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Friday, April 5, 2019

Organ transplant device maker TransMedics files for an $86 million IPO

TransMedics, a medical device company that provides a system for organ transplants, filed on Friday with the SEC to raise up to $86 million in an initial public offering.
The Andover, MA-based company was founded in 1998 and booked $13 million in sales for the 12 months ended December 31, 2018. It plans to list on the Nasdaq under the symbol TMDX. TransMedics filed confidentially on October 19, 2018. Morgan Stanley and J.P. Morgan are the joint bookrunners on the deal. No pricing terms were disclosed.

Neurological disorder biotech Trevi Therapeutics files for an $86 million IPO

Trevi Therapeutics, a clinical stage biotech developing therapies for neurological disorders, filed on Friday with the SEC to raise up to $86 million in an initial public offering.
The New Haven , CT-based company was founded in 2011 and plans to list on the Nasdaq under the symbol TRVI. Trevi Therapeutics filed confidentially on November 19, 2018. SVB Leerink, Stifel and BMO Capital Markets are the joint bookrunners on the deal. No pricing terms were disclosed.

Illinois testing new program to reduce Medicare fraud

Illinois is the first state to participate in a new Centers for Medicare & Medicaid Services program for home health agencies that aims to prevent Medicare fraud, protect patients and minimize the burden on medical providers.
The program, called the Review Choice Demonstration for Home Health Services, was created to test whether choosing from three claim review options reduces fraud in the state among organizations that provide skilled nursing services to Medicare beneficiaries, according to CMS.
Ohio, North Carolina, Florida and Texas will soon participate in the program, as well. The five states were selected because they have “known areas of fraudulent behavior and had either a high home health improper payment rate or a high denial rate,” CMS said in a statement last year.
Between April 17 and May 16, home health agencies in Illinois that submit claims to the Medicare administrative contractor Palmetto GBA can choose from three claim review options: a pre-claim review that occurs after services start, but before submitting the final claim; a post-payment review that occurs after the claim has been processed; or a post-payment option without consistent reviews, which includes a 25 percent reduction in payment.
Agencies that don’t make a selection will automatically be placed in post-payment review. The program officially begins June 1.
Home health agencies will be monitored every six months. Those that demonstrate compliance will have additional claim review choices, including relief from most reviews.
“We expect this demonstration to keep dollars in the Medicare program and away from unscrupulous providers,” CMS Administrator Seema Verma said in a statement today. “We look forward to home health agencies across the Prairie State being a part of this important step in improving Medicare, protecting patients, and safeguarding taxpayer dollars.”

FDA Warns Lab Against Marketing Tests Linking Genes, Drug Reaction

The US Food and Drug Administration (FDA) has warned Inova Genomics Laboratory over illegal marketing of MediMap pharmacogenetic tests that claim to predict patients’ response to a variety of drugs, including those used for anesthesia and to treat cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes.
The warning letter said the following tests are being marketed without clearance or approvals: MediMap ADHD, the MediMap Mind, the MediMap Plus, the MediMap Heart, and the MediMap Baby.
The FDA has not reviewed the safety and effectiveness of the tests, and selecting or changing drug treatment in response to results from the tests could lead to “potentially serious health consequences for patients,” the agency said in a statement.
The FDA said it knows of no data that establish that the company’s tests can help patients or healthcare providers make appropriate treatment decisions regarding the listed drugs.
“Without appropriate evaluation to determine whether these tests work, patients are being put at risk — potentially impacting treatment decisions by providing false promise that they will respond well to a certain medicine or keeping them from using therapies that may benefit them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said the FDA is “committed to supporting innovation” in pharmacogenetic testing but will also be “vigilant in protecting against the potential risks and are therefore issuing this warning letter to help protect patients and providers from acting on data that has not been demonstrated to promote the safe and effective use of drugs.”
Inova Genomics, of Falls Church, Virginia, has 3 weeks to notify the FDA in writing regarding how it will address the violations. Failure to do so may result in regulatory action that could involve seizure, fines, or injunctions.
Last year, the FDA warned consumers and healthcare providers about pharmacogenetic tests being marketed directly to consumers or being offered through healthcare providers that claim to predict how a patient will respond to specific medications.
Healthcare providers are encouraged to report any adverse events related to these or other genetic tests to MedWatch, the FDA’s safety information and adverse event reporting program.

