Some Thoughts on E-sport Comparing to Traditional Sport Industry

E-sport is a very hot growing industry with the future format of living embedded in. It is the intersection between gaming, technology, social, media and entertainment.

There are some related concepts, e.g. streaming gaming, and they share some similar fundamental building blocks.

Future of gaming will be mostly based on cloud. Just like Office Suite and Adobe Suite is moving to the subscription model, the computer gaming industry is making that transition as well and this might be the next growth opportunity for Microsoft (with its cloud computing services, Hololens and Xbox, etc.) and other companies. In fact, most of the mobile games today have already relied on continuous connections, instead of a publisher model like movie/music (buy, download and play).

As certain games (now and in the future) would be considered as “sports”, they inherently include related business opportunities – worldwide competitions, leagues, sale of tickets, game watching and ads, etc. It is very similar to today’s sports and is able to provide a more authentic experience as games are born to be digital (unlike traditional sports that are recorded and digitalized for TV/videos). The concerns here include: 1. the watchableness of players playing games is hard to improve. Players are just sitting in front of the PC or even holding phones. (It is the characters they are playing are watchable) 2. Compared to traditional sports, games usually need a certain level of understanding to enjoy, while sports are commonly understandable and may have some natural beauty to watch.

The leading games that are run like “sports” include LOL (League of Legends), Dota2, Overwatch, etc. The Dota2 international competition in 2018 (TI8) has $25.5 million prize pool. Another major company to “sportify” gaming it Amazon, with its Twitch platform, on which there are 140 million monthly active users. [Netflix has 139 million subscribers globally]

From the technology perspective, the increasing power of cloud is definitely the driver here. Additionally, the coming 5G (low latency, faster transmission of larger data) and AR/VR (actually bringing sports alive; and to solve the watchableness issue maybe) will revolutionize our view on gaming and e-sports. That will even redefine what is “living” and “socializing” in the future (say 25-50 years).

The concept of “playing video games with friends” will be barely used. The line may be so blur that the following concepts are true “life is a real game” and “living on the net”.

And then virtual goods will be huge market. It’s not only buying on the internet (which is e-commerce) but also using on the internet. The virtue clothing on a virtual character we control would have value. Many people are buying or will buy virtual luxury goods. It doesn’t matter if a product’s actually cost is $100 or $0 – they can be sold at $3000. Clothings have already gone far beyond keeping us warm anyway.

E-sports is part of the test field or connection between our current world and the future living.

Smart Phones in 2019 – Foldable

The incremental improvements in smartphones are less exciting in recent years. Besides the introduction of 5G, companies trying to get consumers’ attentions have introduced foldable phones this year – a more dramatic change in appearance (to show that you have the latest/expansive phone).


Foldable Phones by Companies

Samsung: Galaxy Fold

Source: USA Today

Huawei: Mate X, 2299 euros

Source: CNBC.com

Xiaomi

https://youtu.be/w3-aDOMI6Mk

Apple (concept, not released):

Qualcomm Snapdragon 855 To be Crowned for Global Push (?)

No doubt, Qualcomm has dominated the world in 4G and LTE and has invested a lot to prepare for the 5G future. As one of first and steady leaders & supporters & promoters in 5G technology, Qualcomm revealed its flagship Snapdragon 855 mobile platform on December 5, 2018 in Hawaii. [Qualcomm Snapdragon Tech Summit 2018]

With the Mobile World Congress (MWC) happening this week and many world’s leading handset brands having announced their products to be launched later this year, Snapdragon 855’s worldwide penetration map has become clear.

1. First of all, the largest handset manufacturer by shipment Samsung announced its 10th anniversary phones – Galaxy S10 series.

