FDA Approves Clinical Trial of a New approach to treat millions suffering from Enlarged Prostates
Urotronic, Inc. is maker of innovative Optilume BPH Catheter System
Plymouth, MN ( September 26, 2019 ) - Urotronic, Inc., a medical device company pioneering a new solution that could dramatically change the way millions of men around the world with enlarged prostates are treated, announced today it has received approval from the U.S. Food and Drug Administration (FDA) to begin its US pivotal study for the Optilume BPH Catheter System.
The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. More than 12 million American men are reported to suffer from enlarged prostates or Benign Prostatic Hyperplasia (BPH) and over 750,000 new cases are diagnosed each year.
“The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn’t surgically cut, burn, lase, steam or leave anything behind in the prostate like the other BPH technologies,” said Dr. Steven Kaplan, Professor, Icahn School of Medicine at Mount Sinai and Director of the Men’s Wellness Program, Mount Sinai Health System in New York and the principal investigator of PINNACLE “. This technology holds tremendous promise.”
Kaplan says the Optilume BPH balloon is also the first minimally invasive in-office therapy to provide symptom scores and flow rates similar to the more invasive gold standard known as TURP – (transurethral resection of the prostate).
Millions of men struggle to deal with the symptoms of BPH, including frequency, nocturia, intermittency, urgency, weak stream and straining to urinate as a result of being refractory or non-responsive, or unwilling to deal with the side effects of medical therapy, or reluctant to undergo an invasive surgical procedure requiring general anesthesia.
"We are excited about the accomplishments our team has made," said Urotronic CEO David Perry. “FDA approval is really a validation of our work to this point highlighting Urotronic’s potential to truly transform the urology market through an innovative approach and treatment for men suffering from BPH.”
The Optilume BPH procedure is a minimally invasive treatment that gives urologists the opportunity to offer an office-based or outpatient treatment option that may provide relief to men who are looking for an alternative to currently available BPH treatment offerings.
Dr. Kaplan and other investigators will monitor the progress of the PINNACLE clinical trial, which will get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
“This technology is very disruptive, and the end beneficiary is going to be the patients,” said investor and company board member Doug Kohrs. “Urotronic has embarked on an anatomy sparing approach to treating BPH that no one else has ever taken.”
The Optilume BPH Catheter System is an investigational device, not available for sale. CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
The prospective PINNACLE U.S. trial markets will include but will not be limited to; Advanced Urology Institute; Daytona Beach, Fla - Arkansas Urology; Little Rock, AR - Chesapeake Urology Associates; Baltimore, MD - Cornell University : New York, NY - Regional Urology, LLC; Shreveport ,LA - Sheldon Freedman Urology LTD: Las Vegas, NV - Western New York Urology Associates; Cheektowaga, New York- Associated Urologists of NC; Raleigh, NC -AUUA (Academic Urology & Urogynecology of Arizona); Phoenix, AZ- Carolina Urology Clinical Research (CUCR) ; Myrtle Beach, SC - Carolina Urology Partners; Charlotte, NC - Mount Sinai; New York, NY- Urology of Virginia; Norfolk, VA - Chesapeake 2; Baltimore, MD - Integrated Medical Professionals; Long Island, NY
About Urotronic, Inc. Urotronic, Inc., headquartered in Plymouth, Minnesota, is an early stage medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume™ drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary tract conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The drug-coated balloon technology under clinical investigation creates a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and our products, please visit us at http://urotronic.com/ or to schedule interviews with any of these stakeholders contact publicist Robb Leer 612.701.0608
Weekend Blizzard Set to Bring Historic Snowfall to the Northern Rockies
Wavy jet stream consistent with climate change
An early-season snowstorm could bring up to 4 feet of snow in the Northern Rockies. The heaviest snow and most extreme conditions are forecast to happen on Saturday and Sunday, and Winter Storm Watches have been issued across portions of Montana. Such a storm has not occurred in the northwestern part of the state since 1934.
Record-setting September snowfall isn’t what most people think of when they imagine climate change, but there’s a reason scientists prefer the term “climate change” to “global warming.” Global warming describes the average global surface temperature increase from human emissions of greenhouse gases. Global warming causes climate change, a long-term change in a region’s climate, and the change isn’t always what one might expect.
