Category Archives: Healthcare Solutions

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

Pr. Pierre-Yves Benhamou: The outcomes observed in 1,000 patients using Diabeloop DBLG1 are, indeed, very good and encouraging

PARIS, 28-Sep-2021 — /EPR HEALTHCARE NEWS/ —

Real-life data confirm clinical and pre-launch data: TIR significantly improved

Today, Diabeloop presents data¹ from a 1,000 patients equipped with DBLG1 System with Accu-Chek Insight insulin pump in Germany. One of the main insights unveiled is an overall Time in optimal glucose Range (70-180 mg/dL) of 73.4% for the whole cohort of patients.

When looking specifically at data² from patients whose HbA1c was available at initiation, it can be observed that Time In Range improved 17.1 percentage points. This result is consistent with results which have been previously published pre-launch³ showing an increase in Time In Range of 16.7 percentage points.

Hypoglycemia reduction a huge factor for an improved quality of life

Data also showed a significant reduction of time spent in hypoglycemia with Time below 70 mg/dL at 1% while time below 54 mg/dL was 0.2%. This outcome surpasses the targets of the 2019 International Consensus.

Feedback of people with diabetes and their caregivers have shown that reducing hypoglycemia is very important. In addition to the life-threatening risks associated with hypoglycemia, discomfort and a decreased quality of life weighs heavily on people experiencing it regularly.

Pre-launch patients
“It (diabetes) had a big impact on my professional life (…) because of my hypoglycemia.”
“I have almost eliminated lows (…), especially at night, which is important!”

Pr. Pierre-Yves Benhamou commented: “The 2019 International Consensus on Time in Range aimed at achieving >70% in range 70-180 mg/dL, <4% below 70 mg/dL and <1% below 54 mg/dL in the majority of people with type 1 diabetes. This means over 16 hours in target range and less than 1 hour below range. The outcomes observed in 1,000 patients using DBLG1 are, indeed, very good and encouraging.”

Patient satisfaction is high

In the 5 countries where DBLG1 System is currently available, feedback from equipped patients has been very positive about its impact on TIR and hypoglycemia, in addition to the system’s ease of use and enhancement of quality of life.

Public social media posts:
“87% TIR, no hypos”
“The result (related to sport): quite conservative but great. No hypo.”
“Very intuitive, little information needed to provide at initiation.”
“I am absolutely delighted. Sometimes I even forget that I have diabetes.
I let it (DBLG1) do the math and success shows.”

Erik Huneker, founder and co-CEO of Diabeloop, who will be presenting the data at EASD4 declared: “Looking at the great results and listening to patient feedback on real-life experiences with our system has been a great reward for our work, and encourages us to make the system even better going forward. We will be able to bring DBGL1 quickly to many more patients in Europe while we keep working on bringing more choices, more interoperability, and more solutions to people with diabetes”.

About Diabeloop
Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to improve clinical outcomes for people with diabetes while relieving them of their constant mental burden. DBLG1 System, Diabeloop’s first medical device for automated insulin delivery (AID) and DBL-hu, its solution for highly unstable Type 1 diabetes management, are both CE-marked and being deployed in Europe.

A second round of financing of 31 million euros, concluded at the end of 2019, supported the international commercial rollout of the DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of more than 100 talented individuals who work hard to improve the quality of life for every person living with insulin-dependent diabetes.

About DBLG1
DBLG1 is a self-learning algorithm that automates and personalizes the treatment of Type 1 diabetes. The therapeutic artificial intelligence contributes to reducing the heavy mental burden associated with this chronic condition. Hosted on a dedicated handset, it is connected to a continuous glucose monitor (CGM) and an insulin pump. It analyzes the data in real time, and decides whether to maintain current settings, adjust or stop basal insulin delivery to avoid a predicted low/high or deliver a bolus to correct a high.

YourLoops, Diabeloop’s data visualization platform allows patients to access data generated by DBLG1 and share them with his/hers healthcare team.

