Category Archives: Healthcare Information

European public-private project to advance precision psychiatry by introducing biology into clinical routine

PARIS AND MONTPELLIER, 30-Mar-2022 — /EPR HEALTHCARE NEWS/ — ALCEDIAG announces the launch of the EDIT-B Consortium, supported by the European Institute of Innovation and Technology for Health (EIT Health). This newly formed European public-private partnership aims at advancing precision psychiatry by introducing biology into clinical routine.

Around 300M people in the world are affected by depression. Studies show that up to 40% of them may be misdiagnosed and potentially bipolar. As a result, diagnosis is often delayed by an average of 7.5 years, worsening patients’ mental and physical conditions as well as their loved ones’ quality of life.

The EDIT-B Consortium aims to solve this diagnostic challenge by using specific RNA editing based biomarkers and artificial intelligence to validate and commercialize an accurate, reliable, and quick blood test to diagnose bipolar disorder.

The Consortium brings together prominent members from across Europe who will be working over the next three years to achieve this goal: Alcediag, Alcen, Capital Region of Denmark, Fundació Clinic per la Recerca Biomèdica, Fundació Sant Joan de Déu, GHU Paris Psychiatrie & Neurosciences, Hospital Clínic de Barcelona, Parc Sanitari Sant Joan de Déu, ProductLife Group and Synlab. With a total budget of € 5.2 million, EDIT-B is co-funded by the EIT Health (€ 2.5M) and the partners.

“This project will accurately separate bipolar disorder from unipolar disorder. This distinction is extremely important clinically, because the treatments are different. EDIT-B Consortium gathers all relevant expertise and as the principal investigator in the clinical trial, I hope we will be able to validate a test that will improve the lives of many people living with bipolar disorder”, says Prof. Eduard Vieta from the Hospital Clínic de Barcelona.

SYNLAB is the first diagnostic service provider in Europe, present in 36 countries in 4 continents and committed to developing high value solutions for patients  focusing on medical excellence and customer centricity.

Maurizio Ferrari, SYNLAB Italy Chief Medical Officer says: “innovation in healthcare is a key pillar for the customer centricity and  we are very proud to be part of this European research project that really may help patients with psychiatric disorders”.

“I am proud to see that the EDIT-B consortium led by our partner Alcediag – a subsidiary of Alcen – will tackle the challenge of improving the diagnosis of bipolar disorder. In doing so, they support EIT Health main mission which is to help citizens live healthier and longer lives and at the same time put the spotlight on mental health which is key to the proper care management and wellbeing of our communities”, adds Jean Marc Bourez, interim CEO of EIT Health.

“On this World Bipolar Day, Alcediag team is happy to announce its contribution to solving the bipolar disorder diagnostic issue.  We are proud and grateful to our partners and the EIT Health for this opportunity to advance science while having a positive impact on people’s lives”, said Alexandra Prieux, CEO of Alcediag.

SOURCE: EuropaWire

Silencil Reviews: A Scam Supplement Or Does It Really Treat Tinnitus – Critical Silencil Review

NEW YORK, 2022-Mar-24 — /EPR HEALTHCARE NEWS/ — It is no news that tinnitus has been considered an incurable health condition ever since it was discovered. Hence, whereas doctors and clinicians usually prescribe antidepressants or anxiety-relieving medications to assist reduce the internal noise, there are no medications specifically designed to help put an end to it. But can Silencil really cure tinnitus? A YES OR A NO!

The fact that no one believes tinnitus has a cure stems from the story that some people have attempted numerous approaches in an attempt to get rid of their ringing in the ears without success. Nonetheless, recent advancements in medical science are taking us one step closer to finding a cure – brain inflammation as the cause of tinnitus. Fortunately, the Silencil team has rallied around this cause (brain inflammation), and they are determined to see it through.

