Category Archives: Healthcare Solutions

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

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

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

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

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

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

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

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

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

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

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

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

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

Via EPR Network
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2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

Go here to see the full speaker lineup.

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

SOURCE: EuropaWire

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

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

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods which are state-of the art in science and technology.

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

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

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In Germany the number of newly diagnosed patients is about 200,000 annually and it is assumed that this number increases within the next years. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application, applied in one single session with excellent aesthetic outcomes.

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

SOURCE: EuropaWire

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

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

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

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

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

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

SOURCE: EuropaWire

Global Kidney Stone Management Device Market: Higher end user preference for lithotripsy devices, particularly extracorporeal variants prevails

DUBLIN 2, Ireland, 30-Oct-2018 — /EPR HEALTHCARE NEWS/ — Fact.MR has recently announced the launch of a new research study that delivers key market insights on kidney stone management management devices. The comprehensive report on kidney stone management devices market offers actionable intelligence, offering volume and value projections for a 10 year timeline (2018-2028).

Free sample of the kidney stone management devices market report is available on the below link.

https://www.factmr.com/connectus/sample?flag=S&rep_id=1827

Key Insights from Report:

  • United States remains the largest market for kidney stone management devices, accounting for over 88 percent of global sales in 2017
  • Eastern Europe and United Kingdom led demand for kidney stone management devices in Europe during 2018 and the trend is likely to continue in the future as well
  • Sales are encouraging in EU-4; growth is relatively slower than UK and Eastern European countries. EU-4 is likely to create significant opportunities for market players
  • Hospitals are the key sales channel, accounting for nearly 50% of total sales in 2017
  • Higher end user preference for lithotripsy devices, particularly extracorporeal variants prevails – lithotripsy devices will remain the top-selling segment in 2019 and beyond

Lithotripsy Devices Lead the Rally

Fact.MR reveals that sales of extracorporeal lithotripsy devices accounted for over 73 percent of the lithotripsy sales and over 60 percent of overall kidney stone management device sales in 2017, surpassing those generated from ureteroscopes and nephroscopes.

The demand for lithotripsy devices across developed countries of the United States and the EU-4 is projected to expand at a significant pace in the coming years. Sales of kidney stone management devices in United States alone are likely to cross US$ 200 Mn by end of 2018-end, maintaining the status quo of the country as the most attractive market.

The US remains a lucrative market for stakeholders, reflecting a 1.5x lead in sales over EU-4 combined and a 1.2x lead over China, India and ASEAN in 2018.

Kidney Stone Management Devices Sales
Country 2013 2015 2017 2018 2020 2025 2028
US XX XX XX XX XX XX XX
EU-4 XX XX XX 133.2 XX XX XX
China, India and ASEAN XX XX XX XX XX XX XX

(Note: All above figures are in US$ Mn)

Speak to the authors of the report for additional information on the redacted figures  

Medical Tourism Hubs in Asia: The New Growth Frontiers

Kidney stone management devices are likely to witness increasing traction among emerging economies in the Asia Pacific, such as China and India, albeit at a lower base. China remains lucrative, maintaining a 1.5X lead over India in 2018. India and ASEAN currently account for less than 10% share of the global market; however, opportunities abound as these countries position themselves as global medical tourism hubs.

For direct purchase of the kidney stone management devices market report, please click on the link below:

https://www.factmr.com/checkout/1827/S

SOURCE: EuropaWire

IBM Watson Market Study: IBM Watson services have been positively disrupting and reforming operations in the healthcare industry

DUBLIN 2, Ireland, 10-Oct-2018 — /EPR HEALTHCARE NEWS/ — IBM Watson Services continue to get significant traction from end-users, with over 72% respondents in Europe affirmative on using IBM Watson language services, according to a Fact.MR survey. The survey is part of the comprehensive research study on IBM Watson services market which tracks the adoption of this platform across key sectors. The Fact.MR survey also reveals that use of IBM Watson vision services attracted the minimum interest, with only 48% of respondents in Europe affirmative about using it.

