Choose how you want to use our website:

Cookies help to improve your website experience and provide secure services. Some cookies are essential for security and login functionalities, others enable easier use and convenient support. You can revoke your decision at any time.

Price per bond
€500.00
Duration
2 years
Equity offered
Base interest rate p.a.
Invested
€3,250,500
Legal warning: The acquisition of this financial instrument is associated with considerable risks and may lead to the complete loss of the invested assets. The prospective return is not guaranteed and may also be lower.

Investments can be placed up to MEUR 3.3. The maximal funding amount that will be accepted by Injeq is MEUR 3.0. The Convertible Bonds will be allocated to the investor in the order of subscriptions (“First come, first served”).

Jan Rabe, Gründer und Geschäfts­führer der Wechselpilot GmbH

„The company's IQ-Tip® product family is in production and marketing authorisation has been obtained. With the funding, we will launch the IQ-Tip® product family in Europe and in key countries that accept European CE certification, directly or with minor modifications. At the same time, production will be expanded to meet rising demand and potential pricing pressures. 

The aim is also to expand with existing products to other parts of the world and the company is in the process of launching efforts to obtain the FDA approval required by the US market. At the same time, research and development for the next products will be initiated.  

All the above will require investment and will tie up resources in working capital and investment in equipment and development. The capital now being sought will enable all the lines of action to be taken forward, and their speed and scale will be adapted to the amount of capital being raised. 

The financing will bridge the gap for a possible later public listing, as the current market situation with its international challenges is not favourable for an IPO and provide a basis for further financing. We expect the market situation to calm down before the IPO."

Timo Hänninen, Managing Director

Investment information

Investing start:
23/03/2022
Type:
Convertible Bond
Invested:
€3,250,500.00
Price per bond :
€500.00
Min offer:
2 Units
Invested:
€3,250,500
Discount at conversion:
20.00 %
Base interest rate p.a.:
8.00 % p.a., bullet
Maturity date:
31/03/2024
Funding purpose:
Growth
Offered in:
FI, DE
Broker:
Invesdor Oy

Top reasons to invest

A CE certified product launched on the market - IQ Tip smart needle was certified in December 2021, enabling the sale of products within the EU. Sales have already started in several countries through distributors. 

A solution to a prevalent problem - the IQ Tip smart needle can tell you where the tip is, which can help reduce many of the problems associated with blind punctures. The aim is improved patient safety and better treatment response. 

A clear growth strategy - Injeq's three dimensions of growth are to grow with existing products in Europe, expand geographically and develop new clinical applications. 

A scalable business model - first launch a new product in Europe, then export it to the rest of the world and launch the next new product. At the same time, an established customer base continues to use the products. 

Skilled and experienced team - Our last but not least strength is our skilled and motivated personnel. Our personnel and Board of Directors are experienced and trained professionals with a shared desire to improve the world, needle by needle. 

Overview

Injeq in a nutshell

Injeq Oyj (hereinafter "Injeq" or the "Company") is a Finnish medical technology (Medtech) growth company with a mission to deliver smart medical solutions for demanding patient care applications. One of the most challenging blindpunctures is a lumbar puncture. Particularly when done on a leukemia patient, lumbar puncture involves – when unsuccesful – a possibility for cancer cells to enter the central nervous system area which drastically worsens the prognosis of the patient. Injeq wants to play its part in improving patients' prognosis and the effectiveness of treatment with safe, technical solutions. The smart needle with bio-impedance-based sensing technology is the only one of its kind on the market and, as the most sophisticated medical device, it is almost impossible for competitors to enter the market quickly.

The company's first product, the IQ-Tip® smart needle, received CE approval in December 2021 and is now available on the European market. The needle is suitable for lumbar punctures from new-borns to the elderly and can improve the patient safety for all these groups in cerebrospinal fluid sampling and drug administration. The primary target groups for smart needle punctures are leukemia patients - especially children – and babies with suspected central nervous system infections. From these target groups, the use of the product is expected to expand to adult groups, including the diagnosis and treatment of various neurological diseases. Subsequently, Injeq will also promote its growth in new areas of smart needle applications.

