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A new generation of hard hats is promising better protection against on-the-job concussions, also known as mild traumatic brain injuries.

These hard hats incorporate technology that not only protects the head from a direct impact, but also from a glancing blow that causes the head to rotate suddenly – a major cause of concussions.

“The human brain is readily injured by a rotational force,” says Michael Bottlang, director of the Legacy Biomechanics Lab in Portland, Ore. For example, he says, a boxer will “drop like a fly” from a punch to the chin that causes the head to turn rapidly.

So Bottlang and Dr. Steven Madey, an orthopedic surgeon in Portland, have developed a hard hat intended to absorb rotational force. It’s made and sold by WaveCel, a company the two men founded to make safer bike helmets.

The WaveCel hard hat is just the latest effort to update the products, known as industrial safety helmets, which brain injury experts say are overdue for an upgrade.

“Unfortunately, today’s most frequently used hard hats look identical to the ones from the ’60s,” Bottlang says.

MIPS, a Swedish company, offers a competing technology to protect a worker’s brain from sudden rotation.

Upgraded helmets like these, “are keeping the brain more stationary, and that has a lot of potential benefit,” says Dr. Brandon Lucke-Wold, a neurosurgeon at the University of Florida who has no ties to the helmet industry.

Understanding workplace concussions

About one-fourth of all concussions among adults occur on the job, especially at construction sites. Falls, which often cause the head to turn or tip suddenly, are the most frequent cause.

One reason workplace brain injuries are so common is that hard hats — unlike sports helmets — haven’t changed much since their invention a century ago.

Lucke-Wold, who often treats patients with brain injuries, wears a state-of-the art bike helmet during his daily commute.

“But the construction workers I saw biking home today were wearing hard hats that are very similar to what I saw 10 to 15 years ago,” he says.

A typical hard hat consists of a plastic outer shell with an inner suspension system made from webbing. Some models include foam padding on the sides and a chin strap.

This design is good at protecting the brain from direct hit, say a hammer dropped by a worker two stories up. But traditional hard hats aren’t so good when the impact comes at an angle.

Studies show that’s because an oblique impact can cause the helmet, and the head inside it, to turn suddenly and violently. And a growing body of research shows that the brain is highly vulnerable to this sort of rotational force.

The reason is that the brain is a bit like an egg yoke — a soft capsule surrounded by liquid, and contained inside a hard shell.

You can shake an egg forcefully without disrupting the contents. But experiments show that if you spin one hard enough, the yoke inside will rupture even though the shell remains intact.

Most hard hats act like an egg shell.

“They do a job at reducing force, so they serve a purpose,” Madey says. “But if they’re not optimized to decrease the spin, they’re not optimized to prevent injury.”

A helmet that works like sand

Madey and Bottlang initially founded WaveCel to make better sports helmets.

Their inspiration came from observing what happens to a ball when it strikes the ground at an angle, the way a biker’s head often does in a crash.

The ball doesn’t just bounce, Madey says. “It will hit the ground, it’ll have friction and it’ll create spin.”

Unless the ground is made of sand.

“If you throw a ball into a sandpit, the sand gives underneath, it doesn’t impart spin to the ball,” Madey says. And the ball doesn’t bounce.

So Madey and Bottlang developed a helmet liner made from a special plastic honeycomb designed to act like sand.

“The honeycomb structure is a very light, breathable material that is not only good at absorbing linear force, but also breaks that spin the way sand would,” Madey says.

The WaveCel liner can be found in several big-brand sports helmets.

An independent study found that bike helmets with either WaveCel or MIPS technology were better than conventional helmets at reducing rotational force. A study led by Bottlang and Madey found that WaveCel outperformed MIPS for the type of head impacts caused by falls.

One potential barrier to widespread acceptance of the new helmets is price.

WaveCel hard hats cost $169 to $189, which is several times the amount for a standard hard hat and more than many premium models, including some with MIPS technology.

“If I have one goal in the next few years, it’s to bring the price down,” Bottlang says.

Digital mental health company Headspace Health announced Thursday it has acquired the Shine app, a mental wellness platform focused on culturally competent and inclusive offerings.

Founded in 2016, Shine provides self-guided content, including meditations and self-care courses on topics like stress and boundaries, as well as virtual community workshops. 

The company’s cofounders and co-CEOs Marah Lidey and Naomi Hirabayashi will take on leadership roles in Headspace’s product and marketing teams. Some Shine engineers and leaders in its client successes and marketing groups will also move to Headspace. 

