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Serious Illnesses in Nebraska Tied to Exosome Therapy – MedPage Today

Several individuals in Nebraska developed severe infections after receiving unapproved cell-based therapies said to include exosomes, state health officials said.

These patients -- fewer than five -- became seriously ill, with some developing sepsis, Leah Bucco-White, a spokesperson with the Nebraska Department of Health and Human Services, told MedPage Today via email.

All were given an exosome product that was derived from C-sectioned placentas, according to a health alert sent by the state to clinicians. MedPage Today has previously reported on a growing trend of hospitals implementing placenta donation programs and potential links to unapproved stem cell products.

"We continue to carefully and actively assess this situation with our federal partners," including the CDC and the FDA, Bucco-White said. She added that she couldn't share further details at this time, including the name of the product used, the source of the C-sectioned placentas it came from, the clinics where it was administered, or the bacteria that caused the infections.

While exosomes are being evaluated in legitimate research studies, some clinics -- often those peddling unapproved stem cell therapies -- are offering exosome therapy for all kinds of conditions. One site for a clinic in San Diego describes the treatment as "the ultimate anti-aging hack" and even offers financing for the therapy. Delaware Integrative Medicine advertises exosome therapy as being helpful for patients with "chronic inflammation, autoimmune disease, Lyme disease, and other chronic degenerative diseases."

But stem cell researchers say exosomes -- packages of proteins and RNAs that can be transferred from cell to cell -- are nowhere near ready for prime time.

Until 2007, researchers thought exosomes were just a way for cells to get rid of trash. But that year, Swedish researchers showed that some cells use them to transfer genetic material. Chemical & Engineering News reported that companies are looking at exosomes in drug delivery, and a PubMed search reveals scores of experiments with these compounds.

But what's in them, and their actual function, remains up for debate.

"A lot more evidence is required to understand what they are, and it may be that a lot of claims about what they do in the end go by the wayside," Sean Morrison, PhD, a stem cell biologist and director of the Children's Medical Research Institute at UT Southwestern, told MedPage Today. Disagreement continues as to whether exosomes even have a physiologic function, "or if they're just some cellular waste product," he said.

Even the methods for purifying exosomes grown from culture are controversial within the scientific community, he added -- raising questions about what's in the vials being used in treatment.

"What these snake oil salesmen do is they pick a word out of the scientific literature that gets people excited, and they start to sell it," Morrison told MedPage Today.

The same companies that are willing to ignore FDA requirements for safety and efficacy testing are the same ones willing to ignore regulations for good manufacturing practices and cut corners to sell things that are contaminated with bacteria, he added.

The FDA has long been trying to get a handle on unapproved stem cell therapies. Last week, the agency sent a warning letter to Liveyon, the company involved in a spate of infections tied to stem cell products last year. It has warned several other stem cell companies as well. In 2017, the agency issued guidance on regenerative medicine products, with a November 2020 deadline for full compliance.

Morrison suspects the companies not yet in compliance have no intention of doing so: "They're going to keep doing what they do as long as they possibly can."

One of the "unfortunate facts" is that FDA resources for enforcement are limited and many of these companies are "betting on the fact that FDA is not going to have the resources to shut them down," he said.


last updated 01.09.2020

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Optimum Regenerative Offers Alternative to Traditional Care | Health & Fitness –

BETHEL Optimum Regenerative Care, 2 Stony Hill Rd., offers an alternative to traditional medical options. Clinical Director Steve Geoffrion told Voices, Regenerative medicine is taking off because people are looking for more natural options when it comes to chronic joint pain or chronic diseases. He regularly holds seminars to describe the treatments at the facility, which include injections of stem cells.

Interest is high. There are usually 30 to 50 people in the room who dont like the idea of a total knee or hip replacement or the side effects of medicine.

He continued, Regenerative medicine is exactly what it says it is. Our body has an innate ability to heal itself. If you remember when you were younger, you might sprain an ankle or twist a knee and you got better. As we age, the body has a harder time doing that because our stem cells age with us and are lost over time.

According to Mr. Geoffrion, there are 200 types of cells in the human body and stem cells are master cells in charge of healing and anti-aging.

There are many misconceptions about stem cells and a lot of misinformation on the Internet. One of those myths is that this approach is new and not yet proven effective.

He claimed that stem cells are used safely in more than 30 countries.

The Food and Drug Administration has administered stem cell use since November 2017 [in the United States]. Its important for people to know that clinics and stem cell banks are highly regulated,

The staff at Optimum Regenerative Care has a combined 20 years of experience and includes Medical Director Gerald Valletti, M.D., Andrew Paulson, APRN, and Rhovia Lambino, D.C.