MUST SEE: VISIT THE OFFICIAL WEBSITE TODAY FOR YOUR OWN SUPPLEMENT
According to the manufacturer, Silencil was designed to be almost your one and only true protection against tinnitus of all forms. It is a new nutritional supplement that is intended to reduce ringing in the ears as well as any associated symptoms that may occur as a result of the condition by reducing brain inflammation. Silencil is believed to really solve tinnitus by targeting the underlying problem. This Silencil Review is meant to explain everything about this supplement. Real-world customers and doctors have endorsed it as being tested, dependable, approved, effective, potent, legitimate and reliable.

What Is Silencil?
Silencil is a natural tinnitus supplement made up of 28 clinically approved plant extracts and vitamins that have been shown to be effective in treating tinnitus by reducing brain inflammation. It improves overall brain function, as well as strengthening the immune system and repairing any damage that has occurred, thereby curing tinnitus.

CLICK HERE TO BUY THIS NUTRITIONAL SUPPLEMENT FOR YOUR TINNITUS ON THE OFFICIAL WEBSITE
Silencil is a brain-health supplement / vitamin for tinnitus which works to restore your brain and body’s normal function, ultimately treating you of the condition. Simultaneously providing users with a natural blend of plant and vitamin extracts that work on nerve cells and brain tissue, Silencil’s primary purpose is to improve the user’s ability to hear in all ramifications. While Silencil does assist to decrease the ringing in the ears, it does so primarily through the reduction of inflammation and the re-establishment of neural connections inside the brain.

Truly, Silencil should not be seen as a miracle solution for curing tinnitus, and thus, it should not be expected to produce results overnight. It is rather a dietary supplement which is vested with totally lowering the symptoms of tinnitus as a whole. It accomplishes relief to tinnitus sufferers by identifying and resolving the fundamental root of the problem known as brain inflammation. This is only possible if you have adhered to the manufacturer’s prescription and procedure.

According to general consensus, tinnitus is caused by an issue with one’s hearing. However, the inventor of Silencil believes that electrical misfires (inflammation) in the brain are responsible for a considerable percentage of the ringing in one’s ears and the Silencil pills are designed to address it as effectively as possible.

Is Silencil a legitimate treatment for tinnitus, or does it come with potentially serious side effects and allergies? Of course, this Silencil pill addresses and heals brain inflammation, which is the underlying cause of tinnitus in most cases. It is 100 percent legitimate, and the success stories that have been shared are genuine. Because the components in Silencil have all been approved by the FDA and professionally evaluated, there are no known negative side effects from using it. When the supplement is taken as directed, the pills are delivered directly to the brain, where they work to repair the damaged chain, alleviating the continual ringing sound in the ear.

This natural supplement is now widely acknowledged as one of the most effective natural remedies available for the treatment of tinnitus on a global scale. Millions of real clients all over the world have benefited from this superior supplement and have stated that the ringing or buzzing in their ears has been eliminated completely.

Via EPR Network
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Kenneth Research: Increasing Concern for Mental Health Disorders to Drive Market Growth for Mental Health Software and Devices

NEW YORK, 21-Mar-2022 — /EPR HEALTHCARE NEWS/ — Every year, over 7 Million people are known to die by suicide, one of the major concerns of mental health, according to the statistics by the World Health Organization (WHO). Calculatedly, this comes to one person every 40 seconds. Moreover, in the year 2019, suicide accounted for 1.3% of the total number of deaths around the globe. On the other hand, mental health disorders, such as depression, affected 3.8% of the global population, or around 280 Million people. This included 5.0% adults and 5.7% aged adults above 60 years of age.

Kenneth Research recently released a report titled “Global Mental Health Software and Devices Market” which includes a detailed analysis of the market dynamics along with the impact of COVID-19 on the market growth during the forecast period, i.e., 2021-2030. The report also includes the regulatory and standard landscape, and in-depth research about the market growth across the five major regions, i.e., North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

In Europe, Austria (24 males, 5.6 females), Belgium (23 males, 8.6 females), France (22 males, 5.9 females), Finland (22.9 males, 7.6 females), Germany (17.3 males, 4.8 females), Sweden (17.7 males, 7.0 females), Netherlands (15.7 males, 7.0 females), has shown the highest number of death rates and self-harms per 100,000 inhabitants.

