Category Archives: Healthcare Products

Het DBLG1-algoritme: eenvoudige installatie, gebruiksvriendelijk, ontworpeyyn voor elk diabetes type 1 profiel

PARIJS, 2-Jun-2021 — /EPR HEALTHCARE NEWS/ — Vanaf het begin heeft Diabeloop innovatieve systemen ontwikkeld om de behandeling van diabetes type 1 te automatiseren en te personaliseren, waarbij altijd rekening wordt gehouden met de optiek van de patiënt. Het Franse bedrijf streeft ernaar autonomie te geven aan mensen die met diabetes type 1 leven en tegelijkertijd de gebruikerservaring te optimaliseren zodat behandeling van diabetes eenvoudiger en minder ingrijpend is. Het DBLG1-algoritme biedt een bevredigende, geautomatiseerde en gepersonaliseerde ervaring met minimale input van de patiënt.

DBLG1: eenvoudige installatie, gebruiksvriendelijk, ontworpen voor elk diabetes type 1 profiel

De zware mentale last op de schouders van mensen met diabetes type 1 verlichten, begint in de eerste fasen van de ervaring met DBLG1. Gebruikers hoeven maar 4 gegevens in te voeren in het allernieuwste DBLG1-algoritme voor een veilige, geautomatiseerde en gepersonaliseerde insuline-afgifte. In de opzetfase voeren gebruikers van DBLG1 hun lichaamsgewicht in, hun totale dagelijkse insulinedosis (TDD), hun gebruikelijke maaltijden (in grammen koolhydraten) en hun basale insulinebehoefte (alleen voor open-loop). Voor het Diabeloop-algoritme zijn geen ingewikkelde berekeningen nodig. Gebruikers hoeven hun maaltijdratio niet uit te zoeken, noch hun insuline gevoeligheidsfactor noch hun insuline actiecurve.

De 4 gegevens die de patiënt in de beginfase invoert, zijn voldoende voor het DBLG1 zelflerend algoritme om te functioneren, te berekenen en de insulinedosis zo nodig elke vijf minuten aan te passen.

“We hebben het DBLG1-algoritme zo ontworpen dat het zo eenvoudig mogelijk in gebruik is voor mensen met diabetes type 1 en gebruikers tegelijkertijd de gelegenheid hebben bepaalde parameters nauwkeuriger in te stellen afhankelijk van hun specifieke behoeften en/of leefstijl. Het algoritme houdt automatisch rekening met eventuele wijzigingen die mensen invoeren. Het DBLG1-algoritme optimaliseert de werking automatisch zonder dat de patiënt hier iets voor hoeft te doen. Wijzigingen verlopen op die manier heel soepel en worden vrijwel “onzichtbaar” voor de gebruikers van het systeem“ – vertelde Yousra Tourki, Head of Algorithms Design bij Diabeloop.

Naast de eerste input biedt het DBLG1 System ook de mogelijkheid aan mensen die met diabetes type 1 leven om de behandeling en beheersing van hun diabetes nauwkeurig in te stellen met behulp van aanpasbare instellingen zoals de agressiviteit van het algoritme, de grenswaarden van hypo’s en hypers en de streefwaarde van de glucosespiegel.

Nicole Wetzels, Trainer voor Roche Diabetes Care in Nederland en gebruikster van het DBLG1 System met Accu-Check Insight, vertelt: “Ik leef al meer dan 42 jaar met diabetes type 1 en ben een paar maanden geleden begonnen met het gebruik van het DBLG1 System met een Accu-Chek insulinepomp. De opzet was heel eenvoudig: de batterij in het apparaat doen, de handset opladen en maar 4 parameters invoeren. Het invoeren van een maaltijd is een van de weinige dingen die ik zelf moet doen en ook dat is heel simpel! Maar ik heb tevens de mogelijkheid het systeem te personaliseren door bepaalde instellingen aan te passen zoals de streefwaarde van de glucosespiegel of de grenswaarden voor de hypo … Met hele kleine acties heb ik hele goede resultaten. Dankzij dit AID-systeem hoef ik niet meer de hele dag bezig te zijn met het beheersen en behandelen van mijn diabetes. Het is net of mijn diabetes type 1 op vakantie is!”

DBLG1 AID-systeem: minimale input van de patiënt nodig

Om de bruikbaarheid van het DBLG1 System te beoordelen heeft Diabeloop een wetenschappelijk onderzoek uitgevoerd op basis van reële gegevens afkomstig uit de klinisch proef (1) die vóór de lancering vanhet systeem is gerealiseerd. Het doel was het analyseren van het aantal instellingswijzingen door mensen die het systeem in het dagelijkse leven gebruiken. In de eerste week dat patiënten het DBLG1 System gebruikten, voerden ze gemiddeld slechts 1.6 instellingswijzigingen uit (± 2.3), en maar 0.2 wijziging (± 0.5) in de laatste week van de proef na 11 weken gebruik.

De belangrijkste conclusie is dat in het dagelijkse leven, wanneer de gebruikers zich niet in een beheerste omgeving bevinden zonder specifieke medische follow-up en/of aanbevelingen voor instellingswijzigingen van hun zorgteam, de mensen uitgerust met het DBGL1 System minimale aanpassingen hoeven uit te voeren om te profiteren van een bevredigende, geautomatiseerde en gepersonaliseerde diabetesbehandeling.

Verdere wetenschappelijke analyse (2) toont de gebruiksvriendelijkheid aan van het Automated Insulin Delivery-systeem van Diabeloop. Deze analyse gaf aan dat in de eerste week, 50% van de mensen die het DBLG1 System gebruikten, geen instellingswijzigingen uitvoerden. Bovendien wijzigden meer dan 85% van de mensen uitgerust met het systeem geen enkele instelling gedurende de 8ste week van gebruik.

Dit bevestigt dat het zelflerend algoritme van Diabeloop vanaf de beginfase de behandeling van diabetes type 1 optimaliseert en minimale input van de patiënt nodig heeft om de vereiste ondersteuning te bieden.