“The acquisition of the Shine app underscores the continuing importance of infusing diversity, equity, inclusion and belonging into the fabric of everything we do,” Headspace CEO Russell Glass said in a statement. “By integrating both the robust content and talented team from Shine, we’ll be able to collectively scale the diversity of offerings and experiences that we can bring to our customers and members.”

THE LARGER TREND

Headspace Health is the result of the merger between meditation app Headspace and virtual mental health company Ginger, which closed in October last year.

The Shine deal isn’t the company’s first acquisition this year either. In January, Headspace announced it had acquired Sayana, maker of AI-enabled mental health-tracking and sleep apps. When that deal was announced, Headspace pitched the Sayana acquisition as a way to add AI capabilities to personalize content based on the user’s needs.

Mental health is still a leading clinical area in digital health funding, despite the number of competitors in the space. A Rock Health report on the digital health investment landscape through the first half of the year noted merger and acquisition activity has slowed compared with 2021. But the report’s authors noted in July that the number could pick up.

“Like funding numbers, we don’t foresee a return to 2021 M&A pace, though we expect 2022’s M&A activity to grow steadily from 2020 baselines,” Ashwini Nagappan and Adriana Krasniansky wrote. “We’ll be watching to see if well-positioned digital health companies in increasingly saturated segments of digital health start to acquire smaller competitors – which could mean the biggest waves of digital health consolidation are just getting started.”

ON THE RECORD

“After six years of building Shine, we’re thrilled to join Headspace Health to scale the urgent work of closing the equity gap in mental health – something Naomi and I have often felt first-hand,” Shine’s Lidey said in a statement.

“We believe that everyone deserves to feel included in their mental health journey, and with our combined team at Headspace Health, we are on an exciting path to attain that shared vision.”

Akili Interactive hit the public markets in August, bringing in cash the company will use to launch its video game digital therapeutic for children with ADHD later this year.

Akili’s product, dubbed EndeavorRx, is prescription software for kids ages 8 to 12 who have attention issues. It received FDA De Novo clearance in 2020 after years waiting for the agency green light, though a nonprescription version was released after some regulatory requirements were relaxed due to the COVID-19 pandemic.

Matt Franklin, who joined Akili as president and chief operating officer early this summer, sat down with MobiHealthNews to discuss the launch strategy for EndeavorRx, its products in development and why going public was the best move for the company.

MobiHealthNews: There’s definitely been a slowdown when it comes to digital health companies going public this year, compared with 2021. Why do you think this was the best route for Akili? 

Matt Franklin: There were two main drivers for us. First was that this event enabled us to get access to financial resources that are going to enable us to accelerate the commercial launch of EndeavorRx, to be able to impact more lives in ADHD. But I think secondly, we’re also thinking about this opportunity long term. Access to the public markets over time gives us access to funding and capital to expand the impact beyond ADHD into other areas, such as multiple sclerosis, major depressive disorder, autism spectrum, and more acute conditions like COVID brain fog.

MHN: So you’re planning on using the proceeds to launch EndeavorRx, which received FDA clearance a couple of years ago. What’s your strategy to launch it? It’s a prescription product, so how will you engage with providers?

Franklin: The first area that we focused on is building our fulfillment or distribution infrastructure. This is an app that can be downloaded from the App Store or from Google Play. But we needed to build a custom proprietary distribution system to be able to validate prescriptions, to be able to collect insurance information, to collect payments and to actually dispense the prescription. 

So that work, I’m happy to say, is complete. We’ve now seen several thousand orders or prescriptions flow through that infrastructure. We’ve seen prescriptions coming in from all 50 states to date, which has really enabled us to focus on the second phase, which is building up our commercial and medical teams to be able to engage with healthcare providers to provide that education, to drive awareness.

Our goal is really to make EndeavorRx a part of routine clinical treatment in ADHD. So that’s where we’re focused. We’ve hired the first wave of field resources. They’ll be on board here in Q4 engaging with providers, and we’ll continue to build out our full national footprint over time.

MHN: Akili also has other products in development. How did you choose those new clinical areas for expansion?

Franklin: EndeavorRx works on cognitive attention function. So we really looked at those indications, those diseases that had attention or inattention implicated. So ADHD, it’s critical, right? That’s one of the critical clinical manifestations. So our near-term focus is on driving awareness and adoption in pediatric ADHD. We’ll look to expand that to adolescent and adult populations.

