1. What does Elanix Biotechnologies do?
Elanix Biotechnologies Ltd develops and commercializes tissue regeneration products for Advanced Wound Care (acute and chronic), and Advanced Skin Care products for dermatological and gynaecological applications. Additionally, Elanix provides services in cell therapy and related technologies (Cells as a Service).
2. When and why was Elanix founded?
The company was founded in 2012 as a spin-off from the University Hospital of Lausanne (CHUV), Switzerland, to commercialize a patented human progenitor cell technology platform.
3. What are Progenitor Cells?
Progenitor cells are fully differentiated yet immunologically neutral cells that are very potent inducers of tissue growth and healing.
4. Where is Elanix located?
Elanix is headquartered in Berlin, Germany with offices in Nyon, Canton Vaud, Switzerland and Wiesbaden, Germany, and listed on the Frankfurt stock exchange under the symbol ELN.
5. What is the vision for Elanix Biotechnologies?
Elanix aims to become a leading provider of cell-based regenerative medicine for multiple clinical and non-clinical indications.
Elanix could help millions of patients and customers in need of wound and skin care by accelerating the healing process with more efficient, less painful, and less expensive medical solutions as compared with current treatment options.
6. What products does Elanix have in the pipeline?
In the Advanced Skin Care business unit, Elanix is currently marketing two products, CFPC® creams GYNrepair® and SKINrepair® (launching Q4 2018 ) for gynaecological and dermatological applications. Four further ASC products are scheduled by end of 2020.
In the Advanced Wound Care business unit, Elanix is developing a bioactive Wound Dressing under the project name First Cover. First Cover Wound Dressings will be made with progenitor skin fibroblasts that accelerate regeneration and improve quality of the skin in two major applications: chronic and acute wound management. We are in the process of optimizing, industrialising and regulatory clearance of First Cover for randomized clinical evaluation. Under an ongoing compassionate use exemption program at CHUV Lausanne, First Cover is already regularly used to treat more than 100 severe burn patients with over 12 years’ successful follow-up, and is presently among the prime treatment options for burn patients in the hospital.
7. What is Repair-A SA?
Repair-A is a fully-owned subsidiary of Elanix that markets GYNrepair® and SKINrepair®.
SCIENCE & TECHNOLOGY
1. What is the scientific basis of Elanix Biotechnologies?
Elanix was founded to develop progenitor cell-based products emerging from the pioneering research of Prof. Dr. Lee-Ann Laurent Applegate. Progenitor cells are fully differentiated yet immunologically neutral cells that provide critical functions in maintaining skin homeostasis and repair after injury. Progenitor cells will help to heal wounds with inflammation, providing improved scarring regeneration.
2. Does Elanix work with stem cells?
No, our research and product development is based on progenitor cells and progenitor cell derivates. Elanix owns (c)GMP certified human progenitor skin cell banks. We also hold the exclusive worldwide rights and sublicensing rights for a patent related to cell bank set-up & preservation invented by Prof. Lee-Ann Applegate.
3. Is working with progenitor cells better than stem cells?
Progenitor cells are fully differentiated i.e. they have dedicated functionality. This means they are much more stable, easier to control, and hence safer to deploy than stem cells. Stem cells are undifferentiated and pluripotent, meaning they can develop into any type of cell, hence requiring higher controls to ensure the envisioned outcome.
4. How many cell banks are owned by Elanix? What is the value of those banks?
Elanix owns two (c)GMP certified human progenitor skin cell banks. These cell banks include billions of available cells. Calculating with patches of 100 cm2 and the numbers of cells needed for regenerative healing we could cover about 98% of the surface of total Germany.
The estimated the value of our cell banks is as high as 25 to 50 MEUR.
5. Where are Elanix’ cells stored?
The cells are safely and optimally stored at a specialised service facility providing commercial and high quality storage owned by Merck AG.
6. Where do Elanix cells come from?
Human cells for Advanced Wound Care (AWC) originate from a single strictly-controlled and Swissmedic-approved organ donation in Switzerland.
Animal cells for Advanced Skin Care (ASC) are obtained from an ovine foetus. This process is performed under strict regulations and veterinary control.
7. It is mentioned that the bioactive Wound Dressing under development by Elanix has been used for some time under compassionate use. Can you expand on this –in what capacity and by whom?
The compassionate use activities have been conducted in collaboration with the University Hospital of Lausanne (CHUV), Prof. Lee-Ann Laurent Applegate and Prof. Wassim Raffoul. Under the project name First Cover, these dressings have already been used to treat more than 100 severe burn patients with over 12 years’ successful follow-up. It is presently among the prime treatment options for burn patients in the hospital.
