Marketing content

Why invest in PCaVision

Breakthrough in prostate cancer diagnostics
PCaVision is an AI-powered software application that facilitates urologists to diagnose using ultrasound imaging removing the need for MRI scans and radiologist involvement in the diagnostic process. PCaVision enables single visit prostate cancer diagnostics directly in the urology clinic - faster, more accessible, and at reduced cost.

Large, fast-growing market
Over 10 million diagnostic procedures are performed globally each year, with demand rising 10% annually. PCaVision targets this expanding market with a scalable, low-cost alternative to MRI, addressing a key bottleneck in prostate cancer diagnostics.

Clinically validated and ready for market
Built on data from over 600 patients and ongoing multi-centre validation, PCaVision has proven non-inferior to MRI in detecting lesions suspicious for prostate cancer. The product is CE-marked and commercial sales have started. Two clinics have become first customers, one in Germany and one in The Netherlands.

Backed by leading investors and partners
Supported by institutional investors such as NLC Health Impact Fund, CbusineZ, and TU/e Holding, and developed in collaboration with GE Healthcare, BRACCO, and Eindhoven University of Technology, PCaVision combines scientific strength with industrial scale-up potential. The company has already raised €2.4 million in a first close, with an additional €1.9 million anchor investment secured for the current Invesdor round - reflecting strong investor confidence and commitment to its next growth phase.

Scalable, recurring revenue model
PCaVision operates on a per-scan license model, generating predictable recurring income once installed in clinics. First revenues are expected in late 2025, with strong growth potential as adoption expands across Europe.

Mark Bloemendaal, Chief Executive Officer

“The aging population means more men need prostate cancer diagnosis than ever before; demand is set to double by 2040. Yet MRI capacity simply cannot keep up. This diagnostic gap is widening every year.

PCaVision is the solution to this fundamental problem. We deliver MRI-equivalent diagnosis through AI-powered ultrasound, enabling diagnosis in minutes instead of weeks or even months. The technology is clinically proven, cost-effective and scalable worldwide. Ready now.

With your investment, we can accelerate the international rollout of PCaVision and make high-quality diagnostics available to every patient, everywhere.

Join us in transforming prostate cancer care.” 

Mark Bloemendaal, CEO & Founder, PCaVision

Investment information

Days to invest:
20
Investing round ends:
02/12/2025
Type:
Equity offering
Invested so far:
€2,112,478.50
Equity offered:
1.86 – 7.05 %
Price per share:
€181.50
min investment 2 shares
Transaction costs:
1.50 %
Number of existing shares:
131,767
Fully diluted shares:
134,767
Pre-money valuation:
€24,460,000.00
Maximum issue size:
€3,900,072
Offered units:
21,488
Broker:
Oneplanetcrowd International B.V
License:
ECSPR

Overview

Company profile

Prostate cancer is one of the most common cancers in men, with over 10 million diagnostic procedures performed worldwide each year - and demand rising by around 10% annually as populations age and screening expands. Despite this, today’s diagnostic methods remain slow, invasive, and costly.

Current procedures rely either on MRI imaging followed by targeted biopsy or on systematic biopsy without imaging guidance. MRI offers good sensitivity but adds significant cost, is capacity-constrained, and dependent on an expert radiologists, resulting in long waiting times. Systematic biopsy, on the other hand, is widely available but invasive and has a lower cancer detection rate and requires also negative patients to undergo the procedure.

PCaVision, founded in 2018 and operational since 2020, is a spin-off from Eindhoven University of Technology (TU/e) dedicated to transforming prostate cancer diagnosis. The company develops AI-powered diagnostic software that integrates 3D/4D ultrasound imaging with advanced machine learning to deliver MRI-equivalent diagnostic accuracy - faster, simpler, and far more scalable.

The PCaVision software enables urologists to perform a single-consult prostate cancer diagnosis directly in the clinic, eliminating dependence on MRI and external radiology. This innovation reduces diagnostic time from weeks to minutes, improving patient outcomes, streamlining clinical workflows, and lowering costs for healthcare systems.

