Category Archives: Biotech

Diabeloop presents the results of the use of its Automated Insulin Delivery (AID) over the past 12 months by 4,162 patients

PARIS, 21-Sep-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a leader in therapeutic AI applied to insulin delivery, reports today on 12 months of use of its hybrid closed-loop DBLG1 System on a large, multi-country patient cohort. While Time in Range (70-180 mg/dL) still shows constant improvement, time spent in hypoglycemia stays significantly low. Users share how these clinical results, combined with a growing trust in the algorithm has led to fewer interactions with the device and improved quality of life.

New data2: one year living with DBLG1 System
Cohort of over 4,000 patients in 5 European countries

The innovative company Diabeloop, which will be present this week at the EASD Annual Meeting 2022, shares new real-world data on its first Automated Insulin Delivery system use.

DBLG1 System reached the European market a little over a year ago with consistent utilization throughout this period, with merely 1% of users discontinuing use of the product3.

In line with previously presented data4, significant improvement in Time in Range is observed here on a much larger population. The cohort gathers 4,162 patients in five countries: Germany, Italy, Spain, The Netherlands and Switzerland. TIR gain is 17.6 percentage points over a year of real life use.

Pr. Pierre-Yves Benhamou, CMO and President of Diabeloop’s scientific committee and US advisory board, commented:

“When initiating a treatment with DBLG1, it can be expected that the recommended outcomes (i.e., a TIR>70%, a TBR<4% and a GMI< 7%) will be achieved in about half of patients. Currently in Europe, the rate of achievement with standard treatment is only 27%.”

Another significant result is that this improvement in time spent in the target range is combined with a still extremely low occurrence of hypoglycemia: 0.2% < 54 mg/dL, 1.1% < 70 mg/dL. For the patients’ clinical picture and for their overall quality of life, this means less than 20 minutes per day spent in hypoglycemia, whereas the maximum accepted in the international recommendations is 60 mins.

Andrea and Martin, users of DBLG1 System share the benefit they derived from DBLG1 System on their hypoglycemia:

“Before I started using the system, I always had restless nights, because I often got hypoglycemia at night. Now the nights are great, I have to say.”

“I feel safer knowing that I’m not going to start sweating at some point, somewhere, because I have a low. That always made me feel kind of weak. I used to work as a nurse in three shifts, so I wish DBLG1 had been available, because I didn’t really have a daily routine then, where DBLG1 would have supported me.”

Algorithm performance leads patients to entrust it with fuller meal management

In the current commercial version of DBLG1, thanks to the initial parameter (meal ratio) and intuitive food logging functionality, patients:

– have access to meal size pre-configurations (small – medium – large)
– can quickly declare their meal
– personalize the carb intake declaration.

Based on the declaration, the glucose trend at time of meal and incremental patient data, the algorithm will recommend the insulin dose to deliver and manage post-prandial time period.

Diabeloop has already announced it was working on new versions to allow optimal management without declaration. Testimonials and data5 of DBLG1 real-life use however tend to show that patients trust the currently available device’s performance enough to skip some meal declarations and/or to declare approximative carbs quantities, and still get satisfying results.

For example, for the three main daily meals (breakfast, lunch and dinner), the patients used the shortcut (small-medium-large) for half of the 45 million meals declared on DBLG1.

It has also been observed that the longer the patients use DBLG1, the less likely they tend to declare meals altogether and the system will regulate itself. On average, one less meal is declared per day after 6 months of use.

Throughout the first 12 months of commercialization, feedback from users has been tremendous, highlighting time-saving, mental load alleviation and overall quality of life improvement.

Eva shares:

“I would definitely say that the mental burden has become less, or that I have to put in less effort to get good values (…) My sleep in general has gotten much better. The blood sugar levels are much more stable. I remember when I would wake up at night or set my own alarm. That has become much better since I have the Diabeloop system. The nights are fantastic.”

Erik Huneker, co-founder and CEO of Diabeloop reacts to these new real-world data and users comments:

“There is nothing more fueling for us than seeing DBLG1 perform over many months while it contributes to people with diabetes various lifestyles and needs. We have now equipped 10,000 patients and look forward to providing more personalization, ever more simplicity of use and more choices…to more and more people with diabetes.”

