Tuesday, January 8, 2019
Herbalife Nutrition affirms FY19 outlook, sees Q4 volume up 11.6%
As part of its management transition announcement, Herbalife Nutrition also stated its “Q4 preliminary volume point results were up 11.6% worldwide from the same period in 2017 and reaffirmed its initial full year 2019 guidance as announced on October 30, 2018, thereby demonstrating the company’s consistent and continued confidence in the business moving forward.”
https://thefly.com/landingPageNews.php?id=2845867
FDA Clears Novel Eye Tracking Test to Detect Concussion
The US Food and Drug Administration (FDA) will allow marketing of EyeBOX (Oculogica), the first noninvasive, baseline-free test to help diagnose concussion.
The company plans to market the device for use in children ages 5 and older and adults up to 67 years of age, starting with a pilot launch for select, qualified sites.
EyeBOX uses eye-tracking to provide objective information that helps clinicians assess patients who have a suspected concussion with a simple, 4-minute test that does not require a baseline test.
In many situations, a baseline concussion assessment is not feasible, particularly when evaluating trauma patients in the emergency department. Baseline tests can also be “gamed” or memorized so that athletes and military personnel can pass a subsequent test. EyeBOX’s unique eye-tracking algorithm enables it to be baseline-free, the company announced.
“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients. The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the [playing] field,” Robert Spinner, MD, chair of the department of neurological surgery at Mayo Clinic in Rochester, Minnesota, said in a statement.
EyeBOX was evaluated in a clinical trial known as DETECT, which enrolled 282 patients at six clinical sites in the US and compared the EyeBOX results to a clinical reference standard for concussion in patients presenting to emergency departments and sports medicine clinics with suspected head injury.
The study showed that the EyeBOX had high sensitivity to the presence of concussion and that a negative EyeBOX result is consistent with a lack of concussion, the company said.
“Oculogica’s extensive clinical research and validation have shown we can provide an objective assessment to healthcare providers when evaluating patients with suspected mild traumatic brain injury,” Rosina Samadani, PhD, founder and CEO of Oculogica, said in the statement.
“Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA…heralds a new era for concussion diagnosis and management for patients and healthcare practitioners,” said Samadani.
Rescue of Alzheimer’s Pathophysiology by Polymeric Prion Protein Antagonists
Summary
Cellular prion protein (PrPC) binds the scrapie conformation of PrP (PrPSc) and oligomeric β-amyloid peptide (Aβo) to mediate transmissible spongiform encephalopathy (TSE) and Alzheimer’s disease (AD), respectively. We conducted cellular and biochemical screens for compounds blocking PrPCinteraction with Aβo. A polymeric degradant of an antibiotic targets Aβo binding sites on PrPC with low nanomolar affinity and prevents Aβo-induced pathophysiology. We then identified a range of negatively charged polymers with specific PrPC affinity in the low to sub-nanomolar range, from both biological (melanin) and synthetic (poly [4-styrenesulfonic acid-co-maleic acid], PSCMA) origin. Association of PSCMA with PrPC prevents Aβo/PrPC-hydrogel formation, blocks Aβo binding to neurons, and abrogates PrPSc production by ScN2a cells. We show that oral PSCMA yields effective brain concentrations and rescues APPswe/PS1ΔE9 transgenic mice from AD-related synapse loss and memory deficits. Thus, an orally active PrPC-directed polymeric agent provides a potential therapeutic approach to address neurodegeneration in AD and TSE.
Cal., NYC move to provide health care coverage to undocumented aliens
Democratic leaders of California and New York City are taking steps to provide health care coverage to some undocumented residents.
On his first day in office, California Gov. Gavin Newsom proposed a budget on Monday that would make California the only state in the nation to provide coverage to undocumented young adults through its Medicaid program.
New York City Mayor Bill de Blasio announced an even more ambitious program on Tuesday called NYC Care that would provide coverage for all New Yorkers. There are roughly 600,000 residents without health insurance, half of them undocumented immigrants.
