Abu Dhabi Restricts Many Public Areas to Those Free of COVID

 Abu Dhabi, the second-most populous emirate in the UAE, will restrict access to shopping malls, restaurants, cafes and other public places from June 15 to those who have been vaccinated against COVID-19 or recently tested negative.

The new rules were announced late on Wednesday as the United Arab Emirates, a federation of seven emirates, has seen daily cases rise over the past three weeks. The UAE, which does not give a breakdown for each emirate, recorded 2,179 new infections on Wednesday, up from 1,229 on May 17.

The restrictions will also apply to gyms, hotels and their facilities, public parks, beaches, swimming pools, entertainment centres, cinemas, and museums, Abu Dhabi's media office said.

Visitors will have to prove they have been vaccinated or have recently tested negative through the country's COVID-19 app, which displays an individual's vaccination and testing history.

The mobile app will show green if the person has been vaccinated or has tested negative.

Individuals who have not been vaccinated will need to be tested every three days to maintain their green status. A fully vaccinated person would do so every 30 days.

The UAE announced last month that from June 6, attendance at live events and social activities, including weddings and bars, would be limited to those who could prove they had been vaccinated.

The UAE has one of world's highest inoculation rates with the AstraZeneca, Pfizer/BioNTech, Sinopharm and Sputnik V vaccines available to citizens and residents.

In Abu Dhabi, those immunised with the Chinese-made Sinopharm shot are also able to take a dose of Pfizer/BioNTech as a booster.

https://www.usnews.com/news/world/articles/2021-06-10/abu-dhabi-restricts-many-public-areas-to-those-free-of-covid

Two FDA Panel Members Resign Over Alzheimer's Drug Approval

 Two members of the US Food and Drug Administration's (FDA's) Peripheral and Central Nervous System Drugs Advisory Committee have resigned following the agency's approval of the controversial Alzheimer's drug aducanumab (Aduhelm, Biogen/Eisai), against the committee's recommendation.

One of the advisory panel members is David Knopman, MD, a clinical neurologist from the Mayo Clinic in Rochester, Minnesota, who was excluded from participating on the committee for the aducanumab meeting because of his involvement in clinical trials of the drug, and who is a known critic of aducanumab.

"I have been previously honored to serve on the committee as I believed the FDA Advisory committees provided valuable input to the FDA and to the public, Knopman told Medscape Medical News.

"I understand that the advisory committees are just that — advisory — but, the whole saga of the approval of aducanumab, from the biased questions posed to the committee on Nov 6, 2020 at the public hearing to the announcement of the accelerated approval 2 days ago, was deeply disrespectful to the committee members and denigrated their role.

https://www.medscape.com/viewarticle/952802

LifeStance Health Group Prices IPO

 LifeStance Health Group, Inc. ("LifeStance Health" or the "Company"), one of the nation's largest providers of outpatient mental health care, today announced the pricing of its initial public offering of 40,000,000 shares of its common stock at a public offering price of $18.00 per share. Of the offered shares, 32,800,000 shares are being offered by the Company and 7,200,000 shares are being offered by selling stockholders. The underwriters have a 30-day option to purchase up to an additional 6,000,000 shares of common stock from the selling stockholders at the initial public offering price less underwriting discounts and commissions.

LifeStance Health's common stock is expected to begin trading on the Nasdaq Global Select Market on June 10, 2021, under the ticker symbol "LFST." The offering is expected to close on June 14, 2021, subject to customary closing conditions.

The Company intends to use net proceeds that it receives from the offering to repay amounts outstanding under its existing indebtedness and for general corporate purposes, including working capital, operating expenses and capital expenditures. The Company will not receive any proceeds from the sale of shares of common stock by the selling stockholders.

Morgan Stanley, Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies are acting as lead book-runners for the offering. TPG Capital BD, LLC, UBS Investment Bank and William Blair are also acting as joint book-runners for the offering and Capital One Securities, AmeriVet Securities, Drexel Hamilton, R. Seelaus & Co., LLC and Siebert Williams Shank are acting as co-managers for the offering.

https://www.prnewswire.com/news-releases/lifestance-health-group-inc-announces-pricing-of-initial-public-offering-301309600.html

FDA clears CyMedica's app-connected muscle stimulation system to treat osteoarthritic knee pain

 Though osteoarthritis of the knee is estimated to affect at least 14 million people in the U.S. alone, treatments for the degenerative joint disease remain woefully limited

Under the watchful eye of regulators, the CMC team, medical affairs specialists, and ongoing gap analyses keep businesses in a constant state of refinement — driving better purity, yield, and scale-up 

The most popular options are either invasive procedures—regular cortisone or hyaluronic acid injections, bone realignments and joint replacements—or medications ranging from over-the-counter pain relievers to potentially addictive opioids.

