About our project
The problem we solve: The tennis elbow, Lateral Epicondylitis (LE), is one of the most common worldwide work related disorders and by far the biggest orthopedic injury. Evidence based research has shown that approx. 2% of the total population worldwide is suffering yearly from an LE.
Already for the Netherlands this would imply that yearly approx. 350.000 people suffer from a Tennis Elbow and in Europe already over 10 million people.
Despite these high numbers and the relatively easy recognizable injury the tennis elbow has never been paid much attention to by orthopedic surgeons as no real effective standardized treatment is known and consequently the Tennis Elbow has been a bit a forgotten subject.
ITEC Medical has, in collaboration with the leading European elbow surgeons, developed a new standardized method for treating this injury.
About our solution:
ITEC Medical has invented, developed and patented a device treating the exact site of the injured tendon by perforation of a holder with 12 small needles, our ITEC Disposable or short ITEC-id. Exact position of the needles is guaranteed by ultrasound guidance, which shows the exact dimensions beforehand. Instead of 70% failure rate we claim to have zero being by far the most accurate device for an elbow treatment available in the market.
The ITEC Medical method is fast, accurate and standardized. No longer a surgeon is needed but a nurse practitioner can also perform the treatment. Recent studies by (Prof. Dr. D. Eygendaal et al.) showed that the present manual injections, even performed by specialists, have a failure rate of 70 % i.e. injection not in the tendon. This compared to a study with our ITEC device were the failure rate was 0% we can conclude that our ultrasound guided ITEC method will drastically increase the “hit” rate and thus treatment costs
Progress to
date:ITEC Medical is an ISO 13485 certified company and has a patent on both its device and disposable.
Currently our device is stationed in 12 Dutch Hospitals and 2 Belgium. After our certification in May we have sold over 400 disposables and this number is growing every day. The next step is Germany where we are targeting numerous hospitals and clinics directy and through organizing Congresses and seminars. We have an European patent and the US is pending. The next step will be injection moulding as the current production method is labour intensive and more expensive when bigger batches are needed. We are looking for sponsors for the following:
Market expansion in Germany and the rest of Europe
FDA Approval in the US
Injection Moulding of our disposable
About Our Team
Creator: Marco Eygendaal
Location: Zürich (de)
Bio: Result orientated and independent entrepreneur with many years of field experience. Proven track record of many successfully introduced and implemented projects. Main areas are the food industry, medical industry and ICT. Experienced, motivational strong appearance and able to lift ITEC Medical to the next level to achieve maximum results with available resources. In possession of the right network, education and skills to achieve the best possible outcome for stakeholders.
Title: Managing Partner
About Our Company
How We Help Hospitals
Currently the treatment of a Tennis Elbow in a hospital is time consuming, inefficient en very expensive. Our device will dramatically improve turnover time as 4 to 5 patients can be injected in one hour by a trained nurse practioner, leaving valubale time for a surgeon to address his attention somewehere else and be far more efficient.
Challenge Mission
Market Size
Studies have shown that the General Practitioner forwards 2% of his patients to a specialist. https://www.nhg.org/standaarden/volledig/nhg-standaard-epicondylitis
So for the Netherlands, with a strong primary care and low referral rates to Hospitals the numbers for a tennis elbow is as follows:
2% in population è 50% seek medical help at a General Practitioner è General Practitioner sends 2% to Hospital.
For the Netherlands, with approx. 17 mln. inhabitants, this would imply: 17.000.000 è 350.000 è 175.000 è 3.500 patients/year
As can be found in the enclosed tables we have used these statistics for other European Countries as well. However, in most countries these numbers of patients will be higher because of the very rigid primary care we have in the Netherlands and 10% will be not be an unrealistic figure.
Projected 3 Year Growth
Initially, we will use the Netherlands as a pilot market in year one with 2 hospitals. In 2016 we project a number of 30 hospitals and in 2017 this will be copied to the bigger EU countries as the United Kingdom, France, Italy and Spain, totalling 97 hospitals but in potential over 68.000 patients (all based on 2%). In 2018 we will include the US with over 1 million potential patients and over 7.000 hospitals.
Again, in our view these figures are reserved but realistic.
How We Will Make Money
The business model of ITEC Medical can be clearly defined is as only one single Device is being produced for a specific operation, were the total cost of ownership is in control by one company. This enables to exactly determine the market potential and possible earnings.
For our ITEC-id and ITEC-it we will apply in the Netherlands a dual pricing strategy where we market the Medical device as a low cost, easy to use device. The ITEC-it will be sold on cost price plus a small mark-up basis to cover any additional costs. The disposable needle-holder on the other hand will be used as the cash generator. The unique patented needle-holder can be produced at relatively low cost at our own facilities for the coming years. Our cost for the ITEC-id is currently around € 25,- a piece, based at very low batch numbers and we know the cost price will go down further to around € 15,- a unit once we will produce considerable vol
About our Competition
The ITEC Medical Device is patented in the Netherlands with patent nr. 2004558 and EU patent nr. 11161095.2. Our US patent is pending and will probably be registered in 2016. We even have the option to register a worldwide patent.
There are alternatives but currently there is no direct competition. Being the only unique supplier we are in the so-called “Blue-Ocean” (W.Chan; R.Mauborgne, 2005) were only the alternatives can be seen as a threat.
Alternatives:
Currently the five common used interventions for a treatment are:
- Do nothing, basically sit out the pain and hope for a quick recovery, which minimal lasts 6 months.
- Physiotherapy or braces, this has no effect on recovery time but might lead to less pain in the tendon.