As COVID19 sweeps the global economies, Europe is one of the worst hit since 2020. As new COVID guidelines, lockdown and restriction comes into force, economies have reported elevated cases of anxiety and stress. Especially quarantine and its ill impacts have pushed levels of loneliness, depression, drug use, alcohol consumption, suicidal behavior and self-harm are pushed to another level.

Request for Research Report Sample- https://www.kennethresearch.com/report-details/mental-health-software-and-devices-market/10352350

Mental health is a major concern globally and with the rising prevalence of different types of such disorders in recent years, as well as with the growing awareness for these diseases by governmental bodies, the disease has been included in the list of 17 Sustainable Development Goals (SDGs) of the United Nations. Moreover, the situation for the disease has also gained massive focus, especially to treat the elderly population. This can be attributed primarily to the increasing elderly population count over the past few years, and the growing awareness for mental health and well-being amongst these age groups. In the other statistics by the WHO, the proportion of the population of age 60 years and over around the world is expected to double from 12% to 22% between 2015 and 2050. The statistics further stated that over 20% of these adults suffered from a mental or neurological disorder, and 6.6% of all disabilities amongst these population groups accounted for such disorders. Additionally, around 5% and 7% of these populations had been affected with dementia and depression respectively, which are the two most common mental and neurological disorders.

The global mental health software and devices market generated a revenue of USD 3883.94 Million in the year 2020 and is further expected to grow with a CAGR of 13.28% during the forecast period and touch a value of USD 13367.12 Million by the end of 2030. The growth of the market can primarily be attributed to the growing need for advanced patient monitoring and patient management applications amongst healthcare service providers for those treating mental disorders, backed by the surge in the number of mental health patients worldwide. Besides this, the increasing number of these patients is expected to drive the need for advanced devices which can help for early diagnosis and treatment, therefore contributing to the market growth in the coming years. For instance, the prevalence of dementia, which is known for deteriorating the memory, thinking, behavior, and the ability of the patients to perform everyday activities, is expected to increase to 82 Million by 2030, and further touch 152 Million by 2050, according to the statistics by the WHO. On the other hand, according to the statistics by United Nations Children’s Fund (UNICEF), in the year 2019, between the ages 10 and 14, 34,840,000 female adolescents and 44,647,000 male adolescents suffered from mental disorders. Moreover, between the ages 15 and 19, 41,712,000 female adolescents and 44,563,000 male adolescents had suffered from the same disorder. The surge in these cases is expected to boost the demand for diagnostic devices for the treatment of the disorder, and in turn, drive the market growth.

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The growth of the global mental health software and devices market can also be attributed to the increasing number of government initiatives that focus on maintaining good mental health and well-being of the individuals of nations worldwide. For instance, in May 2013, during the 66th World Health Assembly, the Comprehensive Mental Health Action Plan 2013-2020 developed by the WHO was adopted by the Ministers of Health of the 194 Member States. This action plan was further extended until 2030 in the year 2019, during the 72nd World Health Assembly. On the other hand, according to the statistical report titled “Mental Health Atlas 2020”, published by the WHO, 75% of the Member States had a stand-alone policy or plan for mental health. This was an increase from 68% in the year 2014.

Additionally, the statistics also stated that 57% of the Member States had a stand-alone mental health law. This was an increase from 51% in the year 2014. Besides this, since 2017, 46% of the WHO Member States had updated their health policy or plan, while 27% of them had updated their law regarding mental health.