Climate change is making extreme cold events less likely on average, but it is also increasing the frequency of extreme precipitation, and destabilizing the jet stream. The result is that certain areas and seasons are getting a lot more blizzard weather, and in other areas, blizzards are less common. The forecasted blizzard is the result of a wavy jet stream pattern.
Here are the climate change signals related to the current storm:
The Arctic is warming much faster than areas farther south, which reduces the temperature difference between the two regions. Because that temperature difference provides the main fuel for the polar jet stream (a river of strong wind at levels where jet aircraft fly), the jet stream weakens and favors a more meandering north-south path.
The blizzard headed for Montana is due to a wavy jet stream pattern responsible for “record-challenging heat in the East” and “dramatically cooler conditions in the West.”
Climate change increases the frequency of extreme storms.
Warmer air holds more moisture and causes more intense rain and snow storms. NOAA scientists, examining 120 years of data, found that there were twice as many extreme regional snowstorms in the US between 1961 and 2010 compared to 1900 to 1960.
Early autumn extreme snowfall events are less likely.
On average, climate models suggest that early autumn extreme snowfall events in the Northern Great Plains are less likely due to human-caused climate change. This average trend, however, does not preclude extreme weather outbreaks tied to Arctic warming and a destabilized jet stream. These outbreaks of Arctic air can break cold temperature and snowfall records even as the average temperature increases.
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Doctor Burnout: Are We Missing The Elephant in the Exam Room?
A few years out of residency training, I was already feeling the early symptoms of burnout: a loss of motivation in my day-to-day work, and sometimes a feeling of being trapped. Part of this was due to the fast-paced demands of outpatient care. In primary care, I felt overwhelmed by administrative duties, insurance guidelines, and cramming in too many patients into a single day. More so, I felt at a loss for treatment options. In my hospital-based training, acute exacerbations of chronic diseases felt readily treatable with drugs and procedures. But in outpatient medicine, where I was trying to meet patients and their chronic conditions in their day-to-day lives, I felt like the tools in my doctor's bag were few and far between. Anti-inflammatories, antidepressants, and acid-suppressing heartburn medications could only stave symptoms off for a period of time. Patients would be back. Sooner. Sicker. And more frustrated. This pattern fueled within me a frustration toward my own patients--the very people I'd gone into medicine to serve.
One strategy I took, which was also fueled by my own personal health challenges, was to get trained in integrative and functional medicine. Integrative means approaching the body holistically, as dynamic systems rather than isolated organs. Functional refers to the optimal functioning of the body, which involves going down to the root causes of inflammation, the common denominator for chronic conditions. So I added to my doctor's bag a wealth of tools: therapeutic diets, vitamins and minerals and other supplements, movement strategies, mind-body-spirit practices, grief work, and hormone balancing. Personally, I took restorative retreats, modified my schedule for greater work-family balance, eliminated my commute, and set a real intention to "practice pleasure," as I called it. I learned the ukulele, hiked and camped with my family, watched funny movies, and returned to reading novels.
Still, I felt the symptoms of burnout at work simmering within me. I saw the signs in my integrative and functional medicine colleagues, too. Because that's just it--burnout is a symptom. It's not the root of the issue. There was something larger, something more hidden, that wasn't being addressed by me personally. And it certainly wasn't being addressed by the medical culture as a whole.
At the root of burnout is detachment and disconnection. I don't believe we can begin to heal detachment without confronting the elephant in the exam room: grief. With the nature of our work, we're encountering patients in their deepest fears, in their most vulnerable states, and we seem to be taught 2 options: carry it, or detach. If we carry too much of their grief, we risk getting sick ourselves. If we detach in an effort to protect ourselves, we can cope, we can function. The trouble is that we can't heal something or someone we're detached from. What's more, when we detach from others, we also detach from our own humanity. We become robotic.
So how might we address burnout beyond symptom management? We can learn from the ancient medicine men and women who came before us--to embrace grief as a fundamental part of being human, and to respond to grief in a healthy, affirming way. In my own experience, I've learned two pathways. One is release. I attended grief retreats where we did writing practices and poem readings to awaken the soul, to evoke experiences of loss, and then we participated in rituals to help us release any grief that was stored within our bodies. Many indigenous cultures around the world have grief ceremonies as regular "detoxes." Might we as doctors have more space for empathy if we could learn to release better? A second path is transformation. I took up Wisdom Healing Qigong, a moving meditation that integrates consciousness with core-strengthening exercises, and learned that I could more readily receive the suffering of others and, through repetitive sweeping movements of the arms and direct visualizations, I could transform in my mind their suffering into an experience of compassion.