Less traumatic punctures may reduce unnecessary chemotherapy of the patient, and in the long term, it may reduce the risk of secondary cancers later in early adulthood. Failed punctures cause delays in diagnosis because of poor-quality samples, and additional expenses as the patient may have to stay longer in intensive care. Cost of one day in intensive care is approximately 3 500 euros. In treating neurology patients the cost of medicine in one puncture can be as much as  60 000 - 100 000 euros. Thus, it is vital that all punctures are performed accurately.

Founded in 2010, Injeq is based in Tampere, Finland and currently employs 19 people. Injeq's product development is based on an experienced team of physicians, professors and medical engineering experts, whose ideas led to the creation of a spinal fluid sensing device based on bioimpedance spectroscopy.  To demonstrate the functionality and safety of the IQ-Tip® needle, three clinical trials have been conducted in different patient groups at three university hospitals. Injeq aims to bring new technical solutions to different types of medical problems to facilitate, for example, emergency care, cancer biopsies or joint punctures. 

Company history

Unternehmensgeschichte

10 years of development create a strong basis for commercialisation 

From problem to innovation and from need to business - Establishment of the company 

In 2004, three top experts in medicine and medical technology were working on the prevention of regional anaesthesia-related nerve damage by means of medical technology. In regional anaesthesia, the nerve must not be damaged, but the proximity of the nerve must be detected, and the anaesthetic injected before the needle hits the nerve.  

Jari Hyttinen, Katja Paassilta and Riitta Seppänen-Kaijansinkko decided to set out to research and develop a needle that would solve the problem of blind punctures. The result of the research was the IQ-Tip® needle, which, by measuring the bioimpedance of a living tissue, detects the spinal fluid and tells the user when the needle tip is in the spinal cavity.  

Injeq was founded in 2010. The company developed the technology and conducted clinical trials, including joint punctures and cancer tumour biopsies. The go-to-market application of the company's product - lumbar punctures for children - became clearer and product development and clinical trials focused on this important application area. Several successful pilot phase patient studies were conducted in collaboration with the University Hospitals of Helsinki, Tampere and Turku using Injeq's IQ-Tip® smart needle. 

EU requirements changed 

The company completed its first crowdfunding round with Invesdor and started the CE-approval process in spring 2017. The actual process started with the German notified body TÜV SÜD in spring 2018. After the Medical Device Directive (MDD) changed to a Medical Device Regulation (MDR) in 2017, the project was one of the first in Finland to start implementing the new MDR for the highest - class three - medical device CE-approval.  

New premises and CE certification 

In spring 2019, Injeq moved its operations to the Tampere University Hospital campus, where it has clean rooms that meet the requirements of ISO standards. At the same time, complementary clinical trials were launched, and funding was strengthened through a second round of crowdfunding with Invesdor. Despite the COVID-19 pandemic, clinical trials were completed in 2020, and production was also up and running in the new premises. Organisational strengthening prepared for market entry. The quality system and the first products (analyser, cable) were certified in June 2021 and the needle received CE approval in December 2021.  

Growth  

Injeq is commercialising and scaling its business, first with the existing IQ-Tip® needle in the domestic market in Europe. Marketing authorisation processes in other countries, such as China and the US, will be initiated as soon as possible, allowing for global expansion with the existing product. Subsequently, Injeq intends to drive its growth by creating new products for different application areas. 

The products

First generation IQ-Tip® smart needle 

The IQ-Tip® needle consists of the following components, sold together or separately: the IQ-Tip® analyser, the disposable IQ-Tip® spinal needle (three different lengths) and the disposable IQ-Tip® cable connecting the needle to the analyser. 

How does the bioimpedance-based Injeq smart needle work? 


 

Biological tissues and fluids have a specific resistance to the conduction of electric currents.  "The electrical conductivity varies in different tissue types as the number of cells in the fluid and electrolyte concentration are different. The IQ-Tip®️ analyser measures the electrical resistance, or bioimpedance, of tissue touching the tip of an IQ-Tip®️ needle at 15 different frequencies at 200 times per second. At the same time, the analyser classifies the measured tissue based on the measured characteristics and identifies the actual target tissue, such as cerebrospinal fluid. The measurement is virtually real-time and locally very sensitive. The area measured by the needle tip is only about one cubic millimetre. 

