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Face ID Camera Technology Changes How Businesses Approach Security

– Contributed content –

Apple, woman in background

(claudioscott, Pixabay)

20 September 2017. The new Apple iPhone X made a big splash in the tech community when it launched last week. Although the device was still evolution, rather than revolution, it was a showcase of all the technological wonders that can now be shoved inside an object no bigger than your hand.

Among the highlight features was the new Face ID technology: a technology which now allows people to unlock their phones just by looking at them. Facial recognition technology is now so sophisticated that it is able to recognize people automatically, without the need for human intervention.

Although the media focused on the consumer side of the story, the fact that AI is working its way into camera tech has serious implications for business IP surveillance too. For starters, the ability to recognize faces has the potential to significantly reduce the overhead associated with checking people in and out of office buildings. Smart cameras could potentially provide access to buildings to those with the correct clearance, removing the need for posting security or a reception desk. What’s more, companies could segment access to various parts of the building based on a person’s role. Employees, for instance, could be blocked from accessing mission-critical areas, like the company servers or records of account.

Then there’s the anti-crime factor. Facial recognition cameras set up in business could be linked to police databases. Companies could monitor known criminals in the vicinity of their stores automatically, enabling them to direct their security resources to prevent theft. Retail stores, in particular, stand to benefit a great deal. With facial recognition cameras, they can keep track of potential threats and eliminate them before they result in loss of stock.

The MIT Technology Review has recently suggested that we’re only at the beginning of facial recognition technology – and that’s a problem. The concern at the moment is that computer facial recognition systems aren’t analogous to those of humans. Whereas people would never mistake a brick for a face, this isn’t out of the realm of possibility for facial recognition software.

The fundamental problem has to do with the way that these systems work. Although they now have similar accuracy to people – making mistakes around 5 percent of the time – the severity of those errors can be extreme. Because machines lack an understanding of context, they’re often not able to determine whether their answers make sense. A machine might conclude that a face in a picture is something radically different to what it actually is, whereas a person would not.

One thing is for sure: businesses will use this capability to streamline their operations and free up labor for other tasks. Not only will companies be able to segment their digital networks, but also their physical operations too – and at low cost.

Technology will continue to get better, and at a rapid clip,. With the addition of iris, fingerprint and face recognition, the number of mistakes made by facial recognition cameras will decline, as systems collaborate to perform accurate identification of personnel and potential criminal threats.

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Guidelines Designed for CAR T-Cell Cancer Therapies

MD Anderson campus

Aerial photograph of MD Anderson campus in 2011 (MDAnderson.org)

20 September 2017. Cancer specialists and scientists at several cancer care centers propose safety guidelines for patients receiving engineered immune cell treatments that often have severe adverse effects. The team led by researchers at MD Anderson Cancer Center in Houston, part of the University of Texas system, published its guidelines in yesterday’s issue of Nature Reviews Clinical Oncology (paid subscription required).

The researchers led by Elizabeth Shpall, director of MD Anderson’s cell therapy laboratory, and Sattva Neelapu, professor of lymphoma and myeloma, aim to provide guidance for emerging treatments using T-cells, white blood  cells from the patient’s immune system, genetically engineered to express chimeric antigen receptor proteins. The therapies reprogram the T-cells with genetic engineering to find and kill cancer cells like an antibody. These modified chimeric antigen receptor or CAR T-cells are infused back into the patient, seeking out and binding to a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several types of blood-related cancers.

CAR T-cells are being tested in clinical trials among patients who do respond to conventional treatments for a number of blood-related cancers, which report remission rates as high as 90 percent. In August 2017, FDA approved the first CAR T-cell treatments in the U.S. for patients with a form of stubborn or relapsing acute lymphoblastic leukemia. But along with the successes come high rates of severe adverse effects, leading in some cases to patient deaths. As reported in Science & Enterprise earlier this month, FDA put a clinical hold on two trials testing CAR T-cells when a patient died in one of the trials.

The guidelines proposed by the MD Anderson researchers — with colleagues from the Mayo Clinic, Moffitt Cancer Center in Tampa, and Sylvester Cancer Center at the University of Miami — address two of the main adverse reactions experienced by CAR T-cell patients. Cytokine-release syndrome is a set of reactions to immunotherapies with symptoms often resembling the flu, such as fever, nausea, chills, and muscle aches. In severe cases, however, cytokine-release syndrome can pose an emergency for patients and lead to life-threatening complications.