By doing the hard work of grieving and transforming, I've let go of the biggest unstated pressure I've carried as a doctor: that it was somehow up to me, lil' ole me, to alleviate the suffering of the world. And by letting that go, I've experienced greater spaciousness for reconnection to myself and others. I've nipped burnout in the bud.
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CYNTHIA LI, MD graduated from The University of Texas Southwestern Medical Center, and has practiced internal medicine in settings as diverse as Kaiser Permanente Medical Center, San Francisco General Hospital, St. Anthony Medical Clinic for the homeless, and Doctors Without Borders in rural China. Her own health challenges led her to functional medicine, a paradigm that addresses the root causes of chronic conditions. She currently serves on the faculty of the Healer's Art Program at the University of California San Francisco School of Medicine, and has a private practice. She lives in Berkeley, CA with her husband and their two daughters.
Brave New Medicine: A Doctor’s Unconventional Path to Healing Her Autoimmune Illness is available September 1, 2019 in paperback at Amazon and other retailers.
4 Nutrients That Make Your Workouts More Effective
If you want to make your workouts as effective as possible, consuming the right nutrients can help you achieve better results. Many of the best nutrients are known to aid muscle development, boost energy levels, and provide other great benefits that can help people like you reach their fitness goals faster. Here are four important nutrients that your body needs to make each workout more effective.
Carbohydrates
Even though many people seem to fear carbohydrates, they are actually good for your body when consumed in the right ways. Carbohydrates can help you maintain energy levels throughout each workout by supplying your muscles with glycogen. Carbohydrates should make up 45 to 65 percent of your daily caloric intake, and it’s important to not go over your recommended daily amount since carbs that are unused by the body get stored as sugar. Some of the best carb sources include sweet potatoes, chickpeas, and brown rice. Whole-wheat pasta can also be an excellent source when consumed in moderation.
Vitamin C
This nutrient facilitates growth and tissue repair by improving cellular health. Vitamin C can also reduce fatigue and perceived exertion during exercise so that you can work out for longer periods. Eating foods that are rich in this nutrient or taking a supplement that’s high in vitamin C before a workout can be especially advantageous for your progress. Oranges and other citrus fruits and juices are excellent sources of vitamin C. Other good foods for increasing vitamin C intake include Brussel sprouts and red and green peppers.
Protein
Protein is another great nutrient that promotes better muscle development and helps with tissue repair. The amount of protein that your body specifically needs depends on your gender, current bodyweight, workout intensity level, and the amount of time that you exercise. Fish, red meat, and chicken are among the most well-known protein sources, but you can also give your body a healthy dose of this nutrient by trying some of the best hemp protein powderon the market.
Potassium
Potassium works well for recovery after a workout and can help you get ready faster for your next training session. Another benefit of potassium is that it allows the muscles to contract and relax more effectively by keeping them hydrated. You can increase your potassium intake by eating more bananas, cherry tomatoes, or raw spinach. Cantaloupes and avocadoes can also give your body the potassium that it needs to make it through each workout better.
These nutrients play an important role in overall fitness and should be consumed regularly if you want to make the most of your fitness training. Whether you choose to consume these nutrients in food, beverage, or supplement form, you’re sure to notice an improvement in your workouts when you get the right amounts.
Concerned about Vape Products?
Get to Know Medical Cannabis Alternatives and the Difference Between Solventless and Solvent-free.
Kailua-Kona—One of just two licensed medical cannabis growers and distributors on the Big Island of Hawai‘i, Hawaiian Ethos is very concerned about the current news surrounding vaping. Severe lung disease experienced by people vaporizing nicotine and cannabis is serious, but the illness has not been linked to specific cannabinoids or terpenes. The issue has raised very real questions about the processes, ingredients and safety of this delivery method.