8. What is the status of the AWC product development?
Our Chief Technology Officer, Dr. Geofrey de Visscher, is working in close collaboration with our scientific advisors at CHUV Lausanne and other external expert parties to manage the industrialization and market clearance of Elanix’ bioactive Wound Dressing, currently project-named First Cover.
9. When will Elanix begin clinical trials for AWC product First Cover?
Our current time schedule is to start clinical trials with First Cover, our bioactive Wound Dressing for chronic wound patients, in early 2020.
10. How involved is Prof. Applegate in the company?
Prof. Applegate is the scientific founder of Elanix. She continues as a scientific advisor and largest single shareholder.
ADVANCED SKIN CARE
1. What is GYNrepair®?
GYNrepair® is a gynaecological cream that contains Elanix’ proprietary Cell Free Protein Complex (CFPC®), a formulation based on progenitor cell derivates which includes various proteins such as collagen, elastin, and fibronectin. GYNrepair is specifically formulated for the external genital mucosa.
The cream soothes discomfort, twinges and dryness, enhancing the feeling of softness and intimate comfort.
2. What is GYNrepair® used for?
GYNrepair® is a feminine cream specifically designed for use on the vulva, or external genital mucosa, which soothes feelings of discomfort, twinges, and dryness in the vulvar area.
3. Is GYNrepair® available on the market?
GYNrepair® is available in Switzerland, the EU, and Russia through a dedicated online platform https://gyn-repair.com and a growing number of pharmacies.
4. Is GYNrepair® a medical or pharmaceutical product?
GYNrepair® is a cream for Advanced Skin Care and is neither a medical nor pharmaceutical product but classifies as cosmetics. Since it has not undergone clinical evaluation at the level required for pharmaceutical or medical device categories, we cannot make any therapeutic claims on its action. However, women with various unexplained symptoms, some of which are included in female health conditions such as vulvodynia, have reported positive experiences when using GYNrepair®.
5. Why has GYNrepair® not been subjected to the rigorous testing mentioned?
It was a strategic decision to market GYNrepair® as an ASC product and thus to bring it quickly to the market.
6. How do I buy GYNrepair? Do I need a prescription?
GYNrepair® is available online at www.gyn-repair.com , on Amazon, as well as in selected pharmacies in Switzerland and Germany. We are currently expanding the product availability to additional pharmacies in Switzerland, the EU, and Russia.
7. Why did Elanix decide to develop an app for GYNrepair®?
E-Health technology is helping in all aspects of healthcare, particularly when it comes to adherence to a particular regimen. We developed the app to help remind women to apply GYNrepair® cream and to allow them to monitor the level of discomfort they are feeling over time. This monitoring provides a basis for discussions with their physicians.
8. What does the app do?
The app allows women to easily monitor improvements felt in the vulvar area by logging and tracking daily discomfort. Alerts can be set on the app so that each day users are reminded to apply the cream and to identify on a 1-10 scale the intensity of discomfort. These alerts ensure that women benefit continuously from the soothing properties of GYNrepair® cream. As each application has a recommended volume, the app automatically estimates when a refill is needed and offers one click to the website where it can be re-ordered.
9. Does the app collect data? If so, is it private and protected?
The app does not store any personal data and is not intended for diagnostic or commercial purposes.
10. Are there any ongoing running costs to maintain the app?
There are no costs for the user and only very little maintenance and upgrade costs for Elanix.
11. Does Elanix think that the app will help sales?
The main purpose of the app is to help our customers and GYNrepair® users to adhere to recommended dosage and frequency.
12. Will Elanix develop apps for other products?
We will always evaluate the need for any new apps or other e-health solutions to help health care professionals and/or end-users when launching new products.
1. When do you expect to launch SKINrepair®?
We expect to launch SKINrepair® in Q4 2018.
2. What is the commercial strategy for Elanix Advanced Skin Care?
GYNrepair® is the first Elanix product on the market with our innovative CFPC® technology and SKINrepair® will be launched in Q4 2018. Our plan is to develop an Advanced Skin Care portfolio with six to eight products on the market by the end of 2020.
CELL SERVICES / CAAS
1. Does Elanix have any customers for the Cell Services business unit?
We are in ongoing discussions with potential customers: medical, pharmaceutical and cosmetic companies with needs for cells and cell services.
2. How does Elanix intend to grow the Cells as a Service business unit?
We are taking an opportunistic approach for the time being. Whenever we get in contact with a large cosmetic, medical device, and pharmaceutical company, our cell services are a part of the potential offer.