digital therapeutic

Debate: Will digital therapeutics gain the required levels of awareness, adoption, reimbursement and fulfillment to become sustainable?

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Can dig­i­tal ther­a­peu­tics become prof­itable? (MedTech­Dive):

In 2020, the Food and Drug Admin­is­tra­tion cleared Akili Inter­ac­tive’s video game to improve atten­tion in kids with ADHD. It was the first time that a video game for treat­ment was cleared by the agency, and is one exam­ple of a dig­i­tal ther­a­peu­tic, a class of soft­ware-based treat­ments with FDA indications.

Now, as the mar­ket is fur­ther devel­op­ing, these com­pa­nies have built up big ambi­tions. [Read more…] about Debate: Will dig­i­tal ther­a­peu­tics gain the required lev­els of aware­ness, adop­tion, reim­burse­ment and ful­fill­ment to become sustainable?

Trend: Harnessing digital tech to improve mental health and wellness

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From mind­ful­ness apps to vir­tu­al ther­a­py ses­sions, dig­i­tal tools offer instant access to well­ness resources (The Globe and Mail):

In 2015, Brie Code was work­ing at lead­ing video game com­pa­ny Ubisoft as lead arti­fi­cial intel­li­gence pro­gram­mer when she real­ized that many peo­ple she knew – about half, by her esti­ma­tion – found video games bor­ing. [Read more…] about Trend: Har­ness­ing dig­i­tal tech to improve men­tal health and wellness

On cognitive reframing and biases, stress, mental health tech, Aduhelm backlash, Britney Spears, and more

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing this time nine sci­en­tif­ic reports and indus­try devel­op­ments to help pro­mote life­long brain and men­tal health.

#1. To low­er stress lev­els and improve prob­lem-solv­ing, prac­tice cog­ni­tive refram­ing instead of venting

“… vent­ing like­ly doesn’t soothe anger as much as aug­ment it. That’s because encour­ag­ing peo­ple to act out their anger makes them relive it in their bod­ies, strength­en­ing the neur­al path­ways for anger and mak­ing it eas­i­er to get angry the next time around. Stud­ies on vent­ing anger (with­out effec­tive feed­back), whether online or ver­bal­ly, have also found it to be gen­er­al­ly unhelp­ful … To get out of that, you can ask the per­son to step back and help you reframe your expe­ri­ence by ask­ing, “How should I think about this dif­fer­ent­ly?” or “What should I do in this situation?”

#2. Head­space and Gin­ger merge to expand and scale up dig­i­tal men­tal health

“The new com­pa­ny would find it push­ing well beyond its cur­rent mind­ful­ness focus to, “pro­vide the full spec­trum of proven, effec­tive vir­tu­al sup­port – from mind­ful­ness and med­i­ta­tion, to text-based behav­ioral health coach­ing, to video-based ther­a­py and psy­chi­a­try – for all types of patient populations.”

Ambi­tious move!

#3. How to read, under­stand and write great med­ical research

12 good tips for stu­dents and every­one else

#4. Vet­er­ans Affairs won’t cov­er Biogen’s new “Alzheimer’s drug” giv­en con­cerns over safe­ty and lack of evidence

Their inde­pen­dent review con­cludes that “giv­en the lack of evi­dence of a robust and mean­ing­ful clin­i­cal ben­e­fit and the known safe­ty sig­nal, we rec­om­mend against offer­ing this agent to patients with Alzheimer’s demen­tia (mild or oth­er­wise) or mild cog­ni­tive impairment.”

#5. Alzheimer’s & Demen­tia researchers chal­lenge FDA’s approval of Aduhelm giv­en lack of evi­dence for beta-amy­loid as a marker

A strong call to “learn how this reg­u­la­to­ry fail­ure occurred and to ensure that it doesn’t occur again”

#6. Debunk­ing four myths about deci­sion-mak­ing capac­i­ty to keep Brit­ney Spears and oth­ers safe

Address­ing the ongo­ing con­tro­ver­sy about con­ser­va­tor­ships, a USC Pro­fes­sor of Law, Psy­chol­o­gy, and Psy­chi­a­try shares a great arti­cle to debunk these all-too-com­mon myths

#7. Study exam­ines com­mon cog­ni­tive bias­es (have you tried this brain teas­er?) and ways to mit­i­gate them

If you have not encoun­tered the “Lin­da brain teas­er” before, please give it a try! If you have, you’ll enjoy the new paper titled Tver­sky and Kahneman’s Cog­ni­tive Illu­sions: Who Can Solve Them, and Why?

#8. Inte­grat­ing music, move­ment and stroke reha­bil­i­ta­tion, MedRhythms rais­es $25M to devel­op and com­mer­cial­ize dig­i­tal therapeutic

Fas­ci­nat­ing approach to gait training.

