News & Media
Nijmegen (NL) - July 10, 2020
An international consortium led by the Dutch med-tech startup ATRO Medical receives over € 800,000 EUROSTARS funding to address an unmet need for Knee Osteoarthritis patients. These patients often suffer from cartilage degradation related to a dysfunctional meniscus. Based on previous research, the consortium will develop a durable meniscus prosthesis for the outer knee compartment to relief pain and restore mobility. This would change the life of thousands of osteoarthritis patients.
Knee osteoarthritis is one of the leading causes of disability worldwide. Loss of meniscus tissue in the younger years can accelerate this disease, leading to complaints such as severe chronic knee pain, stiffness and immobility. Many patients finally end up with a total knee replacement. The Dutch orthopedic startup ATRO Medical has the mission to create a solution for the long, painful period before total knee replacement.
A durable meniscus prosthesis can serve as a new shock breaker in the knee, reducing bone to bone impacts and as such relief pain in the knee joint. An implant for the inner side of the knee joint is currently in clinical research after ten years of development. However, a solution for the outer knee compartment is still missing. Since forty percent of complaints are apparent in this so-called lateral compartment, many patients would benefit from it.
The consortium of ATRO Medical, the Swiss company Samaplast and the Orthopaedic Research Laboratory (ORL) of the Radboud university medical center receives over € 800,000 EUROSTARS funding as part of a total investment of € 2 million to rapidly change this situation. The team is committed to develop a new meniscus prosthesis for the outer knee compartment and have it ready for a clinical trial within just two years’ time. Both the durable solution for the outer knee compartment and the short development time would be unique in the orthopedic society.
The ORL has been involved in meniscus research for many years as biomechanical expert and was part of the team developing the IP for this innovation. Samaplast is specialized in injection molding of high-precision and medical grade products out of plastic. ATRO Medical is a spin-off from the Radboud university medical center and DSM Biomedical and focuses on the design of durable meniscus prostheses. These three parties together have the required expertise to bring the new meniscus prosthesis to life with EUROSTARS funding.
EUROSTARS supports international innovative projects led by R&D performing SMEs such as ATRO Medical, that help improve the daily lives of people around the world. This EU program aims to bring increased value to the economy, higher growth and more job opportunities.
Nijmegen (NL) - January 20, 2020
Dutch medical innovations are rarely granted the Breakthrough Designation by the FDA. Startup ATRO Medical from Nijmegen is the new kid on the block in orthopedics. This week their Trammpolin meniscus prosthesis, designed to treat chronic knee pain, received the Breakthrough Device Designation from the FDA. The designation demonstrates the innovation potential of this implant and expedites US market access by receiving a priority treatment at the FDA.
The US Food & Drug Administration identifies the Trammpolin meniscus prosthesis as a unique and potentially more effective treatment for knee osteoarthritis patients with a deficient meniscus. At the moment there is no effective treatment available for a large group of these patients.
CEO Jan Hunik is excited to receive the Breakthrough Device Designation: “We still have quite some work to do before we can access the US market and obtain the CE mark for the European market. This designation endorses our conviction that the Trammpolin meniscus prosthesis can make an important impact on the lives of patients suffering from chronic knee pain. We look forward to the more intense collaboration with the FDA and are confident that this will expedite our US timelines.”
The goal of the Breakthrough Device Designation program is to provide patients and their health care providers with timely access to effective medical innovations. The designation ensures a predictable and timely assessment by the FDA. The Trammpolin meniscus prosthesis will have priority in upcoming FDA reviews. The FDA will also give more transparency with respect to the required data for market access of ATRO Medical’s meniscus implant.
Knee Osteoarthritis (KOA) is an irreversibly debilitating disease and is one of the leading causes of disability in Europe and the US. The Trammpolin meniscus prosthesis is a durable anatomically shaped implant that aims to reduce knee pain and restore mobility. Trammpolin is currently being assessed in a first clinical study in the Netherlands. A next study will most likely include clinics in other European countries as well as the United States. ATRO Medical is largely financed by venture capital and is expected to organize a next investment round (Series B) in 2021 to further accelerate its path to the EU and US market.
