Steve Thomas - IT Consultant

Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective. This is a better efficacy rate than Pfizer reported previously, when it announced a 90% effectiveness metric based on preliminary analysis of the Phase 3 trial data.

This result also follows a preliminary data report from Moderna about their own Phase 3 trial of their vaccine candidate, which they reported showed 94.5% effectiveness. Pfizer and partner BioNTech’s vaccine is an mRNA-based preventative treatment, similar to the Moderna one, and now it looks like they should be roughly similar in efficacy – at least in the early offing, based on a limited sample of total cases and prior to peer review by the scientific community, which is yet to come.

The Pfizer data in its final analysis shows that among a total of 170 confirmed COVID-19 cases so far among the 44,000 people who took part in the study, 162 cases came from the placebo group while only eight were from the group of those who received the actual vaccine candidate. The company also reported that 9 out of 10 of the severe cases among those who were infected occurred in the placebo group, suggesting that even in the rare occasion that the vaccine didn’t prevent contraction of COVID-19, it helped reduce its severity.

This should help Pfizer make its case that it be granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to be able to provide the vaccine early pending full and final approval as an emergency measure. Earlier this week, the company reported that it has already collected two months’ worth of follow-up data about participants in its trial, which is a required component for said approval, and it’s pursuing it with hopes of seeking that EUA “within days.” The company intends to ramp production of its vaccine beginning later this year, and achieving a run rate of up to 1.3 billion doses by next year.

Levels today is announcing a large seed round to help bring its biowearable metabolic sensor to market. The innovative platform pairs continuous glucose monitoring (CGM) with an impressive software suite to provide the wearer with deep insights about their health. The company’s founders strongly feel that this approach helps users close the loop between food, exercise and well-being.

Levels provides actionable health information by constantly monitoring the wearer’s blood sugar using proven technology. This isn’t a wearable worn around the wrist; Levels uses medical hardware that’s attached to the wearer’s arm for two weeks. It sounds scarier than it is. I have one on right now, and it’s painless.

The $12 million seed round was led by Andreessen Horowitz with other notable investors participating, including Marc Randolph (co-founder and first CEO of Netflix), Dick Costolo (former CEO of Twitter), Michael Arrington (founder of TechCrunch), and Matt Dellavedova (NBA, Cleveland Cavaliers).

Levels says there are 45,000 people on its waitlist, and with this funding, the company expects to fulfill all pre-orders and millions more. The company expects customers will be able to purchase Levels starting in early 2021.

“Levels is ultimately a behavior change mechanism,” CEO and co-founder Josh Clemente said. “We will continue to establish product development milestones that are focused on achieving that end state before we fully launch. This funding will allow us to grow the team and perform the research necessary to understand specifically which mechanisms to focus on and translate those into the product. Once we reach that degree of efficacy, we’ll launch.”

The founders of Level are passionate about this cause. Over several phone calls with TechCrunch, Levels’ founders Josh Clemente and Dr. Casey Means explained the company’s targets.

“Optimizing metabolic function can improve energy, endurance, memory, mood, and cognitive performance. Seven of the ten leading causes of death in the US are strongly related to metabolic dysfunction,” said Dr. Casey Means, Co-founder of Levels. “Levels helps you improve metabolic fitness by alerting you to foods that negatively impact glucose levels. Armed with this information, you can take control of your metabolic health and make healthier lifestyle decisions.”

Image Credits: Levels

Targeting the population that’s most underserved with new treatment options has been part of the mission fro Twentyeight Health since its launch. Now a new partnership with the venture-backed startup, Healthify, means that the company will be able to expand its reach. 

Healthify works with managed care organizations and case workers to integrate social determinants of health into the healthcare system.

Social factors have a significant role to play in patient outcomes, according to new research, and both Twentyeight Health and Healthify are trying to do their part to ensure that access to care becomes less of an issue.

Twentyeight Health sells and delivers birth control pills, patches, rings, shots and emergency contraception prescriptions at a low-cost — or covered by insurance including Medicaid.

