Pain is usually an indication something wrong with the body and the typical approach to pain is to take appropriate medicine that will help alleviate that pain. However, taking painkillers will have some side effects and it is more complicated, or even life-threatening for those who are allergic to certain painkillers.
Imagine a future where pain can be managed or alleviated using a combination of digital technologies and devices, greatly reducing the risks brought about by conventional painkillers. That is what Alon Ironi, CEO & co-founder of Israel-based biomedical technology company Theranica hopes to achieve.
Could you tell us more about your role as CEO of Theranica?
As CEO and co-founder, from day one, I have been deeply involved in all facets of company activity: inventing the product, developing the architecture, hiring a team, planning the clinical and regulatory path, developing relationships with the professional medical community, raising funds, establishing strategic relationships, and more.
Theranica’s Nerivio Migra, which uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response to treat migraines, was recently granted a De Novo clearance by the FDA. Could you share with us the journey towards a first-in-category product clearance?
Our idea from the very beginning was to create a friendly, clinically effective, drug-free, non-invasive, digitally connected device for managing pain. The specific focus on migraine and the utilization of the CPM principle was inspired by Professor David Yarnitsky, one of the brightest researchers in the area of pain.
We started with a pilot study in Israel. The first part of the pilot study was dedicated to finding the most effective and tolerable neuromodulation waveform, and to solidifying the basic therapeutic hypothesis. The second part of that study applied four different neuromodulation waveforms, plus a sham (placebo) waveform on 71 patients with migraine, over more than half a year. At the end of the study, when we analyzed the results, it was clear that we were onto something.
We approached that FDA and asked for a 510(K) clearance, indicating the Cefaly device as a predicate. However, the FDA stated that, since the Cefaly is applied on the head, it cannot be a predicate device, and in fact there was no device that treated migraine from a remote body location, so we had to go through a DeNovo path. In addition, the FDA indicated that more clinical data would be required, mainly from the USA, and in compliance with the FDA’s guidelines for clinical studies with drugs for acute treatment of migraine.
We designed a large clinical study conforming to these guidelines and executed the study during most of 2018. We had the results in mid-October, and, to a large degree they repeated and solidified what we had seen in the pilot study, but this time on hundreds of patients, from 12 clinics, and with the endpoints in compliance with the FDA guidelines. We submitted the DeNovo request in early November 2018 and received the DeNovo grant in late May 2019.
What other projects/developments are in the works for Theranica?
The most pressing project right now is to gear up and complete all preparations for launching the product in the USA – including putting together the distribution channels, hiring a sales and marketing team in the USA, building initial inventory, etc.
On the development side, we are working on clinical development aimed at expanding the Indication For Use of the device, with the first priority given to obtaining permission to offer the Nerivio to adolescents (12-18 years old). This sector in the population has even a greater need for this than adults. While migraine prevalence among adolescents is quite similar to that in adults, physicians are less equipped when it comes to helping adolescents cope with their migraines.
Most of the prescribed medications for acute migraine are not indicated for adolescents, and even for those that are indicated for that, physicians (and parents) are more reluctant to have people start using these drugs at a young age, due to possible adverse events, and the concern about possible development of Medication Overuse Headaches (MOH), which results in increased migraine frequency, larger need for drug, and so on.
Therefore, there is a strong unmet need for a drug-free, safe and clinically effective solution for these ages. This summer Theranica will begin a huge clinical study with adolescents in order to eventually meet this need.
Despite the small population size of 8 million, Israel has a rather mature and sophisticated health tech ecosystem. In your experience, could you tell us how the health tech ecosystem in Israel has impacted Theranica’s growth as relatively young start up?
Your observation is right. In fact, my view is that, while in 1990-2010 the main advantage of Israel as a high-tech nation was in telecommunication systems and semiconductor chips, this has shifted over the last decade to bio-medical and cleantech technologies. Theranica was lucky to team up early with Dr. Shimon Eckhouse, probably the most successful bio-medical entrepreneur in Israel ever, who joined us as a chairman and co-founder right at the beginning.
Later, we enjoyed the support of local Israeli VCs focused on the bio-medical area, such as LionBird, Corundum, and recently aMoon – the largest VC in Israel these days entirely focused on bio-medical. In addition, the shift I mentioned above influenced some “all-around” VCs, like LightSpeed Ventures, to place more emphasis on bio-medical, which led them to Theranica. Finally, we had the benefit of getting a funding loan from the Israeli Innovation Authority, whose management has recognized the importance of the bio-medical sector.
On top of all that, the labor market in Israel is rich with talented experts, which allowed us to hire fine contributors such as our VP clinical and regulatory, Dr. Harris, and our Chief Scientist, Dr. Lin.
What are your thoughts on the development of digital health in Israel? Which areas of digital health do you see great potential/are you excited about?
It’s really tough to pick one particular field, but I’ll try… My impression is that the core Israeli advantage is not in the “basic” development of new molecules, but rather in the integration of several different technologies into one solution, especially a drug-free solution. Take Epitomee, for example, a company that develops a drug-free capsule that has the potential to treat overweight, prediabetic, and moderately obese people – it’s brilliant! And there are many other ideas that really seem genius.
What are your long-term goals and vision for Theranica?
Our vision is to provide a whole line of drug-free digital devices that will become the global first-line of treatment for several diseases and syndromes associated with pain. It’s time to have effective, safe alternatives to pain killers! And migraine is only the beginning…
Source : MobiHealthNews