Category Archives: Healthcare

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?

If you have any special requirements, please let us know and we will offer you the report as per your requirements.

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Via EPR Network
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Curatronic Ltd. announces the new Ultra-Flash impulse PEMF device exceeding 1 Tesla

Jerusalem, Israel, 2021-Jan-28 — /EPR HEALTHCARE NEWS/ — The brand-new Curatron Ultra-Flash impulse PEMF machine for instantaneous pain relief.

Curatronic Ltd. announces to have started taking orders for their brand-new Curatron Ultra-Flash device completing the Curatron line of pulsed electromagnetic field therapy devices.

Curatronic Ltd. has succeeded in developing a completely service free, ultra-high intensity impulse PEMF device. The Curatron Ultra-Flash ultra-high intensity PEMF pulses are electronically controlled by high voltage solid state semiconductor game changing technology, without any need for service as required for obsolete spark gap technology.

The new Curatron Ultra-Flash has 10 internal computer-controlled programs offering a wide choice for various treatment possibilities. These built-in programs offer superior flexibility, including for use as ringer and oscillating applications of impulse PEMF.

Curatronic offers a wide range of PEMF models to choose from, according to individual needs. A wealth of information can be found on their website, both extensive technical information as well as practical applications.

Ben Philipson, CEO of Curatronic Ltd. said, “The amazing results for instantaneous pain relief have been experienced by me personally! Now that we have completed our line of impulse PEMF devices the new Curatron Ultra-Flash device excels in the ability to generate pulsed magnetic field levels exceeding the 10,000 Gauss barrier making all PEMF spark gap devices on the market obsolete. The new Ultra-Flash system is geared towards use by medical professionals and we are looking forward to start soon shipping to customers who have taken advantage of the large pre-order discount we offer.”

Further information can be found on the Curatronic website www.curatronic.com

Curatronic is the leading innovator in Pulsed Electromagnetic Field therapy. Founded in 2000, the company has clearly established itself as the undisputed leader in the field of PEMF therapy devices in 99 countries around the world.

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

Via EPR Network
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Experts and civil activists demand transparency and information disclosure, including medical history, regarding medical treatment of politicians

RIGA, Latvia, 29-Dec-2020 — /EPR HEALTHCARE NEWS/ — German Charite Medical Center once again is in the limelight of international attention: on December 17 the popular mayor of Kharkov (Ukraine), Gennady Kernes, passed away at the well known hospital after a 3 months struggle with Covid-19.

Kernes got diagnosed 2 days after he was officially elected the Mayor of Kharkiv by 60,34% of voters. The politician was expected to recover and get back to his duties, yet his health condition was rapidly getting worse. In 2014 Kernes was attacked during an assassination attempt and since then had to be moving around in a wheelchair.

Founded in the early 18th century, the Charité Medical Center is considered one of the best in Germany. However, the clinic’s excellent reputation was affected by its repeated involvement in political scandals, that have turned Berlin’s oldest hospital into a kind of an expert center causing major cleavages that increase tensions between those in power and those in the opposition in Eastern Europe. Among the recent cases, that was the high-profile case of Navalny, whom the Charité doctors diagnosed with Novichok poisoning, and in 2013, German doctors provided an equally fatal diagnosis for Ukraine’s ex-Prime Minister Yulia Tymoshenko, who was then in prison. However, following her release from jail and a weeklong treatment, Tymoshenko fully recovered. In 2018, experts at Charité announced that Pyotr Verzilov, a Russian opposition activist with quite limited support and recognition rating, was poisoned with an unknown substance. Earlier, in 2004, doctors at Charité repeatedly changed the diagnosis of Victor Yushchenko, then the frontrunner in the presidential race in Ukraine. Active involvement into political issues and related statements make the clinic’s reputation highly controversial.

As a result, a number of Russian and Ukrainian media outlets now say that Gennady Kernes, who maintained close contacts with Moscow, could have been intentionally mistreated, adding suspicion to his sudden death. The cases of Yushenko, Navalny, Timoshenko, Verzilov, Kernes and other ones that are actively used at the political and geopolitical arena, make more and more experts and civil activists demand transparency and information disclosure, including medical history, regarding the patients whose health and diagnosis can affect the lives of millions.

