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ToxGenSolutions BV

ToxGenSolutions BV

Human relevant biomarker-based tools for preventive medicine

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Deal Type

Convertible Note

Funding Goal

$4,500,000

Current Reservations

$0

Minimum Reservation

$10,000

Deal Stage

Series A

Interest (% per year)

3.00%

Term Length (Months)

60 months

Valuation Cap

$5,000,000

Conversion Discount (%)

20%

Warrant Coverage (%)

N/A

Open Date

03/29/2019

Maximum Reservation

$1,000,000

Closing Date

N/A

Elevator Pitch

The new blood test offers an inexpensive and minimally invasive biomarker-based method to screen and identify patients early, easily and accurately that contributes to improved quality of life.

KPIs

3 Users
4 Employees
3 Issued Patents
$0 Sales
0% ROI
Cash Flow Positive
$132,000 Transaction Volume

Company Overview

Mission of ToxGenSolutions

  • Transferring novel technologies into biomarker-based tools for preventive medicine addressing three high impact pathologies: neurodegeneration, cancer, immunosuppression.
  • Offering discouraged and frustrated patients, caretakers and industry a solution to the deadlock that currently has paralysed Alzheimer's research.

Opportunity for business development in a massive market

  • Current research was proven irrelevant for human health (>95% failure in drug development) leaving >95% of the Alzheimer’s cases unaddressed.
  • These cases are related to non-genetic risk factors (e.g. heavy metals, pesticides, volatile anesthetics, lifestyle diseases, among others) which have largely been neglected in the current research.
  • The impact of the non-genetic risk factors can be investigated using methods that are well established in toxicology.

Definition of the problem

  • Currently diagnosis of Alzheimer's is initiated at the time the patient presents with some degree of cognitive impairment. At that moment irreversible brain damage has occurred. The diagnostic procedure is subjective and slow (questionnaire), expensive (scanning) and painful (lumbar puncture).
  • The problems related to this approach are several:
    1. Accuracy is estimated to be <50%, meaning that probably less than half of the individuals with Alzheimer's are identified.
    2. The diagnosis comes in a late and irreversible phase of the disease.
    3. The approach is expensive, painful.

What is expected?

  • More accuracy: The current strategy for diagnosing Alzheimer's appears to have an accuracy of up to 50%, despite it concerns patients with memory disorders and thus clear brain damage.
  • Early diagnosis: The late and inaccurate diagnosis is considered the reason for the high failure rate (> 99%) during drug development and the absence of options to improve the quality of life of patients and their families.
  • Inexpensive and Peripheral: There is a clear and urgent need for inexpensive and minimally invasive testing to more easily and accurately screen and identify patients in the earliest stages of the disease before irreversible injury and associated symptoms occur.
  • Biomarker profiles: Clinical studies (e.g. for cancer) are twice as likely to be successful if patients are selected using validated biomarkers. This strategy must also be applied to Alzheimer's.

ToxGenSolutions can offer the solution to the problem:

  • During recent years application of novel technologies has resulted in more human relevant approaches. ToxGenSolutions has the nonanimal tools to study in a human relevant way the impact of non-genetic risk factors on initiation and early development of Alzheimer’s.
  • Application of tolls allowing for genetic biomarkers using cultured human neurons has resulted in a biomarker profile that has shown promise with respect to diagnosis of Alzheimer's disease in blood samples.
  • The biomarkers represent events that occur very early after exposure of the cells to non-genetic risk factors.
  • The test method is therefore a potential tool for
    1. Diagnostics: Exploitations of new (epi) genetic data describing the pathological processes of sporadic Alzheimer’s before irreversible brain damage.
    2. Therapy: Application of the novel diagnostics to identify drugs acting on the reversible pathology and reducing the current 99.6% failure rate for new drugs.

The product.

  • A simple, cost-effective and minimally invasive method for diagnosing early phase Alzheimer’s, that eventually can be used as a screening test for persons of >60 years of age, allows for
    1. early enrollment in programs that slow the progression of the disease and therapy as soon as it is available.
    2. improvement of preclinical evaluation and clinical follow-up during drug development.

Market Focus: A market that is discouraged and frustrated.

  • The primary markets for the diagnostic test include Diagnostic, Pharma and Biotech companies, as well as Contract Research Organizations (CROs) that are active in the field of neurodegeneration in general, and Alzheimer’s disease specifically.
  • The envisaged earning models include test performance by TGS at a competitive price (CRO), license fees and royalties, and the sale biomarker kits.

Traction

  • ToxGenSolutions acquired funding ($400,000) from EU Interreg. Vlaanderen-Nederland to evaluate a prototype diagnostics for early Alzheimer's

    January, 2018
  • 3Rs Management and Consulting ApS (Lyngby, Denmark), co-owner of ToxGenSolutions (34%) provides a loan of $32,800 to secure IP rights.

    January, 2017
  • ToxGenSolutions acquired a $107,500 pre-seed loan from UNIVENTURE (Maastricht, Netherlands) to establish the feasibility of the business.

    November, 2015
  • ToxGenSolutions BV was established at Oxfordlaan 70, 6229 EV Maastricht, the Netherlands.