Through the Healthify integration, the company will be able to offer its services through health plans and providers that use Healthify to determine social factors that may influence treatment, the companies said.

“This partnership comes at a time when many women in vulnerable communities are in need of prescription delivery or virtual healthcare services due to COVID-19,” said Amy Fan, Co-Founder of Twentyeight Health. “By working with Healthify, we can strengthen our efforts to ensure that all women who want birth control are able to access it.”

Since its launch two years ago, Twentyeight Health is now operating in six states including Florida, Maryland, New Jersey, New York, North Carolina and Pennsylvania.

“Together, we can expand Twentyeight Health’s impact by offering their services to help individuals receive the low- or no- cost birth control that is right for them,” said Manik Bhat, Founder and Chief Executive Officer of Healthify.

To date, Healthify has raised $25.5 million from investors including Primary Venture Partners and BlueCross Blue Shield Venture Partners. Twentyeight Health recently announced a $5 million early stage round of funding and is backed by investors including Third Prime and Town Hall Ventures.

Activity and fitness tracking platform Strava has raised $110 million in new funding, in a Series F round led by TCV and Sequoia, and including participation by Dragoneer group, Madrone Capital Partners, Jackson Square Ventures and Go4it Capital. The funding will be used to propel the development of new features, and expand the company’s reach to cover even more users.

Already in 2020, Strava has seen significant growth. The company claims that it has added over 2 million new “athletes” (how Strava refers to its users) per month in 2020. The company positions its activity tracking as focused on the community and networking aspects of the app and service, with features like virtual competitions and community goal-setting as representative of that approach.

Strava has 70 million members already according to the company, with presence in 195 countries globally. The company debuted a new Strava Metro service earlier this year, leveraging the data it collects from its users in an aggregated and anonymized way to provide city planners and transportation managers with valuable data about how people get around their cities and communities – all free for these governments and public agencies to use, once they’re approved for access by Strava.

The company’s uptick in new user adds in 2020 is likely due at least in part to COVID-19, which saw a general increase in the number of people pursuing outdoor activities including cycling and running, particularly at the beginning of of the pandemic when more aggressive lockdown measures were being put in place. As we see a likely return of many of those more aggressive measures due to surges in positive cases globally, gym closures could provoke even more interest in outdoor activity – though winter’s effect on that appetite among users in colder climates will be interesting to watch.

Strava’s app is available free on iOS and Android, with in-app purchases available for premium subscription features.

Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. The biotech company says that its COVID-19 vaccine candidate has shown efficacy of 94.5% in its first interim data analysis, which covers 95 confirmed COVID cases among its study participants, of which 90 were given the placebo, and only 5 received Moderna’s mRNA-based vaccine. Further, of 11 severe cases of COVID-19, none were found among those who received the actual vaccine candidate.

This is another very promising sign for the potential of having effective vaccines available to the public in some kind of significant volume at some point next year. As mentioned, it’s worth pointing out that this is just a first interim report, but it is data that comes from the safety board overseeing the trial appointed by the National Institutes of Health, which is an independent body not affiliated with Moderna, so it’s a reliable result that provides hope for continued and final analysis.

Moderna says that it will be submitting for an Emergency Use Authorization of its vaccine candidate based on the results within the coming weeks, looking to get approval from the FDA to use it in emergency circumstances ahead of a full and final approval. That EUA, should it be granted, will be based on data from 151 confirmed cases among the Phase 3 participant group (which included 30,000 participants in total), and data from follow-ups extending on average over two months after case confirmation.

All final data will also be submitted to the scientific community for independent peer review, which is a standard part of the ultimate vaccine trial and approval process.

Both these and Pfizer’s vaccine candidate, which it developed in partnership with BioNTech, are mRNA-based vaccines. These are relatively new in terms of human use, and differ from traditional vaccines in that they use messenger RNA to instruct a recipient’s cells to generate effective antibodies, without actually exposing them to any virus, whereas more traditional vaccines in general use typically use either small, safe doses of active or inactive virus in order to trigger a patient’s immune system to generate their own antibodies.

