L’écosystème grenoblois est très riche et dynamique avec la présence des grands groupes, de superbes établissements de recherches et innovation, mais aussi un ensemble de PME issues des instituts de recherches. Tous ces acteurs travaillent en collaboration et les échanges sont multiples, notamment via des groupes de travail, c’est un réel atout. De plus la filière médicale est très représentée dans les Alpes avec Medicalps, le cluster des technologies de la santé…
Can you tell us about the origins of your company, describe its activities and the special features of the medical device developed by SUBLIMED?
SUBLIMED is a startup, the result of one of CEA’s entrepreneur support programs. It was founded in 2015, in collaboration with Dr. Jean-Pierre ALIBEU. We develop non-drug neurostimulation devices to relieve chronic pain.
SUBLIMED was born in a Grenoble context that favors the emergence of innovative projects in the healthcare field, notably with the inauguration in 2012 of Clinatec by the CEA, the CHU and the University. This biomedical research institute brings together all the key players in healthcare innovation on a single site, with the aim of bringing technology and innovation to the field. Grenoble is also recognized as a center of excellence in the field of neurostimulation, following the major discoveries made by Grenoble neurosurgeon Alim-Louis Benabid in the treatment of Parkinson’s disease using high-frequency deep brain stimulation (DBS). It was at Grenoble Alpes University Hospital that I met Jean Pierre ALIBEU, a doctor specializing in chronic pain at the Grenoble Pain Center, and discovered neurostimulation.
Neurostimulation has been around since the 1960s. It involves sending low-intensity electrical stimuli to the nerves to modify the information reaching the brain in order to relieve the patient’s chronic pain.
It has a wide range of applications in the healthcare sector, and can be used either externally or implanted. Traditional external neurostimulation equipment was very restrictive, difficult for patients to use (heavy boxes, long cables, etc.) and stigmatizing. We wanted to improve the daily lives of these patients, who are often very isolated in their suffering, by developing a product that was discreet, flexible and easy to use.
This is how the SUBLIMED project was born.
The device developed by SUBLIMED combines two effects: inhibition of the pain signal, for immediate relief, and stimulation of endorphin production, a natural analgesic, for an effect lasting several hours. What’s more, with its miniaturized case connected to a smartphone via an app, patients can return to an active life.
This device requires medical supervision. It is only available on prescription from doctors at pain relief centers (actiTENS product) or from rheumatologists, neurologists or neurosurgeons specializing in knee osteoarthritis (VitaliTENS product).
What are the conditions for the operational success of your project? Can you outline the milestones your startup has reached since its inception?
We first raised 700,000 euros in June 2016. This enabled us to obtain CE marking, the regulatory authorization that allows the device to be marketed in Europe, as well as ISO 13485 certification from SUBLIMED. We were able to launch the marketing of our first product, actiTENS in March 2018.
Our second round of funding in 2018, enabled us to accelerate the commercialization of the solution, in particular by opening up prescriptions beyond pain centers. Indeed, 12 million people suffer from chronic pain, but less than 3% of them are treated by a pain center. Our plan was to expand into rheumatology and the treatment of osteoarthritis of the knee. That’s how our partnership with Laboratoires Expanscience began. The group, specialized in the treatment of osteoarthritis, was looking for new solutions following the delisting of slow-acting symptomatic anti-arthrosics since 2015 and hyaluronic acid injections since 2017.
Osteoarthritis of the knee is a particularly widespread and disabling disease.
As current treatments are restrictive (heavy surgery to install the prosthesis), there was a real need to enable patients suffering from this pathology to regain a better quality of life. The results of the clinical study demonstrated the superior efficacy of the VitaliTENS device compared with level 2 analgesics. They also demonstrated an improvement in patients’ joint function (WOMAC score). Reimbursement has been granted by the French health insurance scheme, and the product will be launched on the market in October 2022.
After 6 years of collaboration, SUBLIMED was acquired by Laboratoires Expanscience in March 2023. What do you expect from this collaboration?
SUBLIMED was initially focused on the French market, which was more suited to the scale of the start-up. We wanted to expand internationally, but this presents a number of difficulties: language, of course, but also differences in regulations and market access strategies. It also requires considerable resources to set up local relays. Joining forces with a major group, which already has a strong international presence (13 subsidiaries, over 1,000 employees worldwide, and more than 100 distributor countries), will enable us to benefit from their international reach (particularly in Europe, Asia, South America and Australia).
We also aim to develop our business in the US market. It’s the world’s biggest market for medical devices, and American purchasing power is significant. What’s more, the United States is currently facing a major opioid health crisis, with over 100,000 deaths per year. Our solution offers an alternative that is in the public health interest of the United States, and a real opportunity for us. SUBLIMED received FDA (Food and drug administration) approval in December 2020. But the American market is extremely complex and fragmented, with its division into states, and that takes time. Marketing is starting up in the United States, and we signed up our first two distributors in May 2024.
You have chosen to outsource manufacturing. Who are your industrial partners? What are the skills and expertise of your employees?
We currently have 20 employees. Divided into three divisions:
– an R&D department comprising hardware/software and data science engineers
– a quality and regulatory affairs department, which manages the ISO 13485 quality management system, CE marking (to be renewed every 5 years), and the transition to the new European regulations on medical devices
– a sales and customer service department
Most of our employees have already worked in the medical field, which makes it easier to understand all the standards and processes involved.
Following our acquisition by Laboratoires Expanscience, we are now looking to organize and cross-fertilize skills between our two structures.
SUBLIMED is totally “fabless”, with no in-house production. We chose to outsource, as this enables us to pool equipment (robots, electronic test strips, plastic injection molds, etc.) and skills. Setting up a factory would have required a major investment in terms of costs, plus the development of different, specific skills.
Our two main partners are located in the Grenoble region. Maatel, for electronic circuitry, is also located in Moirans. STI Plastics, in Saint Marcellin, handles plastic injection and assembly. Both companies specialize in the medical sector, and are certified to Iso 13485, an internationally recognized standard attesting to the quality and safety required in the medical device sector. Working with local partners is a more expensive production option, but one that makes sense to me.
How would you sum up the last two years and what are your prospects for 2024?
We’re very proud to have our product reimbursed by the French health insurance scheme. This coverage gives people suffering from osteoarthritis of the knee easier access to a solution to improve their daily lives.
The acquisition of SUBLIMED by Laboratoires Expanscience has enabled us to raise the profile of the Grenoble region. What’s more, being part of a major group has changed the dynamics of the start-up: it facilitates our international deployment, our priority, while consolidating our presence in France.
SUBLIMED will continue to expand in 2024, opening up new fields of innovation with new projects in women’s health and, more specifically, endometriosis.
