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.
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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.