SOURCE: EuropaWire

Het DBLG1-algoritme: eenvoudige installatie, gebruiksvriendelijk, ontworpeyyn voor elk diabetes type 1 profiel

PARIJS, 2-Jun-2021 — /EPR HEALTHCARE NEWS/ — Vanaf het begin heeft Diabeloop innovatieve systemen ontwikkeld om de behandeling van diabetes type 1 te automatiseren en te personaliseren, waarbij altijd rekening wordt gehouden met de optiek van de patiënt. Het Franse bedrijf streeft ernaar autonomie te geven aan mensen die met diabetes type 1 leven en tegelijkertijd de gebruikerservaring te optimaliseren zodat behandeling van diabetes eenvoudiger en minder ingrijpend is. Het DBLG1-algoritme biedt een bevredigende, geautomatiseerde en gepersonaliseerde ervaring met minimale input van de patiënt.

DBLG1: eenvoudige installatie, gebruiksvriendelijk, ontworpen voor elk diabetes type 1 profiel

De zware mentale last op de schouders van mensen met diabetes type 1 verlichten, begint in de eerste fasen van de ervaring met DBLG1. Gebruikers hoeven maar 4 gegevens in te voeren in het allernieuwste DBLG1-algoritme voor een veilige, geautomatiseerde en gepersonaliseerde insuline-afgifte. In de opzetfase voeren gebruikers van DBLG1 hun lichaamsgewicht in, hun totale dagelijkse insulinedosis (TDD), hun gebruikelijke maaltijden (in grammen koolhydraten) en hun basale insulinebehoefte (alleen voor open-loop). Voor het Diabeloop-algoritme zijn geen ingewikkelde berekeningen nodig. Gebruikers hoeven hun maaltijdratio niet uit te zoeken, noch hun insuline gevoeligheidsfactor noch hun insuline actiecurve.

De 4 gegevens die de patiënt in de beginfase invoert, zijn voldoende voor het DBLG1 zelflerend algoritme om te functioneren, te berekenen en de insulinedosis zo nodig elke vijf minuten aan te passen.

“We hebben het DBLG1-algoritme zo ontworpen dat het zo eenvoudig mogelijk in gebruik is voor mensen met diabetes type 1 en gebruikers tegelijkertijd de gelegenheid hebben bepaalde parameters nauwkeuriger in te stellen afhankelijk van hun specifieke behoeften en/of leefstijl. Het algoritme houdt automatisch rekening met eventuele wijzigingen die mensen invoeren. Het DBLG1-algoritme optimaliseert de werking automatisch zonder dat de patiënt hier iets voor hoeft te doen. Wijzigingen verlopen op die manier heel soepel en worden vrijwel “onzichtbaar” voor de gebruikers van het systeem“ – vertelde Yousra Tourki, Head of Algorithms Design bij Diabeloop.

Naast de eerste input biedt het DBLG1 System ook de mogelijkheid aan mensen die met diabetes type 1 leven om de behandeling en beheersing van hun diabetes nauwkeurig in te stellen met behulp van aanpasbare instellingen zoals de agressiviteit van het algoritme, de grenswaarden van hypo’s en hypers en de streefwaarde van de glucosespiegel.

Nicole Wetzels, Trainer voor Roche Diabetes Care in Nederland en gebruikster van het DBLG1 System met Accu-Check Insight, vertelt: “Ik leef al meer dan 42 jaar met diabetes type 1 en ben een paar maanden geleden begonnen met het gebruik van het DBLG1 System met een Accu-Chek insulinepomp. De opzet was heel eenvoudig: de batterij in het apparaat doen, de handset opladen en maar 4 parameters invoeren. Het invoeren van een maaltijd is een van de weinige dingen die ik zelf moet doen en ook dat is heel simpel! Maar ik heb tevens de mogelijkheid het systeem te personaliseren door bepaalde instellingen aan te passen zoals de streefwaarde van de glucosespiegel of de grenswaarden voor de hypo … Met hele kleine acties heb ik hele goede resultaten. Dankzij dit AID-systeem hoef ik niet meer de hele dag bezig te zijn met het beheersen en behandelen van mijn diabetes. Het is net of mijn diabetes type 1 op vakantie is!”