Bernhard Gehr, arts en diabetoloog, Centrum voor Diabetes en Metabole ziekten, gespecialiseerde kliniek m&i Fachklinik Bad Heilbrunn, licht toe: “Ik gebruik het DBLG1 System met de Accu-Chek Insight insulinepomp. De opzet en de eerste handelingen zijn zeer eenvoudig. De eenvoud van de gebruikersinterface maakt snelle en makkelijke invoer van de benodigde informatie mogelijk. Ik ben echt onder de indruk van de prestaties van het DBLG1 System. Vanaf de eerste dag had ik een goede controle over mijn stofwisseling. Ik heb veel meer gemoedsrust aangezien ik veel minder aan mijn diabetes hoef te denken! Dit systeem vereist minder tot vrijwel geen micromanagement van mijn behandeling. Ik was aangenaam verrast over hoe goed het algoritme tijdens de eerste nacht functioneerde, met zo weinig input in de beginfase.”

Met DBLG1 beheersen mensen hun eigen diabetesbehandeling

Het DBLG1 System is gebruiksvriendelijk en kan gepersonaliseerd worden zodat mensen die met diabetes leven verschillende instellingen kunnen beheersen.

In het dagelijkse leven biedt het DBLG1 System mensen de mogelijkheid de aan te passen zodat insuline-afgifte bijgesteld wordt om een hypo of hyper te voorkomen. Een van de onderzoeken (3) van Diabeloop, gepresenteerd op ATTD 2021, onthulde dat een daling van de glucosespiegel streefwaarde over het algemeen een vergelijkbare daling van de gemiddelde glucospiegel tot gevolg heeft. Bijvoorbeeld, -10% van de glucosespiegel streefwaarde leidt tot -10% van de gemiddelde glucosespiegel.

In overeenstemming met de missie van Diabeloop om de zware mentale last op de schouders van mensen met diabetes type 1 te verlichten en hen een ongestoord leven te bieden, bevat het systeem een Zen-modus, ontwikkeld op basis van de ervaringen van patiënten. Deze modus verhoogt tijdelijk de doelwaarde van de bloedsuikerspiegel: om rustig naar de bioscoop te gaan of een vergadering bij te wonen zonder een verstorende hypoglykemie en de bijbehorende waarschuwingssignalen, kunnen gebruikers de Zen-modus aanzetten zodat hun glucosespiegel tijdelijk en voor een door hen ingestelde tijd verhoogd wordt.

Een persoon die het DBLG1 System met Accu-Check Insight insulinepomp gebruikt, vertelde: “Zen-modus is voor al die momenten waarop je je “veiliger” wil voelen: tijdens het autorijden, op school, tijdens een examen.”

Een wetenschappelijk onderzoek (4) geleid door Diabeloop en gepresenteerd op ATTD 2021, toonde aan dat 90 minuten na de activering van de Zen-modus, de impact op de gemiddelde glucosespiegel gestabiliseerd was zonder de hyperglykemie te verlengen.

De conclusie is dat, voor een tijd die door de patiënt wordt bepaald, de Zen-modus de gebruikers uit een hypo houdt en tevens een hyper voorkomt. De Zen-modus leidt tot een lichte verhoging van de gemiddelde glykemie met een zeer beperkte impact op de time-in-range.

Het eenvoudige gebruik van het DBLG1 zelflerend algoritme draagt bij tot een ongecompliceerde diabetesbehandeling en haalt een mentale last van de schouders van mensen die leven met deze chronische ziekte zodat ze ongestoord kunnen leven!

SOURCE: EuropaWire

The biggest dedicated CBD & medical cannabis event in Europe takes place online between 28 and 30 April

LONDON, 21-Apr-2021 — /EPR HEALTHCARE NEWS/ — The CANNAVIST, the UK & Ireland’s essential guide to CBD & medical cannabis, presents CBD Live Europe, the biggest dedicated CBD & medical cannabis event to focus on the European hemp & CBD community this year. This free, virtual event takes place April 28-30.

CBD Live Europe follows the success of two similar events held by the publication in 2020. The virtual exhibition complete with an online auditorium is for consumers, patients, cannabis advocates, and business professionals across the continent.

An online exhibition hall will welcome more than 100 CBD brands, distributors and manufacturers while the auditorium will present three days of live educational material.

Day 1 will see Europe’s leading industry professionals take to the stage on pivotal issues including the post-pandemic hemp sector, regulation, FMCG and the importance of technology in unlocking the potential of cannabis.

Among the speakers to dominate on the B2B day will be Tim Phillips, founder of market intelligence firm CBD-Intel, Catherine Wilson, VP of the European Industrial Hemp Association and the co-founders of the world’s first CBD and hemp exchange, CanXchange.

Day 2 will welcome clinicians, researchers, founders and patients as Europe’s leading medical cannabis advocates share their experience and knowledge.

The line up for this medical cannabis and advocacy themed day will feature representatives from the European Cannabis Advocacy Network and high-profile campaigners, Charlotte & Billy Caldwell.

Day 3 will see a combination of CBD content aimed at health & wellbeing and personal growth goals.

From ‘How to launch your own CBD brand’ to our ‘Rewind, Reset & Reconnect’ online guided meditation, day 3 will focus the mind to end the week on a high note.

A total of 40 speakers will take over the auditorium at CBD Live Europe.

The event will take place entirely online at no cost to visitors to maximise this learning opportunity and make cannabis education more accessible. Those with an interest in CBD & medical cannabis from around the world are invited to log on for free.

CBD Live Europe will be live on virtual exhibition platform, VOXPO Events. In registering for CBD Live Europe, visitors will automatically be entered into a draw for a chance to win €500 worth of CBD goodies.

Visit voxpo-event.com to register. Visit this link to view the CBD Live Europe Auditorium Line Up.