Beyond that, autism spectrum disorder also has a high degree of overlap with attention and cognitive function issues. So that’s an area of expansion. Multiple sclerosis and major depressive disorder are areas that we’ve already studied. And we’ll continue to execute additional confirmatory studies there as well.

MHN: What do you think are the next steps to expand the use of digital therapeutics? 

Franklin: I think we have a near-term opportunity to educate on the different classes or categories within digital therapeutics. For example, EndeavorRx fits in this prescription digital therapeutic category. It is prescription medication delivered in this engaging entertainment format.

Second, we’re driving awareness of our clinical data. One of the things that attracted me to Akili was the strong scientific underpinnings, but also the rigorous clinical evidence. So there is not widespread awareness of the clinical data that supports an approach like EndeavorRx. So we are actively engaged in driving awareness of that strong supporting clinical evidence as well.

Sept. 9, 2022 – A 31,000-year-old skeleton discovered in a cave in Borneo may be the earliest evidence of a surgical amputation in humans.

The skeleton found in 2020 in Liang Tebo, a limestone cave in Indonesian Borneo, was missing its left foot and part of its left leg, according to a study published in the journal Nature.

The leg bone had a clean cut, unlike a bone that had been crushed, leading researchers to conclude it was removed “through deliberate surgical amputation at the position of the distal tibia and fibula shafts,” Nature reported.

There were no signs of infection, ruling out an animal attack and showing the person received community care after the treatment. The surgery happened when the person was a child, and they went on to live 6 to 9 more years as an amputee.

The finding has scientists rethinking the idea that medical knowledge advanced when people switched from foraging to farming societies at the end of the Ice Age. The people who lived in Borneo 31,000 years ago were foragers.

Previously, the earliest known evidence of amputation had been found in France in the 7,000-year-old skeleton of a Stone Age farmer whose left forearm was amputated above the elbow, according to a news release from Griffith University in Australia. (The university worked on the project with Indonesia’s Centre for Archaeology, Language and History.)

“What the new finding in Borneo demonstrates is that humans already had the ability to successfully amputate diseased or damaged limbs long before we began farming and living in permanent settlements,” Maxime Aubert, PhD, an archaeologist with Griffith University and co-leader of the project, said in the news release.

The finding suggests that “at least some modern human foraging groups in tropical Asia had developed sophisticated medical knowledge and skills long before the Neolithic farming transition,” Nature reported.

Researchers determined the skeleton was 31,000 years old by comparing teeth and burial sediment using radioisotope dating. The area where the skeleton was found has some of the earliest known human rock art.

FRIDAY, Sept. 9, 2022 (HealthDay News) — People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades.

Daxxify, made by Revance Therapeutics Inc. in Nashville, Tenn., is injected into the face along worry lines. It lasts longer than Botox, with about 80% of users seeing no or mild facial lines at four months after injection. For half of users, the treatment lasted six months, the company said in a statement.

“Users do not have to go once every three months,” Dr. Balaji Prasad, who covers specialty pharmaceuticals as an analyst for Barclays Investment Bank, told the New York Times. “In a world where time is of the essence, having a product with a long duration factor is extremely useful.”

The new drug now enters the $3 billion field of facial injection drugs. It is also a neuromuscular blocking agent and a botulinum toxin, like Abbvie’s Botox.

“It also opens up the door for what we can do with therapeutics,” said Revance CEO Mark Foley, told the Times. “If you think of migraines, cervical dystonia [a neurological condition that affects the muscles in the neck and shoulders], overactive bladder, there’s a huge medical opportunity as well.”

The company has begun testing the drug on these other medical issues, Foley said. While the company had been trying to create a product that needed no needle, it instead discovered a way to use peptide technology to keep the product stable. Typically, animal protein or human serum is used.

Botox is also used for more than just wrinkles. It has been an FDA-approved treatment for chronic migraines since 2010.

Users of Daxxify in the Revance studies included some who experienced side effects. About 2% of people developed a drooping eyelid, while about 6% experienced headache, the company said.

Toxin-based treatment can carry the potential for other side effects, such as general muscle weakness or breathing difficulties, the FDA cautioned. Daxxify study participants showed none of those symptoms.

Revance had initially hoped for approval of its product in November 2020, but plans were postponed because of pandemic travel restrictions, the Times reported. An inspection finally conducted in June 2021 found problems with the quality control process and the company’s working cell bank, which contain the drug’s active ingredient. Those concerns were resolved, the Times reported.

More information

The National Library of Medicine has more about botulinum toxin.