The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S.

Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America.

The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant.

Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. However, Natural Cycles put a scientific spin on the age-old method by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.”

What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC).

And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri Cornelison said in a statement.

However, she also acknowledged there was a margin of error in the app’s algorithm and other contraceptive methods. “Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she said.

The 5,000% price hike that made Martin Shkreli infamous is no longer paying off

Martin Shkreli’s former pharmaceutical company lost more than $1 million in the first quarter of 2018 amid waning sales of the drug made famous by Shkreli’s more than 5,000-percent price increase. That’s according to financial documents recently reviewed by Stat.

Vyera Pharmaceuticals, formerly known as Turing Pharmaceuticals, had brazenly maintained Shkreli’s despised price hike of the drug Daraprim, which treats relatively rare parasitic infections that often strike babies and HIV/AIDS patients. As founder and CEO of Turing, Shkreli bought the rights to the cheap, off-patent drug and—without any generic competitors—abruptly raised its price from $13.50 a pill to $750 a pill in the fall of 2015.

The move was wildly unpopular (to say the least) and attracted intense public scrutiny to the country’s quickly escalating drug costs. But it was a lucrative decision for Turing and later Vyera—at least until recently.

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Using a virus to kill what antibiotics can’t

Due largely to overuse, we’re at risk of seeing many of our antibiotics lose effectiveness, leaving us without a defense against a number of potentially fatal infections. People are taking a variety of approaches to dealing with this, like looking for combinations of drugs that remain effective, developing entirely new drugs, and trying to reform how we dispense these critical drugs. (Although the latter may be an impossible dream.)

There’s another option that was under consideration even before antibiotic resistance had hit crisis levels: use something that makes killing bacteria part of its life cycle. Like other cells, bacteria often find themselves victims of viral infections, dying as new viruses burst out to infect their neighbors. If this happens out in regular ecosystems, people reasoned that maybe bacteria-killing viruses would also work in a pneumonic lung. But those maybes had always been accompanied by a long list of reasons why a virus wouldn’t work. Now, a group of researchers has tested it on mice with pneumonia, and none of those reasons seems to be an issue.

Meet the phages

Viruses that specialize in infecting bacteria are often called bacteriophages, or simply phages. We’ve known of some of them from shortly after we started studying bacteria, since their spontaneous infections would leave open holes of what would otherwise be an even lawn of bacteria. We’ve studied a number of them in detail, and some of the proteins they encode have become key tools in our genetic-engineering efforts. And they’re not simply oddities that strike when bacteria are forced to live in artificial lab conditions. Surveys of DNA obtained in environments from the deep ocean to the subways show that, wherever you find bacteria, you also find viruses that prey on them.

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Implantable 3D-printed organs could be coming sooner than you think

At MBC Biolabs, an incubator for biotech startups in San Francisco’s Dogpatch neighborhood, a team of scientists and interns working for the small startup Prellis Biologics have just taken a big step on the path toward developing viable 3D-printed organs for humans.

The company, which was founded in 2016 by research scientists Melanie Matheu and Noelle Mullin, staked its future (and a small $3 million investment) on a new technology to manufacture capillaries, the one-cell-thick blood vessels that are the pathways which oxygen and nutrients move through to nourish tissues in the body.

Without functioning capillary structures, it is impossible to make organs, according to Matheu. They’re the most vital piece of the puzzle in the quest to print viable hearts, livers, kidneys and lungs, she said.

“Microvasculature is the fundamental architectural unit that supports advanced multicellular life and it therefore represents a crucial target for bottom-up human tissue engineering and regenerative medicine,” said Jordan Miller, an assistant professor of bioengineering at Rice University and an expert in 3D-printed implantable biomaterial structures, in a statement.

This real-time video shows tiny fluorescent particles – 5 microns in diameter (the same size as a red blood cell) – moving through an array of 105 capillaries printed in parallel, inside a 700 micron diameter tube. Each capillary is 250 microns long.

Now, Prellis has published findings indicating that it can manufacture those capillaries at a size and speed that would deliver 3D-printed organs to the market within the next five years. 

Prellis uses holographic printing technology that creates three-dimensional layers deposited by a light-induced chemical reaction that happens in five milliseconds.

This feature, according to the company, is critical for building tissues like kidneys or lungs. Prellis achieves this by combining a light-sensitive photo-initiator with traditional bioinks that allows the cellular material to undergo a reaction when blasted with infrared light, which catalyzes the polymerization of the bioink.

Prellis didn’t invent holographic printing technology. Several researchers are looking to apply this new approach to 3D printing across a number of industries, but the company is applying the technology to biofabrication in a way that seems promising.