This is more than pain management or reducing inflammation. I got into this field because I enjoy the pleasure of coming to work and knowing I can change peoples lives.

He shared the story of a man named Rick, who began walking four miles each day after retirement.

Rick wanted to keep in shape but had to stop because he had pain in both knees. He visited doctors who diagnosed a torn meniscus in each knee. They recommended surgery but he didnt want to undergo that treatment. Instead, he received stem cell injections in each knee and, after only four weeks, was back to walking four miles each day.

He went from a pain level of nine to zero, Mr. Geoffrion added. Now, to be fair, those results are not typical. Most patients shift from an eight or nine to a three or four but those same patients would consider their results as life changing.

Many patients arrive at Optimum Regenerative Care with joint pain, but Mr. Geoffrion pointed out that the reason they want treatment is to regain activities they miss in life. The real motivation is because they cant play with their grandchildren or play tennis or golf. This is about quality of life; we get people out of pain and back into life.

Optimum Regenerative Care specializes in using stem cells to treat conditions related to arthritis, degenerative joint disease, peripheral neuropathy, and plantar fasciitis but offers alternative therapies.

Pulsed electromagnetic field therapy is all about increasing the voltage or energy in the cells to strengthen them and promote repair.

The clinic is currently offering complementary pulse wave therapy sessions, which are intended to stimulate the production of new stem cells, to those who would like to learn more by experiencing a treatment.

Other therapies include anti-aging treatments, skin rejuvenation with micro-needling, relief for erectile dysfunction, and hair restoration for both men and women.

Im a big fan of modern medicine but if someone has a health concern, theres not much regenerative medicine cannot address in a safer and more natural way, Mr. Geoffrion said.

The next free seminar describing the stem cell and other natural therapy services available at Optimum Regenerative Care will take place at 11 a.m., 2 and 6 p.m. Saturday, January 22, in the Heritage Hotel and Conference Center, 522 Heritage Rd.

Seminar reservations may be made by calling 203-970-4466.

More information is available by visiting or liking Optimum Regenerative Care on Facebook.

Complimentary consultations are available by calling 203-917-4774.

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Southard Med Spa in Tulsa, OK Is Launching Several New Anti-Aging Treatments – MENAFN.COM

(MENAFN - GetNews) Southard Med Spa in Tulsa, Oklahoma is pleased to announce the launch of several new anti-aging treatments. Since opening in 2011, Southard Med Spa has been in a local leader in the medical spa industry and a proponent of science-based anti-aging therapies.

Southard Med Spa in Tulsa, OK is pleased to announce the addition of two new anti-aging injectables to their lineup of aesthetic medicine procedures. As more and more people begin to seek out medical spas for anti-aging services, providers have been called to meet their demands with more affordable treatment options.

One of the most popular treatments available at Southard Med Spa has been Botox . However, many people are starting to seek out similar products. This is why Southard Med Spa is now offering Xeomin and Dysport.

Xeomin is a product like Botox that reduces fine lines around expression - mainly around the eyes, forehead, and between the eyes andDysport is one of our personal favorites, Dysport also reduces expression lines around the same areas, but has a wonderful effect on 'crows feet around the eyes. Dysport has a strong customer loyalty program that Southard Med Spa can assist you in using.

Products like Botox relax muscles that cause wrinkles. "Think of a piece of paper that gets folded over and over until a crease forms. If you stop folding the paper eventually the crease becomes less pronounced. The same thing happens to your skin where expression lines cause creases. You will typically notice a significant difference soon after your first treatment, but the effects can be increased over multiple treatments," said Barbara Southard, owner of Southard Med Spa.

Southard Med Spa is owned by Barbara Southard,MSN, ARNP, Certified Nurse Injector. Barbara and her husband, Dr. Wrany Southard have been operating their Tulsa Med Spa since 2011.

Media Contact Company Name: Southard Med Spa Contact Person: Barbara Southard Email: Send Email Phone: (918) 615-2125 Address: 6333 S Memorial Dr G City: Tulsa State: OK Country: United States Website:


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Alzheimer’s May Be Reversed By Shining Light Directly Into The Brain – Anti Aging News

According to a recent study shining light directly into areas of the brain that have been damaged by Alzheimers disease may help to reverse the course of the disease. Daily treatment with LED lights attached to a headset that beams pulses of gamma waves into the hippocampus is said to boost mitochondria which sweep away toxic proteins that build up in the brain.