SOURCE: EuropaWire

AirGuard™ – washable, reusable, approved 5-Layered Nano-PTFE filtering technology cloth face mask with BFE of over 95%

BOLOGNA, Italy, 31-Mar-2021 — /EPR HEALTHCARE NEWS/ — Creative Concepts Manufacturing Group announces campaign launch of their new innovative cloth mask – AirGuard™. The tested and approved 5-Layered Nano-PTFE filtering technology cloth face mask that is washable, reusable, and that has a bacterial filtration efficiency (BFE) of over 95%. Creative Concepts is ready to secure worldwide distribution and is proud to be a significant part of the solution in helping to protect against the spread of the COVID-19 virus.

Creative Concepts Manufacturing Group is a leading manufacturer of various inventions, creators of the GoTech™ Cordless Technology, and with over 4 decades of experience in the OEM/ODM and License Manufacturing, its Product Managers and owners, Vin and Joe Advani are pleased to announce the launch of their new PPE (Personal Protective Equipment) – the AIRGUARD cloth face mask with the goal of preventing individuals from spreading the COVID-19 virus, while ensuring the safety and comfort in wearing the mask.

ABOUT AIRGUARD™
According to the US CDC and European health authorities, 5 layer or equivalent face masks are mandatory and are the most protective type of a mask in preventing the spread of viruses. Most masks are either uncomfortable and do not help in filtering the size of the microns in the air. Available 3-ply masks can only be worn once before being disposed which creates a lot of pollution – not to mention waste of money. Creative Concepts took those negatives and created something positive – the AIRGUARD. It has a 5-Layer Nano-PTFE filtering technology that has a greater than 95% bacterial filtration efficiency against 0.3 micron particles in the air (like the COVID-19 virus), an equivalency of the N95 respirator. AIRGUARD™ is made from anti-bacterial breathable cotton that makes the airflow smooth and comfortable when wearing. Furthermore, the AIRGUARD™ cloth mask is hypoallergenic and has anti-microbial properties so you do not feel itchy or suffocated. The best part about the AIRGUARD™ cloth mask is that it is washable, reusable and sweat resistant. You can wash or put the AIRGUARD™ mask in the washing machine and reuse them with the same filtering properties and comfort. The AIRGUARD™ can be washed and reused up to 50 times. The outer layer is water-repellent and will not get wet from sweat during your workout or exercise.

Most cloth masks available in the market now have a maximum of 2 or 3 layers and has less or no filtering properties against harmful micron particles in the air.

As per the Director of National Institute of Health, Dr. Anthony S. Fauci – Wearing multiple layers of mask just “makes common sense” and “likely would be more effective”. AIRGUARD™ is the only 5-Layered reusable cloth mask that is more effective in preventing the spread of the virus.

AIRGUARD™ is being distributed worldwide. For more information on AIRGUARD™ cloth mask please visit

http://www.BuyAirGuardMask.com

AIRGUARD™ MASK COMPLIANCE
The AIRGUARD™ reusable cloth mask has passed several mandatory testing required by law and to provide a sense of protection for its consumers. Following are the testing approvals sought by Creative Concepts on the AIRGUARD™ by authorized testing bodies like SGS, Nelson Labs, Intertek, Bureau Veritas and UL.

  • SYNTHETIC BLOOD PENETRATION RESISTANCE (ASTM F1862 under 120 mmHg)
  • 42 CFR PART 84 – NaCI (N95 PARTICULATE FILTER EFFICIENCY)
  • EN14683:2019+AC:2019 (BACTERIAL FILTRATION EFFICIENCY-BFE)
  • FLAMMABILITY CLASS 1 (16 CFR 1610)
  • ANTI-BACTERIAL FINISHES ON TEXTILE (AATC 100-2019)
  • REACH TESTING (FOR EUROPE)
  • Face Fit Test

Via EPR Network
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Smart Wearables in Healthcare Market – Latest Scenario On Innovation, Revolutionary Opportunities & Top Consumers 2027

Albany, New York, 2021-Mar-23 — /EPR HEALTHCARE NEWS/ — The report titled “Smart Wearables in Healthcare Market” offers a primary impression of the Smart Wearables in Healthcare industry covering different product Scope, Characterizations, Classifications, Objectives, and Participants in the industry chain structure. Smart Wearables in Healthcare Market (6 Forces Forecast 2021-2027) research report offers in-intensity insight of the Smart Wearables in Healthcare industry masking all vital parameters along with Marketing Channel, Direct Marketing, Indirect Marketing, Brand Strategy, Pricing Strategy, Market Positioning, Target Client, and Distributors/Traders List.

Smart Wearables in Healthcare Market report profiles major topmost players operating (Apple, Fitbit, Jawbone, Misfit, MyKronoz, Samsung, Philips, Huawei, Qualcomm Technologies, Inc, Adidas Group, Sony Corporation, Lifesense Group, Monica Healthcare, Garmin, Omron, Dragerwerk, Nokia Technologies, Polar Electro, World Global Network [Wor(I)D], Activeinsights, Vitalconnect, Xiaomi, Nuvo Group, TmG-BMC, Scanadu, Proteus, Empatica) in terms of analyses various attributes such as Company Profile, Product Specifications, Revenue, Gross, Gross Margin, Cost, Capacity, CAGR, Production Value and contact information.

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Currently, Asia-Pacific is the largest market for the Smart Wearables in Healthcare having accounted for more than half of the global market size, by volume, in 2020. Among all the countries, China & India dominated the basic polymers market in 2020 in terms of volume, closely followed by Japan. High economic growth rate, rising demand for construction products made up of plastics, growing health awareness applications, improving standards of living and competitive manufacturing costs are the main factors leading to the growth of the market for Smart Wearables in Healthcare in this region.

Global Smart Wearables in Healthcare Market size will increase to xx Million US$ by 2027, from xx Million US$ in 2020, at a CAGR of xx% during the forecast period. In this study, 2020 has been considered as the base year and 2021 to 2027 as the forecast period to estimate the market size for Smart Wearables in Healthcare.