Unfortunately, a direct cause of these instances has yet to be determined, but many speculate the answer may lie in the production process and additives being introduced to the cartridges. The CDC states, “No evidence of infectious diseases has been identified; therefore lung illnesses are likely associated with a chemical exposure.” This refers to chemicals such as Vitamin E Acetate and other additives, used by some dealers to produce vape-oil.
Stacey Marie Kerr M.D., Hawaiian Ethos Medical Advisor, commented on the current vaping situation, “As a physician, I implore all patients to use products that are quality lab tested for content and purity. Hawaiian Ethos’ products contain nothing but the plant with no additives of any kind. Our alternatives to pulmonary products are controlled-dose QDTs, effervescent tables, and capsules, supporting reproducible onset times. We believe in the efficacy of alternatives to pulmonary delivery, and micro-dosing to establish the least amount of medicine needed to achieve desired relief.”
The oil in Hawaiian Ethos’s vape cartridges contains only the cannabinoids and terpenes that were in the original plant, with absolutely no added chemicals, so vaporizing Ethos products remains a viable option for those needing rapid relief. And for those patients who wish to steer clear of vaping altogether, Hawaiian Ethos offers a variety of non-pulmonary Quick Dissolve Tablets and Effervescent Tablets. Dr. Kerr adds: “Our flower, vape cartridges, QDTs, capsules, tinctures, and salves have identical cannabinoid and terpenoid profiles.”
The difference between solventless and solvent-free:
The Hawaiian Ethos product development team has done extensive research on the most responsible and safe methods of production for each of our products. All of our extracts, including those that go into our vape cartridges, are solventless. This means that we only use water, heat and pressure to extract cannabinoids, terpenes and flavonoids from the plant. Along with upholding a pure extraction process, Hawaiian Ethos never adds any outside ingredients to our cartridges. Every extract sold in our dispensary comes straight from the plant with absolutely no additives, from the beginning of processing to the finished product.”
It is important to understand the difference between solventless and solvent-free. Solventless means no solvents were ever used in the production of the medicine. Solvent-free is a term used to describe a cannabis extraction process that uses either ethanol, butane, CO2, or other known solvents to extract cannabinoids from the plant. The solvents are then burned off and evaporated, leaving a cannabinoid isolate extract with no terpenes or flavonoids. Many solvent-free production procedures include introducing outside terpenes, flavors, or fillers to make the product taste better and/or get to the right consistency. In contrast, Hawaiian Ethos products have always been solventless vs. solvent-free.
Traveling to Hawai’i?
Hawaiian Ethos is permitted to serve out-of-state medical cannabis patients.
Hawaiian Ethos’ first dispensary is located on Olowalu Street in Kailua-Kona, on the Big Island of Hawai‘i. Hawaiian Ethos is open from 10:00 a.m. to 7:00 p.m. Monday through Sunday. A Hilo location will be announced soon.
Gout Patients at Higher Risk of Developing Life-Threatening Blood Clot
RICHMOND, BC, Sept. 24, 2019 /CNW/ - An Arthritis Research Canada study has revealed that people with gout (the most common inflammatory arthritis in men) are more likely to develop venous thromboembolism (VTE) – a blood clot that starts in a vein and can travel to the lungs (pulmonary embolism or PE) and deep vein thrombosis (DVT) – a blood clot in the leg veins.
"These are serious cardiovascular events associated with increased mortality," said Dr. Antonio Aviña-Zubieta, a senior scientist of rheumatology at Arthritis Research Canada and the study's lead researcher.
In this study, researchers assessed the risk of VTE, PE and DVT in patients with newly diagnosed gout and found that people with the disease have a higher risk of the three conditions than the general population without gout.
Compared to the general population, the risk of VTE, PE and DVT increased both before (51%, 47%, and 55%) and after the diagnosis of gout (22%, 28%, and 16%), respectively.
The research also revealed that the risk increases gradually even before the gout diagnosis, peaks in the year prior, and then progressively declines. It is believed that gout associated inflammation before and after diagnosis might be a contributing factor for VTE.
Previous studies reported the increased risk of VTE, PE, and DVT in some types of inflammatory arthritis, like rheumatoid arthritis, systemic lupus erythematosus, and ankylosing spondylitis, but not gout. This is the largest population-based study to demonstrate that patients with gout have an increased risk of VTE, DVT and PE after a gout diagnosis compared with the general population.