Another adverse reaction, but less common, is neurological toxicity called CAR-T-cell-related encephalopathy syndrome that in some cases can lead to lethal swelling in the brain. Both of the adverse reactions are treatable, however, and the guidelines offer recommendations for pre-treatment preparations, monitoring, identification of emerging adverse reactions, and treatment recommendations based on the severity of the patient’s condition.

The guidelines are a product of the CAR-T-cell-therapy-associated toxicity, or Cartox, Working Group, made up of professionals from a number of institutions with experience treating cancer patients with CAR T-cells. The group’s recommendations cover diagnostics and treatments for adverse reactions to these treatments. In cases of neurological toxicity, for example, the guidelines recommend a simple question-and-answer test, writing a standard sentence, and counting backwards from 100 by tens. Other recommendations offer ways of controlling expression of the protein interleukin-6, considered a driver of cytokine-release syndrome.

“While we all work on those issues, and learn how to better manage and harness these therapies,” says Shpall in an MD Anderson statement, “the Cartox algorithms provide ground rules for patient safety.”

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Eco-Friendly Technology – An Essential Investment For Today’s Successful Brands

– Contributed content –

Solar panels

(Oregon Dept of Transportation, Flickr)

20 September 2017. During the last couple of years, more people chose to register a business in the United States than at any time in the past. That is because the job market is slow, and unemployment rates are high. Launching a new company is often the only way average folks can improve their quality of life. However, it’s vital that every single entrepreneur out there today understands the importance of green technology. The information published below should help to highlight why eco-friendly methods have become a critical part of the business world, and why everyone who reads this post needs to plan for those investments in their budget.

Eco-friendly technology will save the planet

There is no getting away from the fact that our reliance on fossil fuels is damaging the planet right now. That is something nobody wants to happen because individuals could ruin the world for future generations. An investment in solar panels could make a massive difference if every business owner chose to walk that path. There is more than enough available energy coming to earth from the sun for everyone to power their workplaces. So, now is the best time to search online for solar deals and identify the best providers. In some instances, it’s possible to get a grant from the government or local authority.

Eco-friendly technology will help companies to save money

All business owners should aim to cut back on spending as much as possible if they want to increase their profits. While some folks might have to consider services from smallbusinessloans.co and similar sites to cover the initial cost of solar panels and green tech, the devices should pay for themselves in the long run. That is because most systems will generate more power than they use. So, the energy companies have to send entrepreneurs a check at the end of the year. Not only does eco-friendly technology assist people in saving money, but it could also help them to make some too.

Eco-friendly technology doesn’t have to break the bank

As mentioned a moment ago, there are lots of government-backed schemes and grants business owners could use if they want to go green. It’s sensible to employ the services of a legal representative or advisor with lots of experience to oversee the process. That way, entrepreneurs can make sure they’re not making any mistakes so say writers from entrepreneur.com and other experts. As the old saying goes, the devil is in the details. Professional lawyers have to read contracts all day long, and so they are the people best places to highlight any issues. Contrary to popular belief, most green tech is cheap to purchase, and it will not break the bank.

Business owners who want to learn more about the latest technology and how it could benefit their operations just need to conduct some online research. There are thousands of news articles and blog posts describing the inner workings and advantages of different concepts. So, read as much as possible and then create a plan of action. If nothing else, the next generation will appreciate the effort.

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Neuro Disease Start-Up Gains $30M in Early Funds

Nerve cells illustration

(commonfund.nih.gov)

19 September 2017. A start-up enterprise developing treatments for several neurological diseases that the company says are triggered by a common destructive protein, is raising $30 million its first venture financing round. The one year-old company, Disarm Therapeutics in Cambridge, Massachusetts, is founded by two researchers at Washington University in St. Louis that made the key scientific discoveries leading to these proposed treatments.

Disarm Therapeutics is targeting neurological conditions that result from axon degeneration, a condition found in a number of disorders, affecting axons — the long extended fibers in neurons, or nerve cells — that carry electrical signals from the body of the cell. The degeneration of axon fibers is associated with several neurological disorders, including multiple sclerosis, amyotrophic lateral sclerosis or ALS, glaucoma, Parkinson’s and Alzheimer’s disease, and peripheral nerve pain from diabetes or chemotherapy.