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On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-

  • Smart Wrist Wearables
  • Smart Patches
  • Smart Clothes
  • Smart Head / Neck Wearables
  • Smart Ear Wearables
  • Smart Eye Wearables
  • Other

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Smart Wearables in Healthcare Market  for each application, including-

  • Activity / Fitness Tracking (SMEs)
  • Remote Patient Monitoring & Diagnostics
  • Home Health Care
  • Others

Smart Wearables in Healthcare Market: Regional Analysis Includes:

  • Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
  • Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
  • North America (the United States, Mexico, and Canada.)
  • South America (Brazil etc.)
  • The Middle East and Africa (GCC Countries and Egypt.)

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The Smart Wearables in Healthcare Market Report Helps Answer the Following Questions:
⦿   What is the current size of the overall Smart Wearables in Healthcare Market? How much will this market be worth from 2021 to 2027?
⦿  What are the market shares of the leading segments of the Smart Wearables in Healthcare Market in 2020?
⦿  What are the main segments within the overall Smart Wearables in Healthcare Market? How much will each of these segments be worth for the period 2017 to 2027?
⦿  What are the main drivers and restraints in the Smart Wearables in Healthcare Market?
⦿  What are the leading business manufactures? What are their revenue potentials to 2027?
⦿  What are the major deals happenings in the manufactures Smart Wearables in Healthcare Market?
⦿  Who are the leading manufactures and what are their activities, revenue, recent developments and prospects?
⦿  What are some of the most prominent Smart Wearables in Healthcare Market currently in development? What are their activities, platform technology and recent developments?

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URSAPHARM and CEBINA collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic

SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR HEALTHCARE NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.

With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.

Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays [1].

A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.

If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.

SOURCE: EuropaWire

Code18 Interactive Launches New Websites for Balmex and Balmex Adult

New York, NY, 2021-Jan-20 — /EPR HEALTHCARE NEWS/ — New York digital agency Code18 Interactive gives two health and wellness brands—Balmex Complete Protection and Balmex AdultAdvantage—custom websites that will provide peace of mind and relief for everyone from baby to grandpa. Both sites are fully responsive and built on the WordPress platform.

Code18 Interactive, a boutique digital agency based in New York City, announces the launch of new health and wellness websites for Balmex Complete Protectin and Balmex AdultAdvantage. Both are fully custom and fully responsive WordPress websites – https://balmex.com helps elevate and refresh a legacy brand while providing helpful diaper rash solutions and peace of mind for new parents, and https://balmexadult.com showcases over-the-counter relief for adults who experience skin irritation and chafing caused by incontinence or light bladder leakage. Both sites also feature e-commerce capabilities powered by WooCommerce, enabling the brands to offer Direct-to-Consumer sales for the first time.

The Balmex Complete Protection and Balmex AdultAdvantage brands are both part of the Randob Labs portfolio. Randob Labs is a private, family-held company that specializes in revitalizing and maintaining heritage brands on the OTC healthcare space. “Collaborating and working with Randob Labs has been an exciting adventure. Both Balmex and Balmex Adult provide big relief from common, irritating issues,” says Code18 Interactive founder Steve Pilon. “And providing relief and solutions to everyday problems is exactly what Randob Labs is all about. We’re thrilled to be a part of this process.”

As a well-established presence in the baby aisle, Balmex Complete Protection offers pediatrician-recommended diaper rash cream and multi-purpose healing ointment to help protect, soothe and heal baby’s delicate skin. “Many health and wellness websites only talk about what their product can do for consumers. However, Balmex is all about providing fast relief and reliable, proven solutions. Therefore, the website needed to clearly explain the causes of diaper rash and skin irritation, as well as provide simple steps parents can take to help prevent diaper rash in the first place,” says Pilon. “The brand’s willingness to go the extra mile for new parents is just one of the many reasons parents have been trusting Balmex for over 50 years.”

Clinically proven Balmex AdultAdvantage offers the same key benefits—a cream that protects, soothes and heals irritated and chafed skin—as its 50-year-old sibling brand. Available as a standalone skin relief cream or as part of an innovative on-the-go, 3-in-1 kit, Balmex AdultAdvantage helps older adults live life more comfortably. “For many older adults incontinence or bladder leakage controls their life, and unfortunately, many people just accept this fate,” says Pilon. “With the Balmex Adult website we really focused on awareness—awareness of this fantastic product, awareness of the benefits, and mostly, awareness that you can take back control of your life with Balmex AdultAdvantage.”

Code18 Interactive is a New York WordPress Agency that caters primarily to national consumer and media brands. The agency specializes in the design and development of enterprise-level WordPress and Magento 2 websites. They have the pleasure of working with many wonderful brands, including: GoGo squeeZ, Boursin Cheese, Public Radio International, The Laughing Cow, Grove Atlantic Publishing, C.O. Bigelow and many others.

For more information, please visit http://www.code18.com

Media contact:

Steve Pilon
Code18 Interactive
175 Varick Street, 8th Floor
New York, NY 10014 USA

Phone: 404-585-2725
https://code18.com

Via EPR Network
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When Suffering From Endometriosis, The Natural Therapy Fuyan Pill Is A Useful Medicine For Pregnancy Plan Of Female Patients

Los Angeles, California, U.S.A., 2021-Jan-14 — /EPR HEALTHCARE NEWS/ — Reuters recently reported that British lawmakers called for urgent government action to support 1.5 million females with endometriosis — a debilitating condition that leads to absenteeism from school and work and can cause infertility. Female health experts said the lack of funding for research into the crippling illness — which affects one in ten females worldwide — showed how female health issues were often marginalized.

Female health issues should be paid attention to, while endometriosis is very harmful to the body health in females, which can cause persistent dysmenorrhea, menstrual disorders, urinary pain, low back pain, pelvic bleeding and other problems. If things go on like this, endometriosis will affect their learning efficiency, working performance, social life, relationships and mental health. In addition, they may have to face the problem of infertility.

