LIDBREE™ receives marketing authorization in the United Kingdom

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

SOURCE: EuropaWire

Palette Life Sciences expands distribution network across Europe

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

American Hemp Processing To Roll Out Mobile Extraction Units

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

GD E-BRIDGE™ EARNS FIRSTNET LISTED DESIGNATION

Ridgefield, New Jersey, 2019-May-02 — /EPR Network/ — General Devices (GD) has announced that, after following a rigorous review process, GD e-Bridge™ is now FirstNet Listed and available via the FirstNet App Catalog.

FirstNet – America’s public safety communications platform – features the first-ever App Catalog geared to first responders. This gives FirstNet subscribers a dedicated location to find meaningful new solutions that have been specifically reviewed for use with FirstNet services. Before any mobile solution can be added to the FirstNet App Catalog, it must pass stringent tests for security, relevancy, data privacy and more.

Achieving a FirstNet Listed designation means GD e-Bridge is a vetted and trusted solution for public safety, meeting FirstNet app requirements. Additionally, FirstNet subscribers will be able to experience the benefits of key FirstNet capabilities – like First Priority®, which enables priority and, for first responders, preemption – while using GD e-Bridge. FirstNet subscribers will also be able to take advantage of the GD e-Bridge solution while benefitting from the enhanced security provided by the FirstNet network core, which is the only physically separate network core dedicated entirely to public safety in America.

Out-of-hospital healthcare is changing, and mobile telemedicine is making a real positive difference. The emphasis now is providing the right care, at the right place and right time. This is especially true in rural regions, but also in the case of time sensitive, acute care issues everywhere like heart attack, stroke and sepsis.

“From the first medical contact by EMS in the field, the GD e-Bridge mobile telemedicine and workflow app provides data and team communications that shave precious minutes off lifesaving treatment,” said Curt Bashford, GD’s CEO.

The hospital ED is not always the appropriate destination for non-acute emergencies. The role of Mobile Integrated Healthcare and Community Paramedicine is growing. Plus, the newly announced HHS ‘Emergency Triage, Treat and Transport’ (ET3) program better aligns reimbursement incentives and enables appropriate on-site treatment and transport to alternate destinations, such as urgent care centers – provided they are managed with mobile telemedicine and telehealth support. That’s where GD e-Bridge also comes in and enables simply better, more cost-effective care.

Built with AT&T in a public-private partnership with the First Responder Network Authority, FirstNet is bringing public safety a much-needed technology upgrade to help them connect to the critical information they need – every day and in every emergency.

“Only highly secure, high quality, public safety relevant applications are added to the FirstNet App Catalog. And we’re pleased that GD e-Bridge is now Listed and available to FirstNet subscribers,” said Bob Sloan, chief operating officer, FirstNet Program at AT&T. “GD e-Bridge will bring public safety additional capabilities to improve decision-making, enhance situational awareness, help save lives and improve outcomes.”

“Through our work with first responders, we heard their need for innovative applications to assist with their lifesaving mission. FirstNet is helping to address these needs, and we are pleased to welcome GD e-Bridge to the FirstNet App Catalog,” said Mark Golaszewski, executive director of Technology and Innovation, First Responder Network Authority.

To learn more about GD e-Bridge, go to General-Devices.com. For more on FirstNet, check out FirstNet.com.

FirstNet and the FirstNet logo are registered trademarks of the First Responder Network Authority. All other marks are the property of their respective owners.

Via EPR Network
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Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR HEALTHCARE NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors.

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

 

Via EPR Network
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The LentiGlobin application for cMAA at the EMA from bluebird bio still in review process by CHMP

LONDON, 27-Mar-2019 — /EPR HEALTHCARE NEWS/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for the cMAA is expected to be released soon.

SOURCE: EuropaWire

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