Source: samsung.com

There are four versions:

  • S10e       $750
  • S10         $900 with free Samsung’s wireless earbuds
  • S10+       $1000 with free Samsung’s wireless earbuds
  • S10 5G   bigger screen and battery, an additional rear camera (4!), with Qualcomm’s X50 5G modem, pricier and available on later dates ($1,200 up, depending on sale of S10+ I think) [Read more on S10 5G]

S10 series will use Snapdragon 855 platform in regions including North America, Latin America, Hong Kong, China, and Japan, and in Europe it will be using Samsung’s own Exynos 9820.

2. Xiaomi announced its Mi 9 in China on February 20.

Source: blog.mi.com

Mi 9 might be the cheapest handset with Snapdragon 855 available globally, starting at RMB ¥2,999 in China and €450 in Europe. Xiaomi also revealed Mi 9 SE, priced lower at RMB ¥1,999, featuring Snapdragon 710. And a global launch event is in Barcelona during MWC on 24 February.

Another version of a previous handset by Xiaomi – Mi Mix 3 5G is also announced today at MWC. Mi Mix 3, when introduced in October 2018, uses Snapdragon 845; the new 5G version will use Snapdragon 855, plus Qualcomm’s X50 5G modem. The device will be available in May for €599 (cheapest 5G with Qualcomm’s X50 modem?) in selected Europe market. [TechCrunch]

Source: TechCrunch

Xiaomi is one of Qualcomm’s crucial allies in Chinese market (and globally).

3. OnePlus to announce OnePlus 7 5G with Qualcomm’s Snapdragon 855 and X50 5G modem

A Chinese company that is doing surprisingly well in its global presence I’d say. By not focusing on Chinese market, OnePlus’ majority brand/marking/community efforts are outside of China IMO.

On the Qualcomm Snapdragon Technology Summit mentioned above, OnePlus has said it will work with EE (a division of BT, the largest operator in UK) to be the first to release a commercial 5G smartphone in Europe (second half of 2019 in UK and Finland, according to the recent report by USA Today).

Although OnePlus has been very successful in US before, it will solely focus on Europe at the first launch (different operator partners with Xiaomi).

4. Lenovo Z5 Pro GT – available only in China starting at ¥2698, first Snapdragon 855 phone available

Source: NDTV Gadgets

5. LG G8 ThinQ and V50 ThinQ – announced on MWC today, both with Snapdragon 855, the difference between the two is that V50 has 5G connectivity by Qualcomm partnering with Sprint

Source: Verge

So it becomes clear that Snapdragon 855 will be in

  • US with Samsung and LG
  • Europe with Xiaomi and OnePlus
  • China & Asia with Samsung, Xiaomi, Lenovo, LG

5G modem is more complicated with carriers’ spectrum but Qualcomm seems to be ready for its 5G globally, with the existing X50 and newly released X55. (And Apple will need another year from Intel for 5G…)

Source: anandtech.com

What’s New in China’s Retailing (2) – Influencers, Social and Ads

Tencent and others have tried to challenge Alibaba’s dominance in e-commerce for years. From its investment in JD.com to Meilishuo and Pinduoduo, Tencent has helped an array of companies, giving them “special entrances” on its most powerful app WeChat, while blocking links from Alibaba (e.g. Taobao links).

Tencent’s series of efforts also represents shifts or new forms for e-commerce, at least in China.

Core/Basic Form: Alibaba (Taobao, Tmall), JD – trying to be the everything’s store, the go-to place for shopping

Although they have different business models (record commissions as revenues, record products as inventories and therefore net prices as revenues), they all trying to be the first website that consumers will think of when they want to buy something.

Tencent investments in and supports to JD.com is the direct competition with Alibaba, with some differentiating factors such as specialization in appliances (more quality control, logistics, procurement focus, not just a marketplace to connect buyers and sellers)

When these existing platform is good enough, where are the new opportunities?

Efforts I: To Sell Experiences/Appearances (Influencers)

The idea behind Tencent’s backing for Meilishuo. Mogujie and Meilishuo joined forces together in early 2016, giving them a bigger presence. Mogujie went IPO in December 2018, raising $66.5 million.

But that was only the idea. Selling & buying products is still the main format of user interactions. The difference with the Core/Basic Form is that they list products with prettier models & pics, and with videos/live streaming.

