Make the treatment of chronic pain less restrictive. This is the ambition of Sublimed, which is at the origin of a device capable of relieving patients through electrical impulses. This medical technique, called transcutaneous electrical neurostimulation (Tens), is not at all new. However, medical devices are restrictive since they consist of very long cables. In order to improve user comfort, MedTech iséroise has designed a connected box that can be used anywhere. “It was about making the device less stigmatizing. We realize that most of the patients who have recourse to it abandon the treatment because of the constraints it implies ” , notes Nicolas Karst, CEO and co-founder of the startup, which received authorization in December 2020 to market its product in the United States.
Some 13,000 French users
Sublimed has obtained the approval of the FDA (Food and Drug Administration) allowing it to launch across the Atlantic. A sesame which arrives almost three years after the CE marking, which allows companies to market medical devices in Europe. Since March 2018, MedTech has thus been able to equip 13,000 users – mainly in France. “This is a class IIa product, which is prescribed by a doctor and therefore reimbursed by Health Insurance, says Nicolas Karst. It is, so far, used by 180 of the 250 French pain centers. “ The technology is used in cases of nerve damage, as well as chronic pathologies such as low back pain, phantom limbs or endometriosis. It is the combination of two types of electrical stimulation that make the success of this non-drug technique, which is intended to be “Without adverse effect” . “It’s about bypassing the pain signal using a low-intensity high-frequency current, which trick the brain into replacing the pain with tingling. Conversely, a high intensity low frequency current releases endorphins just like a workout. This is what allows the effect to last for several hours. “
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Once the patient has the device in their possession, they are free to use it “When he wants and where he wants” . The system can, in fact, be worn discreetly under clothing. Sublimed, which has so far raised 3 million euros, is conducting a clinical study aimed at proving its effectiveness in osteoarthritis of the knee. 110 patients have already been recruited to participate. “It’s a subject: 2 million people suffer from it in France and 14 million in the United States” , advance Nicolas Karst, specifying that no treatment today comes to answer this very debilitating pathology. The startup plans to launch a suitable product by January 2022 and is currently conducting a third round of funding to do so. “We hope to raise 5 million euros, which will allow the clinical trial to be completed and the development of more digital functionalities” , explains the leader, arguing that gamification constitutes “A good way to lead patients to physical activity” . But Sublimed has a lot of ideas. It also wants to launch, without delay, an assault on the American market, which represents “60% of the global pain market” .
A 1,000-page file with the FDA
The young Isère shoot considers that its internationalization is a challenge « crucial » . “There are barriers to deployment on the French market. Reimbursement criteria, for example, judge Nicolas Karst. In the United States, patients are used to paying for their health. I do not know if the model is encouraging, but it is still a priori more conducive to development. “ Sublimed co-founder also presses Uncle Sam’s country as “A single market, while the European Union is the result of an association of markets” sometimes divergent regulations. Beyond these administrative advantages, a growing public health issue has attracted the attention of the startup: the opioid crisis. “80,000 people died from the use of these products in 2020 in the United States. And that number is expected to increase further. “ Sublimed believes its solution may help relieve the pain of drug addicts in need. It will first have to find partners.
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The startup is prospecting in the hope of finding a generalist distributor who visits doctors to present their product to them. She plans, in another scenario, to convince a local company offering a complementary product to hers to enter into a partnership. “The latter could even market our product as a white label” , assures Nicolas Karst, who relies on “The marketing capacity of large laboratories” . Obtaining FDA approval is, for the start-up with a team of 16 employees – made up of engineers, salespeople and specialists in regulatory issues – a very first celebration. “There are specific requests, in relation to the CE marking, on the performance and safety of the device. It is a file of 1000 pages, which takes six months to assemble and six others to defend with the shuttles between them and us ” , thus tells the leader, who specifies that the American administration has 90 days to give its answer once the document is considered complete.
Such internationalization presents another interest in the medium term: “Since the end of May 2021, European regulations have been greatly strengthened in the field of medical devices. CE marking is becoming more complex to obtain than FDA approval, since clinical studies are now compulsory, as is already the case for biotechnologies. “ In other words, MedTechs will have to bring their model closer to that of BioTech… which implies more development costs. Being established in several markets thus makes it possible not to put all your eggs in the same basket, when it will be a question of marketing future products. If Sublimed’s choice fell on the United States for its first opening outside France, other regions of the world should follow. With the resumption of congresses and fairs dedicated to medicine, due to the gradual exit from the Covid-19 crisis, the young growth also intends to open “A first market in Europe or the Middle East by the end of 2021” . The canvassing will resume.
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