Carbon Health has raised a $100 million Series C funding round, led by Dragoneer Investment Group and including participation from prior investors Brookfield Technology Partners, DCVC and Builders VC. This funding will be used to help the SF-based healthcare provider startup to continue to expand its nationwide footprint, including with the opening of 100 pop-up clinics planned for across 20 markets across the U.S.

This past year has seen Carbon Health expand from just seven clinics to 27, spread out across six different states. The company, which focuses on primary care, has also introduced virtual care options with an emphasis on what it calls “omnichannel” care, or offering services in whatever method is most convenient, effective and appropriate for its customers. The startup has always aimed at a hybrid care approach, but it’s emphasizing the flexibility of its model in response to COVID-19, and has in particular accelerated its plans around its pop-up clinics.

These are deployed in under-utilized spaces in regions where additional care options are needed, including parking lots and garages. Carbon Health partnered early with Reef Technology on opening these locations, using shipping-container style mobile trailers to provide on-site care. Carbon Health founder and CEO Eren Bali explained to me that while remote care can be very effective, in some instances, it requires some nurse practitioner support with virtual physician-guided services to provide a complete solution for customers.

The company is also looking to support greater testing capacity using this model, and eventually looking ahead to providing an infrastructure that can help with widespread COVID-19 vaccine distribution, once one is ready to go. While some scientific results this week have been very promising, including with Pfizer’s Phase 3 clinical trial, ultimately the effort of undertaking a national vaccine inoculation program will require cooperation among many stakeholders, including primary care providers.

The COVID-19 vaccine being developed by Pfizer and its partner BioNTech has shown to be effective blocking vaccine in 90 percent of participants in its Phase 3 clinical trial, the companies announced on Monday. That’s based on data analyzed by an external, independent committee assigned to check the results of the trial, and reflects only early results from the trial, and not the final verified result, but it’s still extremely promising news for progress towards a viable and more broadly available vaccine.

Pfizer and BioNTech’s vaccine candidate is an mRNA-based vaccine, which is a newer technology that many companies pursued for COVID-19 in part because it offers some advantages in pace of development and potential efficacy. These results from the test were based on an equable case total of 94 confirmed COVID-19 cases among study participants – passing the minimum threshold agreed to by the companies and the FDA of 62 confirmed cases for a proper, scientifically rigorous assessment.

The Phase 3 trial conducted by the companies included 43,358 participants, and Pfizer reports “no serious safety concerns have been observed” thus far in addition to the positive prevention rate. Based on this early data, individuals who receive the vaccine are protected at 28 days after first dose, and the vaccine uses a two-dose process.

There is still additional safety testing and continued studies to conduct, with the companies estimating that two full months of safety data (which is what the FDA requires for Emergency Use Authorization) will be available in the third week of this month. Participants will also be monitored for two full years after they receive their second and final dose in order to test for long-term effects. Pfizer still thinks that it can produce up to 50 million doses of its vaccine by the end of this year, and as many as 1.3 billion doses through 2021.

Full data from this trial still need to undergo peer-review by other researchers and scientific publications, but this is definitely the most promising and clearly positive news yet from the vaccine development front, and could mean that large-scale distribution of a vaccine begins even before the end of 2020 if all goes well.

UK-based Fertifa has bagged a £1 million (~$1.3M) seed to plug into a fertility-focused workplace benefits platform. Passion Capital is investing in the round, along with some unnamed strategic angel investors.

The August 2019-founded startup sells bespoke reproductive health and fertility packages to UK employers to offer as workplace benefits to their staff — drawing on the use of technologies like telehealth to expand access to fertility support and cater to rising demand for reproductive health services.

Challenges conceiving can affect around one in seven couples, per the UK’s National Health Service (NHS).

In recent years fertility startups have been getting more investor attention as VC firms cotton on to growing market. Employers have also responded, with tech industry workplaces among those offering fertility ‘perks’ to staff. Although the access-to-services issue can be more acute in the US — given substantial costs involved in obtaining treatments like IVF.