    May, 2015

Pitch Deck

Press Mentions

Key Customers & Partners

Universiteit Maastricht icometrix reMYND Katholieke Universiteit leuven Universiteit Antwerpen Amoneta Diagnostics

Previous Funding

  • $400,000 Other
  • Raise Source: Other
  • January 2018
  • $32,800 Convertible Note
  • Raise Source: Self
  • January 2016
  • $4,000 Equity
  • Raise Source: Self
  • May 2015
  • $1,800 Equity
  • Raise Source: Friends
  • May 2015

Frequently Asked Questions

Is there a need for yet more research on Alzheimer's disease?

Yes. The lack of accurate diagnostic methods and active drugs, despite decades of research into the causes and underlying processes of Alzheimer's, has led to disappointed and frustrated patients and caretakers. Due to the lack of success, Pharma and Biotech companies have temporary stopped further research and development of new drugs. Causes of failure are several: (1) animal models do not develop human pathology and have little relevance human health, (2) research focus has been on disease stages with irreversible brain damage, and (3) animal models represent genetic Alzheimer's which represents <5% of the Alzheimer’s cases. Thus, there is a need for a new approach making research, and the emerging tools and drugs, more relevant for human health.

Does the ToxGenSolutions product meet the needs of the customers?

Yes. Patients, caretakers and drug developers require more accuracy, early diagnosis, inexpensive and minimally invasive methods and biomarker profiles. 1. Low accuracy: The current strategy for diagnosing Alzheimer's appears to have an accuracy of <50%, despite it concerns patients with memory disorders and thus clear brain damage. This should be >90%. 2. Early diagnosis: The late and inaccurate diagnosis is considered the reason for the high failure rate (> 99%) during drug development and the absence of options to improve the quality of life of patients and their families. 3. Costs and invasiveness: There is an urgent need for inexpensive and minimally invasive testing to more easily and accurately screen and identify patients in the earliest stages of the disease before irreversible injury and associated symptoms occur. 4. Biomarkers: Clinical studies (e.g. cancer) are twice as likely to be successful if patients are selected using validated biomarkers. This strategy must be applied to Alzheimer's.

What is ToxGenSolutions bringing to the market and what is the expected impact?

ToxGenSolutions offers an inexpensive and minimally invasive biomarker-based method to screen and identify patients more easily and accurately in the earliest stages of the disease. This approach has benefits for patients, caregivers, the community and drug developers: (1) Better quality of life: Early diagnosis gives the patient the opportunity to change his lifestyle in time, and to participate in training programs that slow the development of the disease; (2) Faster certainty about treatment: An early and accurate biomarker-based diagnosis gives the doctors and caregivers certainty in an early phase of the disease about the treatment; (3) Lower costs for health care: An inexpensive method that allows minimally invasive, rapid and accurate screening increases the chance that cheaper treatment strategies; (4) New possibilities for the development of active drugs: The test identifies non-genetic Alzheimer's patients (>95% of total) before brain injuries occur and facilitates effective drug development.

Risks & Disclosures

Technologic feasibility:

  • Methods and approaches: NO RISK
    • ToxGenSolutions focusses on non-genetic external risk factors for Alzheimer's disease induction and development.
    • This approach allows for the application of methods and approaches that are well established in the area of toxicology.
    • ToxGenSolutions is experienced with these methods and approaches.
      • Technical assistance as well as access to state-of-the-art technologies is assured by the Universiteit Maastricht (Prof. Dr. Jos Kleinjans).
  • Clinical samples: CONTAINED RISK
    • Proper validation of a diagnostic method for early Alzheimer's requires sufficient human blood samples from patients that were investigated many years before the disease was diagnosed. Such patients may not be abundant.
      • To contain this risk ToxGenSolutions has established collaborations with the Universiteit Antwerpen and the Vrije Universiteit Brussel (Prof. Dr. Sebatiaan Engelborghs), the Universiteit Maastricht (Prof. Dr. Frans Verhey) and Amoneta Diagnostics (Prog. Hüseyin Firat, CEO).

Economic feasibility:

  • The Market: MODERATE RISK BUT ADDRESSED
    • There are about 10,000,000 new cases of dementia each year of which 60-80% are due to Alzheimer's disease.
    • The ToxGenSolutions product fills out a gap by offering an accurate method for screening and diagnosis that assists drug development in pre-clinical and clinical phases.
    • The Diagnostics and Drug markets are anticipated to grow with an 8 - 10% CAGR during the coming years to reach 10,000 to 12,000 m$.
    • The product addresses the needs of the patients, caretakers and the market.
    • The risk is set moderate to compensate for a degree of uncertainty about what industry requires of data to re-engage in Alzheimer's research based.
      • To Address this risk ToxGenSolutions will hire a Business Developer experienced in the market segments of interest who will be responsible for preparing the market for the product while it is being validated.


  • The Competition: MODERATE RISK
    • Cell-based approaches to the processes that drive Alzheimer's are extensively studied by academic and private parties. However, this approach still builds on the old hypothesis, and thus on some individual protein markers and (epi-) genetic markers that can be measured as soon as the brain has been damaged.
    • TGS strives for a blood test that is predictive before noticeable brain damage occurs and disease progression still can be stopped, or even reversed.
    • At this point in time no competitive methods have been identified, but their existence cannot be excluded.




Documents

Confidential

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