to truly understand our vision, our strategy, and how ALSense aims to transform the future of ALS diagnostics.

One Pager

Our one pager provides a quick snapshot of ALSense—summarizing the problem, solution, value proposition, and impact in a single page. It is designed as a clear, accessible tool to introduce our project at a glance.

2) Customers

Problem Statement

The urgency behind ALSense is best understood through the lived experience of ALS patients and the challenges faced by clinicians. Today, the diagnostic journey for ALS is long, fragmented, and often traumatic. Patients and families endure an average of 12 to 16 months of uncertainty before reaching a definitive diagnosis, frequently passing through multiple neurologists and undergoing invasive tests such as lumbar punctures or electromyography. This diagnostic odyssey not only delays the start of supportive care but also excludes patients from enrolling early in clinical trials, where timing is critical.

ALSense directly addresses this problem by offering a fast, accessible, blood-based test that can be implemented in routine hospital workflows. For clinicians, ALSense represents a tool that reduces diagnostic ambiguity and provides a molecular layer of evidence, accelerating triage and decision-making. For hospitals, it creates efficiencies by reducing redundant testing, shortening diagnostic pathways, and lowering per-patient costs. For patients and families, it provides what they value most: certainty and time. And for CROs and pharmaceutical companies, ALSense functions as a recruitment accelerator, enabling faster and more precise identification of eligible patients and generating molecular endpoints for drug development.

In terms of competitive intelligence, current solutions fall short. ALSense is the only solution combining markers of neuronal damage with ALS-specific cryptic peptides, offering both sensitivity and specificity in a single test. This dual capability is a powerful differentiator that sets ALSense apart in a crowded diagnostics landscape.

Customer validation reinforces this value proposition. Interviews with stakeholders. A Spanish ALS foundation, have confirmed that clinicians are actively seeking tools that shorten the diagnostic pathway, while patients emphasize the need for certainty in the face of a life-altering disease. CROs also highlight the bottleneck of patient recruitment for clinical trials, where every month gained in recruitment translates into millions saved in drug development costs. These interviews confirm that ALSense is not just a scientific innovation — it is a solution that resonates deeply with all stakeholders in the ALS ecosystem.

Unique Value Proposition

ALSense is a blood-based multimarker diagnostic platform. It integrates:

• Neurofilaments: Indicators of axonal damage, elevated in ALS and prognostic of disease progression.
• TDP-43 cryptic peptides: Ultra-early biomarkers reflecting the fundamental molecular pathology of ALS, detectable even before clinical symptoms.

This dual-biomarker strategy provides mechanistic breadth: neurofilaments capture neuronal injury, while cryptic peptides identify disease onset at the molecular level. Together, they create a diagnostic window months earlier than current methods.

The detection platform is based on synthetic DNA aptamers, a new generation of molecular binders with clear advantages over antibodies:

• Lower production cost and higher reproducibility, thanks to chemical synthesis.
• Improved stability and scalability in global distribution.
• Flexibility to develop both lab-based ELAA kits and portable lateral-flow formats.

ALSense is designed to be future-proof, with potential for cloud-based analytics and integration with clinical data systems, turning a single test into a decision-support tool for longitudinal monitoring.

For further details on our technology and scientific foundation, please visit the Project Description section.

ALSense creates value across the entire ALS ecosystem:

• Clinicians: Gain access to an early, objective test that complements their expertise, reduces diagnostic uncertainty, and supports treatment decisions.
• Hospitals & Health Systems: Avoid redundant referrals and imaging, reduce pathway costs, and improve patient flow into specialized care.
• Patients & Families: Receive clarity and answers earlier, enabling timely care planning and reducing emotional and financial strain.
• Pharma & CROs: Accelerate patient recruitment, stratify trial participants more effectively, and obtain biomarker-based pharmacodynamic readouts to evaluate drug efficacy.

By addressing each stakeholder's pain points, ALSense positions itself as a catalyst for better care, more efficient systems, and accelerated research.

Know more about our Value Proposition Canvas

1. Customer Profile (Right side – Understanding the customer)

• Customer Jobs → What the customer is trying to get done in their work or life (tasks, problems, or needs).
  Need for a diagnosis when the first symptoms appear.
• Pains → Negative experiences, risks, or obstacles the customer faces while trying to do those jobs.
  Long diagnostic period, many tests, need for specialized doctors…
• Gains → Positive outcomes or benefits the customer expects, desires, or would be surprised by.
  Quick diagnosis or orientation on the diagnosis at the very early stages of the disease.