In general, due to the ectopic endometrium attached to the abdominal cavity or ovarian surface, it can cause periodic shedding, congestion, edema, thus leading to the formation of chocolate cysts on the ovarian surface. The abnormal tissues can affect ovulation and then lead to infertility. Furthermore, the ectopic endometrium in the abdominal cavity will cause the viscera to stick together, causing the fallopian tubes to be blocked. In this case, the sperm and the egg cannot be combined into a fertilized egg in the fallopian tube, resulting in female infertility.

If a female friend has endometriosis and suffers from long-term infertility, doctors generally recommend her to receive a surgery to excise the diseased tissues. However, in some cases, due to the serious adhesions of the lesions, doctors are often unable to make a complete elimination, thus leading to a high recurrence rate of endometriosis.

On the flip side, doctors may adopt the therapeutic surgery, which involves the complete removal of both ovaries and the uterus. Actually, it’s relatively cruel to young and childless females, which not only directly deprives them of the reproductive rights, but also potentially triggers postmenopausal syndrome. Surgery can also induce secondary infections, leading to other inflammations such as pelvic inflammatory disease.

Obviously, surgery is a double-edged sword, which surely has some positive effects, but is not the best option, especially for females who want to raise children. A sound body is essential for a successful pregnancy. If you have to suffer from extra pain and risks due to the treatment method, it’s actually not worth trying. As a result, more and more patients with endometriosis are looking for safer solutions, and the natural therapy Fuyan Pill is a useful medicine for them.

The herbal medicine Fuyan Pill is developed by Wuhan Dr.Lee’s TCM Clinic, which has been granted the national patent in China. It can eliminate inflammations, kill various bacteria and viruses, clear away heat, remove blood stasis, relieve pain and so on. It’s made from more than 50 selected herbal ingredients, including radix bupleuri, poria, scutellaria baicalensis, gardenia, Chinese yam, talc, angelica sinensis, peach seed, safflower, licorice, etc.

The Fuyan Pill can effectively relieve the pain and discomfort caused by endometriosis, unblock the fallopian tubes, solve the adhesion issues, and provide a sound physiological environment for fertilization. In terms of traditional Chinese medicine, the cause of endometriosis is qi stagnation and blood stasis, and Fuyan Pill features the ability to promote blood circulation, remove blood stasis, eliminate inflammation and abnormal tissues. It can also regulate the menstruation and hormones, enhance the body immunity, and improve the female self-healing capacity.

As a natural therapy, Fuyan Pill has a strict formula and ratio in terms of the composition. Based on Dr. Lee’s more than 30 years of clinical experience, Fuyan Pill has been proved as an effective and safe oral product, which won’t lead to toxic side effects or unnecessary physiological pain and discomfort. For females who aspire to be a mother, Fuyan Pill can help them overcome endometriosis and get pregnant naturally.

We once cured a patient with endometriosis. Emily, a 28-year-old married female in America, was diagnosed with endometriosis and blocked fallopian tubes in 2017. After several attempts at treatment methods, including laparoscopic surgery and hormone therapy, her problems remained unresolved. Introduced by a friend last year, she contacted us and expressed her strong desire for childbirth through email, so we suggested her taking the Fuyan Pill.

After a month of treatment, Emily said that those painful symptoms had been improved so much that she didn’t hesitate to continue taking the pill for several months. Her illness has improved greatly and she is happy to tell us that she got pregnant two months ago. Now, she is actively preparing for the arrival of her baby.

As a natural plant medicine product, Fuyan Pill has a broad-spectrum bactericidal action with no side effects, which can not only treat endometriosis but also react well on pelvic inflammatory disease, endometritis, salpingitis, chlamydia infection, pelvic abscess, and other related problems. As a result, it can help females solve infertility caused by these gynecological diseases. We hope that females pay more attention to their body health. If you suffer from some problems mentioned above, Fuyan Pill is worth trying.

For more information about Fuyan Pill, please visits: https://global.fuyanpills.com/

About Dr. Lee Xiaoping:
Dr. Lee Xiaoping graduated from Hubei College of Traditional Chinese Medicine, China. She qualified as a herbalist 40 years ago and is a highly experienced medical professional. She specializes in the field of male and female reproductive and urinary system diseases. She has devoted 30 years to her clinic and worked on the formula of Fuyan Pill for years. The medicine has proven to be effective and cured thousands of people who suffered from endometriosis as well as its complications.

Media contact:

Lee Xiaoping
Herbalist
Wuhan Dr.Lee’s TCM Clinic
+86- 027-87105085
wuhandrli@gmail.com
herbalistlee@yahoo.com
wuhandrlee@hotmail.com

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Palette Life Sciences unveils 4 international sites for its Deflux online presence

SANTA BARBARA, CALIF. / STOCKHOLM, 27-Oct-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today introduced valuable new online resources for healthcare providers in France, Germany, Italy and Spain. By expanding its Deflux online presence to international audiences, Palette Life Sciences demonstrates its commitment to supporting the global paediatric community.

Deflux.fr is a French-language resource for healthcare providers in France. Deflux.com/de is a German-language site serving practitioners in Germany. Deflux.com/es and Deflux.it are English-language sites serving physicians in Spain and Italy respectively. These new sites offer best-in-class online resources, important information and education about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. All of the European sites provide physicians with access to the global Deflux Learning Center, a leading education platform that features information and training for paediatric urologists and their peers who treat VUR. The Deflux Learning Center includes clinical articles, educational videos, webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

The Deflux Learning Center for each respective country also provides downloadable educational materials for parents and caregivers managing children with vesicoureteral reflux (VUR).

“My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence in patients who fail medical management, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for physicians, will help raise awareness of this treatment option in patients with primary VUR, troubled by recurrent febrile UTIs,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Service Lead for Paediatric Surgery at Chelsea & Westminster and Imperial College Hospitals.