The company’s founders, geneticist Jeffrey Milbrandt and developmental biologist Aaron DiAntonio, study axon degeneration at Washington University and identified a common feature to the condition: a protein known as SARM1, short for Sterile Alpha And TIR Motif Containing 1. The researchers discovered the mechanisms behind axon degeneration that result from SARM1, usually a consequence of trauma or injury, but also inflammation or intraocular pressure associated with glaucoma. Milbrandt and DiAntonio documented the role SARM1 plays in breaking down the body’s built-in protections for axons, including the chemical actions used by SARM1 to destroy these protections.

Disarm Therapeutics’ technology, based on this research and licensed from Washington University, is a platform for developing treatments that limit the effects of SARM1 in axonal degeneration. The researchers say SARM1’s enzymatic activity offers a target for new therapies. The company also plans to develop non-invasive diagnostics to determine the extent of axonal degeneration and predict the likely effects of treatments.

Rajesh Devraj, also a co-founder and the company’s current chief scientist, says in a company statement that Disarm plans to translate the research by Milbrandt and DiAntonio into “human proof of concept in a range of neurological diseases, supported by non-invasive biomarkers.”

Milbrandt and DiAntonio are scientific advisors to Disarm Therapeutics, which they founded in 2016 with Atlas Venture, an early-stage life science venture investment company in Cambridge, Mass. Atlas Venture also led Disarm’s new venture financing, along with Lightstone Ventures and AbbVie Ventures, raising $30 million.

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Microfluidics, Sound Waves Combined for Liquid Biopsies

Exosome illustration

Exosome illustration (National Cancer Institute)

19 September 2017. Biomedical engineers from several universities developed a microfluidics, or lab-on-a-chip, device that uses sound waves to quickly isolate tiny packets of cell materials for detecting diseases. The team from Massachusetts Institute of Technology, Duke University, University of Pittsburgh, and Nanyang Technological University Singapore describe the technology in yesterday’s issue of Proceedings of the National Academy of Sciences.

The researchers are seeking faster, less destructive, and more automated methods for diagnosing disease from ordinary blood samples, particularly to capture and analyze exosomes, an emerging target for a number of biomedical applications. Exosomes are tiny — 40 to 150 nanometer — lipid-membrane containers in cells that gather up and secrete cytoplasm, the gel-like material outside the cell nucleus. While originally believed to carry out waste removal and other maintenance tasks, exosomes were shown in recent years to perform useful delivery functions carrying proteins and genetic material to other cells, and drawing increased attention from a range of biological disciplines.

Exosomes offer a great deal of potential in biomedical processes, since they’re found in many biological fluids, such as blood, urine, saliva, and breast milk. Since many of these fluids can be captured with minimal or no invasiveness, they could also substitute for some tissue biopsies now used to detect solid tumor cancers. And exosomes are more abundant than circulating tumor cells, a source of biomarkers in many current liquid biopsies.

Many of today’s processes for isolating, capturing, and accumulating exosomes with high purity and quality use centrifuges, which while effective, can take hours or days to collect a sufficient quantity of exosomes for testing, as well as employ physical forces that can harm exosomes and reduce their useful yield. The authors — led by MIT’s Ming Dao and Subra Suresh (since named president-designate of Nanyang Technological University), Duke’s Tony Jun Huang, and Yoel Sadovsky, director of the Magee-Women’s Research Institute affiliated with University of Pittsburgh — say alternative methods for exosome capture are being developed, but they often run into problems with need for additional reagents, low yields, impurities, or long turnaround times.

Among the more promising methods use chip devices with microfluidics containing fine channels where small specimen samples, often no more than a drop, can be quickly analyzed to expose exosomes. In this project, the researchers start with microfluidics, but add in acoustics, where sound waves can quickly isolate exosomes from whole blood samples. Their device contains a pair of transducers, units that convert energy from one form to another, to create sound waves. The chip first separates blood cells and platelets containing exosomes, then a second module using higher frequency sound waves isolates exosomes from their supporting materials.

Tests show the chip device’s process called acoustofluidics can process blood samples quickly and with high purity. The team’s prototype chip analyzed whole blood samples of 100 microliters in about 25 minutes. The device captured 82 percent of exosomes in the samples, returning exosomes with a purity of 98 percent. “This new generation of integrated device design,” says MIT’s Dao in a joint statement, “makes it possible for centrifugation-free sorting of different blood components, which can drastically reduce the cost and processing time involved with liquid biopsy assays.”

The authors also note that acoustofluidics can be integrated more easily into single-step and automated systems. The device can analyze blood samples and return results in a single process, rather than requiring multiple steps with additional pieces of bulky lab equipment, such as centrifuges, and instruments. In addition, the single-step process is more likely safer and requires less training for operators, as well as better able to return consistent results.