The IQ-Tip®️ device's ability to identify different body tissues and fluids, combined with its fast and locally sensitive bioimpedance measurement, can help the clinician perform a lumbar puncture smoothly and safely. The analyser beeps when the tip of the smart needle touches the spinal fluid. These features make the IQ-Tip®️ smart needle an excellent tool for, among other things, taking a high-quality diagnostic spinal fluid sample and administering medicine into the spinal canal, for example during leukemia treatments and with some rare neurological conditions where high price drugs are used.  The IQ-Tip®️ can be used at the discretion of the physician for lumbar punctures in patients of all ages and sizes, from new-borns to the elderly.   

Awards & press

TÜV Süd

  • ISO13485:2016 certification in June 2021 
  • MDR CE certificates for analyser and cable in June 2021 and for needle in December 2021

CE certified

  • Factsheet for healthcare professionals and health institutions

Kauppalehti

Kauppalehti

Joukkorahoituksella miljoonia kerännyt Injeq tähtää pörssiin keskellä epävarmuutta: ”Tästä se työ vasta alkaa”

Geschäftsmodell

The business model

General Launch of the IQ -Tip® needle 

The IQ-Tip®️ smart needle received CE approval under the Medical Device Regulation (MDR) in December 2021. Prior to the CE approval and marketing authorisation, the performance and safety of the bioimpedance smart needle has been studied in several different clinical trials. The scientific publications related to these studies can be found at www,injeq.com/professionals/publications/

Studies 

The applicability of bioimpedance for tissue recognition was first studied on adults at the Tampere University Hospital, Valkeakoski Regional Hospital and Koskis Hospital. The second study, focusing on lumbar punctures in new-borns and babies, was carried out in the neonatal wards of Tampere and Turku University Hospitals. The third study - leading to the CE approval - was conducted in the paediatric haematology departments of the University Hospitals in Tampere, Turku, and Helsinki on acute lumphoblastic leukemia (ALL) patients. The results of this study were presented in the spring 2021 at the Childhood Leukemia and Lymphoma Symposium under the title High first puncture success rate attained with a novel bioimpedance needle in pediatric hemato-oncologic lumbar punctures. Injeq's research engineer Sanna Halonen has also published on the applicability of bioimpedance measurement for liver biopsies and joint punctures, among others. Injeq's first post-market study is scheduled to start in the summer 2022.  

Identified growth paths 

Sales are initiated where the patient benefits are most obvious. Therefore, initial sales efforts will focus on paediatric oncology, such as ALL- and neonatal lumbar punctures.  

Around 50 children are diagnosed with leukemia each year in Finland. By the same token, it can be estimated that in the Western world about 10 children per one million inhabitants are affected by this disease. Almost 90% of patients can be cured and of the remaining 10%, half die from the disease itself and the other half from the toxicity of the leukemia treatment. A failed lumbar puncture can be crucial for a leukemia patient which - in the worst case – can lead to death. A traumatic lumbar puncture with cancer cells entering the central nervous system (CNS) area – means additional doses of chemotherapy with increasing toxicity for the patient or possibly a relapse in the CNS area. Toxic treatment in the childhood can also lead to secondary cancers later in the adulthood. It is difficult to put a price on these complications, but the life-saving benefits of a successful puncture are a good justification for investing in a safe puncture and the IQ-Tip smart needle in primary cases. Patient safety also brings cost savings as the need for intensive care can be reduced.  

There are about 3 cases of proven meningitis per 10,000 live births. However, this is an underestimate because about 30-50% of children with general infection (sepsis) in intensive care do not receive a lumbar puncture but are treated with antibiotics for sepsis. The lumbar puncture required for a diagnosis of meningitis may not be performed simply because of a challenging procedure. However, about one third of children with sepsis have negative blood culture results but still have meningitis. Infections of the central nervous system have a negative impact on the child's development and, in the worst cases, cause death. Delayed diagnosis can lead to life-long developmental disabilities. In an acute situation, incorrect or missing diagnosis can increase costs through prolonged stays in intensive care. The Injeq IQ-Tip® smart needle is expected to make lumbar punctures easier for even the smallest patients, lowering the threshold to perform this challenging procedure to ensure a correct diagnosis. With a smooth and safe lumbar puncture, the IQ-Tip smart needle can enable patients to have a better prognosis, save on intensive care costs and, in the long run, improve the quality of life of the patient while reducing costs to society. 