“We are excited to offer these new online resources to the healthcare community in France, Germany, Italy and Spain,” said Rich Low, Head of Marketing at Palette Life Sciences. “We are confident they will benefit the global paediatric urology ecosystem and serve as valuable resources by providing critical information and access to educational resources through the Deflux Learning Center.”

SOURCE: EuropaWire

ShigETEC vaccine candidate has the potential to have a major impact on diarrheal diseases

VIENNA, 24-Sep-2020 — /EPR HEALTHCARE NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.

Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.

“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.

“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.

Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.

SOURCE: EuropaWire

CoapTech Raises $7 Million in Series B Funding Led by Hunniwell Lake Ventures

Baltimore, MD, 2020-Aug-28 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD), a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced today the closing of a Series B investment of $7 million led by Palo Alto-based medical device venture capital firm Hunniwell Lake Ventures. The financing will be used to fund CoapTech’s commercialization of its FDA-cleared PUMA-G System.

By simplifying gastrostomy procedures to the point where they can be conducted at the patient’s bedside with ultrasound, hospitals using PUMA-G benefit by freeing up surgical suites and personnel resources for COVID and other clinical priorities, minimizing cross-contamination, and improving efficiencies in care.

CoapTech was founded by critical care physician Dr. Steven Tropello and clinical innovation researcher Howard Carolan, to reduce unnecessary delays, harm, and costs for feeding tube placement, a vital therapy for millions of patients each year around the world.

Howard Carolan, CEO and Co-Founder, states: “We have been receiving fantastic feedback from hospitals in our initial launch program, which are using the PUMA-G System to revolutionize feeding tube placement. By using ultrasound at the patient bedside, rather than the conventional approach of orchestrating expensive and inefficient consults, critical care physicians are completing these procedures in minutes, on the same shift a feeding tube is first indicated. We’re seeing early indications those efficiencies result in patients leaving the ICU sooner, which saves hospitals many thousands of dollars per admission. A substantial portion of this new funding is from physicians who have seen the device and believe it can become the new default method for feeding tube placement.”

Dr. Steven Tropello elaborates, “the PUMA-G System is proving itself ready for standard-of-care adoption for safe and timely gastrostomy tube placement. It is also proving a powerful approach in the fight against COVID, by completely eliminating transport of patients, team members, and reprocessed tools throughout the hospital in favor of a sterile, disposable, bedside solution. I am also very excited about other clinical applications of the PUMA platform we are developing and aim to have for patients in the near future.”

This Series B investment was led by Hunniwell Lake Ventures, a Palo Alto-based medical device venture capital firm.

Daniel Teo, Managing Partner at Hunniwell Lake Ventures, further states “Coaptech’s PUMA System has the potential to transform gastrostomy and many other surgical procedures by allowing them to be performed using ultrasound at the bedside, in hospitals, ambulatory centers, skilled nursing facilities, and LTACHs (Long-term Acute Care Hospitals). This also benefits patients by bringing the procedure closer to the Point-of-Demand (PoD) and giving them more options with a larger community of medical providers capable of performing the procedure.

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LIDBREE™ receives marketing authorization in the United Kingdom

SANTA BARBARA, CALIF., U.S.A. / BUDAPEST / STOCKHOLM, 5-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences AB (‘Palette’) with Gedeon Richter Plc. (‘Richter’), today announced that as a part of a decentralised regulatory procedure including thirty European Union Economic Area member states, Palette and Richter received national marketing authorization for LIDBREE™ in the United Kingdom (UK). The product is a novel, proprietary thermo gelling intrauterine formulation that can provide significant pain relief during common gynecological procedures.

LIDBREE’s marketing authorization is based on compelling data from clinical trials and investigations of sensory innervation in the reproductive area. In a pivotal clinical trial, LIDBREE treatment was associated with a significant reduction of pain and discomfort in women undergoing gynecological interventions.¹

“Our research group has detected pain nerves superficially throughout the uterus, which enable the use of local pain relief in many gynecological procedures such as insertion of an intrauterine device and sampling biopsies from the cervix and/or from the uterus – procedures that are currently routinely performed today without pain relief. LIDBREE is a novel gel containing the local anesthetic lidocaine which adheres to the mucosal tissue upon application to provide excellent analgesic effect”, says Gunvor Ekman-Ordeberg, MD PhD Professor at Karolinska Institute and founder of the LIDBREE program. “The gratification of observing the culmination of over 40 years of research into clinical practice via a new, simple, and effective treatment is a great privilege to share with all of my colleagues.”

In October 2017, Richter and Palette signed an agreement to commercialise LIDBREE, a novel innovative proprietary pain relief pharmaceutical formulation, in Europe and in certain other markets.

“We are very pleased with the approval of LIDBREE in the UK, it is a great accomplishment from everyone involved.  This is an important milestone and allows us to address a significant unmet medical need in women’s health. We look forward to supporting LIDBREE’s product launch through our partner Gedeon Richter and pursuing additional markets, such as the U.S., in collaboration with future regional partners.” says Helena Jansson, Managing Director at Palette Life Sciences AB.

“We’ve been expecting this regulatory development and we are looking forward to successfully introduce LIDBREE to all of the territories covered by our agreement in order to further improve the quality of life of women experiencing pain during their gynaecological interventions,” stated Tibor Horváth, Commercial Director of Gedeon Richter Plc.

SOURCE: EuropaWire

Palette Life Sciences unveils an online resource aimed at paediatric urologists, parents and caregivers in the UK dealing with vesicoureteral reflux (VUR)

SANTA BARBARA, CALIF., U.S.A. / STOCKHOLM SWEDEN, 4-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced the launch of Deflux.com/UK as part of its global expansion. Deflux.com/UK is a best-in-class online resource developed specifically for healthcare practitioners in the United Kingdom, as well as parents and caregivers managing children with vesicoureteral reflux (VUR). VUR, sometimes referred to as urinary or bladder reflux, is a serious paediatric urinary condition in which urine flows from the bladder through one or both ureters toward the kidneys.