The speed is important because it means that cell death doesn’t occur and the tissue being printed remains viable, while the ability to print within structures means that Prellis’ technology can generate the internal scaffolding to support and sustain the organic material that surrounds it, according to the company.

The video above, courtesy of Prellis Biologics, shows real-time printing of a cell encapsulation device that is useful for producing small human cells containing organoids. The structure is designed to be permeable and the size is 200 microns in diameter and can contain up to 2000 cells.

Prellis isn’t the first company to develop three-dimensional organ printing. There have been decades of research into the technology, and companies like BioBots (which made its debut on the TechCrunch stage) are already driving down the cost of printing living tissue.

Now called Allevi, the company formerly known as BioBots has seen its founders part ways and its business  strategy shift (it’s now focusing on developing software to make its bioprinters easier to use), according to a report in Inc. Allevi has slashed the cost of bioprinting with devices that sell for less than $10,000, but Prellis contends that the limitations of extrusion printing mean that technology is too low resolution and too slow to create capillaries and keep cells alive.

Prellis’ organs will also need to be placed in a bioreactor to sustain them before they’re transplanted into an animal, but the difference is that the company aims to produce complete organs rather than sample tissue or a small cell sample, according to a statement. The bioreactors can simulate the biomechanical pressures that ensure an organ functions properly, Matheu said.

“Vasculature is a key feature of complex tissues and is essential for engineering tissue with therapeutic value,” said Todd Huffman, the chief executive officer of 3Scan, an advanced digital tissue imaging and data analysis company (and a Prellis advisor). “Prellis’ advancement represents a key milestone in the quest to engineer organs.”

Matheu estimates that it will take two-and-a-half years and $15 million to bring implantable organs through their first animal trials. “That will get a test kidney into an animal,” she said.

The goal is to print a quarter-sized kidney that could be transplanted into rats. “We want something that would be able to handle a kidney that we would transplant into a human,” Matheu said.

One frame of a 3D map of animal tissue from 3Scan .

Earlier this year, researchers at the University of Manchester href=”https://newatlas.com/working-kidney-cells-grown-mice/53354/”> grew functional human kidney tissue from stem cells for the first time. The scientists implanted small clusters of capillaries that filter waste products from the blood that had been grown in a Petri dish into genetically engineered mice. After 12 weeks, the capillaries had grown nephrons — the elements that make up a functional human kidney.

Ultimately, the vision is to export cells from patients by taking a skin graft or blood, stem cell or bone marrow harvest — and then use those samples to create the cellular material that will grow organs. “Tissue rejection was the first thing I was thinking about in how I was designing the process and how we could do it,” says Matheu.

While Prellis is spending its time working to perfect a technique for printing kidneys, the company is looking for partners to take its manufacturing technology and work on processes to develop other organs.

“We’ll be doing collaborative work with other groups,” Matheu said. “Our technology will come to market in many other ways prior to the full kidney.”

Last year, the company outlined a go-to-market strategy that included developing lab-grown tissues to produce antibodies for therapeutics and drug development. The company’s first targeted human tissue printed for clinical development were cells called “islets of Langerhans,” which are the units within a pancreas that produce insulin.

“Type 1 diabetics lose insulin-producing islets of Langerhans at a young age. If we can replace these, we can offer diabetes patients a life free of daily insulin shots and glucose monitoring,” said Matheu in a statement at the time.

Matheu sees the technology she and her co-founder developed as much about a fundamental shift in manufacturing biomaterials as a novel process to print kidneys, specifically.

“Imagine if you want to build a tumor for testing… In the lab it would take you five hours to print one… With our system it would take you three and a half seconds,” said Matheu. “That is our baseline optical system… The speed is such a shift in how you can build cells and fundamental structures we are going to be working to license this out.”

Meanwhile, the need for some solution to the shortage in organ donations keeps growing. Matheu said that one in seven adults in the U.S. have some sort of kidney ailment, and she estimates that 90 million people will need a kidney at some point in their lives.

Roughly 330 people die every day from organ failure, and if there were a fast way to manufacture those organs, there’s no reason for those fatalities, says Matheu. Prellis estimates that because of the need for human tissue and organ replacement alternatives, as well as human tissue for drug discovery and toxicology testing, the global tissue engineering market will reach $94 billion by 2024, up from $23 billion in 2015.

“We need to help people faster,” says Matheu. 

Grim look at Civil War surgery unearthed by new pit of limbs, bodies

Eleven amputated limbs, two nearly complete skeletons, and scattered artifacts uncovered from a shallow pit at Virginia’s Manassas National Battlefield Park are unearthing rare and grim glimpses of Civil War surgery.