The team next plans to refine the chip device into a practical tool to detect biomarkers indicating diseases. The researchers say they received funding to apply the technology to indicators of abnormal pregnancy, but believe it can be used to detect other disorders as well.

The following video from Duke University, tells more about the acoustofluidics device.

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Avian Flu Vaccine with Longer Protection in Development

Harvesting H7N9 viruses

Scientist at Centers for Disease Control and Prevention harvests H7N9 viruses for research and testing by partners. (CDC.gov)

18 September 2017. A biotechnology company is designing a vaccine to protect against the newly emergent avian flu to provide more sustained protection like seasonal flu vaccines. EpiVax Inc. in Providence, Rhode Island is developing the vaccine, supported by a 5-year, $5.8 million award from National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.

While other vaccines against avian flu are in development, including a candidate by EpiVax, these current vaccines against the H7N9 virus responsible for avian flu do not generate long-term immune responses, unlike seasonal flu vaccines that protect over an entire flu season with one injection. Public health authorities first spotted the human H7N9 virus in China in March 2013, which were believed to first infect poultry and later spread to humans in contaminated environments. Most patients infected with H7N9 experienced severe respiratory illness, with deaths occurring in about one-third of the cases.

While earlier H7N9 outbreaks were sporadic, in 2017 China is experiencing its largest epidemic to date. As of early September, World Health Organization counts 760 new cases in the current outbreak, bringing the total number of human infections to 1,558. While most cases result as before from poultry-to-human transmission, rare instances of human-to-human transmission are also being reported.

The EpiVax team led by company founder and president Anne De Groot is joined by researchers from University of Massachusetts medical school, University of Georgia, and the company Protein Sciences. The researchers plan to apply bioinformatics and molecular modeling to design enhanced hemagglutinin proteins found on the surface of the virus to stimulate  a longer-lasting response from the immune system to protect against H7N9 infections.

Those enhancements involve adding epitopes, or binding regions of antigens that stimulate production of antibodies, to the H7N9 hemagglutinin proteins. The added epitopes would resemble corresponding binding regions found in seasonal vaccines, but missing from wild type H7N9 viruses. These epitopes provide the memory capability of seasonal vaccines, enabling one injection to keep generating a response from T-cells in the immune system that last an entire flu season. Yet, the new vaccine would retain the ability to generate immune system responses specifically against H7N9 viruses.

The researchers plan a two-phase approach, with the first phase designing the new, enhanced hemagglutinin protein that retains the anti-H7N9 epitopes, but adds the more sustained responses, and testing the protein in lab cultures and with animals. In the second phase, the team plans to refine the vaccine to minimize opportunities for mutations, to maintain its potency over longer periods. The eventual outcome of the project is a vaccine candidate ready for final tests leading to an investigational new drug application with FDA.

EpiVax’s earlier vaccine protecting against H7N9 viruses by boosting its immune system response is currently in a clinical trial in Australia. That vaccine is supported by a $600,000 Small Business Innovation Research grant awarded a year ago by NIH.

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Stem Cells Shown to Heal Chronic Leg Wounds

Walking on cobblestones

(Kati, Pixabay)

18 September 2017. Experimental treatments using patients’ own stem cells were shown in a pilot test to heal painful chronic wounds on their legs and feet. Results of the study testing a system made by the company InGeneron Inc. in Houston and Munich, appear in the 4 September issue of the Journal of the European Academy of Dermatology and Venereology (paid subscription required).

InGeneron develops regenerative medicine solutions taking advantage of therapeutic properties in an individual’s mesenchymal or adult stem cells that transform into many types of cells, and thus can be harnessed to heal or replace damaged tissue. Using a person’s own stem cells also overcomes problems of immune system rejection from donors, even close family members.

In this case, the stem cells are derived from a person’s adipose or body fat tissue to treat chronic wounds that appear on feet or legs. Among the leading causes of these chronic wounds is diabetes that reduces blood flow to the legs and feet, leading to nerve damage and reduced feeling in those regions, as well as slower healing of wounds. Centers for Disease Control and Prevention says in 2010, some 73,000 Americans required amputation of a leg or foot because of complications from diabetes. While malnutrition and immune deficiencies can also cause chronic wounds, CDC says people with diabetes are 8 times more likely to lose a leg or foot than people without diabetes.