"The findings call for awareness and vigilance for VTE risk assessment in patients with gout in order to prevent the life-threatening condition," Dr. Aviña-Zubieta said. "It is also important for patients and clinicians to adhere to treatment guidelines under the assumption that this will decrease the risk of gout flares and, thus, VTE."
To read the study, titled "Trends of Venous Thromboembolism Risk Before and After Diagnosis of Gout: A General Population-Based Study," please click here: https://doi.org/10.1093/rheumatology/kez398.
ABOUT ARTHRITIS RESEARCH CANADA
Arthritis Research Canada is the largest clinical arthritis research institution in North America. Our mission is to transform the lives of people living with arthritis through research and engagement. Led by world-renowned rheumatologist, Dr. John Esdaile, Arthritis Research Canada's scientific team of over 100 are creating a future where people living with arthritis are empowered to triumph over pain and disability. Within British Columbia, Alberta and Quebec, Arthritis Research Canada is leading research aimed at arthritis prevention, early diagnosis and treatment, and quality of life issues.
SOURCE Arthritis Research Canada
MANGURAMA BRINGS THE PORTAL
TO THEATRES ACROSS NORTH AMERICA
Calm Your Mind, Open Your Heart, Transform The World
New feature documentary from meditation expert,
Tom Cronin, takes an inside-out approach exploring
how everyday people overcome challenging obstacles.
NEW YORK (September 24, 2019) – Mangurama, a partnership between Abramorama and Giancarlo Canavesio’s Mangusta Productions announced today the acquisition of North American theatrical rights to Tom Cronin and Jacqui Fifer’s, groundbreaking documentary THE PORTAL.The film will be released in theaters across North America starting November 1, 2019.
"The time is certainly ripe for The Portal,” stated Abramorama CEO Richard Abramowitz, "The film’s healing potential is exactly what we need at this moment.”
Directed and written by first-time Australian director, Jacqui Fifer, and written and produced by international meditation expert, Tom Cronin (The Stillness Project) the captivating film has inspired crowds throughout the world and audiences across North America will get their chance to experience THE PORTAL this fall.
“We’re thrilled to be working with the amazing team at Mangurama to help bring THE PORTAL to cinemas across North America,” said Cronin. “The film facilitates a collective shift on the planet that takes us into a new era of united living; it had to be groundbreaking, unique, and go viral.” “THE PORTAL is truly a film for everyone. Its commercially viability raises the genre bar while remaining true to its core message,” Cronin continued.
Mangurama brings THE PORTAL, accompanied by the book of the same name, to theaters opening on November 1st at the Laemmle Monica Film Center in Los Angeles and on November 15th at TheVillage East Cinema in New York City with additional nationwide engagements to follow. The film will also be released in Australia and New Zealand around the same time.
THE PORTAL ASKS: As the doomsday clock ticks progressively louder: What would happen if 7 billion people meditated? Could it shift the trajectory of our planet?
THE PORTAL IS: An immersive, cinematic experience that answers the question: How can we really change the world?
Through heart-opening contemplation and shared experiences of transformation on a personal scale, with global implications, six ordinary people (and a robot) show how stillness and mindfulness can unlock personal change and ignite a planetary shift, providing hope to humankind.
Filmed in the USA, Canada, Australia and a Syrian refugee camp in Jordan, THE PORTAL is richly visual and sonically powerful. Mesmerizing cinematography and the raw intimate stories draw the audience in, while the immersive soundscape breaks ground in film history with its use of binaural beats in an already evocative score.
“I believe real-time change is possible, and that through the poignant personal stories and ideas unfolding and weaving together in this way we've got a portal to our greatest potential,” said Fifer. “This project has been a catalyst for many of us and I’m seeing it jump-start a lot of other people too. I couldn’t have found a more perfect project for my first foray into feature docs and directing. I’ve spent my life preparing for this film, without realizing, and watching many facets of me emerge and harmonize in order to weave it together–the filmmaker, the musician, the dreamer, the feminine and so on–has been a fun process.”
A Diverse Cast and Crew from Across the Globe Featuring an impressive and diverse cast and crew, led by people from all over the world and all walks of life from military veterans, to scientists, performers and more,KITRA CAHANA (HEY TED, DANCING TOWARDS THE LIGHT), JAMES DOTY, RON BOODA TAYLOR and DUE QUACH, the highly relevant thought provoking film will appeal to global audiences.
