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Monday, December 2, 2019

Senseonics launches non-adjunctive Eversense CGM in U.S.

Senseonics (NYSEMKT:SENSannounces that users of the Eversense continuous glucose monitoring (CGM) system who download the new Eversense CGM mobile app can start dosing insulin based on readings from the device without the need of a confirmatory blood glucose measurement from a fingerstick sample.
Shares up 3% after hours.

ViewRay up 37% after hours on Elekta collaboration

ViewRay (NASDAQ:VRAY) is up 37% after hours on the heels of its non-binding memorandum of understanding (MOU) with Elekta AB (OTCPK:EKTAF) for a collaboration aimed at advancing the knowledge and use of MR-guided radiation therapy. The partnership includes an investment by Elekta representing a 9.9% stake in ViewRay.
It has also signed a non-binding MOU with Medtronic (NYSE:MDT) for a clinical collaboration aimed at exploring the benefits of the MRIdian MR-guided radiation therapy system. Medtronic has agreed to take a minority stake in ViewRay.
Both investments are contingent on ViewRay raising at least $75M in new capital. A public offering has been launched.

FDA OKs Amneal’s generic Revatio and Amicar; shares up 2% after hours

The FDA approves Amneal Pharmaceuticals’ (NYSE:AMRX) generic versions of Pfizer’s (NYSE:PFE) Revatio (sildenafil citrate) Oral Suspension 10 mg/mL and Clover Pharms’ Amicar (aminocaproic acid) Tablets USP, 500 mg. Commercialization will begin immediately.
Per IQVIA, the U.S. market for the former is ~$180M and ~$23M for the latter.
Shares up 2% after hours.

UnitedHealth sees ~9% increase in 2020 earnings

Ahead of tomorrow’s Investor Conference in New York City, UnitedHealth Group (NYSE:UNHannounces preliminary 2019 results and 2020 outlook.
2019: Revenues: ~$242B; EPS: ~$14.25 from $14.15 – 14.25; non-GAAP EPS: ~$15.00 from $14.90 – 15.00.
2020: Revenues: $260B – 262B; EPS: $15.45 – 15.75; non-GAAP EPS: $16.25 – 16.55 (+9% from midpoint); cash flow ops: $19.0B – 19.5B.

What Prescription Does This Startup Have For Healthcare Real Estate?

In the medical real estate space, HealCo is a tech startup on a mission.
Launched in 2019, the company conducts a marketplace for medical and wellness office timesharing, management and compliance. HealCo brings together the spectrum of parties involved in the lease agreement process — from the healthcare provider to the medical office building owner and the hospital system operator — via the company’s technology platform.
With the healthcare consumer in mind, HealCo’s work is about connecting the provider with the right space for the right amount of time, and for fair market value. Their tech platform’s early-stage features simplify the search and the securing of space for healthcare practitioners, so that they can focus the vast majority of their time delivering high-quality, cost-effective outpatient care.
“Timeshares involve sharing a space with other providers to ensure optimal use,” said HealCo founder and CEO Kirat Kharode. “As a result, timeshares often lead to an ecosystem of complementary providers operating under one roof. It’s a medical office co-working system of sorts.”
Kharode spent almost two decades as a health system executive. He witnessed the thorny challenges, avoidable inefficiencies and opportunities to improve patients’ experiences. He knew the future of the healthcare real estate sector needed to stretch to accommodate the changes coming from the health and insurance industries.
Incorporated as an S-corp last January, and with seed funding secured, the Jersey City-based startup is growing its customer base. HealCo has more than 1,000 doctors and providers using its platform to find medical space to share. They’ve assisted property owners in timesharing over one million square feet across 42 of the continental 48 states.
HealCo’s mission is to facilitate the entrance of healthcare providers into real estate and communities where they are needed the most, especially as they are ramping up their practice, without binding them in long-term leases and brick-and-mortar investment decisions.
“A major learning from our proprietary data has been how closely our customer base of physicians reflects the same geographic areas as the highest Medicare Advantage concentrations across the country,” observed Kharode. “This patient population tends to be the greatest consumer of healthcare services in the United States. Decreasing their cost of care is extremely relevant to the country’s fiscal wellbeing.”
Right out of the gates, it has been an exhilarating year one. They’ve already rebranded from Healtor to HealCo, to better reflect their focus on the entire medical community. This month, they’ve relaunched their website to reflect the shift.
For capacity and trusted advice, HealCo has assembled an advisory board, with initial representation from the professions of commercial real estate, healthcare law and healthcare insurance, from the likes of CBREHall RenderMarshLincoln Harris CSGLDM Commercial and Meridian.
Next year’s prognosis: more hustle. HealCo shows no sign of slowing down, and they’re getting experimental.
“In early 2020, we’re opening new HealCo-managed office spaces, beginning with two offices in New Jersey,” announced Kharode. “These sites allow us to get closer to understanding the needs of our customers.”
“These locations are different from conventional medical office timeshares, operated by hospitals for example, because we partner with the providers in helping them succeed by hosting community networking events for patients – focusing on social determinants of health – and networking events to meet other physicians in the area.”
Kharode and his team are limbering up to stretch themselves, too.
“We are planning to expand our enterprise offerings to health systems and large medical office building groups. We currently have started exploratory partnerships with four regional, multi-hospital systems in New Jersey, California, Florida and North Carolina.”