2. Value Map (Left side – Your product/service)

• Products & Services → What you offer to the customer.
  An orientatory diagnostic kit for ALS.
• Pain Relievers → How your product/service reduces customer pains.
  Shortens the diagnostic time, and can be used at the early stages of disease.
• Gain Creators → How your product/service creates benefits and outcomes for the customer.
  The patients get a diagnosis earlier, therefore they can be treated earlier.

Customer Interview

Through ALSense's close work with experts, patients, and caregivers, we were able to identify concrete scenarios of use for our biosensor that go beyond the broad concept of "early diagnosis." These interviews not only helped us map out unmet needs, but also allowed us to better define who our customers are and in which clinical contexts ALSense would provide the greatest value.

Key Scenarios

• General patients. Today, ALS diagnosis takes 10–16 months on average, because clinicians must wait for visible neurodegeneration to appear in EMG, MRI, or repeated clinical exams. During this time, patients and families live in uncertainty, and treatment or trial opportunities are often missed.
  
  With ALSense, a simple blood test could provide supportive biomarker evidence much earlier in the process. For neurologists, this means a faster confirmation of their clinical suspicion; for patients, it means earlier access to care pathways, assistive devices, and potential inclusion in trials. In practice, ALSense becomes a tool that complements—not replaces—standard tests, helping reduce diagnostic delays that currently harm patient quality of life.
• Partial or uncertain cases. Neurologists often face patients whose clinical presentation strongly suggests ALS, but whose electromyography (EMG) or MRI do not yet confirm neurodegeneration. This diagnostic "waiting period" can last months. ALSense could reduce this gap by providing supporting evidence at an earlier stage.
• SOD1 mutation carriers. First-degree relatives of ALS patients are sometimes offered genetic testing when mutations in SOD1 or other ALS-linked genes (over 20 identified to date) are found. A positive result alone does not mean immediate disease onset, since progression often depends on age and other factors. ALSense could support long-term monitoring of these individuals, detecting biomarker shifts before symptoms emerge. This is particularly relevant for SOD1-related ALS, where early initiation of targeted therapies is linked to better outcomes.
• Patients stratification. ALS is highly heterogeneous: some patients progress rapidly, others more slowly; some present with bulbar onset, others with spinal. This variability complicates both treatment decisions and clinical trial design.
  
  ALSense can help by measuring biomarker profiles longitudinally—tracking neurofilament levels (disease activity) together with ALS-specific cryptic peptides (disease confirmation). This allows clinicians to stratify patients into subgroups:
  • – Fast vs. slow progressors.
  • – Early vs. advanced stage.
  • – Candidates for specific therapies or trials.

This stratification empowers personalized medicine in ALS: doctors can tailor interventions to each patient's trajectory, and researchers can design more efficient clinical trials with well-defined cohorts. In the long term, this positions ALSense not only as a diagnostic tool but also as a disease-monitoring platform.

3) Feasibility

The feasibility of ALSense is grounded in three pillars: a defensible intellectual property strategy, a clear path to industrialization, and a pipeline strategy that transforms a single-disease test into a multi-disease diagnostic platform.

IP Strategy

At the heart of ALSense is a unique aptamer-based technology targeting both neurofilaments and TDP-43 cryptic peptides.

We have conducted preliminary patentability and freedom to operate analysis. By carefully analyzing the scientific publications and the published patents we have concluded that, while the potential diagnostic use of the biomarkers has been previously reported, no diagnostic kit comprising the same set of biomarkers detected by an aptamer-based technology has previously been reported. This would confer novelty to our invention (first criteria of patentability). The most similar documents published are considerably different from our invention, and we overcome their limitations in an innovative way using aptamers and choosing a new specific set of biomarkers. The fact that the solution we present is not obvious for a mean expert in biomedicine means our invention fulfills the inventive step criteria of patentability. Finally, our invention is clearly technical, the third criteria of patentability.

While the freedom to operate may be partially compromised for the binding-reporting system or for one of the biomarkers, based on prior similar cases we strongly consider the possibility of getting to agreements of the owners of the prior patents.

In both the patentability and freedom to operate analysis further investigation is needed by professionals in the field.

The company's IP strategy begins with filings through the Spanish Patent and Trademark Office (OEPM), followed by a PCT application that extends protection across more than 150 jurisdictions. This approach provides ALSense with a 30-month exclusivity window to refine the claims and expand into national filings within the European Patent Office and the USPTO. This analysis not only secures defensibility against competitors but also enhances the company's valuation in future financing and partnership discussions. All of this is validated through meetings with ZBM, a company specialized in biomedical and pharmaceutical patents.