ENTER THE PORTAL
Supported by insights from three of the world’s foremost futurists and philosophers, THE PORTAL opens hearts and minds to an exciting vision for humanity transformed. Said Cronin, “This is not sci-fi—this is real life. Humankind is staring into an abyss, yet within us all we have the capability to bring ourselves (and our species) back from the brink. We're part of a growing movement of game-changers to create a reimagined global future—I think people are ready for something different."
THE PORTAL weaves a captivating and vibrant tapestry of technology, love, existentialism, human potential, brain-hacking, stillness and inner peace. It is an experiential and genre-defining approach to personal change as we embark on the next phase of human evolution.
"It's clear we just can't play by the same old rules anymore when there's an urgent need for meaning, connection, and harmony staring us in the face,” said Fifer, “We wanted to create a gateway to experience those missing pieces.”
Is an enlightened planet possible? Enter THE PORTAL and see.
Tom Cronina former finance expert with a longstanding successful track record in business as well as meditation is founder of The Stillness Project, a global movement to inspire one billion people to sit in stillness, daily. He is passionate about reducing stress and chaos in people’s lives. Tom’s ongoing work in transformational leadership and cultivating inner peace through meditation takes him around the world presenting keynote talks in such countries as Malaysia, Indonesia, Australia, Mexico and the USA; hosting retreats; mentoring clients across the globe; teaching in schools; writing books; hosting mindfulness courses in the corporate sector; and creating THE PORTAL film-book experience, all as part of his commitment to the current planetary shift.
ABOUT JACQUI FIFER
Jacqui Fifer has had a dynamic career in the film industry line producing such films as BETTER WATCH OUT(2016), The OSIRIS CHILD (2016) and INFINI (2015) as well as producing the multi-award-winning dramatic feature CONCEALED(2017). She also co-directed the 2012 and 2013 “Dones en Art” (Women and Film) festivals in Spain. An advocate of human capacity development, Jacqui is thrilled to turn her hand towards a subject that is close to her heart. THE PORTAL is her feature directorial debut.
ABOUT MANGURAMA
Mangurama, a partnership between Abramorama and Giancarlo Canavesio’s Mangusta Productions, brings films that celebrate “consciousness” to the big, medium, and small screen. Mangurama’s films and episodic programs are the next generation of mind, body, spirit documentaries, covering not only spirituality, eastern philosophy, yoga and meditation, but also economics, politics, philosophy, sexuality and other aspects of the human existence. The company distributes and invests in the completion of paradigm challenging and consciousness expanding visual content. Released and upcoming feature documentaries and episodic series include Abby Epstein and Ricki Lake’s award-winning Weed The People, Adam Schomer’s The Road To Dharma - Riders of The Himalayas, Randall Wright’s Summer In The Forest, Bruce Parry’s TAWAI – A Voice From The Forest, Raz Degan & Appian Way’s presentation The Last Shaman, and Tao Ruspoli’s Monogamish. New paradigm docs on DMT, channeling indigenous wisdom, the metaphysics of Blockchain, and new conscious capitalism are in various stages of development and production for release in 2019/20. Mangurama provides invaluable alternatives to filmmakers and content owners, is an industry leader in the marketing, promotion, global rights management and distribution of “consciousness themed” films and continues to trail-blaze exciting new pathways for filmmakers to find their audience. For more information visit www.mangurama.com.
ABOUT SUPERHUMAN INTERNATIONAL (SHI)
SHI is pushing the boundaries with this unique and transformational hybrid feature film experience, The Portal. SHI is an Australian company registered in the state of New South Wales. Tom Cronin is the company director. The project qualifies with the Australian Documentary Foundation for tax concessions.
Tia Health Enters into a Partnership Agreement with an Online Pharmacy
TORONTO, Sept. 24, 2019 /CNW/ - Tia Health, an online virtual care clinic providing telemedicine to Canadians across the country, announced today that they have entered into a partnership agreement with Well.ca to offer virtual medical services through Well.ca. Tia Health will also provide its patients the opportunity to choose Well.ca Pharmacy for free same-day and next day prescription delivery in Toronto.