The global mental health software and devices market is segmented on the basis of region into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Out of the market in these regions, the market in North America generated the largest revenue of USD 1557.47 Million in the year 2020 and is further expected to touch USD 5382.17 Million by the end of 2030. One of the major factors anticipated to drive the growth of the market in the region is the increasing awareness for mental health and the rising need amongst healthcare service providers to improve their services to patients who are suffering from the disease. For instance, according to the statistics by the National Alliance on Mental Illness (NAMI), in the United States, in the year 2020, 1 in 5 U.S. adults experiences a mental illness, while 1 in 20 experienced a serious one, and 1 in 15 experienced both a substance use disorder and mental illness. In addition to this, 26.3 Million adults in the nation received virtual mental health services during the COVID-19 pandemic. Amongst those who received these services, 17.7 Million people experienced delays or cancellations in appointments, while 7.3 Million experienced delays in getting prescriptions. Moreover, 4.9 Million people were unable to access needed care. The market in the region is segmented by country into the United States and Canada. Out of the market in these countries, the market in the United States is expected to hold the largest revenue by the end of 2030 and also grow with the highest CAGR of 13.36% during the forecast period.

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On the other hand, the mental health software and devices market in Europe generated a revenue of USD 1265.71 Million in the year 2020 and is further expected to touch USD 4360.54 Million by the end of 2030, by growing with a CAGR of 13.31% during the forecast period. One of the major factors anticipated to drive the growth of the market in the region is the growing reforms in the diagnosis of mental health. For instance, on the 13th of May, 2019, the Parliamentary Assembly of the Council of Europe (PACE) on Social Affairs, Health, and Sustainable Development, had urged the member States of the Council of Europe to end coercive practices in mental health settings and further adopt a human rights-based approach which is respectful of medical ethics. The market growth in the region can also be attributed to the increasing government initiatives to improve behavioral health services and the surge in the adoption of electronic health records (EHR). The market in the region is further segmented by country into Germany, France, United Kingdom, Italy, Spain, Russia, Netherlands, and the Rest of Europe. Amongst the market in these countries, the market in France is expected to generate the largest revenue of USD 988.54 Million by the end of 2030 and further grow with a CAGR of 13.75% during the forecast period. Additionally, the market in the nation generated a revenue of USD 275.93 Million in the year 2020. Furthermore, the market in Germany registered the second-largest revenue of USD 249.35 Million in the year 2020 and is further expected to touch USD 911.35 Million by the end of 2030.

The study further incorporates Y-O-Y Growth, demand & supply and forecast future opportunity in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa).

The global mental health software and devices market is segmented by delivery model into subscription model and ownership model. Amongst these segments, the subscription model segment is projected to garner the largest revenue of USD 2442.34 Million by the end of 2022. Further, the segment is also expected to grow with the highest CAGR of 11.82% during the forecast period. In North America, the segment is expected to garner the highest market share by the end of 2030, while in Europe, the segment is projected to garner the largest revenue of USD 762.37 Million by the end of 2022.

The global mental health software and devices market is further segmented by end user into community clinics, hospitals, private practices, and home care settings. Among these segments, the community clinics segment registered the largest revenue of USD 1644.62 Million in the year 2020 and is further expected to touch a revenue of USD 5667.35 Million by the end of 2030. In North America, the segment generated the largest revenue of USD 660.52 Million in the year 2020 and is further projected to reach USD 2285.27 Million by the end of 2030, by growing with a CAGR of 13.35% during the forecast period. On the other hand, in the Asia Pacific, the segment is anticipated to garner the largest revenue of USD 1124.71 Million by the end of 2030, up from a revenue of USD 317.70 Million in the year 2020. Moreover, in Japan, the segment is expected to garner the largest revenue of USD 244.73 Million and further grow with a CAGR of 14.34% during the forecast period.

The global mental health software and devices market is also segmented on the basis of component, functionality, and mode of access.