Currently there is no known cure for Alzheimers disease, this Neuro RX Gamma headset developed by Vielight may offer hope to the millions who suffer from the brain wasting disease around the globe: early testing provided positive results of patients regaining memory as well as improvements in reading and writing skills in three months which has paved the way to a 12 week trial into its effectiveness.

To undergo treatment for 20 minutes a day the patient has to wear the device and a separate nasal clip that also channels light through the nostrils; the light is believed to boost photobiomodulation, this then stimulates the brain to activate microglia immune cells which fight the disease.

In Alzheimers disease these cells can become inactive and plaques build up stopping the brain from functioning normally. Amyloid plaque is a common hallmark of the disease, the sticky build up is thought to lead to the progressive destruction of brain cells.

Photobiomodulation introduces the therapeutic effect of light into our brain. It triggers the body to restore its natural balance or homeostasis. When we do that, we call upon the body's innate ability to heal. Based on early data, we are confident of seeing some measure of recovery in the symptoms not just a slowdown in the rate of decline, even in moderate to severe cases, said inventor Dr. Lew Lim to The Telegraph.

The trail involves 228 subjects across eight sites within Canada and America and is being led by the University of Toronto; half of the subjects will receive a placebo six days a week for 20 minutes over the course of 12 weeks while the other half will be receiving light therapy.

The safety trial involved 5 subjects with mild to moderately severe dementia showed the condition of all subjects conditions improve, and reports improved cognitive function, better sleep, fewer angry outbursts, less anxiety, and less wandering as well as better memory. Brain scans revealed visible improvements in connectivity between brain regions as well as better blood flow. However, once therapy stopped the subjects began to decline.

Currently light therapy is used to treat seasonal affective disorder patterns and traumatic brain injuries; it is believed to trigger the release of the happy hormone serotonin to promote better sleep and stimulate areas of the brain that shut down after damage.

The American Academy of Anti-Aging Medicine (A4M) is also Shining New Light on Dementia with another trial:

Treatment for neurodegenerative disorders using noninvasive, non-drug methods has reached a new level of efficacy with the introduction of transcranial and intraocular photobiomodulation (PBM) and brainwave biofeedback training (NFB). Evidence continues to mount supporting the use 1065-1075nm, pulsed infrared light to significantly improve both motor and behavioral symptoms of subjects with both Parkinsons and probably Alzheimers disease. PBMs proposed mechanism of action is in the mitochondrial functions, microvascular flexibility/perfusion, increased production of ATP and reduction of phosphorylated Tau and Ab42. Cell line studies within a CD-1 mouse model on memory and performance (Michalikova,2007) demonstrated PBMs beneficial effects and (Duggett & Chazot, 2014) demonstrated PBM reducing amyloid-induced cell death. It is proposed that the PBM confers a tissue-level therapeutic effect while NFB training can remediate the neural network connectivity deficits caused by neuronal dysfunction and death. The synergistic effect of a PBM and NFB treatment strategy should result in enhanced electrophysiological connectivity, CNS health and resistance to further tissue damage. (Nichols & Berman, 2019)

Human trials were conducted employing 28 daily, in-office, 6-minute treatments (Berman, 2017) and (Huang, 2018 unpublished) delivering 28, twice daily, home-based, self-administered, 6-minute, transcranial and intraocular treatments (N=12) safely produced marked cognitive and motor behavior improvements. Improvements were associated with frequency of treatment given other relevant variables were invariant.

With safety and pilot trials completed, a randomized, double blind, placebo-controlled version (N=100) has begun at Baylor Research Institute affiliated with Texas A&M School of Medicine, Dept. of Neurosurgery in Temple, TX and Quietmind Foundation in Elkins Park, PA. Recruitment of subjects from the New York and Philadelphia metropolitan regions and Austin and Temple, TX began in March 2018. Subjects will be evaluated 3 times over 60 days using Quantitative EEG and ADNI (ADAS-cog) neurocognitive testing and caregiver evaluations of subject functioning. Subjects and caregivers will be trained to use the study device they will be self-administering twice daily over 28 days and theyll return for an interim evaluation and then another 28 days before final assessments are conducted. Subjects are compensated $75/evaluation session attended and a portion of travel expenses may be reimbursed.

For more information about the A4M shining light, or referrals direct inquiries to Dr. Marvin Berman PhD (610) 940-0488 or

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The Effects of Exercise on Your Skin – LIVESTRONG.COM

You may already know that exercise wields a huge influence on your wellbeing, from improving cardiovascular health to strengthening bones and muscles to boosting brainpower. But it might come as a surprise to discover that a sweat session also has a pretty significant affect on your skin for better and worse.