Boston (US) - September 22, 2019
This weekend ATRO Medical will participate in the MedTech Innovator’s 2019 Accelerator program. Our company was selected as finalist out of over 800 applications.
Together with 24 other finalists, we have the opportunity to give our pitch to investors, meet with regulatory institutes and healthcare providers, and learn from proficient Life Sciences experts. This will strengthen our strategy to bring our Trammpolin® Meniscus Prosthesis to market in the most effective way.
If you are attending the MedTech Conference in Boston and would to meet us, please send an email to firstname.lastname@example.org.
Nijmegen (NL) - August 20, 2019
We are proud to announce that from now on ATRO Medical is ISO 13485:2016 certified. Notified body DEKRA confirms that ATRO Medical meets an extensive framework of requirements regarding product quality.
ATRO Medical has achieved ISO 13485 certification for the design, development, manufacture and distribution of its meniscus prosthesis system. The certification underlines that ATRO Medical is able to deliver a medical product that meets the requirements of the customers and the applicable regulations.
The quality system of ATRO Medical has been extensively audited by DEKRA, a recognized notified body for manufacturers in the medical industry. An intensive period of preparation preceded this audit, to properly design the quality management system and to make it effective for our start-up. With the ISO certification as the crowny glory.
Maastricht (NL) - June 28, 2019
The first TRAMMPOLIN® meniscus prostheses were succesfully implanted at the Maastricht University Medical Center (MUMC+).
On Friday June 28, two patients have received their TRAMMPOLIN® meniscus prosthesis in Maastricht (NL) as part of the AIR study. These were the first patients to participate in the MUMC+, under supervision of Dr. Pieter Emans.
The Dutch local TV station L1 brought the news extensively in a 3 minute video. Orthopedic surgeons Pieter Emans (MUMC+) and Tony van Tienen (ATRO Medical) explain the procedure and its' origin.
The video in the link above is in Dutch.
Nijmegen, 27 February 2019
ATRO Medical is pleased to announce that the first Trammpolin® Meniscus prostheses are placed in 2 patients at Radboudumc clinic on February 27.
Both patients suffer from knee pain as a result of an earlier meniscus trauma and an arthroscopic procedure where damage meniscus tissue was removed. The lack of a functional meniscus led to cartilage wear and development of chronic pain (Osteoarthritis) in the years after the trauma. Treatment options are limited to pain medication, which treat the symptoms, but not the disease.
The two patients received a Trammpolin® prosthesis, restoring their meniscus function as shock absorber in the knee. The procedure took place in Radboud university medical center under supervision of the Orthopedic surgeons Dr Sebastiaan van de Groes of Radboudumc and Dr Koen Defoort of Sint Maartenskliniek.
Koen Defoort and Sebastiaan van de Groes were satisfied with the procedure “It went according to plan and without any unexpected difficulties. The meniscus prothesis is placed and fixed at the correct location”
The patients will start immediately with a rehabilitation program and can walk on crutches (50% weight bearing). The expectation is that these patients will walk without crutches in 6 weeks, which is the first follow-up visit with the surgeon. The full benefit of the procedure will take 6 months.
This can become a major step forward in the treatment of patients with chronic knee pain. Knee Osteoarthritis is a debilitating disease that has a severe impact on the daily life of many people.
These 2 patients mark the start of a larger 18 patient study in the Netherlands in 3 clinics. The patients in the study will be followed, with 6 regular scheduled visits for 24 months. The study aims to have these patients returning to normal daily activities, without pain and pain medication.