Company Info 

Company name: PCaVision
(Registered tradename of Angiogenesis Analytics B.V.)
Managing director: Mark Bloemendaal
Business ID number: KVK 72117583
Founding year: 2018, in operation since 2020
Address: JADS Venture Campus
Sint Janssingel 88
5211 DA ’s-Hertogenbosch
The Netherlands
Industry: Medical Technology / HealthTech
Number of employees: 24
Locations: Headquartered in the Netherlands,
with clinical collaborations in 18+ hospitals and research centers across Europe and the U.S.
Website: www.pcavision.com
Social media:

Products and services

The company has developed PCaVision, a software-based medical device that helps urologists detect and localize clinically significant prostate cancer directly in their own clinics. The solution combines 3D and 4D ultrasound imaging with artificial intelligence to provide MRI-level diagnostic insight - without the time, cost, or capacity bottlenecks associated with MRI.
 

PCaVision Logo

How PCaVision works

Using a standard 3D transrectal ultrasound probe, PCaVision applies AI-based image interpretation to generate a colour-coded heat-map that highlights regions suspicious for clinically significant cancer. This visualisation is overlaid directly in the ultrasound DICOM viewer, allowing the urologist to identify and target potential lesions for biopsy within the same consultation.

A full diagnostic workflow - from acquisition to AI analysis - takes around 20 minutes, with results available within minutes. PCaVision integrates seamlessly with the existing GE Healthcare LOGIQ E10 ultrasound system and the MIM DICOM software.

PCaVision Model

Left: Ultrasound machine capturing prostate images.
Center: Computer running the PCaVision software.
Right: Screen shows where suspicious areas are located. The urologist can immediately plan a targeted biopsy, without MRI referral or weeks of waiting.


Key benefits for clinics and patients

  • Enables same-day diagnosis and biopsy planning, reducing the diagnostic process from weeks to minutes.
  • Eliminates dependency on radiologists and MRI scanners - the entire pathway is managed by the urologist.
  • Reduces unnecessary biopsies by 75% compared to the Systematic Biopsy procedure.
  • Enables cost savings for clinics - a private urology clinic sourcing MRI capacity from an external hospital or MRI center can save over €50,000 annually.
  • Simple to learn: experienced ultrasound users can operate PCaVision confidently after just a few procedures.


With PCaVision, the company introduces a faster, more accessible, and more affordable way to diagnose prostate cancer, helping hospitals expand diagnostic capacity and patients receive earlier, less invasive care.

PCaVision Diagram

PCaVision reduces time to treatment from months to weeks by eliminating MRI dependency. Patients get answers faster, urologists have full control, and healthcare systems increase capacity.

Business model

PCaVision operates a scalable software-as-a-service (SaaS) model built on recurring license income. Clinics pay a per-diagnosis usage fee for scans performed with PCaVision, generating predictable, growing revenue once the system is installed.

Each clinic purchases a compact on-site processing computer and probe fixture from PCaVision. At the same time, the ultrasound scanner, contrast agent, and viewer software are sourced through existing partnerships with GE Healthcare, Bracco, and MIM Software.

This structure supports a lean, high-margin business model with reliable recurring revenues. After installation, each clinic generates ongoing income through tiered monthly licenses, typically ranging from €2,500/month for ~400 scans annually to €6,000/month for ~1,200 scans, plus a modest one-time onboarding package covering equipment setup, hospital integration, and clinical training.

For most hospitals and clinics, the economic case is compelling. Compared to MRI-based pathways, the ultrasound + AI approach reduces per-diagnosis costs, increases throughput, and delivers faster results to patients. The simplicity of implementation and clear operational benefits make PCaVision an attractive upgrade for urology departments.

Because PCaVision’s production is related to software only, scaling is rapid and capital-light. The company projects first customer contracts in 2025 followed by accelerated growth as adoption expands across Europe and international markets. Revenue in 2026 amounts approximately €1.15 million in 2026. Over time, this model enables high-margin, recurring income with minimal variable cost and strong operational leverage.

PCaVision Diagram

Market

Prostate cancer diagnostics represent a large and rapidly expanding global market. Over 10 million diagnostic procedures are performed each year, with demand increasing by approximately 10% annually as populations age and screening programs grow. By 2040, this demand will double to 20 million procedures annually. However, current MRI based diagnostic methods remain costly, capacity-constrained, and slow, creating a clear need for faster and more accessible alternatives.

PCaVision addresses this gap by offering an AI-powered ultrasound solution, capable of delivering MRI-equivalent diagnosis at a fraction of the time and reduced cost.

The company estimates a Serviceable Addressable Market (SAM) of roughly 5 million procedures annually across Europe and the United States, targeting a 12% market share by 2029 equivalent to about 600,000 scans per year.