Exit Strategy

An exit strategy is more than a financial consideration — it is a statement of intent. It demonstrates to investors that ALSense is not only focused on building cutting-edge science but also on delivering concrete returns. By defining our exit pathways from the outset, ALSense reinforces confidence: we set profitability objectives, anticipate divestment windows, and ensure that the venture remains attractive across market cycles.

In biotechnology, where development timelines are long and capital-intensive, a well-structured exit plan is essential. ALSense has carefully evaluated industry-standard exit routes and adapted them to its unique positioning.

ALSense views its exit plan as a signal of intent, ensuring investors see both strong science and clear financial returns.

• Preferred Path — IPO: The primary objective is to go public (BME Growth, Euronext Growth, or Nasdaq by ~2030). This route provides liquidity, visibility, and independence, supported by solid economics (70–80% gross margins, break-even at ~27,000 tests, ROI 2.5–3.5x by Year 5–6). Regulatory milestones (CE-IVD) are aligned with revenue inflection to enable a credible listing.
• Alternative Path — M&A: While IPO is preferred, ALSense keeps channels open with strategic acquirers in diagnostics and pharma, ensuring leverage and flexibility if an attractive offer arises.
• Secondary Sales: Early investors may exit by selling equity to later-stage or strategic investors, maintaining company continuity.

Financial Outlook & Growth: Break-even is projected at ~€4M revenues within 3 years of launch, with €3–5M annually by Year 5 and >5x ROI potential through expansion into Alzheimer's and Parkinson's. Partnerships with Spanish and European hospitals strengthen clinical adoption and industrial scale-up.

Long-Term Vision: ALSense evolves from an ALS-specific test into a multi-disease aptamer diagnostics platform, expanding impact across neurodegeneration and reinforcing its scalability, defensibility, and global relevance.

Market & Impact

• Initial Market: Spain, with ~4,000 ALS patients and 900–1,000 new cases annually, provides an ideal launchpad.
• Expansion: Entry into EU markets via CE-IVD certification, followed by the UK and other regions.
• Global Opportunity: ALS has ~200,000 patients worldwide; the addressable neurodegenerative diagnostics market is valued in billions and growing annually.

ALSense's broader impact lies not only in economics but also in social responsibility: reducing diagnostic odysseys, empowering families, and advancing global ALS research.

TAM SAM SOM

Competitive Landscape

The current diagnostic ecosystem for ALS is dominated by Neurofilament assays—such as Quanterix Simoa®, Roche Elecsys®, and UmanDiagnostics NF-Light™ ELISA—together with centralized testing offered by major reference labs (Labcorp, ARUP, Mayo). These solutions are reliable and increasingly accessible, but they share a key limitation: neurofilament is not disease-specific. It reflects neuronal injury but cannot distinguish ALS from other neurological disorders. In addition, centralized workflows often involve costs of several hundred dollars and turnaround times of 1–7 days, depending on platform and logistics.

ALSense introduces a step change with a professional point-of-care (PoC) blood test that combines aptamer-based detection with a multi-biomarker panel relevant to ALS. This approach enables greater specificity and earlier detection from a simple blood draw. The target is minutes to same-day results at a price of around €150 per test, reducing reliance on central labs, shortening time-to-decision, and supporting faster referrals, patient stratification, and early clinical trial enrollment. In short: while today's market measures "neuronal damage" (useful but non-specific), ALSense aims to measure "ALS" itself, bringing higher clinical value closer to the patient.

PESTEL

4) Planning

The development of ALSense has been carefully structured to balance scientific validation, regulatory compliance, and commercial readiness. The plan is laid out as a sequence of progressive milestones, each aligned with funding rounds, clinical evidence, and risk mitigation strategies.

Lean Business Model Canvas (LBMC)

At the core of ALSense's strategy is a simple but powerful model: identify a critical clinical problem, deliver a superior solution, and capture value through a scalable business model. The problem is clear — a 12-month diagnostic delay in ALS. The solution is a blood-based aptamer biosensor, the only test capable of combining sensitivity and specificity. Customers include hospitals, CROs, and pharmaceutical companies, reached through direct partnerships with neuromuscular centers and KOLs. The revenue model is diversified, with high-margin consumable sales complemented by pharma service contracts. The key resources are the proprietary aptamer platform, the regulatory dossier, and an expanding network of clinical and industrial partners.