The patients in the study are, among other criteria, between 35 and 65 years of age, having a history of meniscus trauma. They suffer from chronic knee pain, requiring increasing levels of pain medication and are hindered in their daily life activities. The knee should demonstrate wear of the cartilage grade 1-2 (on a scale 0-4). The current treatment and prognose of these patients, is several years of increased pain medication and further decrease in mobility and as a consequence reduced daily activity. With wear of grade 4, a patient becomes eligible for a total joint replacement.
The Trammpolin® Meniscus prosthesis is a development of ATRO Medical BV. A medical device company started in 2016 and based in Nijmegen and Oss. It is the first anatomical shaped meniscus prosthesis of a non-resorbable polymer placed in a patient. This is a major milestone for ATRO Medical in the development of a new and innovative way to treat Osteoarthritis patients.
Jan Hunik and Tony van Tienen
Nijmegen (NL) - January 1, 2019
Dr.ir. van der Veen graduated at the department of Mechanical Engineering at Delft University of Technology. After which he started working at Fokker Aircraft in the flight controls group. Next, he worked at Fokker Space B.V. as specialist structural integrity. From 2000 he worked at the department of Physics and Medical Technology at The VU University Medical Center where he obtained his PhD on mechanics of the spine. In the lab he gained a lot of experience in the field of in vitro biomechanical testing.
At the start of 2019 he started as senior scientist at ATRO Medical where he is involved in biomechanical testing of the Trammpolin® meniscus prosthesis.
Nijmegen (NL) - December 10, 2018
ATRO Medical BV has permission from the Healthcare and Youth Inspection to implant the meniscal prosthesis Trammpolin® in eighteen patients. ATRO Medical BV does this together with Radboudumc, the Maastricht UMC+ and the Sint Maartenskliniek. This clinical study is used to determine whether Trammpolin® leads to less pain and a more resilient knee in patients.
In a healthy knee, the meniscus acts as a shock absorber. Without a well-functioning shock absorber, pain and movement restrictions often occur in the knee. There is currently no surgical treatment for this. Only when the knee is seriously worn the whole knee joint is replaced by a total knee replacement. The Trammpolin® polymer prosthesis only replaces the meniscus and thus restores the shock absorber function. This prosthesis is intended for patients who have undergone a meniscectomy in which the meniscus has been completely or partially removed. This allows the period up to a total knee replacement to be bridged. The clinical examination now being performed should show whether the meniscal prosthesis is safe and whether the pain in the knee will actually decrease.
Orthopaedic surgeon Sebastiaan van de Groes van het Radboudumc: "Because the development of the Trammpolin® meniscus prosthesis has taken place in the Radboudumc and the prosthesis is also placed here in the first patients, we can quickly solve any points of interest. This allows a quick, efficient and safe introduction of this new implant.
"At the outpatient clinic we regularly see patients with pain in their knees due to meniscal wear and tear," says orthopedic surgeon Koen Defoort of the Sint Maartenskliniek. "By placing this meniscal prosthesis we expect to be able to offer an effective and safe treatment for this patient group.
Permission to test
Meniscal prosthesis research began in 2011 with a public-private partnership in the field of clinical, biomechanical and materials research with academic centres and companies including the Orthopedic Research Laboratory (ORL) of Radboudumc. This was the foundation for the development of the current Trammpolin® prosthesis. The starting point was a shock-absorbing material, in the form of the natural meniscus, which could withstand the forces in the knee joint and was resistant to wear and tear. The surgical procedure had to be relatively simple and could be performed in any orthopaedic clinic by means of a keyhole surgery. In order to develop a meniscus for patients based on the prototype developed, ATRO Medical BV was founded in 2016. For two years, the meniscal prosthesis was extensively tested for function and safety. Based on these test results, the Healthcare Inspection gave its approval mid-2018 to conduct clinical research on eighteen patients. The first patients will be treated at Radboudumc. If the results are good, patients will also follow in the spring of 2019 at the Sint Maartenskliniek (Nijmegen) and the Maastricht UMC+.