Competition in this segment is limited. MRI remains the current benchmark, but no comparable AI-ultrasound diagnostic solution is commercially available.

PCaVision holds a strong first-mover advantage, protected by a growing patent portfolio, proprietary clinical datasets, and strategic partnerships with GE Healthcare, Bracco and MIM Software. This combination establishes high barriers to entry and a defensible market position.

Technology and intellectual property

The PCaVision technology builds on 12 years of academic research conducted by the Biomedical Signal Processing group, led by Prof. Massimo Mischi at the Technical University of Eindhoven (TU/e), in collaboration with the academic hospital Amsterdam UMC. Since 2020, the PCaVision engineering team has continued to advance the technology, and by 2025, clinical evidence confirmed its equivalent performance in prostate cancer detection.

PCaVision holds a strong intellectual property position, with all IP fully owned by the company and entirely royalty-free.

PCaVision Diagram

Impact

The United Nations Sustainable Development Goals (SDGs) form the international framework for sustainable development through 2030, aiming to reduce poverty, inequality, and improve health outcomes globally.
 

SDG 3

PCaVision contributes directly to SDG 3: Good Health and Well-being by making advanced cancer diagnostics faster, more accessible, and more affordable.

The technology enables hospitals and clinics to detect prostate cancer earlier without reliance on MRI plus expertly trained radiologists. It supports single-consult diagnosis, reduces unnecessary biopsies, and shortens waiting times - all of which improve patient outcomes and healthcare efficiency.

By combining artificial intelligence with widely available ultrasound technology, PCaVision helps democratise access to high-quality diagnostics, ensuring that men everywhere - including those in regions with limited MRI capacity - benefit from timely and precise prostate cancer detection.

Management

  

Mark Bloemendaal, Chief Executive Officer

Mark Bloemendaal

Chief Executive Officer

Mark Bloemendaal is the founder and CEO of PCaVision. With over 25 years of experience in health technology and entrepreneurship, he has built and led multiple ventures dedicated to improving the quality, accessibility, and affordability of healthcare through innovation. Before founding PCaVision, Mark led SmartRollout and Implementation IQ, and held leadership positions at VDG Security, Adelante Technologies and Frontier Design. His extensive background in healthcare innovation, business development, and technology implementation has been instrumental in transforming PCaVision from a university spin-off into a growth-stage MedTech company bringing AI-powered diagnostic technology to market.

  

Wim Zwart, Algorithm Development Lead

Wim Zwart

Algorithm Development Lead

Wim Zwart leads algorithm development at PCaVision He brings over 20 years of experience in signal processing, system architecture, and data science from international technology companies including Cirrus Logic, Wolfson Microelectronics, and imec. After earning his Master’s degree in Data Science from the University of Edinburgh, he joined PCaVision to develop and validate the AI models that form the core of PCaVision’s diagnostic performance. His expertise bridges deep technical design with practical clinical application, ensuring the reliability and accuracy of the PCaVision technology.

  

Armand Wemelsfelder, Product Development Lead

Armand Wemelsfelder

Product Development Lead

Armand Wemelsfelder leads product development at PCaVision. With more than 25 years of experience in software and systems engineering, he has built a strong career in embedded systems and video processing at companies such as Philips, Siqura, and ActiveVideo. He is also the founder of Amoeba Embedded, specialising in hardware and software development for embedded platforms. At PCaVision, Armand oversees software architecture, integrations, and product reliability, ensuring that the PCaVision product operates seamlessly in clinical environments.

  

Mark Maris, Sales Director

Mark Maris

Sales Director

Mark Maris is Sales Director at PCaVision. He brings over 20 years of commercial experience in the medical imaging sector, having held senior sales and management roles at GE Healthcare, Philips Medical Systems, and BK Medical, where he served as VP Direct Sales Europe and Country Manager for several European regions. Mark is responsible for building the company’s global sales network.

  

Anna Garrido Utrilla, Clinical Operations Manager

Anna Garrido Utrilla

Clinical Operations Manager

Anna Garrido Utrilla is responsible for clinical operations at PCaVision. She holds a PhD in medical research and has extensive experience in oncology and diabetes studies across Europe. Before joining PCaVision, she worked as a researcher at Inserm France and the University of Turku in Finland and later as a Health Service Advisor at IQVIA, where she managed patient enrolment and clinical compliance for multi-country trials. At PCaVision, Anna coordinates multi-centre clinical studies, ensuring the highest standards of data quality, regulatory compliance, and clinical validation for the company’s medical devices.

