Lumbar punctures are critical in treating childhood leukemia. Injeq IQ-Tip™ needle knows the position of its tip, aiming to take the safety and success of lumbar punctures to a new level. This is but one of the many applications for the technology.
Injeq Oy (Ltd) was founded when three practitioners and technology experts identified a potential solution for a known unmet medical need. The vision of Riitta, Katja, and Jari of a smart needle has since developed from an idea to a product which is ready to be introduced to the market. It will first be used at neonatal intensive care units and oncology clinics treating childhood leukemia, as the use of IQ-Tip™ needle aims to improve the safety of demanding punctures performed on their small patients.
Injeq IQ-Tip™ smart needle – For the benefit of the patient
Acute lymphoblastic leukemia (ALL) is the most common cancer type diagnosed in children. The treatment for ALL usually lasts for 30 months, during which time at least 20 lumbar punctures (also known as a spinal tap) are performed on the patient to administer chemotherapy to prevent cancer cells from spreading to the brain or spine. Each puncture is a demanding procedure, because the tip of the needle must be inserted precisely into the spinal canal. If the needle is inserted even slightly too far, it can cause bleeding. Bleeding would allow cancer cells to enter the spinal canal, lessening the patient’s chances of recovery. Therefore it is vital to know the position of the needle tip at all times.
Injeq IQ-Tip™ needle was developed for a recognized unmet need
The above example is only one of the situations where it is important to know the position of the needle tip. Three leading specialists in medicine and medical technology studied the problem in Tampere, Finland more than a decade ago when they began developing a smart needle that would solve the problem. The result is the Injeq IQ-Tip™ needle, which is now in process of being CE marked, and then launched onto the market.
The operating method of the IQ-Tip™ needle is unique: The tip of the needle (a.k.a. lumen) and the supporting part inside it (a.k.a. stylet) are used during the puncture to measure the bioimpedance of the tissue touching the needle tip. A tissue analyzer unit (Injeq type 301) measures bioimpedance 200 times per second, at 15 different frequencies. This allows for differentiating the type of tissue surrounding the tip of the needle in real-time. The tissue type options contain e.g. muscle, fat, tendon, skin – or cerebrospinal fluid (CSF). In lumbar punctures, the analyzer unit emits a sound signal when the tip of the needle touches CSF, i.e. when the needle has reached the spinal canal and should not be inserted any further.
As a case example from our previous clinical investigation: Lumbar puncture on a two-day-old baby, to obtain urgently needed CSF sample, had been unsuccesfully attempted multiple times during the night with a traditional spinal needle. The procedure was finally done successfully on the first attempt with IQ-Tip™ smart needle the next morning. IQ-Tip™ needle has also been successfully used in punctures for prematurely born babies in our clinical trials. The smallest baby weighed just 1,4 kg.
More information about the technology behind the Injeq smart needle can be found at the publications section on our website.
The wide range of applications generate a huge market potential
The IQ-Tip™ is suited to a wide range of applications. For lumbar punctures, the most difficult procedures are those carried out on newborn babies and children. In this target group, the benefits of and need for a smart needle are so obvious that it is the first commercial application of the technology – to be used in the treatment of ALL-type cancer and diagnosis of meningitis. Other applications such as lumbar myeolography, lumbar punctures to support diagnosis of Alzheimer’s disease, joint and vein injections, tumor biopsies for diagnosing cancer and administering anticancer drugs provide further opportunities for growth. Each application such as these is a substantial market even on its own, hence the total available market is vast.
In 2025, Injeq IQ-Tip™ smart needle will be a part of standard care
There is no product similar to Injeq IQ-Tip™ needle on the market and we have no knowledge of potential competitors who would be close to market entry. Various products with intention to help injection are being developed based e.g. on pressure sensing and light reflection. However, these technologies have their drawbacks and are still a long way from being introduced into the market. Therefore, IQ-Tip™ has an excellent opportunity to set a new standard for care procedures that involve demanding punctures and injections. The functionality of the IQ-Tip™ needle has been proven in practice. The needle is in production and ready to be launched onto the market as soon as the pivotal IQ-LP-03 clinical investigation has provided the final clinical evidence needed for the product. The company now seeks funding to complete ongoing EC-certification process in compliance with the new Medical Device Regulation (MDR) to gain EU market entry.
Why to invest in Injeq?
Injeq is a promising medtech startup with a unique solution in its possession: IQ-Tip™ smart needle which can help medical personnel to perform safer treatment for patients to whom they need to perform demanding punctures. Our goal is to help more children with leukemia to survive, less patients to suffer from traumatic and unsuccessful punctures, and in general make the lumbar puncture and later all blind and demanding punctures safer for the patients. Investment-wise we combine the search for financial returns with ethical objectives – our priority is to save patients as this is the only way to make successful business in medtech.
What has happened since the last campaign?
We have made lots of progress since summer 2017 when we closed our first campaign at Invesdor. Most importantly, we have been in EC-certification process with TÜV SÜD in Munich, Germany since April 2018. Knowing how overladen the notified bodies are at the moment in the medical device field, we can consider ourselves lucky to have been accepted by TÜV SÜD, which is definitely one of the most reputable entities in its field.
Secondly, we have kept our focus clear: getting our processes and quality system documentation eligible for EC-certification. This is a time-consuming process, to put it mildly: It does not suffice to show that our needle works, but we need to show that we are able to produce, test, store and deliver them in proper manner without any risks during the whole lifecycle of the product. Essentially, before our products can be CE marked, we need to have the manufacturing processes in place and lots of manufacturing done not only for clinical studies, but also for numerous different test and validation purposes – even though we are not allowed to sell our products yet.
At the moment, everything concerning our production is well underway: manufacturing processes, documentation, quality system, risk management and so on. We have also been lucky to find a perfect office with suitable cleanroom facilities for us – we will be moving to new premises during May-June and look forward to the possibility of showing our new premises to shareholders in connection with our Annual General Meeting this summer.
We have also recruited great new professionals, developed our future sales network, managed our patent portfolio, and many other things, but suffered a great loss when our CEO Dr. Rami Lehtinen suddenly passed away last November. We received 30 applications after we started to recruit our new CEO. Now, in May 2019 Injeq has hired a new CEO, who will start in late July 2019. The board feels that the person nominated is a perfect fit with the company.