In the UK the picture is a little different, given that the country’s taxpayer funded NHS does fund some fertility treatments — meaning IVF can be free for couples to access. Although how much support couples get can depend on where in the country they live, with some NHS trusts funding more rounds of IVF than others. There can also be access restrictions based on factors such as a woman’s age and the length of time trying to conceive.

This means UK couples can run out of free fertility support before they’ve been able to conceive — pushing them towards paying for private treatment. Hence Fertifa spotting an opportunity for a workplace benefits model around reproductive health services.

It signed up its first employers this spring and summer, and says it now has a portfolio of corporate clients with an employee pool from a few hundreds to >10,000 — although it isn’t breaking out customer numbers. Rather it says its services are available to around 700,000 UK employees at this point.

“At Fertifa we want to make fertility services more widely accessible to people,” says founder and CEO Tony Chen. “Some levels of fertility services can be provided by the NHS but every single NHS trust is different with eligibility, requirements and resources, and so unfortunately it can too often be reduced to a ‘postcode lottery’.

“We believe that everyone should have easy access to information, resources, education and services relating to fertility — and that working with workplaces is one way to start. With our efforts and partnerships we hope to normalise the conversations about fertility at work, just as other forms of health are openly discussed and provided for.”

Passion Capital partner Eileen Burbidge — who is joining Fertifa’s board (along with Passion’s Malin Posern) — has been public about her own use of IVF and takes a very personal interest in the fertility space.

“The unfortunate fact that over recent years, even though success rates have increased and of course more and more patients are exploring the benefits of IVF, NHS funding has been declining and the number of patients using the NHS for their first cycle has also been decreasing,” she tells TechCrunch.

“This doesn’t take away from the fact that it’s brilliant what we get from the NHS here in the UK, but there’s clearly a lot more which can be done to further increase accessibility and affordability — given less and less funding for the NHS in the face of increasing demand of both the NHS and private routes.”

Fertifa says its model is to provide direct care and support to employees — rather than being a broker or acting as part of a referral system. So it has two in-house clinicians at this stage (out of a team of 10-15 people). Although it also says it “partners” with clinicians and clinics across the UK. So it’s not doing everything in-house.

It offers what it bills as a “full range” of fertility and gynaecology services — from assisted reproductive technology such as IVF, IUI and more; fertility planning such as egg, sperm and embryo freezing to donor-assisted and third-party reproduction such as donor eggs and sperm; as well as surrogacy and adoption.

Its doctors, nurses and “fertility advocates” are there to provide a one-to-one care service to support patients throughout the process.

“We use technology in a number of ways and are ambitious about how it will help us to maintain an advantage over others in the sector and provide the best customer experience,” says Chen, noting it’s developed “a full end-to-end” app for patients to guide them through the various stages of their fertility journey.

“On the employer side we have a full employer portal as well which provides educational resources, support options and access to services for HR/People teams to use and share with their workforces. Additionally, we use telehealth to enable more efficient, convenient (particularly in the age of COVID-19 restrictions) and immediate consultations with clinicians and nurses. Finally, we are refining our machine learning algorithms to help drive more informed decision making for patients and clinicians alike.”

It’s not currently applying AI but says that over time its in-house medical experts will use artificial intelligence to aid decision-making — with the aim of reducing clinic visits, enhancing the patient experience and yielding better clinical pregnancy rates.

Chen points to the UK’s Human Fertilisation and Embryology Authority having already made its data publicly available on more than 100,000 couples and their treatment and outcomes — suggesting such data-sets will underpin the development of new predictive models for fertility.

“With additional insight and data sources could more accurately predict probability of success for a patient — or the best type of treatment for them,” he adds.

While Fertifa’s current focus is UK expansion — targeting workplaces of all sizes and scale — it’s also got its eye on scaling overseas down the line. Although it will of course face more competition at that point, with the likes of Y Combinator backed Carrot already offering global fertility benefits packages for employers.