The surgeon’s burial pit is the first of its kind to be discovered at a Civil War battlefield, the National Park Service announced this week.

Experts from the NPS and the Smithsonian Institute have determined that remains date back to August 1862, the time of the Second Battle of Manassas (also referred to as the Second Battle of Bull Run by Union Forces). The pit was likely at the site of a field hospital, set up to tend to the thousands of wounded following the multi-day battle.

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AssistENT offers an anti-snoring device you stick in your nose

If you sleep next to someone who snores you know that the endless horking and honking isn’t very fun… and it makes the snorer’s life even worse. Some students and doctors in Baltimore, Maryland, however, have created something that acts like an internal breathing strip to help you breathe better and snore less.

Called assistENT, the company uses small, reusable rings that fit into the nostril and open the septum. You insert and remove them yourself with a little pair of forceps and they can survive sneezing and, one would assume, a good, hard midnight snoooorrrrrk. Patrick Byrne and Clayton Andrews created the product and it recently won the $10,000 “Use it!” Lemelson-MIT Student Prize for best product. Other members of the team include Melissa Austin, Talia Kirschbaum, Harrison Nguyen, Theo Lee, and Eric Cao.

The team will be running a Kickstarter soon and is looking into a seed round for manufacture. The product, called N-Stent, costs 15 cents to make and will sell for about $4 a pair.

“The design is inspired by the typical cartilage grafts used in functional rhinoplasty to improve nasal breathing. In essence, the device is a tapered silicone stent consisting of two flexible beams bridging two soft pads whose shape closely follows the complex internal nasal anatomy,” said Byrne. “When deployed, one pad grips the nasal septum and the other presses against the lateral nasal wall to dilate the passage and stent it open. This dilation force comes from the two flexible beams, which bend to provide a gentle spring force while forming a lumen to accommodate airflow.”

The product fits into the nasal vestibule and to get it in and out you can either use the simple applicator or just stick it up there with your finger.

The team is excited about the possibilities, especially since this can help people without forcing them to get surgery.

“Although the mechanism for reversing nasal obstruction is straightforward, there is no viable alternative to surgery for those who struggle with nasal breathing throughout the day. Breathe Right strips lead this nighttime nasal dilator market with annual revenues of $145M, amounting to an 80% market share. However, experts estimate a $250M market opportunity for less-invasive nasal obstruction treatment,” said Byrne.

“We have heard stories from dozens who have had surgery to correct nasal obstruction – with limited success and great expense – and hundreds who are reluctant to undergo surgery in the first place and feel they have no alternative for breathing better throughout the day, at night, or during exercise. This invention has potential to radically change the standard of care for nasal obstruction and provide a convenient, sensible solution to this widespread problem,” he said.

Look for this anti-snort-hork-honnnnnking device in the next few months.

Economics and medicine graduates earn most, finds report

Salary uplift of some degrees in UK exceeds that gained from private education, says study

Students studying economics and medicine at British universities are likely to gain the largest financial benefits from their degrees, outstripping even the considerable advantages enjoyed by private school students or people from the wealthiest backgrounds, a study has found.

An Institute for Fiscal Studies report, using several years of evidence gathered from education and taxation data, showed the higher pay for graduates in a small group of subjects remained even after adjusting for student background and school type.

Related: More degree students graduating with firsts than 2:2s or below

Related: Oxford overtakes Cambridge for first time in QS world rankings

Related: Creative industries fear tuition fees will kill supply of talent

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Training plus a placebo may make a drug more effective

The placebo effect can be incredibly powerful, performing nearly as well as carefully designed and tested drugs, substituting for actual surgeries and even generating side effects. But it’s a tricky thing to apply outside of experiments. After all, not everyone will have a strong placebo response, so it’s unethical to use it in place of actual treatments.

Now, some researchers in Germany have figured out a way to harness the placebo effect to increase the impact of a normal drug treatment. The procedure involves getting patients to associate a taste with a powerful drug that has problematic side effects. Once the association is made, the patients were given a mix of normal drugs and a placebo, along with the flavor they’d associated with the drug. This experiment enhanced their response to the drug, providing an avenue to potentially reduce its dose and, thus, its side effects. And the whole thing worked despite the fact that the patients knew exactly what was going on.

The drug at issue, cyclosporine A, is a powerful suppressor of the immune system, which makes it useful for patients who have received organ transplants or who have a strong autoimmune disorder. But the immune system isn’t the only system affected by this drug; it also kills off kidney and nerve cells and causes heart problems and hypertension. These effects are independent of any changes to the immune system, but nobody has figured out a way to target the body’s response specifically to immune cells. As a result, people taking this drug have to carefully balance its useful features against its toxicity.

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