Advisory Board

  

Massimo Mischi, Scientific Strategic Advisor

Massimo Mischi

Scientific Strategic Advisor

Prof. Massimo Mischi is Scientific Strategic Advisor to PCaVision and Professor of Biomedical Signal Processing at Eindhoven University of Technology (TU/e). As Chair of the university’s Signal Processing Systems Group, he leads research in quantitative biomedical signal analysis with a focus on ultrasound and MRI technologies. Prof. Mischi has been closely involved with PCaVision since its early spin-out phase, providing scientific guidance on imaging algorithms and clinical validation. His research expertise forms a cornerstone of the company’s innovation in ultrasound-based cancer diagnostics.

  

Hessel Wijkstra, Clinical Strategic Advisor

Hessel Wijkstra

Clinical Strategic Advisor

Prof. Hessel Wijkstra is Clinical Strategic Advisor to PCaVision and a Professor at Eindhoven University of Technology (TU/e). A leading expert in ultrasound imaging and urology, he has contributed extensively to research on prostate cancer diagnostics and imaging-based interventions. As part of PCaVision’s Advisory Board, he supports the company’s clinical strategy and ensures that product development aligns with the highest medical and scientific standards.

  

Roland Zegger, Strategic Advisor

Roland Zegger

Strategic Advisor

Roland Zegger is Commercial Strategic Advisor to PCaVision. He brings more than 30 years of leadership experience in the pharmaceutical and MedTech industries, having served as General Manager at Abbott and AbbVie and as a Venture Partner at NLC Health Ventures. He currently holds advisory and board positions at several life-science companies, including Technobis Crystallization Systems and FlowView Diagnostics. Drawing on his extensive background in business development, sales, and strategic growth, Roland supports PCaVision in shaping its commercial strategy and international market expansion.

Company structure

PCaVision is an official trademark of Angiogenesis Analytics B.V., a privately held company headquartered in ’s-Hertogenbosch, the Netherlands. It acts as the holding company of Angiogenesis Analytics Inc., which is incorporated in the United States. Together, these entities form the PCaVision Group.

The Dutch holding company is responsible for the strategic development of the Group as well as all research, product development, regulatory, and commercialisation activities for the Group.

PCaVision Inc. oversees the operational setup and potential future commercial rollout in the North American market.

The Group’s structure is straightforward and transparent. All shareholders hold their equity directly in PCaVision B.V., ensuring clear governance and full alignment of interests across regions. Invesdor investors will participate in the same share class as the existing institutional investors and therefore benefit from identical economic rights.

Distribution of company shares

PCaVision B.V. has a well-balanced shareholder base combining institutional investors, venture builders, family offices, and private entrepreneurs. This diverse mix provides both financial strength and strategic value, supporting the company’s transition from R&D to international commercialization.

The company shares after the first close of the investment are devided as follows:

Uneti Ventures, Regoliet, Black Box Participaties, Van Eerd Capital, and NLC Health Impact Fund (32%)
These venture capital funds and family offices add financial depth and experience in healthcare investments. Their involvement reflects strong confidence in PCaVision’s commercial potential and impact-driven mission.

Angel Investors (26.7%)
A group of experienced entrepreneurs and medical professionals who provided early support and continue to contribute their strategic networks and hands-on industry knowledge.

NLC MSB B.V. (12.6%)
NLC is Europe’s leading healthtech venture builder and has supported PCaVision from its earliest stage. With deep expertise in scaling medical innovations, NLC provides strategic guidance and access to an extensive network of MedTech investors and partners.

CbusineZ (10.9%)
CbusineZ, the investment fund of a major Dutch health insurer, strengthens PCaVision’s access to healthcare markets and reimbursement expertise, offering valuable insight into clinical implementation pathways.

TU/e University Holding B.V. (7.9%)
As the investment arm of Eindhoven University of Technology, TU/e Holding ensures close scientific collaboration and helps translate academic research into practical clinical innovation.

Mark Bloemendaal / Monarch Holding (6.3%)
Founder and CEO of PCaVision, Mark Bloemendaal remains a key shareholder, ensuring strong alignment between management and investors.