Meanwhile, Xiaohongshu is better at letting users generate authentic experiences and become influencers.

After all, Mogu is where consumers could buy fashion & skincare products with fancy demonstration (my understanding). And Xiaohongshu’s position is where users could share their life/day.

Alibaba led the $300m Series D in Xiaohongshu last May, at ~$3 billion valuation.

With Xiaohongshu’s emphasis on user’s journal/blog (e.g. travel and others, not directly relevant to selling products), it is also more like a social app, for users to build their reputation/followers (and social is where Alibaba is trying to compete with Tencent).

You can’t find an “influencer” on Mogu that is not trying to sell a thing; but many users on Xiaohongshu are not selling anything, while writing their stories, commenting and interacting with other bloggers/influencers.

Effort II: Buying Together, Leveraging Existing Social Network

Tencent’s WeChat has tried to push for the use cases of its Mini-program within WeChat. Pinduoduo might be the most successful one.

By incentivizing users to share with their friends and buy together (at extremely low product prices), Pinduoduo has grown its sales rapidly, currently having a $30+ billion market cap.

Making users as their marketing tools sounds a brilliant idea and is indeed very unique to Tencent. No one else could help to build such a big enterprise within a short period of time. (Alibaba has similarly powerful app such as Alipay but not social – can’t make users part of its marketing)

Plus, through this social marketing strategy, plus the low pricing, Pinduoduo could reach out to the rest of Chinese consumers who use smartphones but not served by existing platforms.

It might be the first time that Tencent could generate revenue on many of its WeChat users.

Effort III: Ads

This is more like what Facebook is doing. Tencent is adding new features and more ads to the Moment feature in WeChat, and also in the Public Accounts’ Feed feature.

While WeChat not directly doing e-commerce, it is leveraging the time users spend on the app to be part of the overall e-commerce economy.

In the time of rising consumer acquisition costs (see a previous post/podcast by a16z on consumer goods), it is becoming a vital part of the overall e-commerce.

What’s New in China’s Retailing (1) – A Little Extra Premium

Taobao is powerful but probably should not be the first word to describe Chinese retailing and consumers’ choices.

T-mall and JD might be considered as the second generation e-commerce in China, where branded goods are sold.

With the rise of Chinese middle class and their disposable incomes, retailers found that they are willing to pay a little extra to get a sense of some kinds of “premium”.

So there arises a wave of e-commerce efforts that are selective about their offerings, in terms of quality and design. Meanwhile, some marketplace will emphasize on their own brand (website/marketplace), instead of the brands of the products – somewhat similar to “AmazonBasics” but more correctly “AmazonPremium”.


Yanxuan (网易严选), by NetEase (NASDAQ: NTES), might be the most successful one.

It started with products made by original manufacturers who supply to top international brands, hitting consumers’ sweet spot in price and quality.

NetEase Yanxuan | Source: you.163.com

Xiaomi has a similar strategy but featuring more of its own products or affiliated products. on Xiaomi Youpin (小米有品), independent of its core Mi Store (小米商城).

Xiaomi Youpin | Source: xiaomiyoupin.com

Alibaba has its response under Taobao’s name called Taobao Xinxuan (淘宝心选), making Xinxuan its own brand.

Taobao Xinxuan | Source: good.world.tmall.com

Updated

  • From NetEase 2018 Q4 earnings report, we could see its E-commerce net revenues were RMB6,678.7 million (US$971.4 million), an increase of 43.5%
    compared with the fourth quarter of 2017. (Its e-commerce revenue includes Yanxuan and Kaola)
  • 2018 full year net revenues from e-commerce were RMB19,235.5 million (US$2,797.7 million), an increase of 64.8% compared to RMB11,670.4 million for fiscal year 2017.
  • And Amazon is in talks to merge its China business with NetEase‘s e-commerce site Kaola, ranked as the No.1 cross-border import retail e-commerce platform in China.
  • The new e-commerce unit will be as important as gaming to NetEase, with 3 sub-teams: Yanxuan, Kaola and Amazon China. The latter two might combine into one team.
  • And Yanxuan has opened it first offline store in Hangzhou last December
Yanxuan offline store | Source: 36kr

A New Round of EV/Autonomous-driving Financing

Tesla is the leader in the electric vehicle market obviously, but it may not be the only winner. As technology matures and become more advanced, it will become more of a business competition (assuming design & production generally won’t be a problem in the next decade).