The effects of exercise on your skin aren't always great, but there are steps you can take to tame them.

Credit: PeopleImages/E+/GettyImages

Here, dermatologists describe exactly what happens to your largest organ (yep, you read that right) when you're getting your fitness fix plus skin-care tips to minimize the unwanted side effects of exercise on your skin.

When you sweat it out at the gym, your blood vessels widen a process called vasodilation.

"This increased blood flow ups the supply of oxygen to your skin and nourishes skin cells by carrying nutrients to repair damage from the sun and environment," says Sonya Johnson, MD, dermatologist and CEO of Dermatology Associates, PC.

Not only will your face look brighter, but that surge of hemoglobin gives you a rosy glow that can last up to two hours, according to the book Skeletal Muscle Circulation.

But for those with rosacea, vasodilation has a flip side: It triggers inflammation, which, along with increased body temperature, can worsen the condition.

The fix: Keep a cool cloth nearby to apply to your face to keep from overheating, suggests Sonia Batra, MD, assistant professor of dermatology at University of Southern California and cohost of The Doctors.

Are you on track to achieve your fitness goals? Download the MyPlate app to keep tabs on the number of calories you burn during your workouts and stay motivated.

Perspiration cools you down and pushes toxic free radicals (compounds linked to aging and disease) out of your body via your pores all good things but it can also irritate your skin.

"It can clog sweat glands and body hair follicles, resulting in an acne-like eruption called folliculitis," says Robin Evans, MD, a board-certified dermatologist and clinical instructor of dermatology at the Albert Einstein School of Medicine. "Folliculitis can occur anywhere that is sweaty, especially areas of occlusion like the back and chest."

Dr. Batra points out that those spots also have a higher concentration of sebaceous glands that can become blocked when sweat and dirt dry on your skin's surface. Enter: backne, buttne and boobne.

"Eczema can also be exacerbated by sweat, which breaks down the skin barrier and can worsen itching," Dr. Batra says.

The fix: Wear loose clothing when youre working up a sweat. According to the American Academy of Dermatology (AAD), form-fitting gear can aggravate folliculitis. Shower right afterward with warm water to remove perspiration, followed by a gentle moisturizer to restore the skins barrier.

Washing your face pre-workout is a good way to remove potentially pore-clogging dirt, oil and makeup.

Credit: Tinatin1/iStock/GettyImages

Plugged hair follicles can also trigger blackheads or whiteheads, which might become inflamed or infected and turn into acne, Dr. Evans says.

The fix: To buffer yourself against a zit attack, take off your makeup pre-workout. The polling firm CivicScience found in 2019 that 25 percent of women wear it while exercising. Not only does it clog your glands and hair follicles even more, but its often contaminated with bacteria, which can aggravate the skin and lead to breakouts, Dr. Evans says.

Even if you're makeup-free, it's still best to wash your face first. "Dirt and oil build up on your skin, and you want to remove that," says Debra Jaliman, MD, a dermatologist, professor of dermatology at the Icahn School of Medicine at Mount Sinai and author of Skin Rules. "Use face wipes if you're short on time they don't require water or soap."

Then, if you have a blemish you want to hide, dot on concealer or smooth on a tinted moisturizer instead of coating your face in foundation. "A tinted BB or CC cream adds that hint of color and gives you a glowy look but is usually very light," Dr. Jaliman says.

"You need adequate fluids and electrolytes to ensure proper skin functioning. If your face looks pale or your lips feel dry, that's a sign your moisture level is low."

Everyone's buzzing about gut flora these days, but did you know that your skin also has a microbiome?

"The skin microbiome is an ecosystem of organisms living on your skin, including bacteria, viruses and fungi," Dr. Batra says. "A healthy microbiome protects skin against infection and maintains a strong barrier between your body and external elements."

Exercise-induced sweat can disturb that sensitive microbiome. "Certain organisms, such as yeast, thrive in a moist environment," Dr. Batra says. "Allowing sweat to remain on the skin for a long period of time often shifts the balance of the microbiome and allows yeast to overgrow." That can lead to an itchy, scaly rash on your face and torso, plus dandruff.

And speaking of germs, a hot, humid gym is an ideal bacteria breeding ground. A December 2014 study in the International Journal of Environmental and Public Health found an "alarming" degree of bacteria on equipment like free weights, exercise machines and mats. In 2017, research by the website FitRated which tests and rates popular fitness equipment tested 27 pieces of equipment from three different gyms and discovered that it contained significantly more germs than a cafeteria tray, toilet seat and faucet knobsand 70 percent of it was potentially harmful to humans.