Roadmap and Gantt Timeline

The roadmap is both ambitious and realistic, designed to move ALSense from proof of concept (TRL 3) to market launch (TRL 9) within five years:

• 2025–2026: Proof of Concept & Validation — purification of biomarkers, aptamer discovery, prototype biosensor development, early usability checks.
• 2027: Preclinical Validation — case–control studies (50–100 patients), optimization of performance, establishment of collaborations with hospitals and biobanks.
• 2028: Clinical Validation & CE-IVD Filing — multicentric validation studies, regulatory dossier preparation, scale-up of manufacturing under ISO 13485.
• 2029–2030: Commercialization — launch in Spain and EU-5, expansion into CRO contracts, preparation for multi-disease pipeline expansion.

5) Credibility

No matter how disruptive the technology, investors and strategic partners ultimately place their trust in the team, the ecosystem, and the company's ability to execute. ALSense has been deliberately structured to inspire this confidence, combining deep scientific know-how with a clear plan to close existing skill gaps, a robust SWOT analysis, a due diligence-ready structure, and a value chain that stretches from bench to bedside.

Skill Gap Analysis

The founding team of ALSense is composed of students currently training in biomedicine and bioengineering, bringing a unique combination of motivation, creativity, and a deep commitment to addressing ALS. Our academic background provides solid foundations in biomarker discovery, aptamer design, and translational neuroscience, ensuring that ALSense is not only an innovative idea but also a scientifically grounded venture.

At the same time, we are fully aware of our limitations. While we can rely on the guidance of our mentors for the initial phases of aptamer development, it will be essential to incorporate a senior expert in aptamer technology to strengthen decision-making and accelerate technical milestones. Beyond the laboratory, there are additional areas where we must complement our expertise: regulatory affairs, industrial manufacturing, and EU reimbursement strategy. These are not shortcomings but opportunities to grow as a team by integrating external know-how.

ALSense is already moving in this direction: we are in discussions with regulatory consultants experienced in CE-IVDR, manufacturing partners with ISO 13485 certifications, and advisors with strong payer-market access track records. Building these collaborations is not optional; it is a central part of transforming ALSense into a company capable of standing shoulder-to-shoulder with established leaders in diagnostics.

SWOT

Strengths

ALSense is built on a unique biomarker panel that unites sensitivity and specificity: neurofilaments for neuronal damage and TDP-43 cryptic peptides, present in 97% of ALS cases, for disease-specific confirmation. This dual approach differentiates ALSense from competitors who rely solely on neurofilament assays. The company's aptamer-based platform is protected by a robust IP roadmap (OEPM → PCT → EPO/USPTO), creating strong defensibility in an untapped diagnostic IP space. On the business side, ALSense demonstrates exceptional unit economics: 70–80% gross margins, break-even at ~27,000 tests (≈€4M revenues), and ROI projections of 2.5–3.5x within 5–6 years. These strengths position ALSense as both a scientific pioneer and a scalable commercial venture.

Weaknesses

As with any early-stage biotech, ALSense faces resource constraints. The company is still dependent on successful regulatory approvals under CE-IVDR, and commercialization requires building a specialized network in manufacturing, regulatory affairs, and reimbursement strategy. Early reliance on partnerships for clinical validation may create execution bottlenecks. These challenges are not structural flaws but reflect the typical trajectory of a high-potential biotech transitioning from proof of concept to market.

Opportunities

The upside for ALSense is profound. Beyond ALS, the platform can be extended to Alzheimer's and Parkinson's, creating the world's first multi-disease neurodegenerative diagnostics platform. This scalability significantly expands the addressable market. In Europe, ALSense can leverage innovation funding streams (Horizon Europe, EIC Accelerator, national biotech grants) to de-risk capital needs. Additionally, partnerships with CROs and pharmaceutical companies open a parallel revenue stream through clinical trials, a market segment increasingly reliant on precise biomarkers for recruitment and monitoring. Finally, the broader trend toward personalized and precision medicine creates a strong tailwind, positioning ALSense at the nexus of science, market need, and healthcare policy priorities.

Threats

ALSense operates in a competitive arena where global players such as Roche or Quanterix have larger budgets and established distribution networks. While these incumbents focus narrowly on neurofilaments, their scale and reach represent a latent threat should they pivot toward broader biomarker panels. Regulatory complexity under IVDR in Europe also represents a risk: delays in dossier approvals could push back commercialization timelines. Finally, adoption inertia in hospitals — where new diagnostics often face reimbursement and workflow barriers — must be proactively managed through strong health-economic data and KOL advocacy.

