• by Les Luchter , Staff Writer, July 18, 2024

 

Over the past couple of years, about a thousand people have used a wearable ear device called Sparrow Ascent as a means to withdraw from opioid addiction. The device sends mild electrical signalsthattarget specific nerves to activate areas of the brain that release endorphins.

But Spark Biomedical, the startup behind this neurostimulation medical device, is just getting started.

Within the next couple of years, Spark hopes to get FDA approval for a neonatal version of Sparrow Ascent  -- essentially the same device, but for smaller ears. These newborn babies are “the most innocent lives of the opioid epidemic,” Spark President/CEO/Co- Founder Daniel Powell tells Pharma & Health Insider.

The neonatal indication, though second in the U.S. pipeline, will likely be the launching point for Spark’s international expansion, which Powell says will start January 2025 in Canada, followed by Australia, Japan and Brazil, and then a year or so later in Europe.

“We look at opioid withdrawal as part of our overall mental health category,” Powell explains.  That includes using the technology to treat trauma and PTSD as well as addiction, “both acute withdrawal and then long-term recovery and retention by treating cravings, anxiety and all the triggers for relapse.”

Consumer use of the opioid addiction product has been limited, largely because of its price: now at a whopping $3,500. Powell hopes that will change with reimbursement approval from CMS (Centers for Medicare & Medicaid Services) expected by mid-2025 at the latest.

Sparrow Ascent was sold only to addict rehabilitation facilities until the beginning of this year, when Spark added a consumer telehealth platform. “There’s a whole lot of people who don't want to go to rehab,” Powell explains. “They have a dog, they have family, they have a job, they just can't take off work, but really wanted the product. So we adopted a philosophy that we wanted to meet people where they are in life for their recovery journey.”

Initial marketing efforts have focused on informational asses and videos to “really explain and legitimize what we're doing,” Powell says. “There's a lot of snake oil in this industry, so we really like to back all this with science and with our medical advisors, put them on camera and have them explain how the product works.”

Daniel’s wife Jackie Powell, who is Spark’s chief marketing officer, adds that the firm has also reached out to patients via Google and Meta ads, but mostly uses organic social. To reach the rehab facilities, she says, Spark has used “quite a bit” of digital advertising, including LinkedIn, as well as maintaining a large presence at trade shows and events, such as the American Society for Addiction Medicine.

In addition to rehab centers and consumers, Spark has a few other audiences.

There are nonprofit organizations, who get a reduced rate, such as one Daniel Powell refers to in a Spark video series, aptly titled “Spark a Conversation.” That nonprofit, he notes, is “buying devices for underprivileged families to try to keep them together.” The nonprofits have access to opioid abatement funds distributed through verious lawsuits and settlements.

Then, there’s the federal government.  In addition to Department of Defense funding, which a press release puts at $1.15 million, Spark has received over $10 million from the National Institutes of Health’s National Institute on Drug Abuse to help fund its neonatal and other clinical studies.