Those looking for a non-invasive, drug-free way to relieve their joint pain are finally in luck, however, now that the FDA has given the go-ahead to CyMedica Orthopedics’ muscle-stimulating system for treating symptomatic knee osteoarthritis.

CyMedica’s IntelliHab system relies on neuromuscular electrical stimulation therapy. This form of therapy sends electrical pulses directly to motor nerves in the quadriceps muscle, causing the muscle to contract in the same way it does during squats and other exercises. Those contractions strengthen the muscle, resulting in reduced pressure on the knee and, therefore, less pain.

The CyMedica system sends the pulses through a knee brace that connects wirelessly to the IntelliHab app. In the app, patients can manage and control their own stimulation therapy, while their clinicians can monitor their usage and progress in real-time through a linked portal.

A clinical study of the IntelliHab system found that, after using the app-connected brace for regular neuromuscular electrical stimulation, participants reported significant drops in their knee pain levels and improvements in mobility.

The FDA green light came shortly after the completion of the study and was largely driven by its positive results, the company said. CyMedica will make the IntelliHab system commercially available as a treatment for osteoarthritis of the knee this fall.

“With the regulatory clearance of IntelliHab, we can provide a bridge between conservative management to more invasive treatment options, allowing patients to treat their pain comfortably at home while reducing opioid exposure,” said Rob Morocco, CyMedica’s president and CEO.

CyMedica previously received another 510(k) clearance from the FDA in 2017. That regulatory OK was issued to a similar system called e-vive, which is used in strengthening the quad muscle both before and after knee surgeries for ACL and total knee replacement patients.

CyMedica is in good company in its quest to make noninvasive, opioid-free pain therapy the norm. Just last month, for example, Medtronic unveiled a mobile app and online portal giving patients more control over their spinal cord stimulation regimens for chronic back pain.

And last fall, Abbott began rolling out its own radiofrequency ablation system in the U.S. That nonsurgical device uses heat energy to target and burn out specific nerves, stopping pain signals from reaching the brain.

https://www.fiercebiotech.com/medtech/fda-clears-cymedica-s-app-connected-muscle-stimulation-system-to-treat-osteoarthritic-knee

Prime Day deal? Amazon lands FDA go-ahead to sell COVID-19 tests directly to consumers

 Just in time for its annual online sale event, Amazon has gotten the green light from the FDA to begin hawking its own COVID-19 test directly to consumers—potentially setting up the most coveted Prime Day deal of all.

The FDA’s emergency use authorization allows the retail giant’s subsidiary STS Lab Holdco to sell its Amazon Real-Time RT-PCR test kits to anyone 18 years or older without requiring buyers to obtain a prescription or show proof of any COVID symptoms or recent contact with the virus.

The EUA also allows for pooled testing, in which up to five individual samples may be combined and tested at the same time, exponentially increasing the reach of Amazon’s lab resources.

After each nasal swab kit is sent to one of Amazon’s processing labs using the included prepaid shipping label, users will receive notifications via text message and email once their test results are ready. The results can then be accessed through an online portal located at AmazonDx.com, according to FDA documents, though that site is still currently being used only for Amazon’s employee testing efforts.

STS Lab Holdco’s employee testing initiative received an EUA of its own earlier this year. In March, the FDA cleared the Amazon Real-Time RT-PCR kit for use in screening employees at regular intervals.

With that clearance, Amazon was given the go-ahead to automatically assign biweekly testing appointments to workers in its offices, warehouses and fulfillment centers who participated in the initiative. As with the DTC clearance, the employee-focused EUA allowed for pooled testing of up to five nasal swab samples at once.

The test kit was initially only approved for prescription use—with Amazon contracting a healthcare provider to sign off on a standing-order prescription—and could be administered either on one’s own at home or while being supervised virtually by a telehealth provider.

Through that program, as soon as an employee received a positive test result, they would receive a message urging them to either leave their job site immediately or stay home and prompting them to contact their healthcare provider.

Both versions of the COVID test kit are the product of groundwork Amazon began laying in the earliest days of the pandemic. In March 2020, the company directed a group of its research scientists, software engineers and program managers to begin developing an in-house testing initiative.

Since then, Amazon has opened labs in Kentucky and the U.K., with a recent BBC report noting the U.K. lab had processed at least 900,000 test samples as of early June.