DBLG1 AID-systeem: minimale input van de patiënt nodig

Om de bruikbaarheid van het DBLG1 System te beoordelen heeft Diabeloop een wetenschappelijk onderzoek uitgevoerd op basis van reële gegevens afkomstig uit de klinisch proef (1) die vóór de lancering vanhet systeem is gerealiseerd. Het doel was het analyseren van het aantal instellingswijzingen door mensen die het systeem in het dagelijkse leven gebruiken. In de eerste week dat patiënten het DBLG1 System gebruikten, voerden ze gemiddeld slechts 1.6 instellingswijzigingen uit (± 2.3), en maar 0.2 wijziging (± 0.5) in de laatste week van de proef na 11 weken gebruik.

De belangrijkste conclusie is dat in het dagelijkse leven, wanneer de gebruikers zich niet in een beheerste omgeving bevinden zonder specifieke medische follow-up en/of aanbevelingen voor instellingswijzigingen van hun zorgteam, de mensen uitgerust met het DBGL1 System minimale aanpassingen hoeven uit te voeren om te profiteren van een bevredigende, geautomatiseerde en gepersonaliseerde diabetesbehandeling.

Verdere wetenschappelijke analyse (2) toont de gebruiksvriendelijkheid aan van het Automated Insulin Delivery-systeem van Diabeloop. Deze analyse gaf aan dat in de eerste week, 50% van de mensen die het DBLG1 System gebruikten, geen instellingswijzigingen uitvoerden. Bovendien wijzigden meer dan 85% van de mensen uitgerust met het systeem geen enkele instelling gedurende de 8ste week van gebruik.

Dit bevestigt dat het zelflerend algoritme van Diabeloop vanaf de beginfase de behandeling van diabetes type 1 optimaliseert en minimale input van de patiënt nodig heeft om de vereiste ondersteuning te bieden.

Bernhard Gehr, arts en diabetoloog, Centrum voor Diabetes en Metabole ziekten, gespecialiseerde kliniek m&i Fachklinik Bad Heilbrunn, licht toe: “Ik gebruik het DBLG1 System met de Accu-Chek Insight insulinepomp. De opzet en de eerste handelingen zijn zeer eenvoudig. De eenvoud van de gebruikersinterface maakt snelle en makkelijke invoer van de benodigde informatie mogelijk. Ik ben echt onder de indruk van de prestaties van het DBLG1 System. Vanaf de eerste dag had ik een goede controle over mijn stofwisseling. Ik heb veel meer gemoedsrust aangezien ik veel minder aan mijn diabetes hoef te denken! Dit systeem vereist minder tot vrijwel geen micromanagement van mijn behandeling. Ik was aangenaam verrast over hoe goed het algoritme tijdens de eerste nacht functioneerde, met zo weinig input in de beginfase.”

Met DBLG1 beheersen mensen hun eigen diabetesbehandeling

Het DBLG1 System is gebruiksvriendelijk en kan gepersonaliseerd worden zodat mensen die met diabetes leven verschillende instellingen kunnen beheersen.

In het dagelijkse leven biedt het DBLG1 System mensen de mogelijkheid de aan te passen zodat insuline-afgifte bijgesteld wordt om een hypo of hyper te voorkomen. Een van de onderzoeken (3) van Diabeloop, gepresenteerd op ATTD 2021, onthulde dat een daling van de glucosespiegel streefwaarde over het algemeen een vergelijkbare daling van de gemiddelde glucospiegel tot gevolg heeft. Bijvoorbeeld, -10% van de glucosespiegel streefwaarde leidt tot -10% van de gemiddelde glucosespiegel.