And another round of fresh financing in this field is showing us the future to come, probably with a few leaders in different sub-segments of EV market.

And the self-driving is still a combating ground for companies. Because of its complexity, lots of collaborations and alliances are expected. (e.g. Toyota to invest $500 million in Uber for self-driving cars)


Led by Amazon, the $700 million investments in Rivian, announced on February 15, is the latest move. As the leader in electric pickup and SUV, Rivian will help Amazon to build the next generation logistics network. After all, although amazon is in e-commerce (and other) business, it is also a logistics company (so does Walmart).  In the next 15-30 years will have its own (delivery) network & infrastructure, independent of USPS, UPS, FedEx, etc., comprised of (autonomous) airliner, trucks, delivery robots, etc… Yes, Amazon may become similar to the US postal system in the 19th century.

R1T Electric Truck (updated in Jan 2021; previous link broken) | Source: Rivian
R1T Truck expected spec | Source: Rivian

The R1T and R1S will be produced at Rivian’s manufacturing plant in Normal, Illinois, with customer deliveries expected to start in late 2020.

Just before that, on February 7, Aurora has raised more than $530 million in Series B financing for its self-driving technology, led by Sequoia Capital and includes “significant investment” from Amazon. [Techcrunch]

The investment was reported in early January [recode] and not a good news for companies like Tesla. The team is led by 3 industry leaders: CEO Chris Urmson, who was the CTO for Waymo, CPO (chief product officer) Sterling Anderson, Tesla’s former head of Autopilot, and CTO Drew Bagnellone, one of the founding members of Uber’s autonomous efforts. Aurora is now valued at more than $2.5 billion.

Meanwhile, Tesla Semi is probably still the most ready and earliest e-truck with auto-pilot. First unveiled in November 2017, Tesla Semi has its prototype traveled by itself (without any escort or accompanying vehicles) for a week to arrive at the J. B. Hunt headquarters in Arkansas on August 24, 2018.

Tesla Semi | Source: Tesla

Other self-driving companies have started to explore use cases.

Cruise Automation, the self-driving unit of General Motors, is teaming up with DoorDash to test a food delivery service in San Francisco using autonomous vehicles. The pilot will commence in “early 2019.” [Verge]

Nuro, which raised $940 million from Softbank Vision Fund in Februry, is focusing on self-driving bots and has a (pilot) partnership with Kroger.

Nuro’s vehicles | Source: TechCrunch

And Waymo has launched/tested its self-driving ride service in Arizona in December 2018.

And Ford and Volkswagen might join together to bet on Argo AI, valued at about $4 billion, as Bloomberg reported on February 14.

And Daimler and BMW may go into an extensive cooperation in autonomous driving.


First half of 2019 might be the last chance to get into this game if winning the future of cars is expected.

Airbus A380 to Stop Production… Officially

The European aerospace group said it had made the “painful” decision to stop making A380 after Emirates, the biggest customer, reduced an outstanding order for 53 planes to only 14. [The Guardian]

Airbus announcement on February 14 – capital market liked it.

A History

A380 is the world’s largest passenger airliner, a wide-body aircraft manufactured by Airbus. The project was announced in 1990 to challenge the dominance of the Boeing 747.