The upshot: Every time you put your hands on a yoga mat or cardio machine and then touch your face, you're spreading bacteria across your complexion.

The fix: Dr. Evans suggests bringing your own mat and spraying it down with a cleaner after activity, such as a spray bottle filled with rubbing alcohol. Many gyms also offer wipes to keep germs at bay. Hop in the shower as soon as you can, too, and consider sudsing up with a microbiome-friendly wash, like Mother Dirts Biome-Friendly Foaming Cleanser. Its chock-full of ammonia-oxidizing bacteria (AOB), a good bacteria that converts irritating compounds in our sweat, like ammonia and urea, into skin-soothing nitrate and nitrous oxide. In a small-but-encouraging study of 24 people presented in September 2014 by the American Society for Microbiology, those who applied AOB to their face reported better skin condition and appearance than a control group.

Sweating can dry out your skin, which is one reason it's so important to hydrate during and after your workouts.

Credit: EXTREME-PHOTOGRAPHER/iStock/GettyImages

When you sweat, your body loses moisture including from your skin. Al fresco workouts pack a double punch because sun exposure also zaps hydration.

"You need adequate fluids and electrolytes to ensure proper skin functioning," Dr. Evans says. "If your face looks pale or your lips feel dry, that's a sign your moisture level is low."

The fix: Grab a bottle of coconut water or a sports drink, and snack on an energy bar or a banana. If youre outside, remember to slather on SPF. Sunscreen that contains titanium dioxide and zinc will give you the best broad-spectrum protection, Dr. Evans says. Avoid products containing mineral oil or glycerin, which can clog your pores. Sun-protective workout clothes can also shield you from harmful rays. The Skin Cancer Foundation recommends items with a UPF rating of at least 50.

Chub rub making workouts uncomfortable?

"Repeated rubbing or exposure to moisture or irritating fabrics can break down skin cells, leading to a rash that may sting or burn," Dr. Batra says.

The fix: Apply antiperspirant to areas of your body that sweat a lot, and lubrication such as creams, oils or powders wherever theres friction, Dr. Batra recommends. Also, stick to moisture-wicking clothing that let perspiration evaporate, instead of materials like cotton that hold onto sweat and keep your skin damp.

Research shows that exercise can give you a smoother, brighter complexion.

Credit: Jacob Wackerhausen/E+/GettyImages

Collagen is a protein found in connective tissue that helps make your skin firm, full and smooth. But as you age, your collagen levels drop off, according to the AAD, causing lines and sagging.

The good news: You can partly reverse that process by getting your cardio on. "Fibroblasts are cells that produce collagen," Dr. Johnson says. "When you exercise, fibroblast activity increases, generating more collagen." Hello, bouncy, dewy skin.

And the benefits don't stop there. As you grow older, your top layer of skin becomes thicker, rougher, and drier. At the same time, the deeper skin layers thin by about 6.4 percent each decade, leading to drooping and wrinkles particularly in the face, neck, chest, hands and forearms, according to a February 2013 review in the journal Advances in Wound Care.

Consider exercise your anti-aging elixir: Research featured in the journals Aging Cell in August 2015 and Frontiers in Physiology in May 2019 revealed that working out can make your face look up to 25 years younger.

"Exercise stimulates substances called myokines specifically interleukin-15, which increases the thickness of the deeper layers of the skin and decreases the thickness of the outer layers," Dr. Jaliman says. The result? A smoother, brighter, more baby-faced complexion. Yes, please!

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New Guideline for Testosterone Treatment in Men With ‘Low T’ – Medscape

The American College of Physicians (ACP) has released new clinical guidelines providing practical recommendations for testosterone therapy in adult men with age-related low testosterone.

The evidence-based recommendations target all clinicians and werepublished online January 6 in Annals of Internal Medicine, highlighting data from a systematic review of evidence on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone.

Serum testosterone levels drop as men age, starting in their mid-30s, and approximately 20% of American men older than 60 years have low testosterone.

However, no widely accepted testosterone threshold level exists that represents a measure below which symptoms of androgen deficiency and adverse health outcomes occur.

In addition, the role of testosterone therapy in managing this patient population is controversial.