SOURCE: EuropaWire

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.

Via EPR Network
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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

Exclusive Interview on Addictiveness During the Coronavirus Pandemic with Dr. Henry Balzani, the “Addictiveness Doctor”

Fort Lee, NJ, USA, 2020-May-15 — /EPR HEALTHCARE NEWS/ — In an exclusive interview with Practicomm, nationally recognized addictiveness expert provides valuable update on controversial addiction issues.

Q1. In light of the Coronavirus pandemic, it appears that people who were not addicts could become addictive just from being quarantined? Do you think that would be a large number of new addicts?

Our “Basic Survival Thinking” is mostly negative and being quarantined produces increased life stresses such as, unemployment, financial loss, fear of death, forced isolation and mental illnesses. During the pandemic, there has been an increase in alcohol consumption (as well as other substances) to blunt the negative thoughts. Also, there was an increase in sugary-high carb “comfort foods” used to stimulate positive feelings through the increased production of neurotransmitters like dopamine and serotonin.

But in fact, almost all the Covid-19 deaths are directly related to our addictiveness to high carb, processed food and the abuse of drugs, alcohol, tobacco, especially high blood sugar, diabetes and high blood pressure, which compromise the immune system. In brief, “Yes”, there will be an increase in addictiveness to try to relieve the pressure and mental stress from this pandemic

Q2. Some people say that smoking is a worse addiction than alcohol and drugs. Is that true? If so, why?

Smoking leads to strong persistent cravings for more nicotine within minutes to hours of the last puff. Vaping allows nicotine to almost always “be in hand’ day and night, inside or out. Addiction to different substances varies with the substance and the individual, and is tempered by availability, legality, cost, social acceptance, the onset of health issues, age of user, and more. Smoking health issues usually develop later in life; products are readily available, and vaping is now cool and socially acceptable. Fortunately, tobacco products are banned in buildings and outside in parks, thus making it harder to use freely.

Q3. It seems that most addiction treatment centers have a high percentage of patients who are “cured” for only a small period of time before going back to the addiction. Is that a correct statement?

The LIFETIME tendency to relapse (recidivism) after treatment is still high. The “Post Treatment Cure” is, for most, a physiologic removal of the substance from the body; and, for a time, a psychologic re-education and respite for the client before entering the real world. The “Roots of Addiction” can start early in life and become deeply and unconsciously embedded over years, and can always be reactivated under stress. To achieve a lifetime cure, addicts must always be actively involved in their recovery, because life just doesn’t get easier. I have seen my clients relapse a number of times before being able to maintain sobriety; and, some who have relapsed after many years of sobriety.

Q4. Can addicts actually change the way they think? How would they do that if they could? Does this vary by the type of addiction?

Adult addicts can change the way they think if they have a strong Desire, Interest and Commitment to recover. But, being pushed into recovery usually doesn’t last long.

They must deal with the root causes of their addiction, as they can be reactivated during times of stress. For any addiction, they must fully commit and actively participate in their process of Detox, Treatment, Counseling, and follow up, remove people places and things, and have (or seek out) a strong support system which can help in stressful situations. The stresses of life will always be there and it’s the psychological aspect of addiction that can be persistent!

For more information on the root causes of addiction, visit  addictivenessdoctor.com and/or go to Dr.Balzani on Facebook.

Via EPR Network
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MEDIS expands into new areas of cardiovascular disease with the acquisition of Italian medtech company AMID

LEIDEN, Netherlands, 11-May-2020 — /EPR HEALTHCARE NEWS/ — MEDIS, a leading developer and supplier of software applications for image-based diagnosis and quantitative assessment of cardiovascular disease, today announced that it acquired Advanced Medical Imaging Development S.r.l. (AMID), a developer and supplier specialized in cardiovascular mechanics and innovative image processing in ultrasound and other modalities. The strategic acquisition will expedite MEDIS’ expansion in new areas of cardiovascular disease, and secure MEDIS’ access to key technologies to further enhance its innovative portfolio of post-processing solutions for X-ray, MR, CT, IVUS, OCT and US devices.