Value Chain

ALSense's value chain demonstrates scalability and defensibility at every stage:

• Discovery & Design: aptamer selection and biomarker validation.
• Development & Production: kit assembly under ISO standards, leveraging partnerships with established suppliers.
• Distribution & Adoption: early adoption by hospitals and neuromuscular centers, KOL advocacy to accelerate clinical uptake.
• Expansion & Integration: pharma partnerships for CRO contracts, and eventually, a data monetization layer that provides population-level insights into neurodegenerative disease progression.

This is more than a product roadmap — it is a blueprint for an entire ecosystem. ALSense is positioned not only as a test but as a platform, with defensible intellectual property, validated clinical partners, and a value chain that generates recurring revenues and strategic data assets.

Credibility is the ultimate currency in biotech. ALSense has it in abundance: a world-class scientific foundation, a humble recognition of its current gaps with a clear plan to fill them, operational readiness for regulatory scrutiny, and a value chain that extends its relevance well beyond ALS. For investors, ALSense is not a gamble — it is a calculated opportunity with the infrastructure, vision, and ambition to deliver outsized returns and lasting impact.

For a more detailed description of our stakeholder engagement process and how their insights shaped every aspect of our business, please refer to the Integrated Human Practices section of this wiki.

6) Impact

ALSense is more than a diagnostic test — it is a transformative platform with the potential to reshape the way neurodegenerative diseases are detected, treated, and managed. The impact of this venture must be measured across three dimensions: risk management, alignment with global sustainability goals, and the broader societal change it enables.

Risk Assessment

Biotech ventures live and die by their ability to anticipate and mitigate risks. ALSense has mapped its risk profile across four axes:

• Technical Risk: Will the biomarkers and aptamer system perform reproducibly across diverse patient populations? Mitigation comes from a dual-marker strategy, cross-validated in multiple matrices (CSF, plasma, serum), ensuring robustness beyond single-marker approaches.
• Regulatory Risk: CE-IVDR classification and clinical validation requirements represent a significant hurdle. ALSense is addressing this with staged QMS implementation, early engagement with regulatory consultants, and clinical trials designed explicitly to meet CE dossier standards.
• Commercial Risk: Adoption inertia and pricing pressures can slow market uptake. ALSense counters this with a compelling health-economic case: per-patient cost savings of €2,500–6,000, indirect societal savings of up to €11,000 annually, and system-wide savings of €7–15M per year in Spain alone.
• Operational Risk: Manufacturing and supply chain scalability. Mitigation strategies include modular production planning and partnerships with experienced ISO 13485 suppliers.

The result is a company that does not shy away from risks but faces them head-on, with structured mitigation woven into its roadmap.

Alignment with the UN Sustainable Development Goals (SDGs)

ALSense is not just aligned with industry needs; it is aligned with global priorities:

• SDG 3: Good Health and Well-Being. ALSense accelerates diagnosis, reduces suffering, and provides patients and families with clarity when they need it most.
• SDG 9: Industry, Innovation, and Infrastructure. The aptamer biosensor platform is a breakthrough diagnostic technology, pushing the frontier of precision medicine and building new industrial capabilities in Europe.
• SDG 10: Reduced Inequalities. ALSense democratizes access to cutting-edge diagnostics, beginning in Spain and expanding to the EU, ensuring patients in public and private systems alike benefit from innovation.
• SDG 17: Partnerships for the Goals. ALSense thrives on collaboration — with hospitals, patient organizations, CROs, and pharma — proving that the fight against neurodegeneration cannot be won alone.

Societal and Investor Impact

The ultimate promise of ALSense is twofold. For society, it is the chance to turn ALS from a disease of diagnostic uncertainty into one of diagnostic clarity and timely intervention. For investors, it represents a rare opportunity: a venture with high scientific defensibility, early break-even potential, and transformative long-term upside as a multi-disease platform.

In five years, ALSense will not only be a profitable company — it will be a symbol of how cutting-edge science, smart strategy, and social responsibility can align to create impact far greater than the sum of its parts. In ten years, it has the potential to stand as the standard of care for neurodegenerative diagnostics, a reference platform adopted across Europe and beyond.

ALSense embodies what the future of healthcare innovation should look like: profitable, defensible, scalable, and impactful.