In overeenstemming met de missie van Diabeloop om de zware mentale last op de schouders van mensen met diabetes type 1 te verlichten en hen een ongestoord leven te bieden, bevat het systeem een Zen-modus, ontwikkeld op basis van de ervaringen van patiënten. Deze modus verhoogt tijdelijk de doelwaarde van de bloedsuikerspiegel: om rustig naar de bioscoop te gaan of een vergadering bij te wonen zonder een verstorende hypoglykemie en de bijbehorende waarschuwingssignalen, kunnen gebruikers de Zen-modus aanzetten zodat hun glucosespiegel tijdelijk en voor een door hen ingestelde tijd verhoogd wordt.

Een persoon die het DBLG1 System met Accu-Check Insight insulinepomp gebruikt, vertelde: “Zen-modus is voor al die momenten waarop je je “veiliger” wil voelen: tijdens het autorijden, op school, tijdens een examen.”

Een wetenschappelijk onderzoek (4) geleid door Diabeloop en gepresenteerd op ATTD 2021, toonde aan dat 90 minuten na de activering van de Zen-modus, de impact op de gemiddelde glucosespiegel gestabiliseerd was zonder de hyperglykemie te verlengen.

De conclusie is dat, voor een tijd die door de patiënt wordt bepaald, de Zen-modus de gebruikers uit een hypo houdt en tevens een hyper voorkomt. De Zen-modus leidt tot een lichte verhoging van de gemiddelde glykemie met een zeer beperkte impact op de time-in-range.

Het eenvoudige gebruik van het DBLG1 zelflerend algoritme draagt bij tot een ongecompliceerde diabetesbehandeling en haalt een mentale last van de schouders van mensen die leven met deze chronische ziekte zodat ze ongestoord kunnen leven!

SOURCE: EuropaWire

AirGuard™ – washable, reusable, approved 5-Layered Nano-PTFE filtering technology cloth face mask with BFE of over 95%

BOLOGNA, Italy, 31-Mar-2021 — /EPR HEALTHCARE NEWS/ — Creative Concepts Manufacturing Group announces campaign launch of their new innovative cloth mask – AirGuard™. The tested and approved 5-Layered Nano-PTFE filtering technology cloth face mask that is washable, reusable, and that has a bacterial filtration efficiency (BFE) of over 95%. Creative Concepts is ready to secure worldwide distribution and is proud to be a significant part of the solution in helping to protect against the spread of the COVID-19 virus.

Creative Concepts Manufacturing Group is a leading manufacturer of various inventions, creators of the GoTech™ Cordless Technology, and with over 4 decades of experience in the OEM/ODM and License Manufacturing, its Product Managers and owners, Vin and Joe Advani are pleased to announce the launch of their new PPE (Personal Protective Equipment) – the AIRGUARD cloth face mask with the goal of preventing individuals from spreading the COVID-19 virus, while ensuring the safety and comfort in wearing the mask.

ABOUT AIRGUARD™
According to the US CDC and European health authorities, 5 layer or equivalent face masks are mandatory and are the most protective type of a mask in preventing the spread of viruses. Most masks are either uncomfortable and do not help in filtering the size of the microns in the air. Available 3-ply masks can only be worn once before being disposed which creates a lot of pollution – not to mention waste of money. Creative Concepts took those negatives and created something positive – the AIRGUARD. It has a 5-Layer Nano-PTFE filtering technology that has a greater than 95% bacterial filtration efficiency against 0.3 micron particles in the air (like the COVID-19 virus), an equivalency of the N95 respirator. AIRGUARD™ is made from anti-bacterial breathable cotton that makes the airflow smooth and comfortable when wearing. Furthermore, the AIRGUARD™ cloth mask is hypoallergenic and has anti-microbial properties so you do not feel itchy or suffocated. The best part about the AIRGUARD™ cloth mask is that it is washable, reusable and sweat resistant. You can wash or put the AIRGUARD™ mask in the washing machine and reuse them with the same filtering properties and comfort. The AIRGUARD™ can be washed and reused up to 50 times. The outer layer is water-repellent and will not get wet from sweat during your workout or exercise.