- Injections (corticosteroids, autologous blood, hyaluronic acid, dextrose, and other)
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Innovation Details
Intellectual Property Summary
DE 3108766 A1
The present invention relates to an apparatus for treating a tennis elbow, including: an apparatus body, a fixing part which is arranged near an outer side of the apparatus body for fixably positioning the apparatus body with respect to its surroundings, a part which is arranged in or near the apparatus body and can be extended with respect to the apparatus body, a positioning device which is arranged in or near the apparatus body for positioning the extendable part with respect to the apparatus body and a holder which is exchangeably connected to the extendable part during use, including a holder part with penetration means attached thereto, in which the penetration means are arranged on the holder part in a pattern. The apparatus body or the extendable part is provided with a manipulating element which manipulates a feature of the holder in such a way during use that the holder is made unsuitable for re-use in the apparatus.
Patent Link
https://www.google.nl/patents/DE3108766C2?hl=nl&dq=itec+medical&cl=en
Clinical Information
Accuracy of injection therapy in Tennis Elbows by experienced orthopedic surgeons in cadavers.
Authors:
Renée Keijsers MD, Michel P.J. van den Bekerom MD, Prof Ronald Bleys MD PhD, Prof Niek C.N. van Dijk MD PhD, Denise Eygendaal MD PhD.
Introduction:
Different injection therapies are used in the treatment of Lateral Epicondylitis (LE). Usually, it affects the Extensor Carpi Radialis Brevis (ECRB) tendon. Therefore, an injection should be performed at the location of the ECRB tendon.
What is the accuracy of manual injections performed in the ECRB tendon and what techniques are being used?
Method:
Twenty surgeons experienced in the upper extremity completed a questionnaire about their usual 'work up' to, and injection technique of LE. The ten most experienced of these surgeons have infiltrated a cadaver elbow with acrylic paint, using the same injection technique that they would use in the treatment of LE. Afterwards, an arthroscopy and dissection of the elbow was performed. The injection technique and localization of acrylic paint was reported.
Results:
The 'work up' of LE is similar between surgeons. In the treatment of LE, 88% uses corticosteroid injections, 29% autologous blood and 24% platelet-rich blood plasma. Dextrose and hyaluronic acid is hardly used. Dissection revealed that only a third of the injections in the cadaver elbows was (partially) localized in the ECRB tendon. 60% was localized intra-articular. In addition, the acrylic paint was localized in the Extensor Carpi Radialis Longus tendon (n = 6), anconeus muscle (n = 3), lateral epicondyle (n = 3), triceps brachii muscle (n = 2) and brachioradialis muscle (n = 1). The number of perforations during the treatment varied between 1 and 10.
Conclusion:
The 'work up' of LE is done in a uniform way; however, the treatment is highly variable. Injections carried out manually for the treatment of LE are not accurate, resulting in the majority being localized intra-articular.
Fenestration of the ECRB tendon by means of an innovative standardized, reproducible technique; a pilot study.
Authors:
Renée Keijsers MD, Laurens de Haan MD, Annechien Beumer MD PhD, Denise Eygendaal MD PhD.
Introduction:
No consensus has been reached on which injection therapy is most effective in the treatment of Lateral Epicondylitis (LE), which usually involves the Extensor Carpi Radialis Brevis (ECRB) tendon. Current studies correlate poorly due to great diversity in injection technique, where injections are usually performed manually and ‘blindly’.
Recently, a device (ITEC; Instant Tennis Elbow Cure. ITEC Medical, Enschede) has been developed to standardize the injection technique.
This pilot study describes the first experiences with ITEC for the treatment of LE and focuses on potential complications caused by this new technique.
Methods:
25 patients with LE were treated with standardized fenestration performed by an experienced upper limb surgeon using the ITEC-device. An ultrasound-guided depth measurement of the ECRB was performed prior to the perforation of the tendon. The elbow was positioned in a standardized manner, using laser pointers. The perforations of the ECRB tendon were performed in an automated and standardized manner, using a set of 3x4 needles, adapted to the anatomy of the ECRB. Complications were noted. Pain scores and the Oxford Elbow Score were evaluated at baseline, and 8 and 16 weeks after treatment.
Results:
There were no complications reported during the 16 weeks follow-up. There was no deterioration on the pain score or Oxford Elbow Score.
Conclusion:
Standardized perforation of the ECRB in the treatment of LE via the new ITEC-device demonstrated no side effects or complications in this pilot study of 25 patients. In future studies, ITEC may be used to compare different injection therapies in a standardized manner.
Regulatory Status
As our US patent is still pending we have not applied for an FDA status. However we are ISO13485 certified
How we will use the funds raised
We will use the funding for 4 major ITEMS:
Extending marketing and sales effort in EU, starting in Germany
Switch to injection moulding
Start with FDA approval
Switch from push our product into the market to pull from our users, i.e the patients. Funding will be needed for SEO and SEA
Thank You
Having started this medical company several years ago I never realized how tough and stringent all the rules and regulations were, especially for a start-up with one product for one market. Although the Tennis Elbow is the most common orthopedic injury it took us over three years to get the patents filed, clinical trails performed and certification approved. We are thankful to the first hospitals who adopted our device and the very positive feedback we received from patients as well as surgeons. Our team believes we have the best possibe solution for this injury and we are ready the conquer the world as the number of patients are astronomical with only in the EU already over 10 million people suffering from a Tennis Elbow. Please help us to make the next step in order to speed up our dream and your solution.