"The purpose of this American College of Physicians (ACP) guideline is to present recommendations based on the best available evidence on the benefits, harms, and costs of testosterone treatment in adult men with age-related low testosterone," write Amir Qaseem, MD, PhD, MHA, from the American College of Physicians, Philadelphia, Pennsylvania, and colleagues.

"This guideline does not address screening or diagnosis of hypogonadism or monitoring of testosterone levels," the authors note.

In particular, the recommendations suggest that clinicians should initiate testosterone treatment in these patients only to help them improve their sexual function.

According to the authors, moderate-certainty evidence from seven trials involving testosterone treatment in adult men with age-related low testosterone showed a small improvement in global sexual function, whereas low-certainty evidence from seven trials showed a small improvement in erectile function.

By contrast, the guideline emphasizes that clinicians should avoid prescribing testosterone treatment for any other concern in this population. Available evidence demonstrates little to no improvement in physical function, depressive symptoms, energy and vitality, or cognition among these men after receiving testosterone treatment, the authors stress.

ACP recommends that clinicians should reassess men's symptoms within 12 months of testosterone treatment initiation, with regular re-evaluations during subsequent follow up. Clinicians should discontinue treatment in men if sexual function fails to improve.

The guideline also recommends using intramuscular formulations of testosterone treatment for this patient population instead of transdermal ones, because intramuscular formulations cost less and have similar clinical effectiveness and harms.

"The annual cost in 2016 per beneficiary for TRT [testosterone replacement therapy] was $2135.32 for the transdermal and $156.24 for the intramuscular formulation, according to paid pharmaceutical claims provided in the 2016 Medicare Part D Drug Claims data," the authors write.

In an accompanying editorial, E. Victor Adlin, MD, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, notes that these new ACP guidelines mostly mirror those recently proposed by both the Endocrine Society and the American Urological Association.

However, he predicts that many clinicians will question the ACP's recommendation to favor use of intramuscular over transdermal formulations of testosterone.

Although Adlin acknowledges the lower cost of intramuscular preparations as a major consideration, he explains that "the need for an intramuscular injection every 1 to 4 weeks is a potential barrier to adherence, and some patients require visits to a health care facility for the injections, which may add to the expense."

Fluctuating blood testosterone levels after each injection may also result in irregular symptom relief and difficulty achieving the desired blood level, he adds. "Individual preference may vary widely in the choice of testosterone therapy."

Overall, Adlin stresses that a patientclinician discussion should serve as the foundation for starting testosterone therapy in men with age-related low testosterone, with the patient playing a central role in treatment decision making.

This guideline was developed with financial support from the American College of Physicians' operating budget. Study author Carrie Horwitch reports serving as a fiduciary officer for the Washington State Medical Association. Jennifer S. Lin, a member of the ACP Clinical Guidelines Committee, reports being an employee of Kaiser Permanente. Robert McLean, another member of the committee, reports being an employee of Northeast Medical Group. The remaining authors and the editorialist have disclosed no relevant financial relationships.

Ann Intern Med. Published online January 6, 2020. Full text, Editorial

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How transhumanism will run the office – Livemint

One morning, as Gregor Samsa was waking up from anxious dreams, he discovered that in bed he had been changed into a monstrous verminous bug."

This sentence in Kafkas most popular story, The Metamorphosis, is one of the early instances traversing the essence of existentialism. Gregors body transforms but mentally he remains a human. Is he, therefore, synonymous with only body or also his mind? The Metamorphosis is a glaring sign of the ambivalence Kafka holds for the concept of the body. Biology as humankinds biggest limitation sets the foundation stone for transhumanism.

Transhumanism is essentially the science of improving the human population through technologies such as genetic engineering and artificial intelligence (AI). Humans already exhibit a symbiotic relationship with smart technology but transhumanism tips into a drastic new scale.

According to Hava Tirosh-Samuelson, associate professor of history at the Arizona State University in the US, transhumanism explores different arenas of cybernetics, gene editing, nanotechnology, biotechnology, behavioural sciences and artificial intelligence.

Hugh Herr, a bionic designer at Massachusetts Institute of Technology (MIT), who has led the NeuroEmbodied Design methodology, believes transhumanism will extend our nervous systems into the synthetic world, and the synthetic world into us, fundamentally changing who we are".

Breaking the mould

There was a whole mature era of DIY cyborgs, where biohackers fiddled with technology to enhance their physiological self. Cybernetics saw some stalwarts emerge and own the field with names like Kevin Warwick, the worlds first cyborg, who, in 1998, implanted a microchip in his left arm to control a remote arm. He also linked his nervous system with the internet to control a robot hand directly from his neural signals.