Fact.MR’s IBM Watson services market survey gathered data from over 500 respondents in 10 European countriesThese respondents represented large-scale, SMEs, and micro organizations, with a collective IT spending budget of over US$ 50 billion. The findings of the survey were in sync with the overall expectations and use of IBM Watson services, which are highly reliant on revenue generated from language services.

Growing Realization that Cognitive Technologies Can Empower Decision-Making 

The survey indicates that mitigating the gaps that exist in IT vendors’ execution from data collection to action remains the key concern of organizations. There is an increasing realization among IT vendors that cognitive technologies can empower decision-makers to make sense of colossal structured and unstructured data. The survey offers encouraging insights on the growing use of advanced analytics and cognitive computing in today’s data-driven economy, as over half of the respondents in the survey agreed to using insights- and speech-services of IBM Watson.

Request Sample of IBM Watson Services Market Report at https://www.factmr.com/connectus/sample?flag=S&rep_id=759

“Today, the requirements of organizations are multi-pronged – from gaining a holistic customer view to agile data-to-execution operations, organizations need to invest in cognitive computing and advanced technologies to stay competitive,” says Shambhu Nath Jha, Senior Consultant at Fact.MR and co-author of the study.

“IBM Watson services have been positively disrupting and reforming operations across sectors, especially healthcare. From screening patient’s structured and unstructured data to regulatory requirements and medications, IBM Watson services are witnessing extensive adoption in the healthcare sector,” added Mr. Jha. The growing adoption of IBM Watson services in healthcare is further substantiated by Fact.MR’s findings that the sector currently accounts for nearly 21% revenue share, representing a market value worth US$ 318 Mn.

Improved Business Agility and Seamless Customer Service Identified as Key Advantages 

The Fact.MR survey further reveals that improvement in business agility is the most prominent motivation driving investment in IBM Watson services. Nearly 84% of respondents currently using IBM Watson services said that there was a marked improvement in business agility since the introduction of platform in their organization. An additional 82% said IBM Watson services helped their organizations in improving and transforming customer service.

“Customer service has often remained a key concern for organizations; despite the proliferation of advanced technologies and pervasiveness of smartphones, nearly 50% of customer support calls remain unresolved,” says Shambu Nath Jha. “The integration of artificial intelligence (AI) can mitigate this challenge, and offer seamless support for Tier 1 queries. The system can also effectively gauge the queries that require human intervention, and escalate those queries to a customer support executive if necessary,” adds Mr. Jha.

Know the methodology behind the report 

https://www.factmr.com/connectus/sample?flag=RM&rep_id=759

Effective decision-making, handling colossal structured and unstructured data, and sales assistance are among the other key advantages of using IBM Watson services, according to the Fact.MR survey. “Effective decision-making entails a deep understanding of the unique needs and requirements of customers. Today, businesses are hard-pressed to understand the unique characteristics of their customers, and effectively map their existing and upcoming products to meet the overt and covert needs. IBM Watson can provide sophisticated recommendations that can facilitate effective decision-making,” Mr. Jha added.

Fact.MR’s report on the global IBM Watson services market projects a surge in investments to mitigate cybersecurity risks. According to Fact.MR, a majority of organizations have some level of cybersecurity apparatus in place. However, as Mr. Jha concludes, “tackling the potent cybersecurity threats will require a comprehensive ecosystem, rather than a symbolic front-line defense.”

The IBM Watson Services Market Report is Available for Direct Purchase at

https://www.factmr.com/checkout/759/S

SOURCE: EuropaWire

Study published in World Journal of Urology confirms Fotona SMOOTH® laser technology is a safe, effective & minimally-invasive solution for stress and mixed urinary incontinence

LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR HEALTHCARE NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.

Urinary Incontinence Treatment Options

Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.

Unique Fotona SMOOTH® Technology for Maximum Safety

Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.

Evidence-Based Laser Medicine

Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.

In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.

Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.

The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.

SOURCE: EuropaWire

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Marrongelli selected for her expertise in Botanical Drug Development

LONDON, Jun-16-2018 — /EPR Healthcare News/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference: Exploring New Trends & Innovations in Pharmacology and Natural Compounds. The conference is being held in Paris, France on June 18, 2018.

Dr. Marrongelli, who is an adjunct professor at the Medical University of South Carolina in the department of drug discovery and biomedical sciences will also present “Developing and Marketing Botanical Drugs in the United States”.

The United States, which has the largest pharmaceutical market in the world, demonstrates a strong demand for the use of botanicals as medicine. However, to date only two prescription botanical drugs are currently approved for use in the USA: Veregen® (sinecatechins) and Mytesi™ (crofelemer).

Marrongelli attributes this disconnect between supply and demand to hidden barriers. She notes that with the worldwide herbal drug market is expected to reach nearly $86.74 billion by 2022, businesses must identify and address these barriers so that heterogeneous botanical drug products can obtain the approvals necessary to meet the consumers growing expectations and demands for botanical medicines.

To further explain the barriers to regulation of botanicals, Marrongelli points to the Botanical Drug Development Guidance for Industry from the U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) that was last updated in 2016. According to publication, regulation of botanicals in the U.S. is different from regulation in the rest of world. The U.S. does not have a separate regulatory category for traditional or herbal medicines: A botanical product may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Whether an article is a food, drug, medical device, or cosmetic depends in large part on its intended use.

To learn more about the issues and barriers to the development of botanical drugs, please contact Dr. Marrongelli at Marronge@musc.edu or DrM@pharmD.expert.

SOURCE: EuropaWire

Health Innovation Centre of Southern Denmark, Fraunhofer Institute Portugal and ProjectRay named the winners of the European Silver Economy Awards 2018

Winners of the first European Silver Economy Awards: Boaz Zilberman (ProjectRay), Anne Friis Hansen (Health Innovation Centre of Southern Denmark) and Ana Vasconcelos (Fraunhoder Institute Portugal)

BRUSSELS, Belgium, 20-May-2018 — /EPR Healthcare News/ — On Thursday May 3, the first edition of the European Silver Economy Awards has celebrated its winners under the patronage of Mariya Gabriel, Commissioner for Digital Economy and Society, and Markku Markkula, First Vice-President of the Committee of the Regions. The ceremony took place at the Committee of the Regions in Brussels and has been designed as an event that brings together key speakers and innovators from both the public and private sector.

The first prize in the category Public Authorities has been awarded to the Health Innovation Centre of Southern Denmark (Denmark) for their Generic Telemedicine Platform. The Fraunhofer Institute Portugal (Portugal) submitted a tool for fall prevention and detection (GoLive Solutions) and was the winning Non-for Profit Organisation. Introducing a smartphone solution (RAY Solutions) for visually impaired people, ProjectRay (Israel) has won in the category For Profit Organisation.

The Silver Economy Awards have been launched to recognise and reward innovative ICT solutions from all sectors, to raise awareness of the potentials of this section of the economy and to bring together European stakeholders under a common goal: supporting and improving the quality of life of older persons in society. On behalf of Commissioner Gabriel, Cabinet Member Manuel Mateo Goyet described the first Silver Economy Awards as representing a “milestone on our way towards becoming a truly age-friendly Europe”, and promoted the ceremony as “a unique occasion to send a very positive message on how we see the future of ageing” showing “the true value of collaboration in Europe”.

Celebrating the nine finalists and their dedication to making Europe an age-friendlier place, Markku Markkula, host and moral patron of the Silver Economy Awards, declares his acknowledgement: “I want them in my region”. More than 95 applications coming from 22 countries have been submitted for consideration in three awards categories referring to the type of organisation. Over 40 Silver Economy experts were involved in the three-staged evaluation process to determine Winner, Second and Third.