InGeneron is developing its Transpose RT system as a minimally invasive treatment for chronic wounds at the point of care. The system, administered by trained clinicians, removes fat tissue cells, such as those under the skin in the abdomen, similar to liposuction. The system processes the fat cells with enzymes, then heats and isolates adult stem cells from the rest of the mix. Physicians apply the stem cells directly to the wounds in dressings as a topical treatment.

The study team led by Alexander Konstantinow in the Department of Dermatology at Technical University Munich recruited 16 individuals, age 52 to 84, with chronic leg wounds, 7 with venous ulcers and 9 with mixed arterial and venous ulcers. The researchers looked primarily for healing as shown in changes in wound size after 12 weeks, as well as reports of adverse side effects, but also changes in pain experienced and time needed for new tissue to grow in the open wounds. The team follow-up with participants after 6 months.

The results show all 7 participants with venous leg ulcers reporting full closure of their wounds, as well as 4 of the 9 individuals with mixed venous and arterial ulcers, a process taking from 10 to 25 weeks. In addition, participants reported less pain within 2 weeks of treatment. Among the participants, 3 patients had wounds on both legs, but wounds on only one leg were treated. Nonetheless, in these cases the wounds on the non-treated legs also started healing. None of the participants reported serious adverse effects.

InGeneron plans another clinical study in the U.S. with 36 individuals having venous leg ulcers. In this trial, participants will be randomized to receive Transpose RT system treatments or standard wound dressings. The study is now recruiting participants at Sanford Medical Center in Sioux Falls, South Dakota.

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Will 2017 Be The Year Of The First Human Head Transplant?

– Contributed content –

18 September 2017. If you’ve read this question, no doubt your head is spinning with the thought that we are already three-quarters of the way through the year, so there isn’t much time left alongside images of Frankenstein and questionable medical ethics. Surgeon Sergio Canavero is adamant that a human head transplant is doable and can result in a quadriplegic individual, in time, regaining full use of a body, albeit not the one they were born with. This medical procedure sounds like it belongs in the realm of science fiction. However, 2017 may be the year that this operation is carried out.

Surgery

(skeeze, Pixabay)

What will Dr. Canavero do?

The head to be transplanted and the donor body needs to be cooled to approximately 13 degrees Celsius to ensure their preservation without oxygen. Following the severing of the blood vessels and tissues of the neck, the spinal cord is then cut. The already headless body is then ready to have the head connected to it. The procedure is long and complex with major blood vessels, nerves and tissues needing to be joined with delicacy. The two spinal cords will be merged with polyethylene glycol which has been proven to promote the growth of spinal cords in rats.

Once the operation is complete, the patient will be kept in an induced coma for at least a month allowing minimal movement to the neck. When the patient awakens, Canavero has suggested that the patient will be able to move and talk whereas walking would be relearned within twelve months with the aid of intense therapy.

Surgery

(skeeze, Pixabay)

Controversy

It’s not just us mere lay people who recoil in horror at the thought of such a procedure. The operation and processes involved in carrying out a full head transplant seem simplistic. The fact that both the transplantee and the donor need to be clinically dead before being brought back to life leaves most people skeptical at best and appalled at worst.

The medical profession sees this leap forward in transplanting organs as pure fantasy. As discussed on the site Human Paragon, the ability to transplant artificial organs is already a reality. In 2010, the first artificial kidney was transplanted, and artificial lungs have been utilized for decades. Animal valves and tissues have also been transplanted in patients with weakened hearts and damaged organs. It is quite a leap to suggest that a human head could be transplanted successfully.

There is much speculation that Canavero won’t end up carrying out his procedure due to the potential legal ramifications. Imagine the situation: a qualified surgeon performing an unproven and untested procedure on a human, only for this human to awaken in debilitating pain, before dying a terrible, painful death.

The question of ethics is also mooted. Why perform a head transplant merely because you can? It doesn’t make it the right thing to do even if it could be successful, which looks highly unlikely at the moment.

Dr. Sergio Canavero is a maverick, alone in the world of medical science striving to complete something that, if it miraculously works, could see his name go down in history as the founder of bringing people back from the dead. He could also become infamous as a fantasist who brought nothing but shame to the medical profession with crackpot ideas and Frankenstein like theories.

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3-D Organ Printing Company Gains Seed Funds

Prellis Biologics co-founders

Prellis Biologics co-founders Noelle Mullin, left, and Melanie Matheu (Prellis Biologics Inc.)

15 September 2017. A start-up enterprise seeking to create replacement human tissue and organs with three-dimensional printing is raising $1.8 million in seed capital. Prellis Biologics Inc., a one year-old company in San Francisco, plans to produce human tissue and organs with 3-D printing using its own process for which patents are pending.