"As virtual healthcare becomes a primary means of healthcare delivery in Canada, timely delivery of prescriptions has become critical." said David Del Balso, Co-Founder and CEO of Tia Health. "We want to eliminate any barriers to timely care for all Canadians, especially those with limited mobility, access, or time, to visit a clinic or pharmacy. Now, even for medications that a patient needs to start immediately, they won't have to rush to a pharmacy to get it, Well.ca is bringing it to them, allowing them to complete their entire healthcare experience without leaving home."
About Tia Health: Tia Health is a trusted source of virtual medicine that is changing the way healthcare is provided in Canada. Through the Tia Health platform, patients can connect with Canadian licensed doctors through video chat and phone consultations. Tia is the only platform in Canada to offer true continuity of care by giving patients the choice of which doctor they want to speak with. Patients can choose between doctors with different specialities, languages, and genders. Appointments are available both immediately and can be booked in the future. Tia also offers access to naturopaths, psychotherapists, dieticians and more. Visit Tia Health at https://tiahealth.com for more information.
About Well.ca: Well.ca is a proudly Canadian company that's passionate about our customers, our business, and the products we offer. At Well.ca, we believe that Canadians should never have to compromise on the health, wellness, baby and beauty products that they choose for themselves and their families. With over 40,000-curated products, thousands of peer reviews, and Canada's largest assortment of green and natural brands, we make it easy to make choices you can trust.
SOURCE Tia Health
FDA Approves Clinical Trial of a New approach to treat millions suffering from Enlarged Prostates
Urotronic, Inc. is maker of innovative Optilume BPH Catheter System
Plymouth, MN ( September 24, 2019 ) - Urotronic, Inc., a medical device company pioneering a new solution that could dramatically change the way millions of men around the world with enlarged prostates are treated, announced today it has received approval from the U.S. Food and Drug Administration (FDA) to begin its US pivotal study for the Optilume BPH Catheter System.
The FDA-approved clinical trial, known as PINNACLE, will be conducted at 20 medical facilities around the country. More than 12 million American men are reported to suffer from enlarged prostates or Benign Prostatic Hyperplasia (BPH) and over 750,000 new cases are diagnosed each year.
“The Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn’t surgically cut, burn, lase, steam or leave anything behind in the prostate like the other BPH technologies,” said Dr. Steven Kaplan, Professor, Icahn School of Medicine at Mount Sinai and Director of the Men’s Wellness Program, Mount Sinai Health System in New York and the principal investigator of PINNACLE “. This technology holds tremendous promise.”
Kaplan says the Optilume BPH balloon is also the first minimally invasive in-office therapy to provide symptom scores and flow rates similar to the more invasive gold standard known as TURP – (transurethral resection of the prostate).
Millions of men struggle to deal with the symptoms of BPH, including frequency, nocturia, intermittency, urgency, weak stream and straining to urinate as a result of being refractory or non-responsive, or unwilling to deal with the side effects of medical therapy, or reluctant to undergo an invasive surgical procedure requiring general anesthesia.
"We are excited about the accomplishments our team has made," said Urotronic CEO David Perry. “FDA approval is really a validation of our work to this point highlighting Urotronic’s potential to truly transform the urology market through an innovative approach and treatment for men suffering from BPH.”
The Optilume BPH procedure is a minimally invasive treatment that gives urologists the opportunity to offer an office-based or outpatient treatment option that may provide relief to men who are looking for an alternative to currently available BPH treatment offerings.
Dr. Kaplan and other investigators will monitor the progress of the PINNACLE clinical trial, which will get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
“This technology is very disruptive, and the end beneficiary is going to be the patients,” said investor and company board member Doug Kohrs. “Urotronic has embarked on an anatomy sparing approach to treating BPH that no one else has ever taken.”