DIABELOOP AT EASD, September 20-23:
Booth M06
Meet the Expert session, September 21, 10:00 – 10:30 am
Supporting patient empowerment and improving glycemic outcomes with connected pens and artificial intelligence – From DBLG1 to DBL-4pen.
Networking Hub – with Erik Huneker, Pr. Lutz Heinemann & Pr. Pierre-Yves Benhamou
Platinum sponsor of #dedoc voices program

SOURCE: EuropaWire

New AI-powered predictive algorithm offers unprecedented accuracy in diagnosing NASH and liver fibrosis staging

BOSTON, MA, United States, 18-Jul-2022 — /EPR HEALTHCARE NEWS/ — Metadeq Inc., a global NASH and metabolic diseases diagnostics company, today announced a breakthrough non-invasive blood test that utilizes two novel circulating proteins to accurately diagnose Non-alcoholic steato-hepatitis (NASH) and liver fibrosis, and can score the stages of both diseases, without the need for invasive liver biopsy. The study which details the new blood test – just revealed in Gut, a leading hepatology and gastroenterology journal published by BMJ – was led by King’s College London Professor Geltrude Mingrone, in collaboration with Metadeq.

Approximately one in four people worldwide, or approximately two billion people, have Non-alcoholic fatty liver disease (NAFLD) and therefore are at risk of developing NASH. NASH is the most severe form of NAFLD, a silent disease associated with fatty deposit build-up of the liver. NASH leads to advanced liver diseases such as liver fibrosis (scarring), cirrhosis, and liver cancer, and may ultimately result in death. The annual cost to the US healthcare system alone has been estimated to be over $100 billion per year.

Currently, the only way to diagnose NASH is through the standard of diagnosis, invasive liver biopsy, which is expensive and is associated with significant complications and discomfort. Until now, no reliable blood test has been developed for NASH, nor liver fibrosis. Most importantly, no available test can define the severity (stage), or monitor the progression, of either NASH or liver fibrosis.

Professor Geltrude Mingrone from the School of Cardiovascular and Metabolic Medicine & Sciences at King’s College London, who is one of the most widely cited and influential researchers globally for metabolic diseases and disorders, set out to discover a more accurate liquid biopsy test in support of patient care and in collaboration with Metadeq. The resulting study was published today in leading journal, Gut.

This study identified two novel protein biomarkers, PLIN2 and RAB14, to assist in the diagnosis of patients with NASH and/or liver fibrosis. The ability of these proteins to detect both diseases was tested in cohorts with either NASH and/or liver fibrosis that were confirmed with liver biopsy, the current standard of diagnosis.

“This blood test will allow researchers and clinicians to define the prevalence of NASH across populations, including children and adolescents, avoiding the need for invasive liver biopsy,” said Professor Mingrone. “Critically, it will allow care-givers to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs.”

“Since HEPAR-QTM is the only diagnostic modality that can diagnose NASH and fibrosis staging we expect it to be instrumental in the development of new therapeutics for the management of patients,” said Frank Jaksch, Chairman of Metadeq. “We believe that HEPAR-QTM will advance for the benefit of patients the problem of regular screening, that has resulted in late drug failures during clinical trials, since it is now possible to accurately measure the severity of disease in a non-invasive manner.”

 

The Metadeq predictive algorithm, which uses A.I., provided unprecedented sensitivity (88-95%), specificity (90-100%), and overall accuracy (92-93%) for NASH, and also has near-perfect sensitivity (99%-100%), specificity (90%-96%), and accuracy (98%-99%) for liver fibrosis.

The test results show that the proteins can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This could be an invaluable tool in diagnosing and monitoring cases of liver diseases, allowing people to receive earlier treatment, from lifestyle adjustments to surgical and pharmacological interventions.