Source: The Guardian

Boeing’s 747 project had its origin in a US Air Force requirement for a large heavy-lift transport carrying up to 750 troops over long distances. Losing that contract, however, made Boeing to pursue it in high-capacity commercial jet transportation. [Air Force One, the presidential aircraft version of the 747 will be modified based on 747-8; Boeing received the contract in July 2018 – a $3.9 billion contract to build two, due to be delivered by December 2024]

Boeing’s board of directors decided to launch the 747 in March 1966, making its decision public in April, along with an announcement that Pan Am had placed its first order for 25 at $20 million each. First flown commercially in 1970 with Pan American Airways, the 747 held the passenger capacity record for 37 years.

Conceived as a response to the Boeing 747, the Airbus A380 development program was officially launched in June 1994. It is the largest jet airliner ever built and is the world’s first double-deck passenger aircraft. First flight took place from Toulouse, France on 27 April 2005, A380 completed its first commercial with Singapore Airlines on October 25th 2007 with 471 passengers on board (breaking 747’s record).

Commercial Success?

A380 took the realm and record in terms of manufacturing and engineering, but is often considered an unsuccessful commercial product. As of January, Airbus had received 313 firm orders for the passenger version of the plane, of which 234 had been delivered.

A380 O&D as of Jan 2019| Source: wikipedia

But its target was to sell 700 in total. The whole programme is thought to have cost $25bn (£19.4bn). [BBC]

Consumers like A380 but not airlines do not

The average price of Boeing’s 747-8 as of January 2018 is at $402.9 million and $403.6 million for the passenger and freighter version respectively. The current list price is up 4% at $418-419 million.

The average list price of the Airbus A380 is 10% more expansive, based on its 2018 average list price of $445.6 million.

Common concerns and considerations…

  • too large, hard to fill and thus inefficient
  • high fuel prices, high operating cost and environmental concerns
  • airlines looking at Boeing’s new family of 777s

Now, the world’s largest passenger airliner will not be produced after 2021.

The Economics

The rising global demand in the 21st century is the underlying theme, especially the rapidly rising number of air travelers in the Asia and Middle East market.

The center of Airbus’ pitch for the A380 in the early 2000s was the notion that the core of the long haul business model would be so-called hub-to-hub flights. [AirwaysMag]

On the other hand, Boeing is pursing the point-to-point (more accurately hub-to-spoke) thesis.

Boeing’s 777X, specifically the larger 777-9X variant, offers similar performance (the A380 can fly slightly further) to the A380. And pretty much every other carrier with a hub network large enough to support an A380 has ordered either the Boeing 777X or the Airbus A350. [AirwaysMag]

The airline industry is planned and started as fragmented. Then comes bankruptcy and consolidation.

And airlines are also sharing world hubs or exploring second/third tier cities. (it’s not common for a single airline to secure the majority share of an international traffic hub – which would make A380 a wise choice/investment)

Airbus may have bet that countries like China and India will have large demand centered around one or two cities. But the reality is the opposite. They have planned ahead to spread out and made several international hubs.

First tier airports/cities in terms of size will add new members to its list. That’s how the predicted increase in demand mostly absorbed.

Smart Building (1): Data + Management Startups Roundup

Smart building is a hot topic and will be at the center of future real estate, a $217 trillion giant industry.


So what is the core segments of smart building? This blog will provide a roundup of startups in the data + management space.


Comfy (developed by Building Robotics)

Probably most famous for its collaboration with WeWork in 2016, Comfy is an app that lets users to adjust the temperature, lights etc. in the office from smartphones.

Comfy app | Source: comfyapp.com

Plus a data analysis and insights tool for office managers.

Comfy app | Source: comfyapp.com

The company was founded in 2012, raised Seed & Series A from Claremont Creek Ventures and other investors including the Westly Group. In 2016, shortly before the WeWork collaboration, a Series B of $12 million was raised. Then in 2018, Building Robotics was acquired by Siemens (in a series of acquisitions) for an undisclosed amount.

Euclid

Euclid is a leading spatial-analytics platform based in San Francisco. With fundings from NEA, Benchmark and other investors, It has built a proprietary analytic offering that uses WiFi signals to understand how space is used without the installation of any additional hardware. It can track the identity and behavior of people in the physical world.