Pain clinics could help cut opioid use

Chronic non-cancer pain is sometimes managed with high-dose opioids, which has partially contributed to the current opioid epidemic. New research from pain specialists at the University of Arizona and Banner – University Medicine may provide options other than opioids for patients with non-cancer chronic pain.
“Our study shows the possible potential of  clinics in helping to reduce  use while improving pain and function in patients on opioids suffering from non-cancer ,” said senior author Dr. Mohab Ibrahim, director of the Chronic Pain Management Clinic at Banner – University Medical Center South and an associate professor in the UA departments of anesthesiology and pharmacology.
The study evaluated the role of a pain management clinic with fellowship-trained pain physicians in reducing pain and opioid use in patients with chronic non-.
Patients were asked to rate their pain on a scale of zero to 10, with results showing the average pain score decreased by almost 34 percent. The pain frequency and number of pain episodes improved. Also, the patients reported better ability to sleep, work and perform chores. Finally, the patients were able to reduce their total opioid use by about 55 percent.
The findings were published Nov. 30 in the journal Pain Physician.
In the United States, as much as $300 billion is spent each year to manage pain. Chronic pain affects 100 million Americans – more than than diabetes, heart disease and cancer combined, according to the American Academy of Pain Medicine.
Doctors at pain clinics help patients manage chronic pain and improve their quality of life using not only medications and interventional procedures, but also modalities such as physical, behavioral and psychological therapies.
“Generally speaking, our pain clinic focuses on offering all available options to get people to decrease their opioids or get them off their opioids altogether,” Ibrahim said. “Those include physical therapy, acupuncture, yoga, chiropractors, tai-chi, non-opioid medications, interventional procedures, and sometimes seeking help from our surgical collogues with whom we have excellent and close collaborations.”
Tucson has about 15 pain management clinics, including the Comprehensive Pain Management Clinic. Ibrahim’s study was retrospective and used pain data from 296 patients treated at the clinic between July 2014 and January 2016.
During clinic visits, patients filled out a form asking about changes in the intensity, frequency and duration of their pain, and their ability to fall and stay asleep, work, exercise and perform chores. The team also analyzed patients’ initial opioid use and their opioid use at the most recent visit.
The most common types of chronic pain were: headaches, migraines, neuropathic pain, arthritic pain and abdominal pain. All of the patients were treated with conventional pain-management approaches, ranging from physical therapy to medical non-opioid management to interventional procedures, depending on the patients’ needs and the clinical scenario. For example, if a patient was in severe pain, then physical therapy may not be the best first option, since he or she may not be able to actively participate in .
Ibrahim and his co-authors – lead author Dr. Amol Patwardhan, Dr. Ryan Matika, Dr. Janalee Gordon, Brian Singer and Dr. Michelle Salloum – were able to demonstrate they could decrease pain and opioids at the same time, while maintaining patient satisfaction and improving their functionality. As Ibrahim said, that is really the whole purpose of pain medicine – to improve the functionality of the patients and decrease their reliance on medications.
“We were able to decrease the pain by about 30 to 40 percent while decreasing  by 50 percent,” Ibrahim said.
From 1999 to 2013, prescriptions for opioid painkillers quadrupled, as did opioid-related deaths in the United States. In 2013, an estimated 2 million Americans misused or abused prescription opioids, according to a paper published in BioMed Central in May 2018.
Ibrahim said opioids can cause a vicious circle because once a patients’ pain is no longer controlled, physicians may increase the dosage and the patient will feel better for a while; then, the pain gets worse. This can get to the point where the patient is on such a high dose of opioids it becomes unmanageable – and that is when things can go wrong. However, Ibrahim said he does not want to generalize because some patients’ pain is very well controlled with opioids.
“You can use a hammer to drive a nail through a wall and that’s a good function of the hammer; you are using the tool in the right way. But if someone else with bad intentions gets that hammer and breaks someone’s windshield, that’s a bad use of the tool. It does not mean that the hammer is good or bad, it is just whether the person who used it had good or bad understanding of its function. Same thing with drugs,” Ibrahim explained.
As the authors state, finding nonopioid solutions to treat chronic pain is a work in progress. Much potential exists for future research in pain clinics throughout Arizona and the U.S.
“Pain is better controlled when you approach it from several angles, not just one,” Ibrahim said.

