Theranica Bioelectronics Hopes to Take Migraine Device Global

While Nerivio Migra has been approved by the FDA, the company is aiming to take the device global to treat patients in other territories.

Privately owned Theranica Bioelectronics is aiming to reshape the way migraines are treated in patients all around the world.

The company, which was founded three years ago, is using advanced neuromodulation therapy with wireless technology to develop electroceuticals for migraines and other pain disorders.

In May, the US Food and Drug Administration (FDA) granted a De Novo request from Theranica for Nerivio Migra, a wearable device that is used to treat acute migraines. The De Novo process is a way to classify devices when no equivalent device is being marketed.

According to the Migraine Research Foundation, migraines are the third most common disease in the world and rank as the sixth most debilitating disease globally. Migraines are classified as a neurological condition and are described as a throbbing, recurring pain on one side of the head.

Other symptoms include nausea, vomiting, dizziness, tingling or numbness in the face and sensitivity to sound, light, touch and smell. Visual impairments called auras often accompany migraines and can last for up to an hour.

In an interview with the Investing News Network, Alon Ironi, CEO and co-founder of Theranica, said that the company’s decision to target migraines with a device came largely because of the lack of solutions for patients with this condition.

“(This problem) is surprising because there are a lot of medications specifically designated for migraines — both for prevention and acute (pain) — but (many) patients (Theranica interviewed) are not happy,” he said. “They don’t feel they have a good solution to manage their migraine.”

The company’s De Novo request was approved following a clinical study involving more than 250 patients from 12 different clinics who used Theranica’s non-invasive wearable device to manage migraine attacks. The device, which gets placed on an individual’s upper arm, uses smartphone-controlled electric pulses that send a conditioned pain modulation response.

Nerivio Migra is currently indicated in adults with acute migraines with or without an aura. It has not been indicated for chronic migraines.

Ironi explained that other than the exclusion of those indications, the device can be used for all migraine patients and addresses all levels of pain — from mild to moderate to severe — and associated symptoms of migraines, like sensitivity to light, sound and nausea.

“One-third of patients with migraines have aura at the beginning of their attack and the device showed it is equally effective for migraines with and without aura,” he said.

Ironi also said that the percentage of patients who had any side effects related to the device was “very, very low,” both in terms of number and severity. Side effects included a sensation of tingling due to electrical stimulation from the device, temporary sensation or weakness in the arm where the device was located and redness on the skin where the device was placed.

“There was no significant difference between patients that had exhibited these side effects with the actual device compared to a placebo device,” he said. “That tells you, again, the side effects are very mild, temporary and at a very low percentage.”

Although the device is currently being indicated to treat migraines, Ironi said the company has identified seven different diseases or syndromes where it thinks its technology can “make a dramatic change by providing a drug-free solution.”

“There are a few other (diseases) we have not yet addressed specifically with clinical studies, such as fibromyalgia and irritable bowel syndrome,” he explained. “We made the decision to start with migraines because migraines represent the most prevalent disease or syndrome in terms of the number of people that suffer worldwide and percentage wise.”

The company is looking to pilot launch and market the device in the US with limited availability later this year, but has plans to market the product in other regions as well.

In Q4 of this year, Ironi said Theranica will start with a pilot launch at select health clinics and will expand that reach at the beginning of next year before making the device “widely available” in the US by spring 2020. After the US, Europe and Israel will be next, although the company hasn’t yet completed the regulatory processes in those regions.

“In 2020, we’ll be ready to market the device in these territories, and after that we’ll continue the process,” he said, explaining that the company’s vision is to make the product available everywhere.

Helping the company advance its plans is the US$35 million in Series B funding it received in May, which puts it in a position to continue with its plans to market, sell and develop the product. However, Ironi said that with the future goals the company has in mind — making the device available in other parts of the world and indicating the device for conditions other than migraines — taking Theranica public could help it reach its future objectives.

“We’re not rushing (to go public),” he said. “We think that the right time for taking the company public is when the company already establishes a very solid stream of revenue, with at least one disease in one strong territory, and then we can consider an initial public offering.”

Don’t forget to follow us @INN_LifeScience for real-time news updates

Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Catch up and get informed with this week's content highlights from Charlotte McLeod, our editorial director.

Top Stories This Week: Powell Gets Fed Nomination, Using Gold in a Market Correction youtu.be

We're back after a break last week with quite a bit to cover in the gold space.

After running up past the US$1,860 per ounce mark midway through November, the yellow metal has taken a tumble. At the time of this writing on Friday (November 26) afternoon, it was sitting just under US$1,790.

Gold's losses this week have been attributed to elements like a stronger US dollar and better Treasury yields, although Jerome Powell's US Federal Reserve chair renomination has pulled other factors into play — some market watchers believe he may move to taper and raise interest rates faster than anticipated.


If the Fed follows its previously laid out timeline for tapering, it will wrap up in mid-2022; the central bank has said it won't raise rates until after that. It has also emphasized that its roadmap may change if necessary.

Looking at the larger picture for gold, I heard recently from Nick Barisheff of BMG Group, who believes the stock market is due for a major correction.

"The market is due for a major correction. What will cause it and when it will happen is anybody's guess — it could be tomorrow, it could be six months from now" — Nick Barisheff, BMG Group

It's impossible to know when this correction will happen, but Nick emphasized the importance of acting before it's too late. He pointed out that investors are typically slow to get out of the market once a crash actually begins — they wait for a turnaround, and by the time it's clear there won't be one, they've experienced big losses.

In his opinion, the solution is to get out of the stock market early and transfer money into gold.