A retailer application of Eculid’s technology | Source: marketingland.com

In Feb 2019 (a few days ago), Euclid was acquired by WeWork (“The We Company”). The blog post from The We Company.

Teem

A maker of office management software, Teem was acquired by WeWork in Sep 2018 for around $100 million. Teem has grown from a conference room management tool to include office space management, (office) room display, visitor management, etc.

Booking | Source: teem.com
Display | Source: teem.com
Visitor check-in | Source: teem.com
BuildingIQ

An energy-efficiency focused startup, BuildingIQ listed on Australian Securities Exchang and raised A$20 million in 2015, with an IPO marketcap of A$85 million.

Back in 2013, it raised $9 million from Aster Capital (backed by Schneider
Electric, Alstom and Solvay), the Venture Capital unit of Siemens Financial Services (SFS VC) and Paladin Capital.

BuildingIQ Mobile App | Source: buildingiq.com/app

In 2018, BuildingIQ acquired Buildingsense, another building data analysis company in Australia.

Flywheel

Formerly known as SCIenergy, Flywheel is a maintenance (task) & energy management startup based in Dallas. Invested by DFJ, Flywheel raised its latest round in 2014 by a group of energy focused funds, led by Braemar Energy Ventures and joined by the Westly Group and others.

Source: flywheelbi.com
Source: flywheelbi.com

Consolidation is coming faster than most could imagine…

Apple’s Service Bundle

Apple may know well before the investors that their flagship iPhone would face a slowdown and it needs new growth strategies.

[Read more on iPhone’s sluggish sales and challenges  & its recent pricing strategy]

Apple has talked about its services for a while and it’s not limited to Apple Care or Genius Bar (“Physical Services”), but more about Distribution Services.

System/Platform Level

I guess the most obvious change happened in 2016 when a new revenue sharing scheme was introduced by Apple – from a 30% cut to a 15%-cut-after-first-year. And other features were included such as “subscription group“… marching into subscription-based services revenue model.

85% net revenue after first year | Source: verge.com

Apple News

Apple News | apple.com

Available in Australia, UK, and US, it’s currently a curated display place for publisher subscriptions. It could be developed into a Toutiao-like app for personalization and could be complimentary with Apple’s Stock app.

And it won’t be surprised to me that in the future you can trade stocks through this app – probably by upgrading to a premium version with other complementary benefits (like news/reports).

Apple Music

Anyway, music is where Apple found its turnaround with iTunes and iPod. Plus, it is the most explored region with established companies and new entrants.

Apple Music Subscription | Source: apple.com

Spotify Premium – $9.99 / month

Spotify Subscription | Source: spotify.com/us/premium

YouTube Music – $9.99/month

Youtube Music Subscription | Source: youtube.com/musicpremium

Pandora Plus – $4.99/month & Premium – $9.99/month

Pandora Subscription | Source: pandora.com

Apple TV & Streaming Channel

Apple has long reported to be interested in contents distribution especially video. And rumors about an acquisition of Netflix didn’t come from nowhere.

A New York Times report back in March 2018.

A CNBC report in October 2018 – Apple plans to give away original content for free to device owners as part of new digital TV strategy.

Apple has cash and ability for original contents (and can acquire/build a studio). Apple has educated customer base (thanks for Netflix). Apple has introduced Clip for iOS short videos (think about Snapchat and Douyin, plus its ability in music and messaging). Apple has AppleTV and AirPlay.

Apple TV App | Source: apple.com

There are just too many things to do in this space, broadly speaking.

And the competition is fierce. Netflix, Amazon Prime Video, Youtube TV, Facebook/Instagram TV, Disney/Hulu, AT&T/HBO…

And the AR/VR future…

Let’s see.

Gaming

It might be something new. But Apple could introduce a monthly plan to play most iOS games freely (with some exceptions maybe). Just like what Tencent did with WeChat Read – subscriptions that can read all books on its app.