Major European countries with higher population such as Germany, France and Italy offer significantly bigger market for the Injeq smart needle. Reseller agreements have already been signed in these countries, among others. To follow up the European market, Injeq plans to seek FDA approval and with it the US market between 2025 and 2026, when the market can be expected to grow significantly. 

The first sales targets for Injeq resellers will be European children's hospitals, where Injeq products can be used to improve the success and safety of lumbar punctures. Children's hospitals operate both as part of university hospitals and maternity hospitals and as stand-alone units. Initial sales efforts will focus on leading university hospitals, which will also serve as reference clinics and promote the use of Injeq devices in areas such as paediatric ALL as part of the new European ALLTogether treatment protocol and other demanding lumbar punctures. Once a sufficient foothold in paediatric use has been achieved and the benefits of the technology have been demonstrated to clinicians, Injeq intends to use paediatric wards as references, highlighting the benefits and low risks of the technology to extend its use from paediatric to adult wards. 

Business model 

Injeq uses a dealer-operated sales channel. The resellers are selected based on their existing distribution field, currently mainly from resellers already active in the field of neonatology and paediatric oncology. 

Injeq's business model is to sell through national resellers. The aim is to establish an EU-wide network of resellers to cover the main markets during the first two years of commercialisation. Injeq's management believes that this is a realistic objective and the first partnerships selected in the larger European countries show that the list of candidates is feasible and convincing. Discussions with leading Nordic university hospitals have also already taken place during the development phase of the smart needle. Discussions and previous clinical trials in several hospitals have shown that there is a very good basis for starting sales. Injeq has signed distribution agreements in Germany, Austria, Italy, France, Slovenia, Scandinavia, and Poland. 

The sale of analysers as a one-off transaction will generate a faster revenue stream and its sale to the end customer will also trigger the sale of IQ-Tip® spinal needles and IQ-Tip® cables as disposable products. Depending on the target market and the financing models used by the Injeq reseller, part of the sales of analysers to end-customers can be leased or rented, thus lowering the acquisition threshold. In addition, Injeq will review the business and pricing models appropriate for the different target markets together with its resellers, so that pricing specifically for clinical opinion leaders and early-stage users will support faster market penetration. Injeq also plans to launch local studies and subsequent scientific publications in target markets to demonstrate the efficacy and usability of the IQ-Tip® smart needle at a local level. Injeq also has an obligation under the MRD to collect customer feedback.  The feedback is collected from the doctors using the needle regularly.

There are countries like Slovenia where the distributor must give the device to the hospital for free and the revenue stream is entirely based on the sale of disposable products. In Germany, on the other hand, Injeq's strategy is to enter the market by contracting with local hospitals for trial distributions. Injeq has agreed a trial with two hospitals, for which the hospitals will receive the analyser and the first few needles free of charge and will then purchase additional needles themselves as needed. After a trial period of 4-6 months, the hospitals will make a final decision on the purchase of the device. The distributor redeems these devices from Injeq. 

Lumbar punctures for adults  

Focusing on a limited yet important segment, such as leukemia and neonatal lumbar punctures, as described above, is a sensible way to enter the market. In these indications, it is easier to justify the significantly higher price of a smart needle compared to a standard spinal needle. However, the number of lumbar punctures and spinal anaesthesia performed on adults is significantly higher than on children. For example, spinal fluid markers are increasingly being used to support the diagnosis of various neurological conditions such as Alzheimer's disease. The ageing population and the increasing prevalence of Alzheimer's disease are increasing the number of diagnostic lumbar punctures. New drugs for the treatment of neurological diseases have also emerged in recent years, which can be administered directly into the cerebrospinal fluid, where there is a need for certainty in dosing and where the cost of the injection may be very small compared to the cost of the drug. The company expects that over time the smart needle will become part of standard diagnostics and treatment practices, as the ease and safety offered by digital technology is highly valued. In addition, the IQ-Tip®️ smart needle can be used in the training of new healthcare professionals, as exemplified by a more than year-long collaboration with the Tampere-based Taitokeskus in medical education: every medical student is offered an opportunity to try out Injeq's IQ-Tip®️ smart needle during lumbar puncture exercises. 