There are several examplesJerry Jalavas USB thumb, Claudia Mitchells bionic limb and Jesse Sullivans robotic hands, which have all emanated from the need to rise beyond physical disability or revel in new perspective on human augmentation. Such human enhancement technologies under transhumanism have been proven effective when dealing with clinical depression, post-traumatic stress disorder, colour blindness and Parkinsons disease.

What could be the consequences of transhumanism trickling to everyday life and work?

A futuristic tool like a translator ear-bud could make linguistic barriers dissolve in the global business meetings and make cultural empathy and communication stronger.

Ganesh Chakravarthi, editor at the Takshashila Institution and a researcher of transhumanism, says Neural augmentations can enable cohesive work practices between humans and robots. Powered exoskeletons can be invaluable in disaster management and recovery. Whole armies can be empowered with enhanced capabilities although their ethics and principles will need to be well-fleshed out."

Setting the right protocol

In 2018, a team of researchers from US Cornell University presented a paper, BrainNet: A Multi-Person Brain-to-Brain Interface for Direct Collaboration Between Brains, offering an interface that would allow future colleagues to execute tasks using non-invasive direct brain-to-brain communication. This would mean a whole new definition of a collaborative workspace", where team members could share not just their views and opinions but their sensory and emotional experience with the network.

With the aid of networked implants, which would only respond to workplace Wi-Fi, humans could compartmentalize work and leisure. Just by setting the right protocol for work and home devices, it would be increasingly possible to switch off work mode" and decompress.

There are, however, deep worries about the transhumanist turn of the workforce. Corporate demagogues could rise with the consolidation of tech in the hands of the elite, effectively stifling entry of new players in the market. There could be a whole class of jobs only open to those possessing tech augmentations.

New regulations could be mandated around ownership of employee ideas as once they have been synced to the corporate server, no thought would be private to the employee during office hours. Everything could be monitored. New freedoms will have to be debated upon in HR rules like morphological freedom, where individuals have full knowledge and control of which technology to apply to themselves.

Workforce 2.0 will have a gamut of challenges to wade through, to prevent transhumanism from reducing humans to only their qualities of empathy and compassion.

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The future of implants in the latest Medical Technology – Verdict Medical – Medical Device Network


Medical Technology is now available on all devices! Read it here for free in the web browser of your computer, tablet or smartphone.

To kick off the new decade, we find out how technological innovations are revolutionising hearing aids, speak to industry insiders to understand how 3D printing is changing dentistry, and examine the challenge of regulating implants as the market continues to expand and new technologies continue to blur the boundaries between what is and is not a medical device.

Sticking with implants, we delve into the complicated world of transhumanism and biohacking to find out how rising interest in tech implants could impact medical devices, explore ways that tech can unleash preventative personalised medicine with Verita, and learn more about a computerised kidney, which is helping to shed light on dehydration.

Plus, we take a look at the current state of the medical tourism industry to see how technology is impacting such a profitable sector, find out how combining wearables and drugs could help to treat Alzheimers, and as always we get the latest industry analysis and insight from GlobalData.

Timeline: the evolution of hearing aidsHearing aids have come a long way since the weird and wonderful vacuum tube contraptions of the 1800s, but its only within the last few decades that a truly transformative wave of fashionable, functional devices have started to appear. But how did this happen?Chloe Kentlooks back at the history of digital hearing aids, from the first devices of the 1990s to the innovative AI-powered technologies of the present day.Read more.

Open wide: how 3D printing is reshaping dentistryThe dental 3D printing market is expected to reach $930m by the end of 2025, and its application across different procedures is far-reaching, from the development of dentures to Invisalign retainer braces.Chloe Kentspeaks to Digital Smile Design directorGeorge Cabanasand Formlabs dental project managerSam Wainwrightto learn more about how 3D printing could help us all smile a little brighter.Read more.

Regulating implants: how to ensure safetyAs the implant market expands and new innovations become a reality, the challenge of regulating these new technologies is getting harder. With biohacking implants already being performed in tattoo studios, how will regulators ensure the safety of patients?Abi Millar reports.Read more.

From grinders to biohackers: where medical technology meets body modificationA new generation of patients are demanding medical interventions that not only make it easier to manage medical conditions, but also enhance their day-to-day lives. Engineers and researchers have responded with futuristic innovations that push the boundaries of biohacking.Chloe Kentrounds up the bizarre and brilliant innovations that could be the future of medicine as we know it.Read more.