HMG Medical Group (2.1%)

STAK Early Employees (1.5%)
The company has also a Stock Appreciation Rights (SARS) plan in force to reward and retain employees. This plan is funded by the value of a package of 5% of shares of the venture after Series A Closure. All employees benefit from this plan and is triggered by an exit event.

In this round, preferred shares will be issued to these investors and to new participants joining via the Invesdor Series A round. Invesdor investors will receive the same preferred share class, ensuring full alignment with existing institutional shareholders.


What does this mean for investors?

The presence of respected institutional backers, academic partners, and experienced healthcare investors provides PCaVision with both credibility and strategic reach. For new investors, this means joining a company that is not only scientifically validated but also backed by organisation capable of accelerating market access, commercialisation, and future funding rounds.

Shareholder

Shares

Votes

1 Stichting Administratiekantoor CUDI Investors 26,761 20.3%
2 NLC MSB B.V. 16,558 12.6%
3 Stichting CbusineZ 14,365 10.9%
4 TU/e Holding B.V. 10,400 7.9%
5 Monarch Holding B.V. 8,239 6.3%
Other shareholders (each with ownership of less then 6%) 55,444 42.0%
TOTAL 131,767 100%

Use of funds

PCaVision is currently executing its Series A financing round, which totals up to €6–8 million. A first close of €2.46 million has already been completed with existing and new professional investors, and these funds are being used to advance clinical validation, strengthen the team, and prepare the first commercial rollouts.

PCaVision Diagram


The current Invesdor round forms part of the second tranche, enabling the company to accelerate growth and scale internationally. PCaVision has also already received commitments to the value of €2.4 million for this second tranche.

Depending on the total amount raised, PCaVision will prioritize activities as follows:

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Minimum Scenario

(Minimum funding of ~€2,400,000 collected in the financing round:
~€500,000 by crowd investors and
~€1,900,000 from anchor investors)

In this scenario, PCaVision will focus on its core European activities and maintain a conservative growth pace while preserving full operational continuity.

  • 30% Clinical trials and validation studies
  • 30% Research and product development (AI improvement, regulatory compliance)
  • 25% Marketing and sales enablement within Europe
  • 15% General operations and legal

This allocation ensures the company maintains momentum in Europe and finalizes ongoing studies that support reimbursement and clinical adoption.

Icon 2

Maximum Scenario

(Maximum funding of ~€3,900,000 collected in the financing round:
up to ~€2,000,000 by crowd investors and
~€1,900,000 from anchor investors)

If more than the minimum target amount and up to the full target is reached, PCaVision will accelerate commercialization and expand internationally, particularly into the United States.

  • 35% Clinical trials and validation studies (EU & US)
  • 30% Product and AI development (next-generation PCaVision software)
  • 25% Market expansion and partnerships (commercial rollout, distributor onboarding)
  • 10% Organizational growth, legal, and working capital

This scenario enables the company to execute its full growth plan, moving from early revenues in 2025 toward large-scale market adoption and preparing for a Series B growth round.


Note: All funding amounts are marked with “~” to indicate nearest-rounding. This approach is used to provide a transparent and accessible overview for investors, without implying precise or fixed budget allocations.

The second tranche of PCaVision’s Series A financing round amounts to approximately €1.9 million, provided by existing and new professional investors. This co-investment complements the Invesdor equity round and secures the company’s minimum funding target of €2.4 million.

The funds are contributed by a strong group of committed backers who have supported Angiogenesis in previous rounds and continue to invest in its next growth phase.

Investor Amount
1 Medtech Entrepreneur ~€1,500,000
2 Angel Investors ~€400,000

If the full target amount is not reached, these committed co-investors will ensure that PCaVision maintains a solid 12-month financial runway under the minimum scenario.

Financial figures & growth

Actual and planned figures

Get an insight into PCaVision's financial figures, such as turnover and earnings development. Learn more about the growth forecast.

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Valuation

Icon Money

For the second close of the Series A, PCaVision is valued at a €24.46 million pre-money valuation. The total Series A round was started at a pre-money valuation of €22 million, which is increased by the €2.46 million investment of the first close to reach the valuation of the second close. This valuation has been determined based on the company’s technological maturity, intellectual property portfolio, market potential, and expected commercial traction.

The valuation reflects approximately twice the total capital invested to date and has been benchmarked against comparable MedTech transactions using the venture capital method. It is also in line with the valuation accepted by the company’s existing institutional investors and family offices participating in the current tranche.

