FDA warns on Medtronic pump cybersecurity risks

The FDA says certain Medtronic (NYSE:MDT) MiniMed 508 Paradigm insulin pumps have potential cybersecurity risks and advises patients to switch to better protected models.

Medtronic is recalling the affected MiniMed pumps and providing alternative insulin pumps to patients.

Check the FDA statement for the list of affected products.

https://seekingalpha.com/news/3474401-fda-warns-medtronic-pump-security-risks

NeoGenomics secures new $250M credit line

NeoGenomics (NASDAQ:NEO) inks a new five-year $250M Senior Credit Agreement consisting of a $100M credit revolver, a $100M term loan and a $50M delayed draw term loan.

The company drew the $100M at closing and used the proceeds to retire an outstanding term loan and borrowings under a credit revolver.

https://seekingalpha.com/news/3474432-neogenomics-secures-new-250m-credit-line

Arcturus’ lead candidate designated Orphan Drug

The FDA designates Arcturus Therapeutics’ (NASDAQ:ARCT) lead candidate ARCT-810 an Orphan Drug for the treatment of ornithine transcarbamylase deficiency (OTCD), a relatively rare urea cycle disorder in which ammonia accumulates in the body leading to nervous system damage.

ARCT-810 is an mRNA construct designed to deliver OTC to liver cells.

The company plans to file an IND in Q1 2020.

Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.

Shares are up 5% after hours.

https://seekingalpha.com/news/3474442-arcturus-lead-candidate-orphan-drug-u-s-otcd-shares-5-percent-hours

Key data readout approaches for Chiasma’s Mycapssa

In an update to investors, Chiasma (NASDAQ:CHMA) announces that topline data from the Phase 3 OPTIMAL study evaluating Mycapssa (octreotide) in patients with acromegaly should be released by mid-Q3.

A second Phase 3, IMPOWERED, is also advancing. Only 10 subjects remain active in the run-in phase. Most have been randomized into the nine-month controlled phase. Topline results should be available in H2 2020.

The company says it plans to file a U.S. marketing application later this year based on a positive outcome of OPTIMAL. If all goes well, the FDA nod could happen by mid-2020.

On another note, it will join the Russell 3000 Index effective July 1.

Shares are up 2% after hours.

https://seekingalpha.com/news/3474457-key-data-readout-approaches-chiasmas-mycapssa

HealthEquity Is Buying WageWorks In A $2B Deal

Healthequity Inc HQY 5.47% will acquire Wageworks Inc WAGE 2.04% for $51.35 per share in cash, or approximately $2 billion.

WageWorks is an administrator of consumer-directed benefits such as flexible spending accounts and HealthEquity is designated as a non-bank health savings trustee by the IRS.

“Acquiring WageWorks positions us to accelerate the market-wide transition to HSAs, with greater market access and an end-to-end proprietary platform built to drive members to spend smarter while saving for healthcare in retirement,” said Jon Kessler, President and CEO of HealthEquity.

“Together, we can meet employers and employees wherever they are on their journeys to connect health and wealth, while simultaneously accelerating our growth in an expanding industry.

https://www.benzinga.com/m-a/19/06/13992060/healthequity-is-buying-wageworks-in-a-2b-deal

Under Armour eyes blood pressure monitoring shoes

Under Armour (UAA, UA) filed a patent application for shoes that monitor blood pressure and potentially adjusts soles to improve blood flow for athletes with poor circulation.

Patent language: “A shoe for use by a user and for use with a communication device operable to transmit a blood pressure signal based on a detected blood pressure of the user, said shoe comprising: a sole having a top surface for supporting the foot of the user when being worn by the user; a force actuating mechanism operable to provide a force normal to said top surface of said sole, said force actuating mechanism being disposed at said sole so as to provide the force to a plantar venous plexus of the foot; a receiver operable to receive the blood pressure signal, and a controller operable to generate a control signal to control said force actuating mechanism, wherein said controller is further operable to modify the control signal based on the received blood pressure signal.”

Full USPTO patent filing

https://seekingalpha.com/news/3474355-armour-eyes-blood-pressure-monitoring-shoes

Castle Biosciences readies IPO

Castle Biosciences (CSTL) has filed a preliminary prospectus for $58M IPO.

The Friendswood, TX-based skin cancer-focused company provides doctors and patients with personalized clinically actionable genomic information to support more precise treatment decisions. Its non-invasive products use proprietary algorithms to assess a patient’s specific risk of metastasis or recurrence of their cancer, enabling physicians to identify those who may benefit from more aggressive care and those who do not need certain medical and surgical interventions.

Its DecisionDx-Melanoma genetic test predicts the risk of metastasis/relapse in patients with a deadly type of skin cancer called invasive cutaneous melanoma. Its DecisionDx-UM predicts the risk of metastasis in patients with a rare eye cancer called uveal melanoma.

2019 Financials (Q1): Revenues: $8.7M (+135.1%); Net Loss: ($2.3M) (+48.9%); Cash Flow Ops: $1.3M (+152.0%).

https://seekingalpha.com/news/3474358-castle-biosciences-readies-ipo