The Optilume BPH Catheter System is an investigational device, not available for sale. CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
The prospective PINNACLE U.S. trial markets will include but will not be limited to; Advanced Urology Institute; Daytona Beach, Fla - Arkansas Urology; Little Rock, AR - Chesapeake Urology Associates; Baltimore, MD - Cornell University : New York, NY - Regional Urology, LLC; Shreveport ,LA - Sheldon Freedman Urology LTD: Las Vegas, NV - Western New York Urology Associates; Cheektowaga, New York- Associated Urologists of NC; Raleigh, NC -AUUA (Academic Urology & Urogynecology of Arizona); Phoenix, AZ- Carolina Urology Clinical Research (CUCR) ; Myrtle Beach, SC - Carolina Urology Partners; Charlotte, NC - Mount Sinai; New York, NY- Urology of Virginia; Norfolk, VA - Chesapeake 2; Baltimore, MD - Integrated Medical Professionals; Long Island, NY
About Urotronic, Inc. Urotronic, Inc., headquartered in Plymouth, Minnesota, is an early stage medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume™ drug-coated balloon technology provides a low cost, minimally invasive treatment option for men suffering from urinary tract conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. The drug-coated balloon technology under clinical investigation creates a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and our products, please visit us at http://urotronic.com/ or to schedule interviews with any of these stakeholders contact publicist Robb Leer 612.701.0608
CANNA BATH CO. LAUNCHES NATIONAL CBD WELLNESS LINE
Oakland-based entrepreneur Jessica Bernardo releases her line of handmade, all-natural bath salts, bombs, and lotions to stores across the U.S. for the wellness consumer who doesn’t want to visit a cannabis dispensary
OAKLAND, CALIFORNIA – SEPT. 24, 2019 Perfect for those who wish to enjoy the pain relieving medicinal effects of the cannabis plant without any of the psychoactive elements of THC, Canna Bath Co. announces that its new line of CBD-infused products is now at some 100 outlets across the U.S.
Founded in Jessica Bernardo’s Oakland kitchen (and bathtub!) in 2015, Canna Bath Co. originally paired its therapeutic grade essential oils and salts with THC extract for pain relief. Still federally illegal but permitted in many states, THC is the psychoactive ingredient found in cannabis and is a regulated product sold only in dispensaries. Bernardo soon found that her customers didn’t want to have to visit a cannabis dispensary to receive the relief her products offer.
Switching to hemp-derived CBD this year helped demand for Canna Bath Co.’s products to explode across the nation as stores try to keep up with consumer interest in CBD-infused products. A recent Acosta study found that 28% of all consumers use CBD in one form or another daily.
A unique line of bath bombs, salts, and lotions made of all-natural ingredients, scented with essential oils, and blended with intuition and grace, Canna Bath Co. products are for those seeking a luxurious bath experience, softer skin, and pain relief but who don’t want to use a THC product. CBD, a palliative derived from the hemp plant that has no psychoactive properties yet can offer pain and stress relief, is the perfect solution.
Infused with CBD derived from legally grown and tested North American hemp, Canna Bath Co. products include a blend of Epsom and Himalayan CBD Bath Salts to help you relax, breathe more clearly, and soothe sore muscles.
Scented with a variety of natural essences such as lavender, bergamot, jasmine, coconut, lime, ylang ylang, vanilla, rosemary, or peppermint, Canna Bath Co.’s CBD Bath Bombshelp you to sleep, reduce anxiety, energize, and soothe sore muscles.
The proprietary line of after-bath CBD Lotions offer muscle relief and smooth dry skin.
Canna Bath Co. works with Nardo’s Naturals and sources essential oils to produce clean, holistic bath and beauty products perfect for today’s wellness practitioner and those looking to enjoy self-care at home.
Trained as a massage therapist, founder Jessica Bernardo, 34, has always had an interest in health and natural remedies. Making her own CBD-infused bath products with natural holistic ingredients that offer pain relief and produce glowing skin was a logical step.
“When I was in massage school, my focus was on helping people feel better without harsh pain medicine,” she says. “I was already playing around with bath products and supplements using apple cider vinegar, lavender, rosemary, and other natural ingredients. This is the perfect combination of my two passions.”
Handmade with essential oils and therapeutic-grade CBD that has been third-party lab tested for quality and potency, Canna Bath Co. products are available at cannabathco.comand at select stores across the U.S.
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ABOUT CANNA BATH CO.
Canna Bath Co is a woman-owned business based in Oakland, CA, whose products are all sourced for sensitive skin. We believe in holistic healing approaches and offering the benefits of the hemp plant in a form everyone can enjoy. Learn more: cannabathco.com and @cannabathco #plantsoverpills #cbd #womanownedbusiness #bossbabe #cbdbathbomb #soakitup
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