At this valuation level, Invesdor investors will acquire the same preferred share class as the most senior existing shareholders, benefiting from identical economic rights, with the same preferred share class as current institutional investors.

The company’s long-term valuation potential is supported by its strong IP position, first-mover advantage in ultrasound-AI diagnostics, and scalability across global markets, which together create significant upside for investors entering at this stage.


PCaVision is currently executing its Series A financing round, structured in two tranches to support the company’s transition from R&D to commercial rollout.

The first tranche, amounting to €2.46 million, was completed in August 2024 and funded by existing shareholders, including NLC Health Impact Fund, Regoliet Family Office, Uneti Ventures, and several angel investors.

The second tranche, totaling €2.4 million, combines the €1.9 million in co-investments from existing and new professional investors with up to €0.5 million raised via the Invesdor platform. Together, these funds secure the minimum funding scenario of €2.4 million and provide a runway of approximately 12 months.

In the maximum scenario, the Series A round may be extended to €6-8 million, enabling accelerated international expansion, additional clinical studies, and market entry in the United States.

A follow-up Series B financing round of around €10 million is planned for December 2026, supporting large-scale global commercialization and operational scale-up.

Since its founding in 2018, PCaVision has raised approximately €12 million in a combination of equity, convertible loans, grants, and innovation credits. These funds have supported the development, validation, and certification of the company’s PCaVision diagnostic platform.

The early funding rounds were led by NLC Health Ventures, which supported PCaVision during its spin-out from Eindhoven University of Technology (TU/e). Additional capital was provided by institutional investors such as CbusineZ, Uneti Ventures, and TU/e University Holding, along with several family offices and angel investors.

The current Series A round builds on this foundation, following years of product and clinical development that have brought PCaVision to market readiness with CE certification and a clear commercialization roadmap.

This continuous investor support underscores strong confidence in PCaVision’s technology, management, and growth potential in the global MedTech market.

Exit scenarios

PCaVision is positioned for a clear value uplift following CE certification, U.S. market clearance, and commercial rollout. These milestones open the door to several realistic exit opportunities commonly seen in the MedTech sector:


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Strategic acquisition by a MedTech or diagnostics company
Global healthcare technology leaders such as GE Healthcare, Philips, or Canon may pursue the acquisition of PCaVision to strengthen their diagnostic imaging and AI portfolios. PCaVision’s proven clinical performance and integration with ultrasound systems make it a highly attractive acquisition target once commercial traction is demonstrated.

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Secondary share sale in a future growth round
After market launch and early revenue growth, PCaVision may raise a larger Series B round to scale international operations. This would provide the opportunity for early investors to exit partially or fully at a significantly higher valuation, based on validated technology and recurring revenue performance.

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Out-licensing or regional distribution agreements
PCaVision may pursue strategic licensing or distribution deals with major healthcare companies, especially for markets outside Europe. Such partnerships can generate upfront payments, royalties, or milestone-based income - offering earlier liquidity options while expanding the company’s global reach.

The management team and lead investors have extensive experience with licensing, growth-stage fundraising, and strategic transactions, ensuring that exit opportunities will be professionally evaluated and pursued when the time is right.


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Risks

Investing in growth companies always involves risks. Below you can find the detailed list of risks related to this investment, as described in the Key Investment Information Sheet (KIIS). Please review this information carefully before making your investment decision.


