TAli Train, has cleared regulation requirements in US, Europe and Australia. FDA class 2 medical device
Here's from FDA website,
TAli Train received CE Mark for European markets.
FDA, class 2 medical device.
FDA cleared TAli Train is included in US reimbursement code system.
PCK(former EPT) received CE Mark,
Will big pharmacies be interested in NHL?
World's first FDA cleared ADHD app, targeting ages 3 - 8, also received European CE mark, and now being included in US reimbursement CODEs.
Peer, Akili sold a right for Japan & Taiwan’s markets for USD$20m cash plus USD$105m milestone payments. Their ADHD app is not FDA clearance yet.
Plus they raised USD$140m over last few years.
Akili raises $55M to bring video game ADHD treatment to market
by Nick Paul Taylor |
May 9, 2018 8:45am
Akili's video game (Akili) ShareFacebookTwitterLinkedInEmailPrint
Akili Interactive has raised $55 million to bring its prescription video game treatment for ADHD to market. The Temasek-led series C round comes five months after Akili posted positive data from a pivotal clinical trial of its digital medicine.
The trial partly validated Akili’s belief it can improve outcomes in ADHD and other conditions through video games designed to act on neural systems. Participants randomized to play the therapeutic game, AKL-T01, for four weeks performed better on a score of attention than those who played a nontherapeutic control game.
Misses against secondary endpoints weakened the dataset somewhat, but Akili has still persuaded some notable investors to bankroll its plans. In addition to national wealth fund Temasek, Akili raised money from Baillie Gifford and the VC wings of Amgen and Merck KGaA.
Akili Interactive Labs has raised a total of $140.9M in funding over 4 rounds.
More news to come:
The Company intends to provide further guidance on the deployment and billing schedulefor TALi Detect in the near future as it works with physicians and customers in the U.S. during initial launch.
Price for TAli Train Program:
Australia: $199/child
Singapore: $400
HongKong: HKD2,500.
What does 'FDA cleared' mean?
Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.
For instance, let's say hypothetically Samsung wanted to create an app that can record a singlechannel electrocardiogram (ECG, aka EKG), which is what Apple's ECG app does. It could get FDA clearance if it can compare its product to Apple's and demonstrate that it is safe, effective and equivalent in how it works.
Companies must submit a "premarket notification submission" or 510(k)to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.
Akili Strikes $125m Digital Med Deal With Japanese Partner
Executive Summary
PureTech Health's Akili has announced a $125m partnership with Japanese pharmaceutical company Shionogi to commercialize two of its digital therapeutics in Japan and Taiwan.
Under the terms of the accord, Akili receives upfront payments totalling $20 million with potential milestone payments for Japan and Taiwan commercialization of up to an additional $105 million in addition to substantial royalties. Shionogi will also help fund development costs and commits to a future equity investment in Akili. Akili will maintain exclusive global rights to develop and commercialise AKL-T01 and AKL-T02 in all territories outside of Japan and Taiwan.
DO NOT RELY ON HC POSTS.
GLTA.
NHL Price at posting:
8.9¢ Sentiment: Buy Disclosure: Held
(20min delay)