5 Top Medical Device News Stories of 2019

Throughout the course of 2019, investors in the medical device space were interested in a variety of stories on the growth and catalysts available to companies in this sector.

From US Food and Drug Administration (FDA) news to global expansion and updates on the development process for medical devices, there was no shortage of company developments in the medical device space for investors to stay updated with.

Here’s a look back at which medical device news stories caught the attention of our audience.

1. Helius Medical Still Positive After FDA Rejection

This story is an interview with Helius Medical Technologies (TSX:HSM,NASDAQ:HSDT) from back in April.

CEO Philippe Deschamps discusses how the FDA made additional requests for the company’s De Novo classification and 510(k) clearance for its Portable Neuromodulation Stimulator (PoNS) device. In an April 10 press release, Helius Medical disclosed that the FDA didn’t think there was enough information regarding the relative contributions of the device versus physical therapy in the company’s clinical trials.

At the time, Deschamps said that Helius Medical remained hopeful that it would eventually receive the approval and clearance from the FDA.

“(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.

2. Helius Medical to Expand Globally

In this article from March, the Investing News Network (INN) spoke with Deschamps about the company’s aim to take its PoNS device global.

“(The device) stimulates the brain through the tongue, of all things,” he explained. “Why the tongue? The tongue is tied to your brain with four major cranial nerves, two of which are stimulated by this device.”

At the time of the interview, Deschamps said the company had submitted an application to the European Union in December of last year for a CE Mark for the PoNS device. Deschamps also said the company anticipated submitting applications in Australia and China over the course of the year.

3. Titan Medical CEO: SPORT System Design Freeze Now in Place

At the Bloom Burton & Co. Healthcare Investor Conference in May, INN caught up with Titan Medical (TSX:TMD,NASDAQ:TMDI) CEO David McNally to discuss the hardware design freeze for the company’s SPORT Surgical System.

“We gathered the input in 2017 from surgeons in three continents who operated our system and put the system through 45 different types of procedures and four subspecialties,” McNally said. He further explained that during these procedures, surgeons were able to show the feasibility of the system, but also discovered that the system could be improved before it is commercialized.

Watch the full interview below for more of what McNally had to say:

4. LexaGene Eyes Q2 2020 for Commercialization, Builds on Funding

In November, INN spoke with Dr. Jack Regan, CEO and founder of LexaGene (TSXV:LXG, OTCQB:LXXGF), about the company’s most recent round of funding, totaling C$7 million, and its intentions to become fully commercial next year.

As the company moves toward its first commercial sale, Regan said, “(LexaGene needs to) be more serious about ramping up (its) boots on the ground in regards to a sales force.”

According to the executive, the company remains on pace to become fully commercial by June 2020.

5. BrainsWay’s TMS Device is Reshaping Brain Disorder Treatments

Closing out the list is another interview INN did, this time with BrainsWay (NASDAQ:BWAY,TLV:BWAY), a company that had not yet begun trading on the NASDAQ at the time.

INN spoke with Joseph Perekupka, vice president of sales and operations for BrainsWay in North America, about the company’s Deep Transcranial Magnetic Stimulation device.

“(BrainsWay is) using a unique patented coil technology where we’re using magnets to create an electrical field that will penetrate the brain. The goal of it is to polarize or depolarize the neurons,” he explained.

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.