Most cloth masks available in the market now have a maximum of 2 or 3 layers and has less or no filtering properties against harmful micron particles in the air.

As per the Director of National Institute of Health, Dr. Anthony S. Fauci – Wearing multiple layers of mask just “makes common sense” and “likely would be more effective”. AIRGUARD™ is the only 5-Layered reusable cloth mask that is more effective in preventing the spread of the virus.

AIRGUARD™ is being distributed worldwide. For more information on AIRGUARD™ cloth mask please visit

http://www.BuyAirGuardMask.com

AIRGUARD™ MASK COMPLIANCE
The AIRGUARD™ reusable cloth mask has passed several mandatory testing required by law and to provide a sense of protection for its consumers. Following are the testing approvals sought by Creative Concepts on the AIRGUARD™ by authorized testing bodies like SGS, Nelson Labs, Intertek, Bureau Veritas and UL.

  • SYNTHETIC BLOOD PENETRATION RESISTANCE (ASTM F1862 under 120 mmHg)
  • 42 CFR PART 84 – NaCI (N95 PARTICULATE FILTER EFFICIENCY)
  • EN14683:2019+AC:2019 (BACTERIAL FILTRATION EFFICIENCY-BFE)
  • FLAMMABILITY CLASS 1 (16 CFR 1610)
  • ANTI-BACTERIAL FINISHES ON TEXTILE (AATC 100-2019)
  • REACH TESTING (FOR EUROPE)
  • Face Fit Test

Via EPR Network
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Smart Wearables in Healthcare Market – Latest Scenario On Innovation, Revolutionary Opportunities & Top Consumers 2027

Albany, New York, 2021-Mar-23 — /EPR HEALTHCARE NEWS/ — The report titled “Smart Wearables in Healthcare Market” offers a primary impression of the Smart Wearables in Healthcare industry covering different product Scope, Characterizations, Classifications, Objectives, and Participants in the industry chain structure. Smart Wearables in Healthcare Market (6 Forces Forecast 2021-2027) research report offers in-intensity insight of the Smart Wearables in Healthcare industry masking all vital parameters along with Marketing Channel, Direct Marketing, Indirect Marketing, Brand Strategy, Pricing Strategy, Market Positioning, Target Client, and Distributors/Traders List.

Smart Wearables in Healthcare Market report profiles major topmost players operating (Apple, Fitbit, Jawbone, Misfit, MyKronoz, Samsung, Philips, Huawei, Qualcomm Technologies, Inc, Adidas Group, Sony Corporation, Lifesense Group, Monica Healthcare, Garmin, Omron, Dragerwerk, Nokia Technologies, Polar Electro, World Global Network [Wor(I)D], Activeinsights, Vitalconnect, Xiaomi, Nuvo Group, TmG-BMC, Scanadu, Proteus, Empatica) in terms of analyses various attributes such as Company Profile, Product Specifications, Revenue, Gross, Gross Margin, Cost, Capacity, CAGR, Production Value and contact information.

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Currently, Asia-Pacific is the largest market for the Smart Wearables in Healthcare having accounted for more than half of the global market size, by volume, in 2020. Among all the countries, China & India dominated the basic polymers market in 2020 in terms of volume, closely followed by Japan. High economic growth rate, rising demand for construction products made up of plastics, growing health awareness applications, improving standards of living and competitive manufacturing costs are the main factors leading to the growth of the market for Smart Wearables in Healthcare in this region.

Global Smart Wearables in Healthcare Market size will increase to xx Million US$ by 2027, from xx Million US$ in 2020, at a CAGR of xx% during the forecast period. In this study, 2020 has been considered as the base year and 2021 to 2027 as the forecast period to estimate the market size for Smart Wearables in Healthcare.