Deflux.com/UK features important information about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. Comprised of hyaluronic acid (HA) and dextranomer polysaccharides to form a gel, Deflux is a minimally invasive biocomopatible treatment for VUR. Endoscopic treatment with Deflux takes about 15 minutes in a day procedure setting, and generally allows the child to go back to normal activities the next day.

Deflux.com/UK also provides physicians with access to the Deflux Learning Center, a leading global education platform that features information and training for paediatric urologists and their peers who treat VUR as well as other paediatric urology conditions. The Deflux Learning Center includes clinical articles, educational videos and webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

“Deflux is an effective, minimally-invasive treatment option that many caregivers simply aren’t aware of,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Clinical Director for Paediatric Surgery at Chelsea and Westminster Hospital. “My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for both physicians and caregivers, will help raise awareness and utilisation of this treatment option.”

“The entire Palette commercial team is excited to launch Deflux.com/UK, which we believe will help elevate the standard of care for VUR patients in the UK,” said Rich Low, Head of Marketing, Palette Life Sciences. “Deflux.com/UK will serve as a truly valuable resource for caregivers, providing critical information to paediatric urology healthcare professionals through the Deflux Learning Center, and to caregivers, connecting them to highly-trained specialists who provide high quality care.”

SOURCE: EuropaWire

Palette Life Sciences expands distribution network across Europe

STOCKHOLM, SWEDEN / SANTA BARBARA, CALIF., USA, 15-Jun-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced global distribution expansion for two of Palette’s products, Deflux and Solesta. The expansion provides commercial access to more than 20 countries through five distributors around the globe, while adding direct sales in four additional countries: Cyprus, Greece, Hungary and Portugal.

KEBOMED, a leading European distributor of medical devices and equipment, will distribute the products in France, Sweden, Norway, Finland, Denmark and Iceland. Stratarium Sarl, will commercialize the products in Germany, Austria, Belgium, Luxembourg, Netherlands and Switzerland leveraging their urology focused subsidiary, RA DistributionCJ Medical, a UK-based distributor of innovative technologies specializing in surgical and medical devices, will distribute the products in Ireland and the United Kingdom. Grifols, one of the leading companies in the production and sale of plasma-derived medicines and a top distributor of a broad range of products within their country will cover Spain, and GP Dermal, a specialist with deep ties across urology and pediatric call points will serve as the distributor in Italy and Malta.

“This enhanced distribution network allows Palette to ensure our customer and patient needs are adequately met across Europe,” said James Leech, Head of Corporate Development at Palette Life Sciences. “We have selected strong partners with deep experience and relationships in the urology and pediatric setting who will help us serve the product and education needs of physicians and hospitals. Palette and its network of partners are making significant investments within local markets to improve physician access to Palette resources, best management and treatment practices, and renewed product training.”

For more information or to place an order, please contact a Palette Life Sciences representative at eusales@palettelifesciences.com. Contact information for product orders or inquires by distributor are as follows:

KEBOMED: ordre@kebomed.dk
Stratarium Sarl: deflux-solesta@stratarium.com
CJ Medical: office@cjmedical.com
Grifols: jose.sagales@grifols.com
GP Dermal: luigi.galandini@gpdermal.com

SOURCE: EuropaWire

American Hemp Processing To Roll Out Mobile Extraction Units

Sacramento, California, 2019-Dec-10 — /EPR HEALTHCARE NEWS/ — American Hemp Processing (AHP) is excited to announce the design completion of their Mobile Hemp Extraction Unit (MEHU). This is a key step in AHP’s expansion to increase production to 400,000lbs of hemp per month that will be completed 1st quarter 2020. The mobility of the MEHU reduces overall processing costs, mitigates many of the risks associated to transportation, and increases transparency with farmers.

The MHEU units bring significant benefits to the farmer from both a financial and risk mitigation perspective. “Most hemp farms are not close to processing facilities. Transportation is a large cost and increases the risk of degradation and contamination. On top of that, farmers still have to deal with legal issues in states that aren’t familiar with hemp and mistake it for marijuana,” says Andrew Alvarez Co-Founder and Chief Technology Officer “Additionally, it increases transparency with farmers and helps educate them along the way to build synergistic relationships”.

“The design of the MHEU was Phase 2 of our strategy,” says Shick Park Co-Founder and Chief Operations Officer, “Phase 1 was developing a scalable extraction and remediation process enabling us to create high quality and compliant CBD oil, and Phase 3 is the roll-out of the mobile extraction units on to farms fall of 2020.”

“This caps off a 12 month design process by our engineers and now we go to the assembly phase. These units will take approximately 120 days each to build, and we plan to initially build 3,” says Co-Founder and CEO Tom Richardson. “This has been a very rewarding journey for us, from meeting farmers all over the country, to government legislators, to fine tuning the extraction process, to meeting other processors and sharing ideas, we feel very confident about the Cannabinoid Sector business.”

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Parenteral Drug Association’s “ICH Q7 GMP for APIs” online training module is now endorsed by ICH

BERLIN, 22-Nov-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is proud to announce that its “ICH Q7 GMP for APIs” online training module is now endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an “ICH Recognised Training Programme.”

The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.

The free “ICH Q7 GMP for APIs” training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.

SOURCE: EuropaWire

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First Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany done by Dr. Lutz-Hendrik Holle

HANAU, Germany, 4-Oct-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that Dr. Lutz-Hendrik Holle, Medical Director of the interregional professional association for nuclear medicine in Hanau, has accomplished the first Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany. This state-of-the-art technology of local radionuclide therapy offers a painless and non-invasive treatment option for patients with basal cell carcinoma and squamous cell carcinoma (BCC and SCC) and the interregional professional association for nuclear medicine Hanau is the first center in Germany that offers the Rhenium-SCT®.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods. The key argument for the expansion of the spectrum was that the Rhenium-SCT® is a new, painless and highly efficient treatment option that also delivers excellent cosmetic results. Besides being a painless alternative to other procedures, the Rhenium-SCT® also allows the treatment of numerous NMSC lesions consecutively in a single session, which was already realized during the first treatment in Hanau. This has also attracted international attention so that an American patient travelled to Hanau for the treatment.

