Known for its wines and historic 1,000-year-old cathedral, there is more to Strasbourg and the Alsace region of France than grapes and gothic architecture. In fact, there is a thriving medical device industry, along with the ambition to create a global center for new medical technology.
The key driver for this is IRCAD – the Strasbourg-based institution that is pioneering minimally invasive surgery techniques, and its spin-off, the Institute for Image Guided Surgery, which is pioneering the use of imaging systems in these surgical procedures. Around these two institutes, local and regional governments are building a medtech campus where they envision start-ups from around the world developing new medical technology.
This is the eco-system in which medeuronet is fortunate to sit. To give you a glimpse of this rich environment we will feature some of the exciting innovations under development in Alsace .
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By Kathleen Mackay
Patients who suffer from severe depression, chronic pain, or other psychiatric and neurological illnesses such as schizophrenia or stroke may benefit from a remarkable new robotic innovation from Axilum Robotics. The Alsace Biovalley start-up has developed and sells the first robot specifically designed for Transcranial Magnetic Stimulation (TMS).
TMS consists of applying high intensity magnetic impulses via a coil placed on the head of the patient. These impulses generate an electric current that stimulates the neurons of the cortex. TMS- Robot automates and improves the accuracy and repeatability of this non-invasive and painless brain stimulation technique, which doctors usually implement manually.
Axilum Robotics is a spin-off of the medical robotics research group at iCube (Laboratoire des Sciences de l’Ingénieur, de l’Informatique et de l’Imagerie), a research unit of the University of Strasbourg, CNRS (National Centre of Scientific Research), ENGEES (National School for Water and Environmental Engineering), and INSA (National Institutes of Applied Sciences).
The President and CEO of Axilum Robotics, Dr. Michel Berg (picture), explains the start-up was founded in April 2011 by a team composed of researchers and robotics engineers. The three inventors of the robot are Michel de Mathelin, Pierre Renaud and Bernard Bayle of iCube. The operations team of the start-up includes Dr. Berg, a physician who graduated from a business school; and Dr. Romuald Ginhoux and Dr. Benjamin Maurin, two engineers with doctorates in robotics.
Previous Stimulation Techniques Not Precise
The use of robotics revolutionizes TMS. When brain stimulation procedures are implemented manually, explains Dr. Berg, it is a challenge to keep the planned position and the orientation of the coil above the stimulation target. “Indeed, sessions last as long as 30 minutes and it is important to permanently compensate for potential head movement of the patient to ensure the quality of the procedure,” says the CEO.
Dr. Berg, who has experience within the pharmaceutical and medical device industry, and is a graduate of the HEC business school, also explains, “By automating the positioning of a TMS coil, the robot improves accuracy and repeatability of TMS protocols while maintaining a high level of safety for the patients. In addition, the automated procedure brings comfort to the operator who can reallocate part of its time to other tasks while watching over the patient.”
According to the First International Brain Stimulation Conference, “Brain stimulation methods are new approaches used to research how the brain works and to treat diseases. In many ways, the field of brain stimulation is a new paradigm shift , replacing the prominent neuropsychopharmacological paradigm of the past three decades.” (Reference)
The TMS- Robot is the flagship product of Axilum Robotics, which has other products in the R&D stages. Axilum Robotics TMS-Robot is a CE marked and Health Canada licensed medical device. In 2015, the company had its first international sales in Brazil, Indonesia, Denmark and Spain for both therapeutics and research in neurosciences. The SARAH rehabilitation hospital of Brasilia, Brazil bought a TMS- Robot for its facility, which treats patients for rehabilitation following strokes.
Alsace Biovalley Support to Company
Dr. Berg believes that being a member of Alsace Biovalley has been a great help to this start-up . He says, “Alsace Biovalley helped us build the collaborative R&D project, and by endorsing it, helped us to get public funding.”
Among the public funders of the project are Fonds Unique Interministériel, BPI France, the Alsace Region, the European Regional Development Fund, and Strasbourg Communauté Urbaine for a total of 1.3 million Euros for all the consortium partners.
“We did our first fundraising in 2012 with private investors,” notes Dr. Berg. “The investors included Inserm Transfert Initiative and Sodiv Alsace. The company raised 900,000 Euros in this round. Now we are looking for a second round of funding, and are seeking from 1.5 to 2 million Euros.”
In turn, Dr. Berg believes Axilum Robotics will help the Alsace Biovalley life sciences cluster. “As our company continues to receive international recognition, we will contribute to offering more visibility for this region,” the CEO says.
Axilum Robotics has a Board of Directors along with a Scientific Committee. The Scientific Committee includes Bernard Bayle, Michel de Mathelin and Pierre Renaud. All three are world-recognized experts in medical robotics. They were also involved in the development of the TMS- Robot proof of concept and were co-founders of the company.
Advice for Other Medical Device Start-ups
Dr. Berg says that based on his experience with Axilum Robotics, he would advise other start-ups to “ raise as much funding as possible in your first round of fundraising because the second round is much more difficult as investors will expect a significant commercial footprint. There is a real investment gap between the first and second round. In addition, only a few funders are comfortable with funding capital equipment. We needed to look for private funding outside of the region.”
While the market offers challenges, because TMS is a new area, Dr. Berg emphasizes that “the growth potential is also very high: about 10% a year. One of the key drivers of the growth is the reimbursement of patients’ treatment.” In the U.S., TMS is reimbursed for major depression. In Germany, TMS is reimbursed at hospitals, states the CEO. “And for the first time recently, an agreement has been made in Strasbourg to allow reimbursement for TMS for outpatient depression and chronic pain treatment,” he adds.
Impact on the World at Large
The current objective is to market the TMS- Robot in the U.S. The Mayo Clinic reported about transcranial magnetic stimulation, “ Depression is a treatable condition, but sometimes standard treatments aren’t effective . TMS may be used when standard treatments such as medications and talk therapy (psychotherapy) don’t work.” The Clinic continued, “How TMS relieves depression isn’t completely understood. It’s thought that magnetic pulses stimulate nerve cells in the region of your brain involved in mood control. This stimulation appears to affect how this part of the brain is working, which in turn seems to ease depression symptoms and improve mood…..”
The Mayo Clinic report added, “ TMS is the least invasive of the brain-stimulation procedures used for depression . Unlike vagus nerve stimulation or deep brain stimulation, TMS doesn’t require surgery or implantation of electrodes. And unlike electroconvulsive therapy, it doesn’t cause seizures or require complete sedation with anesthesia.” Side effects, reported the Mayo Clinic, may include headaches and lightheadedness. (Reference)
The U.S. National Institutes of Health reported that in America: “ Major depression is a common debilitating disorder affecting 10%–15% of the population per year . Despite advances in the understanding of the psychopharmacology and biomarkers of major depression and the introduction of several novel classes of antidepressants, only 60%–70% of patients with depression respond to antidepressant therapy. Of those who do not respond, 10%–30% exhibit treatment-resistant symptoms coupled with difficulties in social and occupational function, the decline of physical health, suicidal thoughts, and increased health care utilization. Treatment-resistant depression represents a dilemma for health care providers.” (Reference)
Dr. Berg, believes the TMS-Robot could have a significant impact on patients around the world. “Our objective is to improve the treatment of patients suffering from drug- resistant neurological and psychiatric diseases while enabling health care professionals to greatly improve the precision and reliability of the TMS procedure. We also want to improve medical resources management. This invention is an example of robotics being able to improve medical procedures done manually in the past. It will bring superior value to all stakeholders.”