Concord Neonatal: Let's get birth right!

1 in 10 babies is having problems at birth. Around the world this affects over 35.000 newborns, and their families, every day. 

Research shows that clamping the umbilical cord before a baby is breathing, causes a shock in the baby’s blood flow; a drop in heart rate and blood oxygen levels, increasing the risk of injury to its organs, especially the brains and intestines.

Concord Neonatal enables caregivers to provide lifesaving care with the umbilical cord intact for as long as needed. Close to mom, the baby gets maximum benefit from the blood from the placenta, up to the moment it is breathing on its own. 

We call this the Concord Birth Flow. Key to the Concord Birth Flow is the Concord Birth Trolley, a new treatment platform, allowing to keep the baby close to its mother, with the umbilical cord connected. Mom can see and touch her baby.

Birth is the pivotal moment when the natural support in the womb of the mother transitions into having to breathe and live on your own strength. These first minutes have a crucial impact on the rest of life.

1 in 10 babies do not breathe or breathe insufficiently at birth. Around the world, this affects over 35.000 newborns every day. Most of these babies are born premature, some experience asphyxia or other problems. Birth complications are the leading cause of death among children under 5 years of age and over 1.5 million children die each year due to birth complications.  Many survivors face a lifetime of disability.

Medical convention prescribes to cut the umbilical cord immediately after birth, to provide urgent care, taking the baby away from its mother. Scientific research shows that clamping the umbilical cord before a baby is breathing, causes a shock in the baby’s blood flow; a dangerous drop in heart rate and blood oxygen levels, increasing the risk of injury to its organs, especially the brains and intestines. We are denying babies the oxygen-rich blood from the placenta. As a result, we often need to repair, or even live with, the damage.

Prof. Arjan te Pas from Leiden University Medical Center developed a new way of thinking and working to give babies a shock-free birth. This new approach allows neonatal caregivers to provide lifesaving care with the umbilical cord intact for as long as needed. The baby gets maximum benefit from the blood from the placenta, up to the moment it is breathing on its own.

We call this the Concord Birth Flow. Key to the Concord Birth Flow is the Concord Birth Trolley, a mobile trolley that can be equipped with all devices for adequate monitoring and treatment of babies who need extra support. There is no urgency to cut the cord, all necessary care can be provided immediately, while allowing to wait calmly with clamping the cord until the baby is ready. It has a uniquely shaped cradle with a patented opening for the umbilical cord, to position the baby very closely above mom. The baby, whether it is a very premature or term newborn, can be placed safely on the cradle, even with a very short umbilical cord connected. Mom can see and touch her baby.

The Concord Birth Flow offers a shock-free birth for all newborns that do not breathe or breathe insifficiently in the first minutes after birth. These baby's need urgent care for their survival. The majority of these newborns are born prematurely, before 37 completed weeks of gestation. But this also affects term babys with birth complications like asphyxia or have congenital abnormalities. 

As a spin-off of Leiden University medical Center, Concord Neonatal is working closely with caregivers and scientists to develop the knowledge and insights around the process of birth. We are building a company that brings innovation to the market that support a "shock free birth flow" for every baby, and their family.

For over 10 mln. newborns worldwide every year, the Concord Birth Flow reduces the risk of complications at birth, like sepsis, intraventricular hemorrhage (IVH) or necrotizing enterocolitis (NEC). This prevents long term disabilities and may even prevent the loss of lives. At the same time, the Concord Birth Flow reduces the cost of care. 

Moreover, Concord keeps the baby close to mom, ensuring essential bonding between mother and baby immediately after birth.

The Concord Birth Flow is an new and innovative way of working, a process innovation, facilitated by a new product the Concord Birth Trolley. Whether it is in the delivery room or the operating room, obstetrics and neonatal caregivers need to collaborate at the mother’s bedside, to provide the best care for the baby and its mother. 

Delaying cord clamping is gaining great momentum in neonatology, with hospitals looking for solutions to monitor and treat the newborn with an intact cord. Current solutions include self built trolley's, existing resuscitation tables, or even placing the baby on moms legs. The LifeStart trolley was specifically developed to provide initial care with the cord intact.

The Concord Birth Trolley is the only adequate solution to provide resuscitative care, in accordance with ERC/NRP guidelines, offering a true alternative for conventional resuscitation tables. Concord has a uniquely shaped cradle with a patented opening for the umbilical cord. The newborn, whether it is a very premature or term newborn, can be placed safely on the cradle, even with a very short umbilical cord.

The Concord Birth Flow is an new and innovative way of working, a process innovation, enabled by new technology, the Concord Birth Trolley. 

The Concord Birth Trolley is a new and first of its kind treatment platform with a patented slot for the umbilical cord, to keep the baby very close to its mother, even with a very short umbilical cord connected. The Concord Birth Trolley is a mobile trolley that can be equipped with all necessary devices for adequate monitoring and treatment of babies that need extra support during transition. There no longer is any urgency to cut the cord, all necessary care can be provided immediately, while allowing to wait calmly with clamping the cord until the baby is fully stable and breathing on its own.

The WHO recommends late cord clamping (performed approximately 1–3 min after birth) for all newly born term or preterm babies who do not require positive-pressure ventilation. These newborns are excluded to ensure effetive ventilation is performed immediately. Due to lacking technology, this is only possible today by cutting the umbilical cord and taking the baby away from its mother. 

With the availability of the Concord Birth Trolley, it is no longer needed to cut the cord immediatley and allows to provide positive-pressure ventilation immediately after birth with the cord still intact.