And while demand for COVID-19 tests is rapidly drying up, Amazon’s healthcare aspirations are only growing bigger. Sources close to the company have previously revealed that the same scientists who led the in-house testing efforts may be tapped to develop even more diagnostic offerings, including tests for respiratory illnesses and sexually transmitted infections as well as clinical genomic assays.

That growth would build on Amazon’s many other forays into healthcare. Last August, for example, it launched the Halo smartwatch. The wearable is designed to be worn around the clock and tracks not only a wearer’s daily physical activity and vital signs but also changes in their emotions and energy levels, thanks to machine-learning-powered voice analysis.

Additionally, this summer, echoing its COVID test’s evolution from an employee benefit to a nationwide moneymaker, the company will expand its Amazon Care telehealth service to employers across the U.S.

Ultimately, all of these disparate projects could one day coalesce to form an end-to-end healthcare service.

“The Halo device can monitor the vitals of someone with a chronic disease, Alexa can then remind them that it’s time to make an appointment. They can do a virtual visit and also get a test kit in the mail for lab testing,” Michael Abrams, a managing partner at consulting firm Numerof & Associates, previously told Fierce Healthcare.

Abrams added, “They are taking steps that are synergistic. Amazon Care is synergistic with Amazon Pharmacy, and both of them would be synergistic with a diagnostics line of business as well.”

https://www.fiercebiotech.com/medtech/prime-day-deal-amazon-lands-fda-go-ahead-to-sell-covid-19-tests-directly-to-consumers

Funding Surges For Startups Serving Older Adults

 Over the past 100 years, the average human lifespan has roughly doubled. And as life expectancy rises, the senior population is growing, too. By 2050, well over a fifth of Americans are expected to be 65 and over. An American born today, meanwhile, can expect to live to nearly 80.

In short, we’re getting older. And startups and venture investors — ever cognizant of growth markets — are scaling up efforts to serve our fast-growing aging population.

So far this year, VCs have poured over half a billion dollars into U.S. startups focused on eldercare and home health care, Crunchbase data shows. Funded companies include Papa, a platform connecting older adults with people to provide companionship and assistance; Ruby, a startup that helps seniors make safety upgrades to their homes; and Harmonize, a remote care platform focused on people with serious conditions.

The funding comes as seniors are increasingly opting to stay put, with survey data showing that three-fourths of older adults prefer to continue living in their homes as long as possible. The space got a further boost in 2020 as the pandemic fueled demand for at-home and remotely delivered health care.

“There are so many tailwinds coming out of this pandemic,” said Helen Adeosun, founder and CEO of Cambridge, Massachusetts-based CareAcademy, a venture-backed startup that provides training for home health providers. “One is that we as a country have discovered that a lot of things can be done at home, including health care.”

Certainly startup investors have discovered this. In the last five calendar years, venture backers have invested more than $2.5 billion into eldercare and home health startups. Though not all home health care startups are specifically focused on seniors, they are power users on most platforms, accounting for an outsized share of overall health spending.

Using Crunchbase data, we break down the numbers in the chart below:

Eldercare and remote health care are seeing activity across all stages of the startup investment spectrum, from seed to later stage and pre-IPO. There’s even a unicorn or two in the mix.

For remote care, the most heavily funded private company is DispatchHealth, a Denver-based provider of mobile and remote health care that has raised more than $400 million in known funding to date. Seniors are a core target demographic for the startup, which touts its partnerships with Medicare providers.

Other well-funded startups include Honor, a tech-enabled platform for finding skilled home care providers that has pulled in more than $250 million in venture capital, AlayaCare, a home health software platform with around $110 million in funding, and Papa, which has raised over $90 million.

There’s plenty of seed-stage activity as well. Recent seed-funding recipients include New York-based Aloe Care Health, provider of a voice-activated medical alert system for older adults and caregivers, Serenity Engage, a HIPAA-compliant messaging app platform for senior care, and Grayce, a tool for family members navigating care needs for aging relatives.

For a sense of where startup funding is happening across stages, we put together a list of funded startups for 2021:

Political action could provide a further boost to the eldercare space. Earlier this year, the Biden administration called on Congress to put $400 billion toward expanding access to home- or community-based care for aging relatives and people with disabilities.

In addition to expanding at-home care, the administration says it is seeking to improve compensation for homecare workers, a workforce composed disproportionately of women of color who “have been underpaid and undervalued for far too long.”