Let’s see what Steam will do… Steam has subscription-based products, although not a bundle.


A master bundle plan for Apple users in the future? Possible.

 

Novel FDA Approvals

Since the new FDA Commissioner Dr. Scott Gottlieb was sworn in on May 11, 2017, the traditionally cumbersome regulatory body has shown an unprecedented embracement for novelty in treatments and beyond.

Overarching guidelines:

Here is a roundup of those approvals

Novartis, Kymriah, first gene (transfer) therapy (first CAR-T) available in the United States

  • August 30, 2017
  • Biologics License Application (BLA) submitted on February 2, 2017
  • Approval basis: the safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent. (FDA statement)

Pear Therapeutics, the Reset app, first mobile application to treat substance use disorders (SUD)

  • September 14, 2017
  • de novo premarket review pathway
  • Technology: the device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.
  • Approval basis: a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of Reset which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used Reset, 40.3 percent, compared to the patients who did not, 17.6 percent. The clinical trial did not demonstrate the effectiveness of using the Reset device in patients reporting opioids as their substance of abuse. (FDA statement)
reSET app | Source: New York Times

Memorial Sloan Kettering Cancer Center,  IMPACT test, first tumor-profiling laboratory-developed test to receive authorization through the FDA

  • November 15, 2017
  • de novo premarket review pathway
  • Technology: the IMPACT test uses next-generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.
  • Approval basis: results indicated that the assay is highly accurate (greater than 99 percent) and capable of detecting a mutation at a frequency of approximately 5 percent (range of 2-5 percent). Additionally, detection of certain molecular changes (microsatellite instability) using the IMPACT test was concordant more than 92 percent of the time across multiple cancer types in 175 cases, when compared to traditional methods of detection.
  • Along with this authorization, the FDA is also establishing a Class II regulatory pathway for the review of other NGS-based tumor profiling tests for use in patients diagnosed with cancer. Class II designation allows these types of tests to be eligible to use the FDA’s 510(k) clearance process, either by submitting the application. (FDA statements)
Source: mskcc.org

Proteus Digital Health x Otsuka Pharma, Abilify MyCite, first drug in the U.S. with a digital ingestion tracking system

  • November 13, 2017
  • New Drug Application (NDA) dated and received June 26, 2015
  • Technology: the system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
  • Approval basis: Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. (FDA statement)
Source: npr.org

Spark Therapeutics, Luxturna, first (directly administered) gene therapy approved in the U.S. to target a disease caused by mutations in a specific gene

  • December 19, 2017
  • Biologics License Application (BLA) dated April 26, 2017, and received May 16, 2017
  • Approval basis: The efficacy of LUXTURNA in the Phase 3 study was established based on the multi-luminance mobility test (MLMT) score change from baseline to one year. LUXTURNA Phase 3 clinical study results showed a statistically significant difference between the intervention group (n=21) and control participants (n=10) at one year in median bilateral MLMT score change (intervention minus control group difference of 2; p=0.001) and median first-treated eye MLMT score change (intervention minus control group difference of 2; p=0.003). (Spark press release)
  • FDA statement
Luxturna | Source: Spark Therapeutics

Loxo Oncology, Vitrakvi, first time that an entirely new treatment has received a tumor-agnostic indication at its initial approval

Source: genengnews.com

Apple, the ECG app (with Apple Watch), first FDA clearance for retail ECG watch technology

  • September 11, 2018
  • De Novo clearance from the Center for Devices and Radiological Health, classified as Class II under the generic name electrocardiograph software for over-the-counter use
  • Technology: the ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform
  • FDA statement
  • FDA letter to Apple
  • covered in a previous blog: New Era of Medical Grade Consumer Device
Apple Watch Series 4, the ECG app | Source: Apple
  • January 17, 2019 update: Alphabet’s life sciences unit Verily received 510(k) clearance from FDA as a Class II medical device for its on-demand ECG feature
Study Watch | Source: Verily