Currently no NASH drug has been approved by either the FDA or EMA, which may be a direct result of the lack of an accurate, reliable, and non-invasive test. More than 65% of patients who enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure, which causes major monetary losses to companies developing and testing NASH drugs. The improved accuracy and ability to detect NASH staging will help in identifying and enrolling the appropriate people in clinical trials, speeding up the development of NASH drugs.

About Metadeq
Metadeq Corp. is a diagnostics company that provides innovative liquid biopsy solutions for liver and metabolic diseases. For the first time, Metadeq allows people to measure the whole spectrum of liver diseases – from NAFLD, to NASH, and liver fibrosis – with a blood test. www.metadeq.com

SOURCE: EuropaWire

Diabeloop, a high-growth health tech firm that automates the treatment and the management of diabetes, announces EUR 70 million funding

PARIS, 2-Jun-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop secures 70 million euros to pursue its solid and sustained growth strategy.

The company, an Automated Insulin Delivery pioneer, develops machine-learning software for diabetes treatment. Its highly sophisticated algorithms are integrated into easy-to-use products helping facilitate chronic disease management impacting patients’ clinical outcomes and their quality of life.

Diabeloop has seen impressive growth in the last few years with two products on the European market, rapidly approaching 10,000 equipped patients one year after commercial launch and major developments with various device partners.

The first closed-loop solutions commercialized by Diabeloop offer personalized management for Type 1 (DBLG1) and highly unstable Type 1 diabetes (DBL-hu). By connecting a Continuous Glucose Monitoring device (CGM) and an insulin pump, Diabeloop’s world-leading algorithms analyze data in real time and automate insulin delivery. It transforms the lives of people with diabetes by taking over many of the therapeutic decisions that used to fall to patients.

Erik Huneker, founder & CEO of Diabeloop, declares: “Being able in 2021 to bring the benefits of our products to thousands of patients and hearing their enthusiasm, is why all of us at Diabeloop work so hard. The financing round announced today recognizes the team’s successes, and more importantly, the great opportunities ahead.”

The financing round is led by prominent private equity player LBO France. The Venture division of the sustainability-conscious private equity fund is a European leader in digital health, supporting young companies with ambitious projects showing international footprints.

“Diabeloop’s team has developed a unique data driven product that has the potential to revolutionize the daily life of millions of diabetic patients by taking away most of their daily mental burden and significantly improving the control of their disease. We are eager to join the investor base and help the company become a global leader in diabetes closed-loop software solutions,” says Valery Huot, Partner, Head of Venture at LBO France.

International healthcare leader Terumo Corporation also participates in Diabeloop’s Series C round. After entering into development agreements with one another in 2020, Terumo extended this to a comprehensive strategic partnership agreement with Diabeloop in 2021.

“We are excited that Diabeloop successfully completed this important milestone and the great opportunities will continue to expand for all corners of the world. Together with Diabeloop, we are committed that we will be able to contribute to all stakeholders by providing patient-centric and personalized solutions,” comments Hikaru Samejima, President of Terumo’s Medical Care Solutions Company.

Innovacom, a key player in the French and European startup community specialized in deep-tech and industrial projects, joins LBO France and Terumo Corporation as new investors.

Comforted by the commercial launch of Diabeloop first devices and the break-through potential of its projects to address a 10-million patients market in the mid-term, previous investors CERITD, CEMAG invest, Kreaxi, Supernova Invest, AGIR A DOM., Crédit Agricole, Odyssée Venture, UI Investissement (Sofimac) and Promontoires all have decided to reinvest.

Additionally, Bpifrance and the historical bank pool are supporting Diabeloop via debt financing.

“We are grateful for the confidence of our existing investors and proud of our distinguished new financial and industrial shareholders. I have full trust in the talent and commitment of the Diabeloop teams to pursue their groundbreaking value creation path for patients and become a trusted leader and partner in the highly reactive diabetes market,” concludes Catherine Dunand, Diabeloop’s Chairman of the Board.

In 2019, Diabeloop secured the highest recorded European financing round in Therapeutic Artificial Intelligence and went on to commercially launch two products, with several thousand patients equipped in less than a year. Their CE-marked data visualization platform accompanies healthcare professionals and patients as a telemedicine and remote patient monitoring solution. High-impact projects such as the adaptation of the core-algorithm to the multi-million users Connected Pen market and development of smart-watch devices also have contributed to Diabeloop’s tremendous momentum.