  • The revenue projections may not materialise if clinic uptake is slower than modeled. As the procurement cycles are long (hospital IT integration, training, and pathway change management create friction) the risk for not reaching the sales forecast should be considered. In this case, there might be a need for additional funding before exit scenarios become actual.
  • Even though the technical feasibility and clinical practicability of PCaVision have been sufficiently proven through earlier clinical trials and empirical studies, a peer-reviewed publication (expected in H1 2026) is still pending. If the peer-reviewed publication would not take place or be delayed, this could result in slower adoption by the market than expected.
  • CE approval does not ensure payment. Market access remains country-specific and can be slow or unsuccessful, limiting adoption or shifting costs to patients/clinics. Even where reimbursement codes exist in each region, payer policies and utilization caps can restrict volumes negatively impacting profitability.
  • There is a structural risk resulting from the fact that there is approximately at € 4.2 million of debt outstanding, which is significant. In 2027, debt repayments will be at € 1.6 million, consisting of a yearly repayment of innovation credit of € 666,000, a repayment of a CLA of the Brabant Startup Fund (€ 558,000) and several other smaller loans. 2028 and 2029 show a repayment burden of c. € 780,000. The project owner will need to raise further funding to service this debt. There is a risk that the project owner may fail to raise further capital in the future. Failing to do so completely or raising capital at a later stage than planned or less capital than planned may lead to the project owner not being able to realize an exit as forecasted. In addition, there is a structural risk resulting from the crowded shareholder structure. Even though to date there hasn’t been any issues around decision making with the shareholder base of the project owner, there is a risk that future fund-raisings or an exit could be slower to execute due to the crowded shareholder structure of the project owner.
  • Angiogenesis Analytics’ biggest operational risks revolve around execution with hospitals and partners: rollout depends on OEM/channel partners staying aligned; hospital onboarding is slow due to procurement, IT/security reviews, clinician change-management and consistent scan quality plus a robust data pipeline are essential to avoid rework and delayed revenue. As deployments scale, cybersecurity/privacy obligations and eventual FDA clearance for the U.S. add may cause delays.
  • As scale relies on Original Equipment Manufacturer/software partners, any changes in partner priorities, contractual delays, or channel conflicts could slow access to customers or require higher direct sales investment negatively impacting profitability.
  • The project owner may be unable to compete effectively with existing and potential new competitors or to respond to changes in the competitive environment, it may adversely affect its business performance. Competition may become significantly more intense if competitors with more capital or better technology enter the market.   Also MRI-led pathways (with or without AI) are entrenched and may improve on cost. Ultrasound competitors could add diagnostic AI and pursue similar claims, although currently Angiogenesis has a first-mover advantage.
  • There is a risk that the project owner will get negative media attention. This may lead to significant sales decline and losses for the project owner because there is insufficient demand for the project owner’s products because of the negative media attention.
  • As first revenues are to be generated in late 2025 the key technology risk, namely whether the AI maintains diagnostic performance across different scanners, sites, and operators, remains relevant. E.g. poor ultrasound clip quality or inconsistent contrast protocols could decrease accuracy, which involves uncertainties with regard to the cash flow. Even though currently there are first key partners, in who the project owner has found a reliable development and has done extensive testing for the current product, there remains a residual risk that a new technical or clinical issue with the products of the project owner could arise potentially leading to a (partial) recall and negatively impacting profitability.
  • In accordance with Article 2(1)(a) of Regulation (EC) No 1893/2006 of the European Parliament and of the Council (Regulation), the project owner's business is best described by the classification of Section C in Annex 1 of the Regulation.
  • Inflation, the increase in VAT and the consequences of the war in Ukraine could have a dampening effect on the market, and continued or even rising inflation may lead to a deterioration in market conditions, which could reduce demand for the products of the Group and the project owner’s range of services and thus result in a total loss of the capital invested.
  • As a software company the project owner has no direct suppliers. Indirect suppliers that interact with the clinics are the contrast fluid agent suppliers and the providers of the ultrasound scanners and peripherals and the Graphical User Interface (GUI) software (software program that displays an interface on the screen with which users can interact). These are high-quality suppliers which make them easy to deal with. At present both the ultrasound scanner and the contrast fluid agent are critical components. As the suppliers offer these components as standard products to the market and these are produced in volume, the project owner deems risk of non-availability low. The suppliers also have a strong business interest: the revenue of the PCaVision solution is evenly divided among all suppliers. Even though the products of the project owner are compatible with other scanners and contrast fluid agents and the project owner intends to pursue that compatibility to reduce reliance on these suppliers, there remains a residual risk that in the event of insolvency of the current key suppliers alternative high-quality suppliers cannot be found quickly. This could lead to temporary reductions in the Group’s income.
    • The main financial risk is the adequacy of funding to support the project owner’s growth objectives. The project owner may require additional funding in the future, but the necessary funding might not be accessible to the project owner.