Global Mental Health Software and Devices Market, Segmentation by Component

  • Software
    o Integrated Software
    o Standalone Software
  • Devices

Global Mental Health Software and Devices Market, Segmentation by Functionality

  • Clinical Functionality
    o Electronic Health Records (EHR)
    o Clinical Decision Support (CDS)
    o Care Plans/Health Management
    o E-Prescribing
    o Telehealth
  • Administrative Functionality
    o Patient/Client Scheduling
    o Document/Image Management
    o Case Management
    o Workforce Management
    o Business Intelligence
  • Financial Functionality
    o Revenue Cycle Management
    o Managed Care
    o Accounts Payable/General Ledger

Global Mental Health Software and Devices Market, Segmentation by Mode of Access

  • Desktops/Laptops
  • Tablets/Smartphone

Some of the prominent industry leaders in the global mental health software and devices market that are included in our report are Cerner Corporation, Netsmart Technologies, Inc., Qualifacts Systems, Inc., Valant, NXGN Management, LLC, Core Solutions, Inc., Holmusk USA, Inc., The Echo Group, Welligent, Inc., Credible Behavioral Health, Inc., IBM, and others.

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SOURCE: EuropaWire

Cole & Van Note Announces Mon Health Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Monongalia Health System, Inc. on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with Monongalia Health System, Inc., your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
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Cole & Van Note Announces SAC Health System Data Breach Investigation

Oakland, California, USA, 2022-Mar-05 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of SAC Health System on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with SAC Health System, your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
LinkedIn Page

Via EPR Network
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Cole & Van Note Announces Logan Health Medical Center Data Breach Investigation

Oakland, CA, USA, 2022-Mar-03 — /EPR HEALTHCARE NEWS/ — Cole & Van Note, a leading consumer rights law firm, announces today its investigation of Logan Health Medical Center on behalf of its consumers/clients, arising out the company’s recent data breach. According to the company, the private information of a massive number of people may have been stolen in the hacking of its information network. It is currently unknown how many people have had their information used for criminal purposes.

If you received a notice of this alarming data breach and/or have transacted in any way with , Logan Health Medical Center your information may already be in the hands of cybercriminals, making your urgent attention to this situation very important.

Cole & Van Note is ready to discuss your options and can be contacted at (510) 891-9800, by email at sec@colevannote.com or through its  website by clicking below:

Cole & Van Note has been successfully handling consumer and employee rights matters since 1992. The firm has recovered compensation for millions of individuals and stands ready to help you get paid for your losses.

Attorney Advertisement. Our previous results do not guarantee or predict a similar outcome.

Full Name: Scott Cole
Organization Name: Cole & Van Note
Phone: (510) 891-9800
Email Address: sec@colevannote.com
Facebook Page
LinkedIn Page

Via EPR Network
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EU Patients as Partners in Medicines Development conference to be held virtually on Jan 24-25, 2022

(PRESS RELEASE) New York, NY, United States, 5-Jan-2021 — /EPR HEALTHCARE NEWS/ — The Conference Forum announced the launch of the 6th annual EU Patients as Partners in Medicines Development conference to take place virtually on January 24-25th, 2022 GMT time.

​​This annual event, the first of its kind in Europe, will feature successful collaborations between patients and pharma where patient input directly impacted aspects of how a pharmaceutical company either designed or conducted a clinical trial.

Of the 20 sessions, half include a patient or patient advocate. This two-day program will demonstrate how patient-led research can improve the way pharma conducts clinical trials.

Examples include UCB developing new assessment tools to measure the effectiveness of novel treatments for Parkinson’s disease, changes in the design and implementation of an MS trial for greater patient engagement, and the development of a new toolkit to change the way patients are compensated for their contributions in clinical research.

“Patients have become more empowered,” says co-chair Michaela Dinboeck, Head, Center of Excellence for Patient Engagement at Novartis. “So patient engagement must be integrated into the DNA of how medicines are developed, approved, and used. Patients as Partners Europe will provide Pharma with valuable insights on how to achieve this.”

Participating pharma companies include Novartis, Pfizer, Merck KGaA, EMD Serono, Janssen, Johnson & Johnson, GSK, Ipsen, UCB, Takeda, AbbVie, Noema Pharma, Gilead Sciences, Regeneron, and Pierre Fabre.

Other topics to be addressed include: Scaling patient engagement activities company-wide, engaging patients in early clinical development, leveraging social media to gain patient insights, diversity and inclusion in research and updates on patient engagement activities in Eastern Europe.