About Diabeloop
Diabeloop’s mission: Making innovation accessible to people living with diabetes, improving clinical results while relieving them of their constant mental burden.

Created in 2015, Diabeloop is a high-growth company that offers AI-based, personalized solutions to automate the treatment and the management of diabetes. 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. Diabeloop just completed its Series C financing round, securing 70 million euros, to accelerate its commercial roll-out, support its sustained growth strategy and its high-impact projects.

Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.

About LBO France
With €6.6 billion of capital raised since its inception, as a key player in private equity, LBO France is supporting growing French and Italian companies for more than 30 years.

Its investment strategy is based on five distinct segments managed by dedicated teams:

(i) Mid Cap Buyout through the White Knight funds, and Small Cap Buyout through the Small Caps Opportunities funds,
(ii) Venture capital through the Digital Health funds,
(iii) Real estate through the French White Stone funds, OPCI Lapillus, impact fund Newstone and the Italian management company Polis Fondi SGR
(iv) Debt, notably in Italy through the Vita Superbonus program to finance energy efficiency in real estate assets
(v) Public Equity through the France Développement fund

LBO France is 100 % owned by its management and employs nearly 70 professionals.

SOURCE: EuropaWire

Diabeloop, a medtech firm that automates T1D treatment, presented new real-life results for its DBLG1® System at ATTD2022 in Madrid

PARIS, 28-Apr-2022 — /EPR HEALTHCARE NEWS/ — ATTD 2022 – Diabeloop, pioneer in therapeutic artificial intelligence for diabetes management, presents today new results from a real-life cohort in Germany. The data show a constant improvement in Time In Range (70-180 mg/dL) combined with a significant reduction of hypoglycemia.

DBLG1, Diabeloop’s hybrid closed-loop, showed improvement of Time In Range and reduction of hypoglycemic episodes which allows for better diabetes management and improved quality of life.

Time In Range: a continuous improvement, with even more people equipped

Presented today at ATTD, the latest data from DBLG1¹ real-life cohort demonstrates an increase of 18.4 percentage point in Time In Range (TIR 70-180 mg/dL) on 974 patients.

This significant gain confirms the constant improvement in Time In Range, a key indicator of glucose control, in people living with Type 1 diabetes equipped with DBLG1 System since the WP7² pivotal trial (+12 points), the commercial pre-launch³ (+16.7 points) and the results of the first real-life cohort in Germany4 (+17.1 points).

With several thousand people equipped, Diabeloop’s solution continues to increase the Time In Range and thus improves the associated clinical benefits, such as better glucose control, less complications and improved quality of life.

These significant performances confirm the ability of Diabeloop’s solutions to improve glycemic control of people with T1D, in real-life, in a less controlled environment than in hospital supervised studies.

DBLG1 users in Germany, included in the real-life cohort, benefit from basic support at initialization. This demonstrates the ease of use of Diabeloop’s automated and personalized insulin delivery system and its interface.

Prof. Pierre-Yves Benhamou comments: “From the first study – WP7 which showed an increase in Time In Range of 12 points, to today with +18.4 points following the European commercial launch of DBLG1, the continuous improvement of the TIR is significant. The results observed on the new real-life cohort of nearly 1000 people in Germany are very impactful, with patients with a baseline TIR (70-180 mg/dL) of 54.6% reaching 73% TIR in closed-loop with DBLG1. The other very positive result observed in this cohort is the significant reduction in hypoglycemia”.

A significant reduction of hypoglycemia combined with improvement in TIR

Associated with the increase in TIR, the retrospective data of the real-life DBLG1 cohort show a very significant reduction in time spent in hypoglycemia. Users of DBLG1 whose HbA1c was available at initiation spent only 0.9% of the time below 70 mg/dL and 0.1% of the time below 54 mg/dL5.

