Helius Medical Still Positive After FDA Rejection

Helius Medical’s CEO says the company will resubmit its application and knows what it needs to supply to the FDA.

While Helius Medical Technologies (TSX:HSM,NASDAQ:HSDT) didn’t get the answer it wanted from the US Food and Drug Administration (FDA) for its request for De Novo classification and 510(k) clearance for its Portable Neuromodulation Stimulator (PoNS) device, the company remains positive that it will receive it — eventually.

The company explained in a press release issued on April 10 that the regulatory agency feels it does not have enough information to understand the relative contributions of the PoNS device and physical therapy in Helius Medical’s clinical trials.

The PoNS device aims to improve a variety of neurological symptoms and has been studied in various US- and Canada-based trials with physical and cognitive therapy in patients with mild to moderate traumatic brain injuries (mTBI).

In an interview with the Investing News Network (INN) on Thursday (April 25), Philippe Deschamps, CEO of Helius Medical, said that, while the FDA is satisfied with patients’ improvement in these clinical trials, and that the device is safe, it wants more information on the individual contribution of neuromodulation versus physical therapy.

“[We] thought that we had provided ample evidence through our submission, [including] affidavits from people who are experts in the field that physical therapy alone doesn’t produce the results that we had, but the FDA chose to want to rely more purely on the prospective science that we did,” he explained.

Deschamps further added that Helius Medical is engaging with the FDA to better understand what kind of data it needs and what the source of that data could be. The agency has encouraged the company to resubmit its De Novo classification and 510(k) clearance of the device.

“We’re certainly very disappointed in the position [the FDA] took, but we’re heartened by the fact that they do feel the treatment works, they [just] want to know what the technology contribution is,” he said.

Deschamps further said that the company’s goal is to be able to bring its therapy to the 1.5 million Americans living with chronic balance deficit resulting from mTBI’s, which is a “highly unmet need area.” Despite the news from the FDA, Helius Medical has regulatory clearance in Canada, where it plans to continue expanding its efforts and treating patients north of the US border.

When it comes to regulatory approvals, Deschamps said that Health Canada chose to approve the treatment because the agency feels the data is safe and compelling. He said that the company submitted the same package to the FDA, but that the US agency went in a different direction when it came to its decision.

“The FDA chose to want the technicality to be discerning of [independent contributions of the device and physical therapy],” Deschamps said, adding that the regulatory agency offered Helius Medical a pre-submission meeting in order to discuss how the company will “deliver on that data.” He explained that it will be a 60 to 70 day process based on the guidance the FDA allows back and forth, but can’t predict exactly until the company knows for sure what the FDA will require.

“In the meantime, we’re really focusing our energy on treating Canadian patients and making sure the patients in Canada, where we’re fully commercial, are able to avail themselves of the treatment,” Deschamps said.

Shares of the company took a massive hit following the FDA’s decision, dipping more than 66 percent the day of the announcement in early April from C$8.44 to C$2.84 on the Toronto Stock Exchange. As of market close on Thursday, shares of Helius Medical were trading at C$3.13.

However, Deschamps said that, while there was, of course, disappointment following the FDA’s decision, the company saw very little anger and “incredible votes of confidence” from its investors.

“It was emotionally difficult … not only because it was the disappointment that we had to share together, but it was also very uplifting knowing the majority of our investors … really want to see this through, not only until we get American clearance, but clearances in other countries around the world,” he said.

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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