    • Uncertainty in the core markets of the Group, the global economy and financial markets may adversely affect the project owner’s business and operating results.
    • The project owner may be unable to implement its expansion strategy and take full or timely advantage of new business opportunities.
    • The project owner’s business idea might not assert itself on the market or the planned business development might not be implemented as planned.
    • There is always risk that the project owner or Angiogenesis Analytics Inc. may be subject to bankruptcy or other insolvency proceedings and other events may occur in relation to the project or the project owner or Angiogenesis Analytics Inc. which may result in the loss of the investment for the investors. Such risks may be caused by a variety of factors, including for example but not limited to, changes in the macro-economic circumstances, mismanagement of the project owner or Angiogenesis Analytics Inc., lack of experience of the project owner’s or Angiogenesis Analytics Inc.’s employees and/or management, fraud, project owner’s financing not fitting the business purpose or lack of cash flow.
    • Various risk factors and circumstances may lead to a fall in the market price of the project owner shares, which may result in a partial or total loss of the invested capital.
    • Even though the subscription price for the depositary receipts issued to the investor and the new shares issued to the STAK corresponds to the project owner’s Management understanding of the fair value of the depositary receipts and shares, the price may have been set too high, which may result in a partial or total loss of the invested capital when selling the depositary receipts.
    • There may be no return on the investment at all.
    • The project owner’s financial projections are subject to risks, as forward-looking estimates, targets, and other statements always involve uncertainty, and they are only predictions, not guarantees of the future. 
    • In the future, the project owner may issue new shares or convertible bonds, or it may enter into agreements which might dilute the depositary receipts of the investors if they are not financially able or willing to buy new depositary receipts according to their pre-emption right.
    • If a drag-along clause is included in the Shareholder’s Agreement of the project owner and it is applied, the investors have the obligation to sell their depositary receipts on the same terms which might lead to a lower price the investor would have expected (drag-along clause).
    • As a growth company, the project owner does not, as a policy, pay dividends but rather reinvests returns into the further growth of the business and its valuation.
  • A temporary or permanent failure of the crowdfunding platform may cause the crowdfunding service provider being unable to provide its services. This may lead to investors being unable to subscribe for the offered depositary receipts or delays in the payment processes, such as when the invested funds are being transferred to the project owner or when investors’ funds are repaid due to revocation or resolutory condition.
  • As the invested funds are being held in an escrow account of an authorized EU payment provider, and the crowdfunding service provider does not possess the funds at any point, a loss of the invested capital based solely on a failure of the crowdfunding platform is unlikely.
    • The depositary receipts are not publicly or multilaterally traded on any marketplace, so there is no active or liquid secondary market for the depositary receipts. There is a risk that the depositary receipts may not be sold at the desired time or at all, or that the price offered may be lower than its subscription price or its actual value. The transferability of the depositary receipts is restricted as described in Part F (b) and (c) of this KIIS and the costs also described therein will be incurred.
    • The Group is dependent on its management and qualified employees. Key-person risk is concentrated in founder-CEO Auke Jan Bloemendaal, who drives strategy, fundraising, and major partnerships; loss of his leadership would likely slow business development momentum and capital formation. Technical continuity relies on early senior hires, with deep knowledge know-how on the AI models, software architecture, integrations, and release process. Disruption here would directly affect productization and clinical performance. Even though the project owner mitigates these risks by equity/Stock Appreciation Right participation for key managers, a relatively wide, seasoned management team (>200 person-years), and structured oversight via Clinical/Advisory Boards that incorporate key opinion leaders and academics, the loss of key personnel could be detrimental to the business.
    • Failure to recruit and retain qualified personnel may adversely affect the business performance of the Group.    
    • The software products of the project owner (EU MDR Class IIb software) require strict regulatory compliance( e.g. ongoing ISO 13485/14971/62304/62366 obligations, and added EU AI Act requirements). Failure to comply with laws, regulations and general social responsibility relating to the project owner’s or Angiogenesis Analytics Inc.’s activities and products may result in sanctions and damage its image with its customer groups.
    • Compliance with data protection regulations also entails risks. Especially handling of patient data, cross-border transfers, and cybersecurity incidents could block deployments and trigger penalties and damage the Group’s image with its customer groups.
    • The project owner and Angiogenesis Analytics Inc. have no pending lawsuits or other open litigation, but as the project owner’s and Angiogenesis Analytics Inc.’s operations expand, legal risks may become more significant. E.g. clinical performance or misdiagnosis claims plus vigilance/complaint handling requirements could raise legal exposure.
    • The Group’s legal regulatory environment may change, potentially making it more difficult for the project owner to conduct its business. Especially, country-specific guidelines and reimbursement procedures may lead to uncertainties regarding timing, even after certification.

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