Explore further

More information: Exploring the Role of Chronic Pain Clinics: Potential for Opioid Reduction. Pain Physician. 2018 Nov. www.painphysicianjournal.com/c … MA%3D%3D&journal=114
Journal information: BioMed Central

CDC: Violence against seniors on rise, especially among men

There has been an increase in the rates of violence among older adults, especially among older men, according to research published in the April 5 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
J.E. Logan, Ph.D., from the CDC in Atlanta, and colleagues analyzed rates of nonfatal assaults and homicides against  (≥60 years) during 2002 to 2016 using data from the National Electronic Injury Surveillance System-All Injury Program and the National Vital Statistics System.
The researchers observed a 75.4 percent increase in the nonfatal assault rate during the 15-year period among men (from 77.7 to 136.3 per 100,000) and a 35.4 percent increase from 2007 to 2016 among women (from 43.8 to 59.3 per 100,000). The  increased by 7.1 percent among men from 2010 to 2016; among men aged 60 to 69 years, there was a 19.3 percent increase from 2013 to 2016.
“Violence against older adults is an emerging and underreported public health problem,” the authors write. “Emergency departments might be promising settings to identify older adults at risk for violence and treat and support those already affected.”

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More information: Abstract/Full Text

Whooping cough evolving to beat antibiotics and possibly vaccine

A new strain of Bordetella pertussis – the bacterium that causes whooping cough – has become resistant to antibiotic treatment and may also be resistant to the vaccine used in China. A UNSW Sydney academic says the growing threat of it spreading to Australia should be taken seriously.
A joint study led by Ph.D. student Zheng Xu, between UNSW Sydney and Xi’an Centre for Disease Control and Prevention, China examined 167 pertussis samples from China. They found that 98% of pertussis bacteria isolated were resistant to erythromycin, the main antibiotic used to treat whooping cough. The study also found that the new strain has a mutation in one of the vaccine antigen genes, which may help the bacteria evade the two-component acellular vaccine used in China.
In the paper published in the journal Emerging Microbes & Infections, co-author Professor Ruiting Lan, of UNSW School of Biotechnology and Biomolecular Sciences, said the pertussis strains appear to be adapting to the acellular vaccine used in China, as well as developing resistance to the antibiotic most commonly used to treat the disease.
“This has rendered the antibiotic ineffective for treatment and prophylaxis,” Professor Lan said.
“Our findings suggest that treatment with erythromycin and prevention with vaccination with the acellular vaccine used may be less effective in China. We hope that therapies and prevention strategies will adapt to these findings to reduce the public health burden of pertussis.”
Professor Lan said that looking ahead, the Chinese pertussis strain needed to be watched closely from within and outside China. He stressed that the potential threat of the new variant spreading globally was real.
“But exactly how high the threat is, we don’t know at this stage,” Professor Lan said.
“In Australia we use azithromycin, which is the same type but a newer drug than erythromycin, but the Chinese variants have also shown resistance to this antibiotic. The treatment and prophylaxis have an important role in curtailing the spread of , so if the strains are resistant to and not curtailed by the antibiotic used, there is definitely a potential to cause an epidemic in Australia.”
“We really need to find out how competitive the Chinese strains are in Australia with a different  – the one used in Australia has one more antigen component. And we also need to understand the organism better.”
“We want to know how likely it is that these strains spread globally, and how we can curtail the spread of such . And further ahead, we need to design more effective vaccines to control these new variants,” he says.
Professor Lan stressed the need to maintain our own high vaccination coverage to prevent this new strain from gaining a foothold.

Explore further

More information: Zheng Xu et al. Genomic epidemiology of erythromycin-resistant Bordetella pertussis in China, Emerging Microbes & Infections(2019). DOI: 10.1080/22221751.2019.1587315