“From this moment on in New York City, everyone is guaranteed the right to health care,” said de Blasio, comparing it to the universal pre-K program his administration implemented several years ago.
NYC Care will start rolling out in coming months and will take more than two years to be fully implemented, de Blasio said. It will cost at least $100 million, but the mayor said that the city would save a lot because fewer people would go to the emergency room, which provides pricey and inefficient care.
De Blasio told MSNBC’s “Morning Joe” that the city would not raise taxes but would instead fund the program through the city’s public health care system, which is now in better financial shape after years of dire straits.
“We’re spending a lot of money right now and we’re not spending it the way we want to because people go to the emergency room,” de Blasio said at a news conference. “You have a lot of savings over time by not having people get health care the wrong way.”
The mayor’s two-pronged approach will harness the MetroPlus Health Plan, a subsidiary of the city’s public hospital system that offers coverage to more than half-a-million New Yorkers via Medicaid, Medicare and Affordable Care Act policies. It will seek to boost enrollment among those who qualify, but are uninsured.
Also, the city will use NYC Care to connect New Yorkers who are not eligible for health insurance, especially the undocumented or those who can’t afford coverage, to health care. They will be assigned a primary care doctor and have access to specialty care, prescription drugs, mental health services and hospitalization. Services will be priced on a sliding scale and will be free for the poor.
Wait times to see a primary care doctor would be in line with the one to two weeks it currently takes, officials said.
One question is whether undocumented immigrants will sign up at a time when the federal government has increased deportation efforts, said David Sandman, CEO of the New York State Health Foundation, a health care policy, research and grantmaking organization.
“It’s a very challenging time to roll out that welcome mat,” Sandman said.
In California, Newsom would allow undocumented residents up to age 26 to enroll in Medi-Cal, the state’s Medicaid program. The Golden State became the first to cover undocumented children up to age 19 in 2016.
“Undocumented young adults should not have to worry about losing their health coverage when they turn 19,” said Newsom, describing the effort as “another major step toward universal coverage.”
In a nod to creating a state-based single-payer system, the Democratic governor sent a letter to President Donald Trump and congressional leadership on Monday requesting that the federal government “empower States like mine to design and implement truly transformative solutions for securing affordable health care for all.”
Covering more undocumented Californians is part of a broader health care package Newsom unveiled Monday. The new governor also signed an executive order to create “the largest single purchaser for prescription drugs and allow private employers to join the state in negotiating drug prices,” according to a statement from the governor’s office.
“No state has more at stake on the issue of health care. California must lead,” Newsom said in the statement. “We will use our market power and our moral power to demand fairer prices for prescription drugs. And we will continue to move closer to ensuring health care for every Californian.”
High drug prices have been in the national spotlight lately, with the Trump administration and Congress both promising to lower costs.
In addition, Newsom wants to expand the Affordable Care Act’s financial assistance to middle-income Californians. More than 80% of Obamacare enrollees take advantage of federal premium subsidies, and one of the main criticisms of the law is that premiums are unaffordable for those who don’t receive subsidies.
Newsom’s plan is to expand access to financial assistance to individuals earning up to $72,840 and families of four earning up to $150,600. Currently, individuals making up to $48,000 per year and families of four earning up to $98,000 can receive federal subsidies under the Affordable Care Act.
Amgen Gets Japan OK for Treatment Of Osteoporosis
Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the Japanese Ministry of Health, Labor and Welfare has granted a marketing authorization for EVENITY™ (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture.1 Amgen and UCB are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.
“The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment.2 With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture.”
EVENITY is a bone forming agent that both increases bone formation and reduces bone resorption to increase bone mineral density (BMD) and reduce the risk of fracture. The approval is based on results from two pivotal Phase 3 studies: FRAME,3 which included 7,180 postmenopausal women with osteoporosis, and BRIDGE,4 which included 245 men with osteoporosis. The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.