It’s a policy objective that could use some help from entrepreneurs, said CareAcademy’s Adeosun, noting that currently there is a lack of professional infrastructure for direct care workers to develop skill sets that could boost job opportunities and pay. Her startup is looking to address this by providing online courses for senior care professionals in topics such as working with dementia patients, transporting wheelchair-bound seniors, and caring for stroke survivors.

The eldercare sector isn’t only of interest to the venture crowd, of course. Public investors are watching the space as well, with an eye to expanding options to buy shares in fast-growing companies.

A couple of special-purpose acquisition companies have already cropped up with plans to acquire a promising player in the eldercare space. Senior Connect Acquisition, a SPAC launched late last year by UnitedHealth Group founder Richard Burke, seeks to put $300 million toward acquiring and taking public a company in the senior care and home health market. Another SPAC, EQ Health Acquisition Corp., has $220 million to put to work and lists home care and hospice providers among its target areas.

The most recent IPO in the space, home care provider Aveanna Health, offers services across age groups. Shares have traded mostly flat since the Atlanta-based company made its market debut in April with a market cap around $2.2 billion.

For now, talk of hot new offerings for senior-focused companies is running ahead of actual deals. But for those who see demographic trends as the core driver of market demand, it’s clear this is an area that’s poised for growth. And as our population grows older, we could use more help from younger companies with innovative approaches to aging gracefully.

https://news.crunchbase.com/news/eldercare-senior-home-care-startups-funding/

New Study Finds Slightly Elevated Risk of Bleeding Disorders After AstraZeneca Vaccine

 Researchers studying records of 1.7 million adults who received the AstraZeneca PLC Covid-19 vaccine in Scotland found a small increased risk of bleeding conditions also sometimes associated with several vaccines routinely given to children, and usually treatable.

The blood disorders are different from a very rare but sometimes deadly blood-clotting condition that -- coupled with low platelet levels -- researchers in Europe have already linked to the AstraZeneca vaccine. That possible side effect has been the focus of regulatory and government scrutiny in recent months.

In the new paper, published Wednesday in the journal Nature Medicine, researchers from the U.K. and New Zealand said their findings shouldn't change policies in the U.K. and elsewhere to continue deploying the AstraZeneca shot as a generally safe and effective tool against Covid-19. AstraZeneca and regulators have said they are studying the blood-clotting matter further and that the benefits of the shot outweigh risks for most people. AstraZeneca didn't immediately comment on the new findings in the Nature study.

The new analysis concludes that the benefits of the AstraZeneca vaccine, along with heightened risks of internal bleeding and blood clots from Covid-19 itself, far outweighed any increased risks from the shot for most people. Because incidents of blood clotting have occurred more often in younger adults, some health officials have said that they should be offered an alternative to the AstraZeneca shot.

The vaccine was developed with the University of Oxford. The new paper, which hasn't been peer reviewed, provides a deeper dive into a large number of vaccine recipients in a single country. Because these bleeding conditions have been associated with other, long-used vaccines, researchers decided to study potential occurrences in Covid-19 vaccines.

Researchers said the findings show the need for countries to closely monitor vaccine rollouts to help standardize definitions of possible side effects and flag problems that might take months or years to surface.

The study also examined records of around 800,000 people who received the Pfizer Inc. vaccine, and found no additional risk of blood clotting or hemorrhaging.

The bleeding risks highlighted in the findings are caused by low platelet levels brought on by a condition called immune-induced thrombocytopenia, or ITP. Platelets are blood cells that promote clotting and prevent bleeding. ITP is rare but has been seen for years after other common vaccines, including for hepatitis B, measles, mumps and rubella, the researchers said. They and other scientists not involved in the study said the condition often goes undiagnosed and rarely causes death.

Normally the U.K. sees ITP in roughly six to nine people out of 100,000, researchers said Wednesday. Covid-19 has increased that incidence, making a baseline number difficult to pinpoint in the pandemic, they said. In the study sample, an additional estimated 1.13 people out of 100,000 experienced the low-platelet condition after one dose of the AstraZeneca shot.

In total, the Nature study examined records of 2.5 million people who received their first of two scheduled Covid-19 vaccine doses in Scotland between Dec. 8 and April 14.

In an accompanying Nature editorial, scientists not involved in the study said immune-induced thrombocytopenia is often difficult to diagnose. It is also challenging to separate pre-existing conditions from the effects of vaccines, they said. "The risk of vaccination-induced ITP at the rate proposed seems to be far lower than the many risks associated with Covid-19 itself," they wrote.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/New-Study-Finds-Slightly-Elevated-Risk-of-Bleeding-Disorders-After-AstraZeneca-Vaccine-35561821/