For more details on the winner entries and an overview of the final ranking of the first European Silver Economy Awards 2018 edition please visit www.silvereconomyawards.eu/sea/2017/awards#Winners.

SOURCE: EuropaWire

Alliance Life Sciences to present expanded portfolio of pricing & market access services at the World Pharma Pricing and Market Access Congress 2018

SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is a sponsor at the World Pharma Pricing and Market Access Congress 2018 taking place March 20-21 in London, United Kingdom. As part of the largest pharmaceutical commercialization organization that services more than 300 of the industry’s top pharmaceutical, biotech and medical device companies, Alliance will present its expanded portfolio of pricing and market access services. The focus will be on pricing and reimbursement data managed by PricentricOne and pricing governance, reference and tender pricing software manage by PriceRight.

Now in its 12th year the World Pharma Pricing and Market Access Congress brings together the most innovative leaders and organizations to discuss all aspects of evidence, access and pricing. This year’s event will feature over 150 speakers and a greater range of topics being covered including Big Data & AI, rare diseases, advanced therapies and other emerging, innovative areas.

Alan Crowther, President of Global Markets noted “Alliance Life Sciences is pleased to be a sponsor of the World Pharma Pricing & Market Access congress, particularly this year. We have made a number of investments in our people and infrastructure in Europe. Our acquisition by Water Street partners in 2017 allowed us to offer enhancements in our Market Access offerings too. Europe continues to be our focus market and World Pharma Pricing & Market Access congress is a great venue to showcase our expended capabilities”.

SOURCE: EuropaWire

Multispectral Optoacoustic Tomography (MSOT) can now more reliably detect early stages of inflammation

GERMANY, Mar-30-2017 — /EPR HEALTHCARE NEWS/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.

Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.

“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.

The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.

Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”

In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.

The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).

SOURCE: EuropaWire

Startup mentored by Promwad created one of the best IoT products in Europe

Vilnius/Lithuania, 2016-Oct-18 — /EPR Healthcare News/ — ZIVE smart radiation monitor has reached the final of Elektra Awards 2016, a big influential contest for the electronics market players. This device designed by R-NOX startup with the assistance of Promwad Electronics Design House was named one of six best innovative products of Europe exploiting the Internet of Things potentialities.

ZIVE is a portable radiation monitor of the next generation that can connect to smartphones and tablets via Bluetooth. It’s the first device of professional level designed for common people. It has a user-friendly interface, a Geiger-Muller counter, and a low market price comparing with other high-precision radiation monitors.

promwad-mobile_zive

ZIVE radiation monitor measures gamma rays, ionizing radiation, and X-rays. Differentiating features of the device:

  • Calibrated by accredited European laboratories (CE).
  • High accuracy at a lower price in comparison with other similar devices.
  • “Smart monitor” mode that provides users with specific health and well-being advice: how to interpret the measurements and reduce the risks.
  • Working with maps to create eco-routes: save radiation spots, find cleaner routes.

The collected ZIVE data is used for the real-time global map of radiation contamination.

Roman Pakholkov, Promwad’s CEO and R-NOX’s mentor, says that the data collected by ZIVE users is stored in the eco-platform, which is becoming the most detailed in the world. This platform allows accelerating the innovations development for the environmental management and can be integrated into other devices and applications via the open API.

To date, R-NOX has developed partnerships with the largest tour operator in the Chernobyl Nuclear Power Plant Zone of Alienation; Greenpeace; companies and organizations in Japan, Finland, Singapore, and other countries.

Promwad continues its work in supporting new electronics design projects in the IoT field. The company believes in the high potential of this popular trend and are ready to share their experience in the development and manufacture of electronic products for the global consumer electronics market.

The best companies of Elektra Awards 2016 will be announced on Thursday, 1st December, at the awards ceremony taking place in The Ballroom, Grosvenor House Hotel, London.

Contact-Details:
promwad-logo
Promwad

Olga Potonya
olga.potonya@promwad.com
+370 (5) 214 12 44 ex.227

Via EPR Network
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