This variable has been constantly improving since the real-life WP72 study, which had already demonstrated a halving of the time spent below 70 mg/dL, a gain of more than 30 minutes less spent in hypoglycemia each day. More recently, the first real-life cohort in Germany demonstrated a time spent below 70 mg/dL at 1% and 0.2% below 54 mg/dL(4).

Thus, DBLG1 strongly contributes to reducing the short-term risks associated with hypoglycemia, such as discomfort, dizziness or even life-threatening situations. Diabeloop’s technology, based on artificial intelligence, allows an optimal diabetes management with less glycemic variations responsible for complications, and a life without interruption associated with the chronic disease.

“It is a great satisfaction to see that these new data extracted from an even larger cohort of patients show a simultaneous performance on TIR and reduction of hypoglycemia. Combined with the positive and very concrete feedback from the people equipped, this motivates us to go even further, to address more and more populations affected by diabetes” states Erik Huneker, CEO and co-founder of Diabeloop.

Testimonials: positive impacts in diabetes management, quality of life and mental burden

Since the commercial launch of its first solution in Europe last year, Diabeloop has received numerous feedback on the improvement of diabetes management and clinical benefits.

“I was skeptical about letting my diabetes be controlled by technology. But my diabetologist advised me to try it. My HbA1c dropped from 10% to 7% within two months. DBLG1 has improved my quality of life. I sleep better, I’m fitter, I’m very curious about what the next updates of DBLG1 will bring.” says Martin, living with diabetes for 45 years, equipped in Germany.

“My life has definitely changed with DBLG1. I have much less mental burden. I really noticed that I can have more time for other things and don’t have to concentrate on my diabetes all the time, as long as I take everything responsibly and estimate the carbs of my meals correctly. When I go to parties or some birthdays or other events, I know that DBLG1 always corrects me automatically. I’m really happy!” comments Eva, T1D using DBLG1 in Germany.

“DBLG1 has a “high-fat meal” feature that I use very often, even though I don’t eat that much fat but I don’t eat a lot of carbs either. It allows the delivery of biphasic boluses, adapted to the blood sugar level before meals and it works magically on me to avoid postprandial hyperglycemia!” says Stéphanie, equipped with DBLG1 in France.

Listen to all the testimonials in the first episode of the exclusive podcast Diabeloop Stories on Spotify : https://open.spotify.com/show/3GNcl…

Come and meet the Diabeloop team at ATTD, booth n°34 in the TechFair area.

CEO Erik Huneker and Pr Pierre-Yves Benhamou will present these results at Diabeloop session “AID pipeline perspectives & clinical outcomes” on Thursday, 28th April from 12:10 in the Exhibition Area.

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 DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.

——————
References:

1 Real-life internal data (YourLoops data extract, from September 1, 2021, to December 31, 2021): 974 patients from Germany, who gave consent, equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump, with HbA1c available at initiation.

2 P.Y. Benhamou et al., «Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial», The Lancet Digital Health, Vol 1 (1), E17 – E25, 2019. DOI: 10.1016/S2589-7500(19)30003-2

3 C. Amadou et al., «Diabeloop DBLG1 Closed-loop system enables patients with Type 1 diabetes to significantly improve their glycemic control in real-life situations without serious adverse events», Diabetes Care 2021 Jan; dc201809. doi:org/10.2337-dc20-1809

4 Data from 152 patients equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump in Germany from April to September 2021 with available HbA1c at initiation, based on [Beck and al. 2019] equation for hb1Ac <=9% and hb1Ac>=6%”

5 Real-life internal data (YourLoops data extract, from September 1, 2021, to December 31, 2021): 1914 patients from Germany, who gave consent, equipped with DBLG1 System with Accu-Chek® Insight (Roche) insulin pump..

SOURCE: EuropaWire

Diabeloop to integrate insulin pens into its hybrid closed-loop system using a unique app

PARIS, 12-Apr-2022 — /EPR HEALTHCARE NEWS/ — Diabeloop, a pioneer in the field of therapeutic artificial intelligence, leverages the potential of its diabetes technology to enable the integration of insulin pens into its hybrid closed-loop system using a unique app. With DBL-4pen, Diabeloop offers new opportunities for personalized diabetes management for people with Type 1 and Type 2 diabetes, further advancing the quality of patient care.