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On the basis of product, this report displays the sales volume, revenue (Million USD), product price, market share and growth rate of each type, primarily split into-

  • Smart Wrist Wearables
  • Smart Patches
  • Smart Clothes
  • Smart Head / Neck Wearables
  • Smart Ear Wearables
  • Smart Eye Wearables
  • Other

On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate of Smart Wearables in Healthcare Market  for each application, including-

  • Activity / Fitness Tracking (SMEs)
  • Remote Patient Monitoring & Diagnostics
  • Home Health Care
  • Others

Smart Wearables in Healthcare Market: Regional Analysis Includes:

  • Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)
  • Europe (Turkey, Germany, Russia UK, Italy, France, etc.)
  • North America (the United States, Mexico, and Canada.)
  • South America (Brazil etc.)
  • The Middle East and Africa (GCC Countries and Egypt.)

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The Smart Wearables in Healthcare Market Report Helps Answer the Following Questions:
⦿   What is the current size of the overall Smart Wearables in Healthcare Market? How much will this market be worth from 2021 to 2027?
⦿  What are the market shares of the leading segments of the Smart Wearables in Healthcare Market in 2020?
⦿  What are the main segments within the overall Smart Wearables in Healthcare Market? How much will each of these segments be worth for the period 2017 to 2027?
⦿  What are the main drivers and restraints in the Smart Wearables in Healthcare Market?
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⦿  What are the major deals happenings in the manufactures Smart Wearables in Healthcare Market?
⦿  Who are the leading manufactures and what are their activities, revenue, recent developments and prospects?
⦿  What are some of the most prominent Smart Wearables in Healthcare Market currently in development? What are their activities, platform technology and recent developments?

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Via EPR Network
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URSAPHARM and CEBINA collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic

SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR HEALTHCARE NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.

With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.

Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays [1].

A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.

If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

Via EPR Network
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Palette Life Sciences unveils 4 international sites for its Deflux online presence

SANTA BARBARA, CALIF. / STOCKHOLM, 27-Oct-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today introduced valuable new online resources for healthcare providers in France, Germany, Italy and Spain. By expanding its Deflux online presence to international audiences, Palette Life Sciences demonstrates its commitment to supporting the global paediatric community.

Deflux.fr is a French-language resource for healthcare providers in France. Deflux.com/de is a German-language site serving practitioners in Germany. Deflux.com/es and Deflux.it are English-language sites serving physicians in Spain and Italy respectively. These new sites offer best-in-class online resources, important information and education about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. All of the European sites provide physicians with access to the global Deflux Learning Center, a leading education platform that features information and training for paediatric urologists and their peers who treat VUR. The Deflux Learning Center includes clinical articles, educational videos, webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

The Deflux Learning Center for each respective country also provides downloadable educational materials for parents and caregivers managing children with vesicoureteral reflux (VUR).

“My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence in patients who fail medical management, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for physicians, will help raise awareness of this treatment option in patients with primary VUR, troubled by recurrent febrile UTIs,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Service Lead for Paediatric Surgery at Chelsea & Westminster and Imperial College Hospitals.

“We are excited to offer these new online resources to the healthcare community in France, Germany, Italy and Spain,” said Rich Low, Head of Marketing at Palette Life Sciences. “We are confident they will benefit the global paediatric urology ecosystem and serve as valuable resources by providing critical information and access to educational resources through the Deflux Learning Center.”

SOURCE: EuropaWire

ShigETEC vaccine candidate has the potential to have a major impact on diarrheal diseases

VIENNA, 24-Sep-2020 — /EPR HEALTHCARE NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.

Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.

“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.

“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.

Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

Via EPR Network
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LIDBREE™ receives marketing authorization in the United Kingdom

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

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

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

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

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

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

SOURCE: EuropaWire

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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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