A phase 1 feasibility study (https://fn-bmj-com.ezproxyberklee.flo.org/content/104/4/F396) and a phase 2 effectiveness trial (https://www-sciencedirect-com.ezproxyberklee.flo.org/science/article/pii/S0300957219307300?via%3Dihub) have been completed, using a first and second generation prototype. The results include:

• A Concord Birth Flow is safe and feasible
• There were no adverse effects for the baby nor the mother
• A more stable heartrate during transition and no bradycardia (dangerously low heartrate)
• Oxygen saturation quickly increased
• Infants receiving a Concord Birth Flow needed less time (-1:19min) to reach stability compared to infants receiving standard care.
• A Concord Birth Flow is at least as effective as current standard care.

In September 2019, the newly developed Concord Birth Trolley received CE marking and today, 9 hospitals have succesfully implemented the Concord Birth Flow.

Delaying cord clamping is gaining interest among neonatologists and obstetricians accross the globe, to improve care are birth for baby's requiring support and lower the risk of complications, in order to prevent long term disability and even death. 

Many clinical trials have been performed and prove the benefit of delaying cord clamping. Unfortunately until now it was not feasible to prove the benefits for baby's requiring (respiratory) support. The availability of the Concord Birth Trolley allows for further clinical research. The ABC3 trial is therefore currently ongoing in all Dutch Neonatal Intensive Care Units to jointly prove the clinical benefit. Quantified data on the improved outcomes for these vulnerable baby's will be the main driver for change, aiming for this new workflow to become standard of care and will be included in WHO and ILCOR guidelines.

Today we are mainly targeting top clinical and academic hospital, who strongly believe in the benefits of delaying cord clamping and who are joining us in the dirve towards change.

Since Concord is implemented in all Dutch NICUs, we are serving all preterm newborns in The Netherlands, born below 30 weeks of gestation. This is a total of 1,500 newborns per year.

We aim to implement the Concord Birth Flow in at least 70 hospitals by the end of 2021, who have an average of 150 elligible births annually, resulting in serving over 10,000 newborns.

In 5 years, the number of hospitals is anticipated to be over 500, where it is serving over 75,000 infants. 

Ultimately, a Concord Birth Flow has the potential to improve the lives of 10 milion newborns every year, who need all the strength and support they can get in the first critical minutes after bith.

Our goal within the next year is to implement the Concord Birth Flow in at least 50 leading hospitals in Europe and Australia. Additionally we are anticipating the finalization of the ABC3 trial, the multicenter randomized controlled trial to prove the benefits of this new way of working.

Within the next 5 years, the main goal is to include physiological-based cord clamping (the scientific term for the Concord Birth Flow) in the ILCOR guidelines.

The most important barrier today is the lacking clinical evidence in quantifying the benefit of the Concord Birth Flow for newborns. The ABC3 trial is therefore essential to overcome this barrier. We are also working closely with other academic hospitals to support other clinical trials, for example in children with Congenital Diaphragmatic Hernia (the PinC trial at Erasmus MC).

There will be cultural barriers to overcome in countries where caregivers are not used to provide care for newborn baby's in the presence of parents. This will require a guideline change and reference site hospitals and caregivers who succesfully perform the Concord Birth Flow. Here also, clinical evidence will be an important driver for change.

The Concord Birth Trolley in its exisiting form is a facilitator to drive this change via clinical research and scientists. When this workflow is more and more becoming standard of care, there will be a need to design the delivery room for the future, for developed economies and for developing economies.

See previous question.

Not applicable

Our team consist of 5 people, with 3.7 fte.

The team today consists of a mix between commercial, technical and clinical knowledge:

Rianne Rotink, MSc, CEO: Rianne leads all activities of Concord Neonatal with a focus on business development. She has over 17 years’ experience in international leadership roles in medical device companies. Rianne’s expertise includes strategy, innovation, product development, marketing, business development, sales and service.

Alex Vernooij, PDeng, CTO: Alex is co-inventor and developer of the Concord Birth Trolley and was the project leader of Concord at the Medical Technology Department at the LUMC. With his knowledge of the product, its application and his engineering background he will continue to drive all product development activities. Alex is a qualified medical engineer by training.

Bjorn Valentijn, Clinical Training Manager: Bjorn is a NICU nurse at Maastricht University Medical Center and is a certified NLS trainer. Bjorn is working as training manager at Concord Neonatal in conjunction with is nursing role at MUMC. At Concord, Bjorn is responsible for development and accreditation of our training programs and for performing customer training.

Nerea Grisalena, MSc, Product Engineer: Nerea is master of science in mechanical engineering and is repsonsible for product engineering and technical customer service of the Concord Birth Trolley, to ensure that the product continuously meets customer and business requirements.

Concord Neonatal is currently hiring a Quality Assurance Manager and a Sales Director.

Concord Neonatal has setup a scientific advisory board led by Prof. Arjan te Pas, with key clinicians from 5 different continents.

We have created a network of organizations around us to support our activities, including graphics design, finance, regulatory affairs. An important partner is the producer of the Concord Birth Trolley, and external supplier who also supports engineering activities.

Our most important partner is Leiden University Medical Center, where the invention originates and that is leading the ABC3 trial.

We are offering our solution as a complete workflow implementation program to hospitals specializing in neonatal care. This program consists of the Concord Birth Trolley and services like installation, training and implementation support. This is a one time capex investment for hospitals. As soon as hospitals are more comfortable with the new workflow, they are expectged to purchase additional trolleys. Technical services willl be offered to customers, generating recurring revenue.

We have raised dilutive and non-dilutive funding to fund our activities for developing and building Concord Neonatal towards cashflow neutral.

To generate more attention for our solution and the benefit it has for infants accross the globe.

Our solution improves the lives of many babies across the globe and with this foundation we could make a translation of our solution for developing economies.