Are Dangerous Microbes Hiding In Your Makeup? New Study Says Yes

A new study has revealed that the majority of opened, in-use makeup products, such as lip gloss, mascara and blending sponges are contaminated with potentially dangerous bacteria such as E.coli and Staphylococci.
The research published today in the Journal of Applied Microbiology by researchers at Aston University in the U.K., found that 9 out of 10 products tested contained bacteria capable of causing illnesses such as skin infections and even blood poisoning if used near the eyes, mouth or cut or grazed skin.
The risk is especially high in people who are immunocompromised and more susceptible to contract these infections from bacteria which might normally be otherwise kept in check by the immune system. However, the presence of potentially dangerous bacteria in this makeup does not necessarily mean people will get sick and substantial research is currently lacking correlating this.
The research looked at a variety of makeup products, comprising 467 individual items, including ‘blending sponges,’ contoured sponges used to apply makeup such as skin foundation to the face. These sponges were found to have the highest levels of potentially harmful microbes, likely due to often being left damp after use, creating a breeding ground for harmful bacteria.
The study found that two-thirds of users had dropped their sponges on the floor at some point, but that 93% of them had never been cleaned by their owners, further contributing to the likelihood that harmful microbes would be present.
“Consumers’ poor hygiene practices when it comes to using make-up, especially beauty blenders, is very worrying when you consider that we found bacteria such as E.coli – which is linked with fecal contamination – breeding on the products we tested,” said Dr Amreen Bashir, lead author of the study from Aston University’s School of Life and Health Sciences.
The requirements to put expiry dates on makeup vary widely around the world. In the European Union, most cosmetic products are required to have a “date of minimum durability” i.e. “best used before the end of” or a “period after opening” to show how long the product should be kept or used. However, in the U.S., there are no laws or regulations that require cosmetics to have specific shelf lives or have expiration dates on their labels, according to the FDA.
“More needs to be done to help educate consumers and the make-up industry as a whole about the need to wash beauty blenders [blending sponges] regularly and dry them thoroughly, as well as the risks of using make-up beyond its expiry date,” said Bashir.

Ardelyx conference call tomorrow on late-stage tenapanor data

Ardelyx (NASDAQ:ARDX) will host a conference call tomorrow, December 3, at 8:00 am ET to discuss results from the Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease patients on dialysis.
In September, the company announced that the trial met the primary and all key secondary endpoints.
Shares up 1% after hours.