Here's how Nick explained it:

"Instead of taking your money off the table and going into cash … you go to gold (because cash is devaluing daily). Gold will at least hold its own and probably appreciate … so by sitting it out in gold you can wait until the market finishes correcting and then buy back in" — Nick Barisheff, BMG Group

With gold's future in mind, we asked our Twitter followers this week what price they think the metal will be at the end of 2021. By the time the poll closed, most respondents had voted for the US$1,800 to US$1,900 range.

We'll be asking another question on Twitter next week, so make sure to follow us @INN_Resource or follow me @Charlotte_McL to share your thoughts.

Finally, in the cannabis space, INN's Bryan Mc Govern spoke with Dan Ahrens of AdvisorShares to get his thoughts on 2021 trends and what's ahead in 2022.

Dan was candid, and said if he had to choose one word to describe the cannabis market in 2021, it would be "painful." Like many others, he's been disappointed in the industry's performance — while positivity initially ran high due to excitement about potential federal changes in the US, ultimately progress has been slow.

"Cannabis started with a big run-up in January and February ... and things dragged from there" — Dan Ahrens, AdvisorShares

Still, Dan has hope for 2022 and said it will be a "huge year" for cannabis. He believes US reforms will come sooner rather than later, and in his opinion those widely anticipated changes will bring a wave of M&A activity.

Specifically, he expects to see alcohol, tobacco and other consumer packaged goods companies making deals with cannabis players, not just cannabis entities doing transactions with each other.

"Those big alcohol companies, tobacco companies, other consumer packaged goods product companies — they're waiting. They're waiting on the US" — Dan Ahrens, AdvisorShares

Want more YouTube content? Check out our YouTube playlist At Home With INN, which features interviews with experts in the resource space. If there's someone you'd like to see us interview, please send an email to cmcleod@investingnews.com.

And don't forget to follow us @INN_Resource for real-time updates!

Securities Disclosure: I, Charlotte McLeod, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

cannabis plant layered with German flag graphic
Dmytro Tyshchenko / Shutterstock

Catch up on some of the biggest news of the week for the cannabis investment world.

Three political parties have formed a coalition in Germany, leading to a new government, and it has promised cannabis reform in the European nation.

Meanwhile, a popular cannabis retailer confirmed consumers will now find its products available for delivery on the Uber Eats mobile application in Ontario.

Keep reading to find out more cannabis highlights from the past five days.


Coalition of parties promises forward-looking cannabis policy

Germany, a country with comprehensive and elaborate medicinal rules for cannabis, is in a time of transition as a new government is set to begin to take over after 16 years of Angela Merkel.

Olaf Scholz, the proposed next chancellor of Germany, leads a three party coalition that will become the country's governing body. As part of its promises, talk of adult-use cannabis regulation has now gained even more momentum. A report from MJBizDaily quotes a German policy document that shows the coalition's stance:

"We are introducing the controlled distribution of cannabis to adults for consumption purposes in licensed shops. This controls the quality, prevents the transfer of contaminated substances and guarantees the protection of minors."

However, despite the promise and excitement, it remains to be seen how these ideas will be applied since no formal regulations have been drafted or approved yet.

Canadian cannabis retailer partners with popular delivery app

Tokyo Smoke, a cannabis retail operator in Canada owned by Canopy Growth (NASDAQ:CGC,TSX:WEED), announced a collaboration agreement with Uber Canada (NYSE:UBER) whereby cannabis consumers will be able to use the Uber Eats app to order products before they visit stores.

While the app won't let consumers get cannabis delivered to them, this new method opens the doors to more dynamic ways of buying cannabis.

"As a market leader in innovation and a platform used by so many Canadians, we believe this is the ideal next offering that can be done safely and conveniently on the Uber Eats app," Mark Hillard, vice president of operations with Tokyo Smoke, said in a press release.

A report from the Canadian Press indicates Ontario is considering allowing dispensaries to have delivery and pickup options made available to consumers permanently. The province allowed some of these purchasing options at the outset of the COVID-19 pandemic, but then removed them.

Lola Kassim, general manager of Uber Eats Canada, said this new end-to-end experience will provide consumers with responsible access to legal cannabis products.

Cannabis company news

  • Organigram Holdings (NASDAQ:OGI,TSX:OGI) issued financial results for its Q4 2021 period. In its report, the company notes a net loss of C$26 million despite a 22 percent uptick in net revenue to C$24.9 million. Beena Goldenberg, the newly appointed CEO of the firm, is encouraged by the market share position earned by the company, which said it became the fourth biggest producer in Canada during the reporting period.
  • Halo Collective (NEO:HALO,OTCQB:HCANF) confirmed the decision for Akanda, its spinoff company focused on international cannabis opportunities, to begin trading on a US exchange. "The number of shares to be offered and the price range for the proposed offering have not yet been determined," the company told investors in a press release.
  • High Tide (NASDAQ:HITI,TSXV:HITI) announced the acquisition of 80 percent of NuLeaf Naturals, a CBD product wellness developer, for an estimated US$31.24 million. The deal includes a three year option clause for High Tide to complete a total acquisition. "As international markets open up and as export regulations evolve, NuLeaf's cGMP-certified facility positions us to take advantage of the global CBD business opportunity," Raj Grover, president and CEO of High Tide, said.
  • Humble & Fume (CSE:HMBL,OTC Pink:HUMBF) released the financial report for its first 2022 fiscal quarter to shareholders and the market. "As the legal cannabis market in North America continues to mature, Humble remains agile and focused on providing a leading solution for brands to scale quickly and retailers to focus on their customers," Joel Toguri, CEO of Humble, said.

Don't forget to follow us @INN_Cannabis for real-time updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

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