Q&A: how tech can unleash preventative personalised medicine with VeritaVerita Healthcare Group is a company with fingers in many pies, but one of its key focuses is on bringing preventative healthcare to the masses through technology.Chloe Kentcatches up withJulian AndrieszandJames Grant Wetherillto find out more about the companys latest digital health acquisitions and what it sees in its future.Read more.

No filter: understanding how medicines impact dehydrationComputer models of a kidney developed at the University of Waterloo could tell us more about the impacts of medicines taken by people prone to dehydration.Natalie Healeyfinds out more.Read more.

Medical tourism: how is digital tech reshaping the industry?Medical tourism is a large and growing sector that is being driven by high costs and long waiting times in developed countries. But how is the rise of digital technology and Big Data influencing the development of medical tourism hotspots around the world?Chris Lofinds out.Read more.

Triple combo: calming Alzheimers agitation with ai, wearables and a novel drugBioXcel Therapeutics is developing an acute agitation drug, BXCL501, for Alzheimers disease. To improve management and prevention of agitation, the company is leveraging an existing wearable device and developing AI algorithms to predict and prevent aggressive agitation.Allie Nawratexplores this novel, triple combination initiative to prevent and treat symptoms of Alzheimers.Read more.

In the next issue of Medical Technology we take a look at the need for a more proactive approach to encourage health screening uptake, and explore ways that AI could help to make healthcare more human-centric.

Also in the next issue, we find out how a combination of virtual reality and haptics is being used to help virtually train surgeons to perform complex procedures, examine the potential of smell-powered diagnostics, and investigate the rise of chronic illness groups on social media platforms.

Plus, we examine how the uncertain future of Ehtylene oxide could impact device manufacturers, speak to Medidata about the companys merger with Dassault Systmes, and take a look at the recall of Bayers Essure contraceptive implant.

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OVME to open location in east Cobb | Cobb Business Journal –

OVME announced they will open a location in East Cobb.

The medical aesthetic company, founded by David Cox and Dr. S. Mark McKenna M.D. M.B.A., will officially open the doors on Jan. 20 at EDENS Merchants Walk in Marietta.

The 1,550-square-foot tech-enabled studio will include ve treatment rooms. The waiting area will feature a living wall and a retail space for guests to purchase select premium OVME skincare products.

Guests can expect a fully curated experience as OVMEs services are tailored to meet each patients individual needs. Offerings include facial services such as Botox and Dysport, dermal llers and Vivace RF Microneedling; body services that included CoolSculpting and laser hair removal; mens services such as testosterone replacement therapy and PRP for hair loss; and wellness services which include vitamin B-12 shots and hydration therapy.

With existing locations in the Buckhead area of Atlanta, Charlotte, Dallas and Nashville, services can be booked by scheduling an appointment or walking in.

For more information, visit

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DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Lipocine, Inc. and Encourages…

NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the District of Utah on behalf of investors that purchased Lipocine, Inc. (NASDAQ: LPCN) securities between March 27, 2019 and November 8, 2019 (the Class Period). Investors have until January 14, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

Lipocines lead product candidate is TLANDO (LPCN 1021), an oral testosterone replacement therapy. The Company has previously submitted New Drug Applications (NDA) for TLANDO twice and, both times, received Complete Response Letters (CRL) from the U.S. Food and Drug Administration (FDA) rejecting the NDAs. The Company received the first CRL in June 2016 and the second in May 2018.

On March 27, 2019, Lipocine issued a press release announcing new topline results from a study evaluating TLANDOs effects on blood pressure (one issue cited by the FDA in a prior CRL rejecting TLANDOs NDA), as well as the Companys intention to refile the NDA for TLANDO in the second quarter of 2019.

On November 11, 2019, Lipocine issued a press release announcing receipt of a CRL from the FDA regarding its NDA for TLANDO. In the press release, Lipocine advised investors that the FDA had again rejected the NDA for TLANDOthis time because an efficacy trial had not met three of its secondary endpoints.

On this news, Lipocines stock price fell $1.93 per share, or 70.7%, to close at $0.80 per share on November 11, 2019.

The Complaint, filed on November 14, 2019, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Companys business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the results from Lipocines clinical studies of TLANDO were insufficient to demonstrate the drugs efficacy; (ii) accordingly, Lipocines third NDA for TLANDO was highly likely to be found deficient by the FDA; and (iii) as a result, the Companys public statements were materially false and misleading at all relevant times.

If you purchased Lipocine securities during the Class Period, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit Attorney advertising. Prior results do not guarantee similar outcomes.

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DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Lipocine, Inc. and Encourages...

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