The acquisition of AMID, based in Sulmona (Italy), will further increase MEDIS’ share in the cardiovascular market. “This acquisition expands our product portfolio and brings in new sales channels. The combination of AMID’s products with our product and services portfolio will enable us to provide our customers a unique and more complete multi-modal offering for cardiovascular imaging analysis”, said Hans Brons, CEO of MEDIS.

“As part of MEDIS we will have significantly more leverage to position our portfolio of innovative technologies in the global market for cardiovascular imaging software,” commented Giovanni Tonti, CEO of AMID. “Our technology offerings will allow MEDIS to complement and further enhance its already impressive suite of clinical offerings and spur innovation.”

“MEDIS and AMID have already had an excellent cooperation for over five years, both commercially and in product development. I am very excited about our access to the unique know-how and innovative power of AMID’s founders and their technology, and to intensify the cooperation leading to new solutions that ultimately will benefit the patients“ says Hans Reiber, founder and CSO of MEDIS.

MEDIS will leverage AMID’s proprietary state-of-the-art software and know-how to provide even more sophisticated cardiac and cardiovascular imaging software solutions to its customers. “The integration of both companies will take place over the next months. We expect to significantly strengthen our power to innovate and are very excited about our new relationships with AMID’s existing OEMs and sales channels” added Hans Brons. “Our new customers will continue to receive the same high quality of service which they have come to expect.”

AMID, which will continue to operate under that name is now a wholly owned subsidiary of MEDIS.

Over the last 6 months Van Herk Ventures has made significant further equity investments in MEDIS with the aim to help accelerate the growth of the company and to enable the acquisition of AMID.

“With this investment, Van Herk Ventures enables us to further expand on our position as an independent vendor of high specialty software and a leader in this industry,” stated Hans Brons, CEO of MEDIS.

“We have been intrigued by the broad spectrum of innovations in the cardiovascular imaging domain that MEDIS has created and commercialized over the years, and in particular the more recent exciting and disruptive opportunities in the field of interventional cardiology.

MEDIS has been recognized worldwide as a company that develops high quality software, listening to the needs of the clinicians and researchers and supporting them with new and expanded applications. We believe that there is a great upwards potential in MEDIS and we like to stimulate these developments and see the company grow to the next level. We are therefore very excited about the MEDIS acquisition of AMID,” said Dharminder Chahal, managing director of Van Herk Ventures.

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.”

Via EPR Network
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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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Medis: The new 4D Flow Module reduces the complexity of HeartMRI scans substantially

LEIDEN, Netherlands, 4-Nov-2019 — /EPR HEALTHCARE NEWS/ — Innovative cardiovascular imaging technology solutions developer Medis today announced a new module for the company’s Medis Suite MR. The new 4D Flow module is intuitive and easy to use, and provides essential, practical tools to enable 4D flow to be incorporated into clinical routine and to allow the measurement of flow volumes from a single 4D flow scan instead of multiple 2D flow scans – reducing complexity and easing the process.

“With 2D flow scans, reconstructions must be planned while the patient is on the table,” said Hans Brons, CEO. “For complex scan protocols, this can be tedious and challenging – and the post-processing can be both time-consuming and complex. With the help of this new module for Medis Suite MR, it is now possible to acquire flow in 4D from a single scan and to create flow plane reconstructions retrospectively, allowing the complexity of HeartMRI scans to be reduced substantially – and also reducing the time it takes. This is especially relevant for paediatric HeartMRI units as well as units scanning patients with grown up congenital heart disease.”

Among its numerous differentiators, the new module is advantaged by its ease of use with an intuitive GUI, as well as single click noise removal and single click background offset correction.

As well as reducing the time taken, the new 4D Flow module supports the experienced MR technician in being more effective, more productive and able to deliver better diagnostic information. In addition to reducing the time taken, the new module is straightforward to learn and use for measuring flows in a variety of vessels, allowing the efficient incorporation of 4D Flow post processing in daily clinical practice.