Diabeloop opens a new segment in the insulin therapy market

Several tens of millions of people worldwide require insulin everyday. However, only 2 million of them1 are equipped with insulin pumps, because of their relative complexity and significant cost. Most diabetes patients in Europe and the U.S. on intensive insulin therapy are multiple daily insulin injections (MDI) pen users.

Diabeloop is developing a product for people living with diabetes who do not have access or want to wear an insulin pump. Using self-learning algorithms, DBL-4pen will bring most of the clinical improvement from DBLG1’s closed-loop to insulin pen users, while the overall cost will be significantly lower for the payer.

DBL-4pen: real-time mobile insulin dosing and telemedicine solution

People on multiple daily insulin injections using pens face the challenge of determining the correct amount and timing of insulin depending on individual blood glucose levels, physiology and lifestyle. To reduce hypoglycemia, risks of associated complications while lowering the mental burden of managing diabetes for patients using insulin pens, Diabeloop is developing a unique smartphone app that embeds its self-learning algorithm. The app is connected via Bluetooth® to a connected insulin pen and a CGM that measures blood glucose levels every 5 minutes.

On the way to more automation, DBL-4pen requires a minimal input from users. They only need to enter meals and physical activities into the app. DBL-4pen then automatically recommends the ideal insulin dose in real time, which can be delivered via the pen with no more calculation to do.

In addition, the measured data can be transmitted to the physician, healthcare providers or family members via YourLoops, the cloud based data visualization platform, if the patient so desires.

Strong partnerships to foster interoperability

DBL-4pen complements Diabeloop’s existing product line with another user-friendly and personalized solution that offers more control and customization possibilities regarding diabetes management.

“The integration of insulin pens into hybrid closed-loop systems is a substantial progress. Especially diabetes patients for whom pump therapy is a hurdle can benefit from this new solution. Moreover, diabetes therapy with insulin pens can be a viable solution for different healthcare systems,” said Prof. Hélène Hanaire of the University Hospital of Toulouse.

Diabeloop announces the extension of its partnership with BIOCORP, a French company specialized in the development and manufacturing of medical devices and connected healthcare solutions, to integrate Mallya®, their smart cap for insulin injection pens into Diabeloop’s technological environment.

This and other planned partnerships are expected to create new opportunities to bring Diabeloop’s interoperable technologies to people with diabetes who use insulin pens for their daily multiple injections.

“With DBL-4pen, we are able to bring the power of self-learning algorithms and connectivity to the majority of people who can not or do not want to wear an insulin pump. The combination of smart sensors for insulin pens with our self-learning algorithm gives us the opportunity to integrate a wide range of insulin pens into our hybrid closed-loop system in the future. Our goal is for this innovative solution to be compatible with almost all pens on the market,” said Erik Huneker, CEO and co-founder of Diabeloop.

Dynamic bolus insulin titration doses

DBL-4pen is currently a unique solution for MDI patients to dynamically titrate bolus insulin doses. Personalization is at the core of this solution because the app takes into account both entered meals and physical activities, as well as glucose trend, and uses the entire patient history to fine-tune bolus amounts based on the patient’s response to previous boluses.

“DBL-4pen offers a customized solution for MDI patients that can be integrated into hybrid closed-loop systems. Currently, we are in the process of launching a clinical trial in France to strengthen Diabeloop’s positioning in the insulin pen therapy market,” said Marc Julien, Chief Operating Officer of Diabeloop.

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 DBLG1 iController and Diabeloop’s ambitious R&D program. Today, Diabeloop gathers the personality, passion, and skills of over 160 talented individuals who work hard to improve the quality of life for every person living with diabetes.
——————
Reference:
1 2021 internal extrapolation based on Seagrove Partners and Simon-Kucher reports data

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Meet Diabeloop at ATTD 2022 (27-30 April 2022, Barcelona, Spain) or contact us for further information at: partnership@diabeloop.fr

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Global Mental Health Software and Devices Market, Segmentation by Component

  • Software
    o Integrated Software
    o Standalone Software
  • Devices

Global Mental Health Software and Devices Market, Segmentation by Functionality

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

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

  • Desktops/Laptops
  • Tablets/Smartphone

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

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SOURCE: EuropaWire

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

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

Key study findings:

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

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

About the ELIOS procedure:

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

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

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

Why are these findings relevant?