Expanding sales outside Europe 

Investing in children's well-being is a global growth area. CE approval is a good basis for approval processes in many countries. New marketing authorisation applications and expansion of the sales network will be considered following EU approval. Product development towards FDA approval, as well as US regulatory actions and planning for the necessary clinical trials, will start during 2022. US market entry is targeted for 2025.

The management

  

Oliver Dannenberg, Geschäftsführung

Tommi Rasila

Chairman of the Board

Tommi Rasila is a serial entrepreneur, government professional and Doctor of Science (Engineering), with a major in business strategy. He has founded, owned, and managed many companies, including Sample Rate Systems Oy, which was sold to the US in 2000. Mr Rasila also serves on the boards of Juvenes Oy, Techila Technologies Oy, Pirkanmaa Hospice, among others. 

  

Jan Rabe, Gründer und Geschäftsführer

Timo Hänninen

Managing Director

Timo Hänninen is a Doctor of Science (Engineering), MBA, a technology management professional with extensive experience in international business development and strategy. He has worked in areas such as medical technology, cyber security, and space technology, and has held management positions at Nokia Corporation for almost 20 years. 

  

Maximilian Carl Both, Gründer und Geschäftsführer

Riitta Seppänen-Kaijansinkko

Vice Chairman of the Board, Founding Member, Chairman of the Scientific Advisory Board

Riitta Seppänen-Kaijansinkko has worked as a Professor at the University of Helsinki and Chief Physician at Helsinki University Hospital since 2015, and before that as a Professor of Biomaterial and Tissue Engineering Research at the University of Tampere and Chief Physician at Tampere University Hospital from 2003 to 2014. Seppänen-Kaijansinkko has more than 30 years of experience in clinical work, research and business.

  

Oliver Dannenberg, Geschäftsführung

Jari Hyttinen

Member of the Board, Founder, Member of the Advisory Board

Jari Hyttinen is Professor of Medical Technology at the University of Tampere. Hyttinen has more than 30 years of experience in research and teaching of medical devices and medical technology, and more than 15 years of experience in research and leadership positions in international organisations in the field, including as President of the European Association 2015-2017. 

Distribution of the company shares

Injeq has a total of 1 218 shareholders, most of whom have joined through Invesdor's funding rounds. The company has a total of 4 553 939 registered shares. All shares belong to the same share series. Each share carries one vote at the General Meeting. 

The largest single owner, the EAKR Aloitusrahasto, holds around 19.2% of the company's shares. 

The members of the Board of Directors own, directly or through companies they manage, 12.4% of the company's shares. 

Personnel own 1.0% of the company's shares. 

The remaining 67.4% of the company's shares are held by more than 1200 small shareholders. 

Company structure

Injeq employs 19 full or part-time personnel.  As commercialisation progresses and new applications are further developed, the number of employees will increase to around 30 by 2025. The company will recruit personnel for sales and customer support, marketing, production, quality management, research and regulatory functions and product development. 

Use of funds

The company is prepared to accept up to EUR 2 million in the issuance of this equity convertible bond. The Board of Directors reserves the right to increase the maximum size of the financing round to EUR 3 million. 