The new 4D Flow module for Medis Suite MR is part of a wide-ranging suite of enhancements for the platform, including the 3D View module – further reducing the time needed for post-processing. In the 3D View module, a double caliper has been added for simple measurements. In addition, loading speed has been increased and it is now also possible to create straightened CPRs (curved planar reformats). Finally, Medis Suite AutoQ pre-processing can now be enabled to run autonomously, initiating Deep Learning contour detection and other advanced algorithms automatically.

Based on over 15 years of experience with cardiac MR, and over 30 years of cardiovascular medical image analysis in general, Medis Suite MR is a vendor-independent post-processing solution for HeartMRI cases. The workflow in Medis Suite MR includes a practical HeartMRI viewer, advanced clinical applications and convenient reporting all in one, making it highly efficient to work with. Seamlessly embedded in the workflow are advanced clinical applications considered best-in-class by many, such as the renowned QMass® and QFlow® applications. In addition, highly innovative and cutting edge research apps such as QStrain RE and QMap RE are also integrated.

Able to run on any workstation, Medis Suite MR is simple to integrate within the hospital IT environment. Connecting it to the DICOM network is straightforward.

4DFlow is cleared for market in the US Market. Clearance approvals for Australia, Brazil, Canada and Europe are pending.

Further information on Medis and its products is available at https://www.medis.nl/

SOURCE: EuropaWire

Wilson Dental of McLean, a Veteran-owned Business Teams Up With Soldiers’ Angels to Collect Halloween Candy for Troops and Veterans

 

McLean, Virginia, 2019-Oct-30 — /EPR HEALTHCARE NEWS/ — Every year, millions of pounds of candy end up in the trash after Halloween. From over-buying, to kids collecting more than they can eat while Trick-or-Treating, candy is wasted across the country. This year, Wilson Dental of McLean is participating in a program that will help our community produce less waste after Halloween while also showing our support for our service members and veterans! Owner, Dr. Lois Wilson, is herself a Veteran who proudly served as an Army Dentist both here and overseas.

Soldiers’ Angels, a national 501(c)3 nonprofit, hosts an annual collection drive for excess Halloween candy. The organization ships the candy to deployed service members around the world for a sweet treat from home! They also utilize their “Angel” volunteers to distribute candy to veterans of all eras in VA Hospitals across the country.

Wilson Dental of McLean is proud to team up with the national organization to get our local community involved with giving back to the brave men and women who have sacrificed so much for our country. Our business has registered with Soldiers’ Angels to be an official drop-off site for Halloween candy. Once our collection drive is over, Wilson Dental of McLean will donate all collected candy to Soldiers’ Angels where it will be packaged and shipped to deployed or distributed in VA Hospitals.

“As a veteran of the US Army, I am excited to facilitate a donation for our service men and women who are deployed or currently in the hospital. I know first hand that being away from your family during joyful holidays is extremely difficult and I hope that this small token can help bring joy to those who sacrifice so much for our country.” – Dr. Wilson

The vision of Soldiers’ Angels is: May No Soldier Go Unloved. Although the gesture of handing out miniature candy bars may seem small, the impact that small gesture can have on troops and veterans is huge.

“When you are deployed to a combat zone, there are many comfort items you may go without for an extended period of time,” says Amy Palmer, President and CEO of Soldiers’ Angels. “Receiving care packages from home is a wonderful and unexpected surprise. The joy these service members get from opening a package of treats from home is immense and has a profound impact on their morale. The same can be said for veteran patients in VA Hospitals. Some patients have no family or regular visitors. When our Angel volunteers come in with treats like candy, the spirits of these patients are immediately lifted!”

Our collection drive will run from October 25th 2019 to November 18th 2019. Please call ahead before stopping by our location to drop off your candy:

Wilson Dental of McLean
1447-C Dolley Madison Blvd
McLean Virginia 22101

For more information on the program, or if you are interested in registering your business as a drop-off site, visit: www.SoldiersAngels.org/TreatsForTroops

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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