Major step forward
"The start of clinical research is a major step forward for patients with chronic knee pain for whom there is currently no effective treatment," said Tony van Tienen, orthopedic surgeon responsible for implant development at ATRO Medical. "In current practice, after years of treatment with painkillers, injections and physiotherapy, it is often decided to replace the entire joint with a total knee replacement. Our meniscal prosthesis can change this with a simple, effective procedure. We expect that with our meniscal prosthesis we can postpone the placement of a total knee replacement for 10 years.
With good results from this clinical study, the meniscal prosthesis could be approved on the European market in 2022.
Important: Trammpolin® has not yet been approved for commercial purposes and may only be used in clinical trials.
About ATRO Medical
ATRO Medical BV is a medical startup that is fully focused on developing the Trammpolin® meniscus prosthesis with the ultimate goal to market this Dutch invention and thus make it available to patients worldwide. ATRO Medical originated as a spin-off of Radboudumc and DSM and is based in Nijmegen and Oss.
For more information, please visit www.atromedical.com
In addition to top clinical and top referral patient care, the core tasks of the Maastricht University Medical Centre+ are scientific research and education/training. The MUMC+ distinguishes itself nationally and internationally by its focus on prevention. This means not only health restoration, but also health preservation and health protection.
Radboudumc is a leading academic centre for patient care, education and research, with the mission to have a demonstrable impact on healthcare.
About Sint Maartenskliniek
As a specialized hospital, the Sint Maartenskliniek has been leading the way in the treatment of posture and movement disorders in the Netherlands and Europe for more than 80 years. The Sint Maartenskliniek is always looking for new possibilities, technologies and applications, with the aim that it leads to better quality of care.
More information: www.maartenskliniek.nl
Nijmegen (NL) - July 11, 2017
Today ATRO Medical announces the successful closure of a Series A financing round for the development of a polymer based meniscus implant.
The funding provided by a syndicate led by Thuja Capital Healthcare (Seed) Fund II and includes Brabant Development Agency, DSM Venturing, Cascara Ventures and Radboud university medical center.
ATRO Medical will use the new funding for the development and market registration of Trammpolin®; an anatomically shaped Meniscus Implant. This investment will enable ATRO Medical to treat the first patients in 2018 and complete a First in Man clinical trial in 2019.
Osteoarthritis, resulting from the wear and damage of the articular cartilage, is a common disease affecting 10% of the men and 18% of the women globally according to the WHO. Osteoarthritis of the knee joint is a major cause of joint pain and reduced mobility of patients. The debilitating consequences of Osteoarthritis adversely effects a patient’s quality of life, ability to work and increases the cost of health care.
Meniscus damage and wear are important causes of Osteoarthritis of the knee. The Trammpolin® device intends to replace the damaged meniscus with an implantable prosthesis, with the aim of restoring the protective function of the meniscus by acting as a joint spacer.
Trammpolin® will become the first anatomically shaped polymer based meniscus implant. The device serves a market with over 1.000.000 clinical procedures a year in the US and EU, in which damaged meniscus tissue of the knee joint is removed. A large number of these patients will develop Osteoarthritis during the 10-20 year period following the removal of damaged meniscus tissue.
Co-founder and Chief Medical Officer Tony van Tienen, an accomplished orthopaedic surgeon, is excited about great potential for the pain reduction and mobility improvement in knee patients offered by Trammpolin®. Osteoarthritis patients have no effective treatment options with the current health care offerings.
“ATRO Medical is addressing a large unmet medical need, as an increasing number of patients with knee injuries undergo meniscectomy (partial or total removal of the meniscus). These patients gradually develop osteoarthritis, resulting in pain and reduced mobility. Current treatment options for these patients are limited and have poor outcomes. Trammpolin® aims to provide a cost-effective solution to reduce pain and restore mobility.”, commented Harrold van Barlingen, managing director of Thuja Capital.