“Fertility and reproductive health is important to people all over the world,” says Chen. “Globally one in four women experience a miscarriage, every LGBT+ individual requires support to become a parent, and everyone needs to be increasingly empowered to take control of their reproductive health through fertility preservation treatment.”

Here’s an example of ad targeting that’s actually good for public health: In a campaign encouraging people to wear masks, the Illinois state government has been focusing its digital ad dollars on the counties with highest COVID risk.

To achieve this, the government’s been working with Civis Analytics, the data science company founded by Dan Wagner, who was previously chief analytics officer for Barack Obama’s 2012 reelection campaign. The campaign kicked off in August, but the state is now sharing more details about its work, including a map that shows the week-by-week risk assessment that it used for targeting.

Crystal Son, Civis’ director of healthcare analytics, explained that every week, her team pulls together the latest county-level COVID data for Governor J.B. Pritzker’s team, who then use that data to determine where ad dollars for the It Only Works If You Wear It ad campaign should be spent.

Cameron Mock, chief of staff at the Governor’s Office of Management and Budget, said in a statement that the government is using “a one-of-a-kind formula to concentrate media dollars in the areas with the most risk.”

Mock continued, “The risk-based formula uses trends of cases and mobility on the county level to designate higher, medium and lower risk counties. It then uses a pro rata share to dedicate the most dollars to the highest risk areas.”

All In Illinois

Image Credits: State of Illinois

This formula divides counties into five tiers, with Tier 1 being the highest risk and Tier 5 being the lowest. Tiers 4 and 5 will still receive a baseline level of ad spend, but Tier 3 counties will see more spending and Tiers 1 and 2 receive the maximum amount.

While the mask campaign isn’t limited to online advertising, the formula is only being used on the digital side because it’s more difficult to adjust funding for more traditional ad channels on a week-by-week basis.

“Each county has unique and changing circumstances due to the virus, so we designed this campaign to respond to the on-the-ground situation in all 102 counties in Illinois,” said Alex Hann, deputy press secretary to Governor Pritzker, in a statement. “As an area’s risk increases, so too will its concentration of public health messaging. As the pandemic continues and another wave of coronavirus looms, the state of Illinois will continue to listen to scientists and follow the data to keep our residents safe.”

Son said she’s not aware of any other campaign responding to COVID-19 that uses a similar model to prioritize spending in the highest-risk geographies. Is it working? While this data doesn’t show the effects of a specific campaign, according to Carnegie Mellon University, 89% of Illinois residents wear masks — currently the 15th-highest usage rate in the U.S.

In the future, Son said she’s hopeful that we’ll see other organizations adopt “a much more customized communications approach” for healthcare.

“We still have the habit in healthcare of treating groups of people as if they are homogenous, as if they all act the same think the same,” she said. “There are widespread applications beyond mask-wearing for more tailored approaches.”

Global fitness giant Under Armour announced this morning that it will be selling MyFitnessPal to investment firm Francisco Partners for $345 million, five and a half years after acquiring it for $475 million. The company also announced that it will be winding down the Endomondo platform which it also acquired at the same time for $85 million.

In a press release announcing the news, Under Armour said the reason for this decision was to simplify and focus its brand, keeping it aimed at its “target consumer – the Focused Performer” in the interest of building “a singular, cohesive UA ecosystem.” The fact that Under Armour is selling MyFitnessPal at a discount (not even including five years of inflation and stated MyFitnessPal user growth) indicates there’s more to this than just maintaining focus.

It’s definitely true that both MyFitnessPal (which claimed 80 million users in 2015 at time of acquisition, and has over 200 million users according to today’s press release) and Endomondo were aimed at more casual and entry-level fitness users, who might be working out for the first time, or looking to improve their daily health, but aren’t likely training for endurance sport competitions. Under Armour’s overall brand image is more associated with professional athletics, and with an enthusiast/semi-pro clientele (or those aspiring to that designation).

