What is endogenous tissue growth (ETG)?
ETG or Endogenous Tissue Growth is a new therapeutic category in which surgeons use implants designed to allow the body to repair itself by spontaneously growing natural, healthy tissue from the inside without the use of stem cells or animal-derived products.
Why has ETG previously not been possible?
Xeltis’ proprietary technology holds the promise to enable ETG for the first time. While it is true that there are other implants that can help the body grow tissue, they use animal-based tissue to accomplish this, or stem cells or growth factors at a more research stage, which can bring a host of complications.
Xeltis’ implants require no stem cells, growth factors or animal-based tissue and leave no foreign material behind.
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Please can you outline Xeltis’ first-in-human feasibility study that has recently been announced?
In Xeltis’ first-in-human feasibility study five children who were born with only one instead of two heart ventricles were enrolled. In order to restore the appropriate circulation of blood, they are implanted an artificial connecting tube which is built from Xeltis technology to enable Endogenous Tissue Growth.
The feasibility study is led by the renowned cardiac surgeon Dr. Leo Bockeria at the Bakoulev Center for Cardiac Surgery of the Russian Academy of Medical Sciences in Moscow, one of the largest and most experienced hospitals in the world for the treatment of complex congenital heart diseases in children.
The patients will be followed up on as part of the clinical trial every three months for one year. Longer-term, these children will typically require only a yearly visit to their hospital.
Why is this study focussing on pediatric patients?
Children are an especially vulnerable population that deserves every chance to live long, healthy and carefree lives. The clinical limitations of currently available products, which are made of non-resorbable plastics or of animal tissues, are particularly serious for children.
The fact that they live their whole lives with these implants in their body unfortunately means that they will have to undergo several surgeries over time to replace the implants, and will often be on medication for their entire lives.
If our technology is proven feasible, safe and effective, it could eliminate the need for repeat procedures, as well as the use of life-long medication, which is a physical, emotional and often financial drain on these children and their families.
How many children are born with single-ventricle heart physiology each year and how many operations on average do they currently require?
Single-ventricle physiology is fortunately a relatively rare heart malformation. Xeltis’ first product will be a replacement valve for children born with a congenital heart malformation requiring replacement of their pulmonary valve. Nearly 100,000 children are born every year with such a medical condition.
However millions of people of any age around the world suffer from congenital heart defects, degenerative heart damage and vascular diseases and could benefit from ETG.
Xeltis’ technology is said to be based on ‘Nobel prize-winning science’. Please can you tell us more about this?
The Nobel prize-winning science that builds the foundation of Xeltis’ technology is “supramolecular chemistry,” or the chemistry of assembled molecules, which is inspired by biological systems such as the double helix of DNA. Prof. Jean Marie-Lehn shared the Chemistry Nobel Prize in 1987 with two other chemists for their pioneering work in the field.
Using this technology, Xeltis produces synthetic matrices designed to stimulate and guide the body’s natural healing response without the need for stem cells, growth factors or animal tissue. Xeltis’ products are also intended to biodegrade as the natural and functioning tissue grows, leaving no foreign material behind.
What are the matrices made from?
The synthetic matrices that are produced with Xeltis’ technology are made of a novel biodegradable supramolecular polymer. They are designed to stimulate and guide the body’s natural healing response without the need for stem cells, growth factors or animal tissue.
Xeltis’ products are also intended to biodegrade as the natural and functioning tissue grows, leaving no foreign material behind.
How do the matrices work in the body?
Once implanted in the patient, the Xeltis matrix is designed to attract proteins and cells that trigger a cascade of physiological events leading to natural tissue growth.
As it biodegrades over time, components of native tissue, including collagen, endothelial lining and capillary blood vessels, develop and organize themselves into natural functioning tissue.
When the matrix has completely biodegraded, the intended end result is a fully functional heart valve or blood vessel.
If this technology is proven to be safe and effective, what impact do you think it will have?
If Xeltis’ technology is proven feasible, safe and effective, it has the potential to revolutionize the practice of cardiac and vascular surgeries, since it could eliminate the need for repeat procedures, as well as the use of life-long medication, which is a physical, emotional and often financial drain on these children and their families.
With hundreds of thousands of patients every year, the technology has the potential to save billions of dollars annually by eliminating the need for repeat procedures, as well as the use of life-long medication.
Ultimately, the company’s technology has potential for broad application across a number of cardiovascular conditions and patient populations, serving as the platform for a multi-billion dollar business.
What are Xeltis’ plans for the future?
Xeltis is extremely pleased with the early patient follow-up in the feasibility study with the pulmonary valve replacement for children with congenital heart malformations. The company expects to enter into clinical studies with the replacement valve in the next few years.
Where can readers find more information?
For more information, readers are welcomed to visit the company’s website www.xeltis.com. As a part of the recently launched media campaign, a video on Xeltis and its proprietary technology is available on the website, which can also be accessed via here.
About Laurent Grandidier
Laurent Grandidier joined Xeltis from medical device company Endosense, where he was vice president in charge of global commercialisation and portfolio management.
Mr. Grandidier previously held leadership positions at a number of brand name global medical device companies, including Teleflex Medical, Boston Scientific and Guidant.
He started his career at Procter & Gamble. Mr. Grandidier holds an MSC from INSA-Lyon and an MBA from INSEAD.
He is a former international rowing athlete who has participated in two world championships. Mr. Grandidier co-founded one of the first social venture capital funds in France, Investir&+, where he sits on the supervisory board and investment committee.
The relationship between calcium consumption at various times of the day and cardiovascular disease