The company’s two founders are bringing expertise in tissue engineering and stem cell biology to Prellis Biologics. Melanie Matheu, the company’s CEO, received a Ph.D. in physiology and biophysics at University of California in Irvine, and later completed a postdoctoral fellowship at University of California in San Francisco. In her doctoral research, Matheu studied the laser-based imaging processes underlying the company’s technology, including the application of those processes to print the fine blood vessels, called microvasculature, permeating human tissue and organs.

Noelle Mullin, chief scientist at Prellis, received her Ph.D. at UC-San Francisco and later served as a postdoctoral researcher at UC-San Francisco and Stanford University, where she studied stem cell biology related to breast and skin cancers. Her work underpins the company’s plan to develop 3-D tissue scaffolding that recreates a supportive environment for stem cells making it possible rapid, large-scale production of vascularized tissue and organs.

The founders say their technology can overcome many of the obstacles that so far prevent 3-D printing from producing human tissue, particularly speed and high resolution. According to the company, Prellis is already producing prototypes of microvasculature and organoids, miniature and simplified organs.

The process, says the company, uses lasers to put down fine layers of extracellular matrix, secretions from cells that provide structural and biochemical support, already containing cells at near instantaneous speeds. Unlike most current tissue engineering methods, the Prellis process, according to the company, does not require previous cell seeding or additional culturing to produce tissue matrix.

Prellis Biologics currently resides at IndieBio, a start-up incubator for bioscience enterprises in San Francisco that provides initial funding of $250,000 plus 4 months of training and mentorship. The company first plans to produce human tissue samples for drug testing, and later tissues for transplant, including connective tissue like tendons and ligaments, and organs. “We believe our technology,” says Matheu in a company statement, “will jump-start the practical use of lab-printed tissue for life-saving drug development, rapid development of human antibodies, and production of human organs for transplant.”

The company’s new seed funding of $1.8 million is led by venture investor True Ventures in Palo Alto, California, with participation by Civilization Ventures, 415 Ventures, and other angel investors.

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FDA Clears First Mobile App for Substance Abuse

White smartphone

(kote baeza, Pexels.com)

15 September 2017. A smartphone app designed to help treat substance abuse disorders received approval from the U.S. Food and Drug Administration. FDA approved the reSet app, created by Pear Therapeutics, for use in outpatient therapy prescribed for individuals abusing alcohol, cocaine, marijuana, and stimulants. The agency says it’s the first app cleared for substance abuse disorders.

These conditions, as defined by the Substance Abuse and Mental Health Services Administration, occur when individuals face significant clinical or functional impairment from recurrent use of alcohol or drugs, such as health problems or disability, as well as failure to meet home, work, or school responsibilities. Substance abuse disorders can range from mild to severe, based on evidence of impairment.

Pear Therapeutics, in Boston and San Francisco, designed the reSet mobile app to encourage adherence to medications and support outpatient therapy for substance abuse. The app adapts cognitive behavioral therapy, a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. Users of the app receive incentives and rewards for sticking with their therapy, while clinicians can track clients’ progress with a dashboard in a desktop software program.

FDA based its approval in part on results from a clinical trial with some 400 individuals with substance use disorder enrolled in a 12-week therapy program. Participants were randomly assigned to receive the standard counseling therapy alone or with an earlier version of the software, known then as Therapeutic Education System. Individuals receiving the electronic assistance had two hours less counseling time than those receiving the standard counseling. The results show participants using the software in their therapy reporting a higher rate of abstinence from drugs and alcohol (40%) than those receiving the standard therapy (18%).

This and other clinical trials did not reveal any adverse side effects from the software. While participants in the trial experienced adverse events associated with substance abuse disorders, such as depression and suicidal thoughts or behavior, they were not associated with the tested software.

FDA, however, did not approve reSet for opioid addiction therapy. Results of the clinical trial show participants abusing opioid drugs were no more likely to be helped by the software than those receiving counseling alone. As reported in Science & Enterprise in July 2017, Pear Therapeutics is developing a separate version of reSet, called reSet-O, designed specifically to help in opioid addiction therapy. The company received a $180,000 Small Business Innovation Research grant from National Institute of Drug Abuse, an agency of NIH, to accelerate its development.

FDA used the agency’s de novo premarket review procedure to clear the reSet app. This process is reserved for new types of low- to moderate-risk medical devices where there are few, if any, earlier equivalent devices.

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