What’s more likely going on here is that Under Armour sees diminishing value in this segment over the long term, and there a number of possible reasons about why that might be. One is that Apple has been more aggressive about targeting entry-level fitness users, through both its expanded Apple Watch hardware and Apple Health software offerings, and through its forthcoming Apple Fitness+ service, which launches later this year.

While you’d expect the self-guided fitness segment to be a significant growth opportunity in light of the ongoing pandemic and restrictions on shared workout spots including gyms, Apple’s aggressive moves provide a fairly comprehensive default that users essentially get for free, or for a very low cost subscription, with the hardware they’re buying anyways. And the growth of Peloton, through both its dedicated home workout gear and its subscription platform, is also likely sucking up a lot of oxygen in the beginner to casual/habitual fitness user category.

Under Armour did note that it’s going to continue to own and operate the MapMyFitness platform, which includes MapMyRun and MapMyRide. It acquired that company in 2013, and the Under Armour line of connected footwear integrates with those apps for connected tracking of workouts.

Nutrium, a digital health startup which links dietitians and their patients via an app, has raised a €4.25 million Seed round led by Indico Capital Partners, alongside the the Social Innovation Fund in Portugal (SIF) and previous investors. It now offers professional nutrition software to 80,000 nutrition professionals and 800,000 patients in more than 40 countries.

With this investment round, Nutrium plans to double the team size in the next 24 months in order to focus on platform development and expand global sales in markets like Spain, France, Italy, USA and the UK where the company already has a strong customer base.

With the Nutrium platform, patients get integrated nutrition counseling which combines professional advice, continuous monitoring and access to commercial products.

André Santos, CEO and Co-founder of Nutrium commented: “We are moving closer to our vision of enabling the improvement of eating habits for millions of people globally.”

Stephan Morais, managing general partner at Indico said: “Nutrium will become a full-fledged platform bringing together nutritionists, patients, products and wellness data that will enable healthier and happier lives. We are pleased to back this jointly developed vision with capital and knowledge.“

Rui Ferreira, Vice President at Portugal Ventures said: “In 2017, when Portugal Ventures invested in Nutrium’s pre-seed round, the company was mainly present in two markets. Today, Nutrium operates in more than 40 markets, having increased its turnover exponentially.”

Nutrium’s competitors include NutriAdmin, AppointmentPlus, Evolution Nutrition which has raised $2.3M.

CoreCare, a provider of revenue management services for healthcare companies dealing with public health benefit providers, has raised $3 million in a seed financing round.

The company, which uses machine learning, automates large swaths of billing and revenue cycle management to reduce the burden on hospitals, according to chief executive, Dennis Antonelos.

Already, companies like Creative Solutions in Healthcare, a nursing facility operator in Texas, which operates nearly 80 locations has signed up for the service.

Antonelos started the company in January, had the first product up by March and was accepted to Y Combinator in April. It now boasts over a dozen customers in Texas.

With the new $3 million in hand from investors including Primetime Partners, Goat Capital, Funders Club and Liquid2Ventures, Antonelos said the company would look to expand its sales and marketing and product capabilities.

CoreCare automates processing of billing and paperwork and clinical notes by linking electronic health records and medicare and medicaid information services and payers.

“We’re going through the organization and eliminating administrative waste so the organization can invest newly found resources into patient care,” Antonelos said.

The company uses a standard software as a service payment model and charges somewhere between $300 to $500 per-facility, per-month, according to Antonelos.

“These initial results are outstanding,” said Gary Blake, president, and co-founder of Creative Solutions in Healthcare, and one of CoreCare’s early customers. “In only a matter of months working with CoreCare’s CoreAccess software, we’ve seen a notable impact on our financial position. It has truly exceeded our expectations. CoreCare has changed the way we work with Managed Care, from top to bottom. We have been able to streamline our entire billing process, reduce admin costs, shorten the number of accounts receivable (AR) days and free up cash for growth. Every healthcare provider that works with managed care should work with CoreCare.”