“In Japan, osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care. As the aged population of Japan increases, preventing such fractures should be given high priority,” said Steve Sugino, Amgen vice president and president and representative director of AABP. “Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption.”1
“Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent,” said Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university’s Fujii Memorial Institute of Medical Sciences. “Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan.”
Japan has one of the longest life expectancy rates in the world, and it is believed that by 2050, over 37 percent of the population will be aged 60 or older. 5 Age is one of the most common risk factors associated with developing osteoporosis, as bone mass is lost over time.6,7 Today, the prevalence of osteoporosis in the country is around 12 million, and the hip fracture incidence rate in the population over 75 is increasing dramatically in both men and women.8
IRIDEX Prelim Operational and Financial Results for 2018 4th Quarter and Full Year
IRIDEX Corporation (Nasdaq: IRIX) today provided preliminary operational and financial results for the fourth quarter and full year ended December 29, 2018.
Highlights
- Shipped approximately 460 to 465 Cyclo G6® Glaucoma Laser Systems and 45,500 to 46,500 G6 probes in the full year 2018
- Shipped approximately 119 to 124 Cyclo G6® Glaucoma Laser Systems and a record 12,000 to 13,000 G6 probes in the fourth quarter 2018
- Total revenue for 2018 expected to be $42.1 million to $42.4 million, representing an increase of 1.3% to 2.0% over 2017
- Total revenue for the fourth quarter of 2018 expected to be $11.0 million to $11.3 million, representing an increase of 7.4% to 10.3% over the fourth quarter of 2017
“Our fourth quarter results completed an exciting year for IRIDEX. Our commercial teams continued to drive growth in Cyclo G6 placements and we shipped a record number of G6 probes in the quarter. Overall, I am encouraged by the progress we made throughout the year, as we executed on multiple fronts across the organization,” said William M. Moore, Chairman and Chief Executive Officer. “Heading into 2019, we remain focused on driving awareness and sales among a broad base of glaucoma specialists and comprehensive ophthalmologists, while continuing to innovate and advance our platform to treat the spectrum of the disease.”
These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 29, 2018 and are subject to further internal review and audit by the Company’s external auditors. IRIDEX expects to issue full 2018 financial results in early March 2019, at which time the Company plans to provide guidance for full year 2019.
Globus Medical Reports Prelim Record Fourth Quarter and Full Year Sales
Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2018. The company anticipates fourth quarter 2018 sales of approximately $195.5 million, an increase of 11.0% over the fourth quarter 2017. Full year 2018 sales are expected to be approximately $712.5 million, an increase of 12.0% over the prior year.
“Our fourth quarter and full year results are indicative of strong momentum in several key strategic areas,” said Dave Demski, CEO. “The fourth quarter marked the fifth consecutive quarter of double digit organic revenue growth, which is particularly outstanding considering the strong comparable quarter last year. Emerging Technologies delivered $14.8 million, or 35% growth, a significant accomplishment given the pent up demand implicit in the fourth quarter of 2017 when we launched our robotic system. The U.S. spinal implant business grew by over 9% year-over-year, continuing the acceleration we saw in the third quarter, driven by robotic implant pull through and strong recruiting.”
“We are pleased with our fourth quarter and full year performance,” said Dan Scavilla, CFO and Chief Commercial Officer. “We delivered 12% revenue growth and maintained our industry-leading profitability while investing significantly in growing our Emerging Technologies business. While we are not announcing fourth quarter or full year EPS or EBITDA at this time, our performance in the quarter was consistent with our long history of growing efficiently and profitably.”
The company established full year 2019 guidance of $770 million in sales and fully diluted non-GAAP earnings per share of $1.72. This EPS guidance assumes continued investment in Emerging Technologies.
These preliminary results are unaudited and are based on management’s initial analysis of operations for the periods ended December 31, 2018, and are therefore subject to change. The company expects to announce its fourth quarter and full year 2018 financial and operating results on February 21st.
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