“This therapy is particularly suitable for tumor localizations where good cosmetic results are to be achieved. The fact that the treatment is completely painless and can be performed in just one session is a great advantage”, says Dr. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are very happy and proud to be able to offer our revolutionary treatment to patients in Germany now. The interregional professional association of nuclear medicine in Hanau is an excellent partner for NMSC patients in the fight against NMSC”, said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Unfortunately, Germany is one of the countries that has experienced a drastic increase in newly diagnosed NMSC cases in recent years. Our highly qualified team strives to provide physicians and patients with a non-invasive and affordable solution to treat NMSC, while focusing on the needs of the patient.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In certain analyzed areas of Germany there was an increase in the incidence between the year 2005 and the year 2014 by about 30%1. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application in most of the cases, applied in one single session with excellent aesthetic outcomes.

Via EPR Network
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CoapTech and Fidmi Medical to Collaborate on Groundbreaking G-Tube Systems

Baltimore, MD, 2019-Sep-18 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD) and Fidmi Medical, Ltd. (Caesarea, Israel) announced today that they will be collaborating on bringing to market a set of next-generation products for the initial placement and long-term maintenance of gastrostomy tubes (G-tubes). The collaboration between CoapTech and Fidmi will focus on integrating the company’s two technologies and expanding their collective market opportunities.

Gastrostomy tubes, which help patients receive long-term nutritional support, are typically placed endoscopically and need to be replaced every 3-6 months.

CoapTech’s PUMA-G System allows initial gastrostomy tube placement by non-surgeons/ gastroenterologists, outside of the endoscopy suite, using point-of-care ultrasound at the patient bedside. This novel approach can be performed in the ICU, emergency room, and eventually outside of the hospital setting, substantially reducing costs for tube placement.

Fidmi Medical’s innovative low-profile gastrostomy system is unique in that it can be utilized for both initial placement and replacement and has several features which make it more durable and comfortable for patients. Gastrostomy tubes very often get dislodged, clogged, or infected, and need to be replaced frequently. Fidmi’s improved low-profile gastrostomy tube is placed just like any standard PEG tube but has an easily replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures. This will result in fewer complications with patients’ g-tubes, therefore potentially reducing healthcare costs for payers and healthcare systems; as well as providing a substantial improvement in quality of life for patients and their caregivers.

Fidmi Medical Chairman, Lloyd Fishman, commented, “We are excited to collaborate with CoapTech in development and marketing. Both companies have developed cutting-edge technologies that will improve patient care and contribute to the ease, efficiency and confidence of clinicians’ work in the gastrostomy field.”

Dr. Steven Tropello, CoapTech’s founder and CMO said, “In combination these systems will be compatible with Push or Pull methods, be implantable in a wide variety of clinical settings, and require minimal readmission to the hospital and fewer visits to the ER. The synergy will reduce both front and back-end costs for hospitals and payers, and make care safer and more patient-centered.”

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2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

BERLIN, 14-Aug-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:

  • Danish Medicines Agency
  • Dutch Medicines Evaluation Board
  • European Medicines Agency
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • Swedish Medicines Agency

Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.

After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.

Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s 2025 regulatory science strategy.

The meeting will close with a panel discussion including all the regulatory representatives participating.

Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference

Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form

SOURCE: EuropaWire

Personally Delivered, Inc., Introduces a New Line of Daytime and Overnight Adult Incontinence Pull-On Protective Underwear with Exceptional Absorbency and Comfort

Personally Delivered, Inc., Introduces a New Line of Daytime and Overnight Adult Incontinence Pull-On Protective Underwear with Exceptional Absorbency and Comfort

Lake Mary, Florida, United States, 2019-Aug-12 — /EPR HEALTHCARE NEWS/ — Personally Delivered, Inc., a leading expert in-home delivery of incontinence, skin care, ostomy, urological, and related supplies, is launching its new, competitively-superior line of Personally Delivered™ Premium-Plus Pull-On Protective Underwear in both Daytime and Overnight styles.

Leveraging 40+ years of listening to incontinence customers and helping them find the right products for their unique situations, Personally Delivered has incorporated the most advanced technologies to create a new unisex pull-on Protective Underwear available in both Daytime and Overnight styles. These state-of-the-art products offer superior absorbency and comfort to help users remain more comfortable, confident, and in control. Customers can now have industry-leading, superior products discreetly delivered right to their front door.

Made in the USA, Personally Delivered™ Pull-On Protective Underwear incorporates gentle cloth-feel stretch panels for maximum comfort and easy removal.  A dual-core system plus super-absorbent polymers provide rapid absorbency and superior leak protection. A gel core locks in odors, prevents leaks, and keeps the wearer drier.  Comfortable leg gathers deliver active protection and a secure fit.  Combined, these features provide the new standard in incontinence comfort and absorbency.

“We speak with people every day who struggle with incontinence and provide real-life feedback on what works and what doesn’t when it comes to leak-free protection,” said Seth Segel, CEO of  ConvaTec’s  US Home Distribution Group, the parent company of Personally Delivered, Inc.  “We understand what these individuals are going through. We listened to them and then went to work creating products to address their problems.  Our new Personally Delivered™ Protective Underwear delivers optimal dryness and a leak-free experience.”

Personally Delivered™ Overnight and Daytime Protective Underwear are available exclusively through www.PersonallyDelivered.com. They are available in a range of sizes from Small to Extra-Extra Large.

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2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

SOURCE: EuropaWire