#9. Neu­rotech start-up Paradromics rais­es $20M to address brain-relat­ed dis­or­ders via next-gen brain-com­put­er interfaces

Neu­ralink vs. Paradromics vs. non-inva­sive plat­forms — quite a stim­u­lat­ing space to track

 

Wish­ing you and yours a hap­py and healthy back-to-school and month of September,

The Sharp­Brains Team

Blue Note Therapeutics raises $26M to help treat cancer-related distress via cognitive behavioral stress management (CBSM)

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Blue Note Ther­a­peu­tics Rais­es $26.25 Mil­lion in Series A Financ­ing (press release):

Blue Note Ther­a­peu­tics, Inc., today announced the clos­ing of a Series A financ­ing round of $26.25 mil­lion. Pro­ceeds will allow the com­pa­ny to scale the orga­ni­za­tion and fund near-term clin­i­cal tri­als of its lead pre­scrip­tion dig­i­tal ther­a­peu­tic (PDT), which will poten­tial­ly improve the treat­ment of can­cer. The cap­i­tal will also sup­port the devel­op­ment of Blue Note’s pipeline assets. The Series A financ­ing was led by JAZZ Ven­ture Part­ners and joined by Sum­mer VC. [Read more…] about Blue Note Ther­a­peu­tics rais­es $26M to help treat can­cer-relat­ed dis­tress via cog­ni­tive behav­ioral stress man­age­ment (CBSM)

FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares

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FDA grants De Novo clear­ance to pre­scrip­tion Apple Watch app for night­mare dis­or­der (Mobi­Health News):

The FDA grant­ed Min­neapo­lis-based Night­Ware a De Novo clear­ance on Fri­day for its Apple Watch and iPhone app designed to improve the sleep qual­i­ty of those expe­ri­enc­ing night­mare dis­or­der and night­mares relat­ed to PTSD. [Read more…] about FDA grants clear­ance for Night­Ware app designed to reduce PTSD-relat­ed nightmares

Update: A life of cognitive and physical exercise helps you stay sharp in your 70s and beyond

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing 13 fas­ci­nat­ing brain research find­ings, use­ful resources–and a brain teas­er to test your atten­tion skills.

#1. Good news of the month: Elders today are in sig­nif­i­cant­ly bet­ter shape–physically and cognitively–than three decades ago

#2. A dis­tinc­tion WITH a dif­fer­ence: Actu­al, sus­tained practice–not mere knowledge–is need­ed to har­ness neu­ro­plas­tic­i­ty and improve cog­ni­tion over time

#3. “Be mind­ful that with the rapid changes we are expe­ri­enc­ing, our brains are going through accel­er­at­ed learn­ing. Our brains get tired just as our bod­ies would if we ran a marathon with­out train­ing.” How COVID-relat­ed stress can dis­rupt your brain cir­cuits and nine tips to pre­vent it

#4. Yes, Yes, and Yes. To har­ness our best selves, “Tem­per your empa­thy, train your com­pas­sion, and avoid the news”

#5. Things start ear­ly. Marsh­mal­low Test with a twist: 3- and 4‑year-olds kids dis­play more self-con­trol when their rep­u­ta­tion is at stake

#6. Which is why we look for­ward to see­ing 9,000+ stu­dents, plus their many teach­ers and admin­is­tra­tors, fur­ther devel­op their unique brains and minds in years ahead: Help­ing shape the future of life­long learn­ing via SEK Edu­ca­tion Group

#7. “… it would cer­tain­ly be pre­ma­ture to sug­gest that mov­ing to a high alti­tude state would improve a child’s ADHD symp­toms. How­ev­er, the find­ings high­light the val­ue of keep­ing an open mind in efforts to under­stand the devel­op­ment of ADHD and the role nat­ur­al envi­ron­ments may play in poten­tial­ly alle­vi­at­ing it.” Study finds sur­pris­ing cor­re­la­tion between states’ ele­va­tion and ADHD prevalence

#9. Time to start pay­ing seri­ous atten­tion to the brain/ cog­ni­tive side effects of com­mon med­ica­tions. Anti­cholin­er­gic drugs found to sig­nif­i­cant­ly increase risk of cog­ni­tive decline, espe­cial­ly among those with Alzheimer’s Dis­ease bio­mark­ers or genet­ic predisposition

#10. Fas­ci­nat­ing: “After a 14-day train­ing peri­od … visu­ospa­tial skills improved by 40%. This increase in visu­ospa­tial abil­i­ty was shown to be direct­ly respon­si­ble for a reduc­tion in motion sick­ness by 51% in the sim­u­la­tor … and a 58% reduc­tion in the on-road tri­al.” Study: Self-dri­ving cars will increase motion sickness…unless we retrain our brains to improve visu­ospa­tial skills

#11. Behav­ioral health and neu­ro­plas­tic­i­ty meet big phar­ma to hope­ful­ly address a huge need. Click Ther­a­peu­tics and Boehringer Ingel­heim part­ner to devel­op and mar­ket a dig­i­tal ther­a­peu­tic to treat schizophrenia

#12. Neu­ralink: Thumbs up or down?

#13. Brain teas­er: Did you notice the numer­i­cal error as it hap­pened? If not, feel free to go back and find it now 🙂

 

Wish­ing you a safe and healthy October,

 

Alvaro Fer­nan­dez and the Sharp­Brains Team