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

SOURCE: EuropaWire

Exopharm: exosomes seen as an alternative to lipid nanoparticles (LNPs) and adeno-associated viral vectors (#AAVs) for targeted multi-dose delivery of modern medicines and vaccines

MELBOURNE, Australia, 3-Feb-2022 — /EPR HEALTHCARE NEWS/ — Australian technologist Dr Ian Dixon founded Exopharm in 2013 with the vision to harness the unique properties of exosomes as a new class of medicine. Dixon’s decisive early entry into exosome therapeutics is now bearing fruits.

Less than 10 years after its founding, Exopharm possesses a granted US patent for its key exosome manufacturing technology, LEAP™, and has run successful first-in-human clinical trials demonstrating the safety of its exosome products.

Exosomes have the potential to revolutionise medicine in many areas, including delivery of gene therapies into cell nucleus for rare and common genetic disorders, improving therapeutic window of small and large molecules by cell targeting, and by selective cellular delivery of next-generation DNA/RNA products.

In 2022, excitement around exosomes has converged on exosomes as an alternative to lipid nanoparticles (LNPs) and adeno-associated viral vectors (AAVs) for targeted multi-dose delivery of modern medicines and vaccines. Drug delivery accounts for a significant slice of the global pharmaceutical industry spend –around US$160b p.a. and growing strongly – and exosomes represent nature’s way to deliver a bioactive cargo into cells efficiently and safely.

Primed for growth

Dixon’s establishment of a specialist exosome medicines company has been followed by US based Codiak Biociences in 2015 (established by Arch Ventures) and Oxford based Evox Therapeutics in 2016. Today, only two dedicated exosome companies are listed on the public markets: Codiak (NASDAQ: CDAK) with a market cap of around US$200m; and Exopharm (ASX: EX1) with a market cap of around A$73m at the time of writing this article.

The field of exosome medicines is attracting the attention of financiers and pharmaceutical industry leaders. In late 2021, multinational pharmaceutical manufacturing services company Lonza jumped into exosome manufacture, a sign that they see big things over the horizon.

Over the past 9 years, Exopharm has grown and evolved but remains true to Dixon’s vision of exosome medicine development. The company now employs around 40 people most in its Melbourne, Australia, facility. Exopharm has built a toolbox of exosome technologies and knowhow which, in addition to the LEAP™ scalable exosome manufacturing platform, includes exosome analytical tools (Exoria) and technologies to load exosomes with a specific therapeutic cargo (LOAD) and target exosomes to select cells (EVPS).

Our business development team is attracting the attention of similar innovative biopharmaceutical and biomanufacturing companies, and validating the Exopharm technologies via collaboration research agreements.

Exopharm is not simply a technology company, however. Exopharm is pursuing a pipeline driven platform technology strategy, on the way to generating a revenue stream from technology out-licensing while developing its own exosome medicines for selected markets. More news on its pipeline products is expected to be ready for release later in CY ’22.

The Exopharm team has grown and changed to becoming more international in focus, improving on messaging and communications with the wider pharmaceutical industry. In 2021 Dr Jenn King joined the Board of Exopharm, bringing a wealth of big pharma and US biotech experience with her.

In 2022 we look to engage with more experts, as members of our advisory panels, as consultants, executives or Key Opinion Leaders. Please reach out to us if you want to be part of our vision.

At the company’s 10-year anniversary in late 2023, Exopharm will be a key part of the exosome medicines revolution.

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

To learn more, please visit Patients as Partners Europe.

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

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

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

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

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

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

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

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

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

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

SOURCE: EuropaWire

Palette Life Sciences expands distribution network across Europe

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

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

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

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

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

SOURCE: EuropaWire

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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