To learn more, please visit Patients as Partners Europe.

SOURCE: EuropaWire

Origami and citoQualis will work together to help Medical Device startups get products to global markets faster

KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.

Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.

Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.

The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis” says Mr. Wolfgang Werner, CEO of citoQualis.

According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.”

Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.

Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.”

Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.

SOURCE: EuropaWire

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

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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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.”

Via EPR Network
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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

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

EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.

Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.

A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.

Learn more about the topics that will be examined in-depth.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference

BERLIN, 28-May-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.

Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”

Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”

The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”

The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.

Go here to see the full speaker lineup.

Press passes are available here to bona fide members of the press.

SOURCE: EuropaWire

The interregional professional association for nuclear medicine in Hanau has become the first treatment center in Germany to offer the Rhenium-SCT® (SCT= Skin Cancer Therapy)

GARCHING N. MUNICH, Germany, 13-May-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), is pleased to announce that the interregional professional association for nuclear medicine in Hanau now offers the Rhenium-SCT ® (SCT= Skin Cancer Therapy) as the first treatment center in Germany.

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 which are state-of the art in science and technology.

“Offering NMSC skin cancer patients a highly efficient, painless, innovative therapy with excellent aesthetic results was the driving reason to establish this treatment method in our clinic,” says Dr. med. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are delighted that our innovative skin cancer therapy Rhenium-SCT® is now being offered by the Nuclear Medicine in Hanau and we are looking forward to this collaboration”, states Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “For us, this is an important step to offer the treatment method in addition to Italy, South Africa and Australia now also in Germany. In order to provide our treatment to as many skin cancer patients as possible, it is of course our goal to offer the availability of the therapy nationwide in Germany in the future.”

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 Germany the number of newly diagnosed patients is about 200,000 annually and it is assumed that this number increases within the next years. 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, applied in one single session with excellent aesthetic outcomes.

If interested, patients and doctors can either contact the interregional professional association for nuclear medicine in Hanau directly or OncoBeta® GmbH.

SOURCE: EuropaWire

University of Pretoria Prof. Mike Sathekge is First in South Africa to Treat Non-Melanocytic Skin #Cancer Patients with Rhenium-SCT®

Garching n. Munich, Germany, 26-Nov-2018 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today that Prof. Mike Sathekge from the University of Pretoria, Steve Biko Academic Hospital Nuclear Medical department and his clinical team has treated the first non-melanocytic skin cancer patients in South Africa with the innovative Rhenium-SCT® skin cancer treatment System. This next-generation radionuclide therapy technology applied by the nuclear medicine physician offers a new singles session, painless treatment for patients suffering from Basal Cell – and Squamous Cell Carcinomas (BCCs and SCCs).

The global incidence of non-melanoma skin cancers has drastically increased over the few past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. Approximately 80% of non-melanoma skin cancers are basal cell carcinomas or squamous cell carcinomas with South Africa having one of the highest incidence rates in the world.

Prof. Mike Sathekge and his team at the University of Pretoria, Steve Biko Academic Hospital are focused on providing patients with personalized care using state-of-the-art technology that can deliver high-precision therapy and diagnostics with minimal side effects. The specialized team of experts in the nuclear medicine and medical physics, work closely with other disciplines within the university hospital, referring physicians, and other institutions, to ensure patients receive the best possible treatment for their specific type of cancer.

Martin Magwaza, CEO of Tautomer (PTY) LTD Oncobeta®’s distribution partner for the Rhenium-SCT® in Africa, is dedicated to providing South Africans with new innovative and effective therapies across the continent, coordinating with representatives from all levels of government and state for the health care landscape.

“The start of the Rhenium-SCT® in South Africa is a significant milestone in the international expansion of our ground-breaking treatment for BCCs and SCCs.,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Our vision of bringing a revolutionary affordable skin cancer therapy to physicians and patients all over the world has come one step closer today”.

SOURCE: EuropaWire