The Company intends to use the funds raised in the financing round as follows: 

Use of funds

If the Company raises EUR 1 million: 

  • 17% for working capital 

  • 33% for European market access and development of production processes 

  • 50% for development work for new markets

If the Company raises €2 million: 

  • 17% for working capital 

  • 33% for European market access and development of production processes 

  • 50% for the development of new markets 

If the Company raises €3 million: 

  • 17% for working capital 

  • 33% for European market access and development of production processes 

  • 50% for the development of new markets 

Market

Target market trends 

Injeq's first target market is Europe and lumbar punctures in the region, starting with lumbar punctures for children with leukemia and neonates. The aim is to expand the market with the current application, both geographically and to new target groups. For example, in Alzheimer's disease and M.S., markers indicative of the disease is searched for in cerebrospinal fluid. Interest in Injeq's smart needle solution has also been shown by the global pharmaceutical industry, which produces medicines for rare neurodegenerative diseases in children. These autosomal recessive disorders cause severe developmental and behavioural disorders in children, in the worst cases death - some diseases also affect adults. For these diseases, often caused by enzyme metabolism disorders, drugs have been developed that are administered intrathecally (IT). The cost of these drugs can run into hundreds of thousands of euros, making the cost of a smart needle a modest part of the overall treatment. Modern treatments have relied on the use of implantable catheters, for example, to administer these drugs repeatedly IT. However, the infection problem associated with implantable catheters has led pharmaceutical companies to consider other alternatives for IT drug delivery, and the Injeq smart needle has emerged as a safe and smooth single-puncture alternative for the delivery of these expensive drugs.  

New areas of application based on bioimpedance measurement have been enthusiastically discussed by Injeq's multidisciplinary advisory board. Preliminary clinical trials have already been carried out, e.g., in cancer biopsies as liver biopsies and in joint punctures (publications related to these trials can be found at: https://injeq.com/professionals/publications/). Other potential new applications for the bioimpedance spectroscopy needle include cancer drug injections into muscles, vascular punctures, urological therapeutic punctures or pericardiocentesis in emergency medicine. 

Market potential 

For the last 100 years, the spinal needle market has not seen any innovation; needle manufacturers have mainly competed on the sharpness of their needles. Market penetration with a special needle for a standard procedure, which is several times more expensive than a standard needle, is still very challenging. The clinical market has accepted the risks associated with a conventional needle and the added value of a smart needle - safety and the savings that come with it - needs to be presented in an understandable way. However, the operation of the Injeq IQ-Tip smart needle is easy to understand, and the benefits are obvious. 

According to a market review (Global Industry Analysts, Sep 2021), the total global market for specialty needles - of which the Injeq IQ-Tip® smart needle for lumbar puncture is a fundamental part - is expected to grow from around $9.5 billion (2020) to $16.9 billion by 2027 (estimated annual growth rate of 8.5%).  

The US is the largest regional market for specialty needles, estimated at $3.2 billion in 2020, with the US market size projected to reach $5.5 billion by 2027. For Europe, the market size for special purpose needles is estimated at USD 2.8 billion in 2020. Asian countries (excluding China, Japan) are forecast to emerge as the fastest growing regional market with an average annual growth rate of 10.3% (China 9.9%, Japan 7.6%) over the analysis period (Special Purpose Needles - Global Market Trajectory & Analytics, September 2021). 

According to Injeq's management, there is no fully comparable product on the market yet. In the special-purpose needles product segment, the total global market for conventional needles is estimated to be around USD 360 million in 2020 and is projected to reach USD 565.6 million by 2027. It is therefore forecast to grow at a steady 7% per annum. The US is the largest regional market in the segment, accounting for an estimated 33% of global sales in 2020. 

Injeq estimates the market potential in European children's hospitals for ALL alone at around €15 million per year. The company's sales strategy is to cover the total demand for demanding lumbar punctures in each paediatric hospital within a reasonable transition period. 

Financial figures

Actual and planned figures

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

Login Sign up

Valuation

Please login

This content is only visible to registered users.

Login Sign up

Issue Terms

Please login

This content is only visible to registered users.

Login Sign up

Risks

Please login

This content is only visible to registered users.

Login Sign up

Updates

On 24 March 2022

Due to high demand, the Board of Directors of the Company has decided according to the issue terms to increase the round maximum to €3M. The subscription period remains the same.

Questions? 
We are here for you!

You can reach us by mail, by phone and via our chat. 

 service@invesdor.fi

 +358 20 735 25 90

 You will find the chat in the bottom right corner.

Invesdor Kontakt: Anne Schnürpel