Category Archives: Healthcare Services

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

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

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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

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8-year follow up results revealed for the ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery

LOS ANGELES, CA, United States, 17-Feb-2022 — /EPR HEALTHCARE NEWS/ — Elios Vision Inc. announced today 8-year follow up results of its novel ELIOS® Excimer Laser Trabeculostomy procedure combined with cataract surgery.

Key study findings:

  • 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract received Phaco-ELIOS, and were followed over an 8-year period
  • Significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mmHg after 8 years of follow-up (p=0.0040)
  • Significant reduction in medication requirements
  • Only 3.7% of patients required secondary surgical glaucoma intervention during the 8-year follow-up period
  • No serious intra- or post-operative events were observed

“This large cohort study provides encouraging evidence that the ‘implant free’ Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota. Dr Samuelson added that, “it is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to 4 years and remained below baseline levels across the entire 8-year follow-up period.”

About the ELIOS procedure:

  • The ELIOS procedure creates ten ‘microchannels (210µm)’ in the trabecular meshwork using an excimer laser.
  • The microchannels facilitate aqueous outflow into Schlemm’s canal, the eyes natural outflow pathway, reducing IOP2 and preserving the integrity, structure, and function of the trabecular meshwork.
  • Combining ELIOS with phacoemulsification is an ‘implant free’ minimally invasive glaucoma procedure with a rapid learning curve for ophthalmic surgeons.
  • The ELIOS procedure is approved in Europe for use in adults with glaucoma, with or without cataract, and is undergoing clinical trials in the US under an investigational device exemption (IDE).
  • Data on the ELIOS procedure has been published in 12 clinical studies2 with over 850 eyes treated showing an IOP reduction of 20-40% from baseline, a significant reduction of medication for up to 4 years, and up to 81% of patients ‘medication free’ at 1 year,3 and a favorable safety profile.

Over the past decade minimally invasive glaucoma surgeries (MIGS) have transformed the treatment of mild to moderate glaucoma and are an attractive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts. Despite the growing popularity of MIGS, combining cataract and glaucoma surgery is not yet the preferred choice by most surgeons.

This clinical study shows that the ELIOS procedure is attractive to all ophthalmic surgeons for patients with glaucoma that are not controlled by medications or SLT because it reduces IOP to mid-teens for at least 8 years, minimizes postop inflammation, avoids intraocular implants, has a favorable safety profile, with or without cataract surgery.

Why are these findings relevant?

  • In 2022 it is estimated that around 29 million people globally will undergo cataract removal and around 20% also have glaucoma or ocular hypertension4.
  • These findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.
  • Routinely combining cataract and glaucoma treatment is appealing since it can reduce the undesirable burden and side effects of drops and it can avoid patients undergoing two separate surgical procedures which also is more efficient for healthcare systems.

SOURCE: EuropaWire

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

Black-Owned FitTech Start-Up Aims to Fix Healthcare for African Americans

LOS ANGELES, CA, 2021-Sep-21 — /EPR HEALTHCARE NEWS/ — JunBugg Fitness Social Network, Wall Street’s “first and only luxury social media brand,” created by African American founder Louis Green, today announced the launch of its NextGen fitness website. Using computer algorithms, JunBugg integrate entertainment into health by sharing unique fitness solutions related to one’s body-type, that leads to better fitness results in least time — influencing success for a higher quality of life.

The start-up website boasts a sleek interface, vibrant logo, sophisticated font-type, and beautiful images, built on sophisticated software engineering. Through social engagement, members of similar health conditions and body-types share fitness strategies and medical solutions to get fit. JunBugg use algorithms that recommend relevant solutions to newsfeeds, the same technology that has allowed — TikTok, Netflix, and Amazon to be successful. The NextGen Search Database deliver relevant fitness matches for personalized training.

A personalized fitness solution, members engage, collaborate, and work as a team. Teamwork allows members to foster camaraderie, innovate, and better problem solve fitness and health obstacles. The bigger the network grows, the more cures that are created. Algorithms see patterns of successful fitness solutions, learns the most effective ones, and recommend them to newsfeeds. As solutions evolve and improve, the algorithm learns and thus recommend those.

The African American community was hit hard by COVID19, who stand to gain the most from JunBugg, for a higher quality of life. The platform is easily accessible and allows equal quality of health care while being affordable. The management of health conditions is the biggest benefit, and prevention of disease as opposed to disease treatment, by being fit through exercise and eating healthy. See boutique fitness solutions — https://www.junbugg.net

Unlike traditional social media services — TikTok, Facebook, Instagram, Snapchat, and Twitter, whose services are free, JunBugg’s boutique membership offerings range between $30 and $500 a month. Fees are comparable to other boutique studios and fitness services, such as — Equinox, SoulCycle, Peloton, and YogaWorks.

It’s all about fitness wealth and a higher quality of life. The first of its kind, JunBugg will forever change fitness and healthcare,” said Louis. “People are an amazing resource that’s never been used in this way — through the power of social media technology, to solve problems through entertainment.”

 

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University of Freiburg spin-off with strong preclinical evidence for significant breakthrough in curing prostate cancer

FREIBURG, Germany, 1-Jul-2021 — /EPR HEALTHCARE NEWS/ — Prostate cancer is the second most common cancer. According to the American Cancer Association, 1 in every 8 men will be diagnosed with it in their lifetime. In 2018 around 1.2 million men were diagnosed and there were 360,000 deaths. In Europe alone, 450,000 men are diagnosed with prostate cancer every year. But there could be a cure on the horizon.

B66, a new company in Germany and a spin-off from the University of Freiburg, Germany, has strong preclinical evidence that its research has made a significant breakthrough after 6 years of dedicated work. Professors Roland Schule, Manfred Jung and Dr Eric Metzger have pioneered research into inhibitors of the histone methyltransferase KMT9 that controls the growth of castration and enzalutamide resistant prostate tumours. These small molecular inhibitors are superior to current state-of-the-art Gold Standard drugs in preclinical models. This new treatment has the prospect of increasing survival in the normally fatal outcome of castration-resistant prostate cancer and becoming the universal therapeutic agent. In addition, the research team’s work shows that their new therapeutic agent has potentials in other cancers including colorectal, breast, bladder and the biggest of all killers, lung cancer.

Professor Roland Schule, one of the B66 founders, and a professor of Biochemistry in the University Medical Centre of Freiburg said “Our findings and approach to treatment is far in advance of anything that is going on in the world at the moment.”

Fellow founder, Professor Manfred Jung, added “many cancer treatments cause damage to the patient’s normal cells but the B66 inhibitor does not target normal cells indicating that our treatment will have minimum side effects”.

Although focused on prostate cancer right now, the B66 team’s long-term objective is to create a world-class development platform that will work on the defeat of many other types of cancer. The Freiburg region, thanks to the University, is a unique centre of leading medical knowledge. B66 will expand their work and draw in some of the skilled scientists from the area to help them work towards building a leading medical development hub.

The B66 team is already seeking commercial partners in order to forward their breakthrough work and advance as quickly as possible to defeat this major cancer.

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

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

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

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

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

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

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

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

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

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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.

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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

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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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

Via EPR Network
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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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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