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Results From Sequana Medical’s RED DESERT alfapump DSR® Study Selected for Presentation at the Heart Failure 2021 Online Congress

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GHENT, Belgium, June 09, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that the abstract on the results from its RED DESERT alfapump DSR (Direct Sodium Removal) study has been selected for presentation at the Heart Failure 2021 Online Congress as part of the Late Breaking Science Results.

Heart Failure 2021 is organised by the Heart Failure Association of the European Society of Cardiology and will be held virtually from Tuesday 29 June to Thursday 1 July 2021. The abstract “First in Human Experience with Alfapump DSR System in Diuretic Resistant Chronic Heart Failure” will be presented by Dr. Jeffrey Testani, Associate Professor of Medicine and Director of Heart Failure Research at Yale University School of Medicine.

Details of the presentation:

  • Title: First in Human Experience with Alfapump DSR System in Diuretic Resistant Chronic Heart Failure
  • Presenting: Dr. Jeffrey Testani
  • Presentation available on demand throughout the congress (29 June – 1 July)
  • To register for the event, click here

For more information, please contact:

Sequana Medical
Lies Vanneste
Director Investor Relations
Tel: +32 498 05 35 79
Email: IR@sequanamedical.com

LifeSci Advisors
Guillaume van Renterghem
Tel: +41 76 735 01 31
Email: gvanrenterghem@lifesciadvisors.com

About Sequana Medical

Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 850 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status. The SAHARA DESERT study of alfapump DSR in decompensated heart failure patients is ongoing.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Note:alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

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Source: https://www.biospace.com/article/releases/results-from-sequana-medical-s-red-desert-alfapump-dsr-study-selected-for-presentation-at-the-heart-failure-2021-online-congress/?s=93

Medical Devices

New Research Shows Nearly Half of Elderly Suffer Decreased Mobility During Lockdown

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Decreased Mobility During Lockdown: Kepler Vision Technologies, a global leader in computer vision monitoring technology, reveals that while people are still concerned about the possibility of elderly relatives catching Covid, day-to-day concerns such as loneliness, mental health and falling over are of an almost equal concern according to new research.

decreased mobility during lockdown, Kepler Vision Technologies

Parental Loneliness and Falls a Huge Worry for Brits

In a survey of UK adults with parents over the age of 75, while over half (52%) of respondents remain worried about their parents catching Covid, 48 percent are concerned about parental loneliness, and 46 percent about their parents falling alone and not being able to get up or get help. This figure remained high even among those whose parents are in care homes, with 37% of respondents still most concerned about parents falling over.

Physical Mobility in Elderly People Massively Impacted During Lockdown

There is also concern that the long-term effects on the mental and physical health of the elderly are still being felt. Four in ten respondents (41 percent) revealed that their parent’s physical fitness and mobility have decreased during the lockdown, as a result of being confined to homes for months at a time with little opportunity to exercise or physically engage with others.

Dr. Harro Stokman, CEO of Kepler Vision Technologies said: “With fears about Covid beginning to recede, those with older relatives are rightly concerned with the more common problems faced by the elderly both in care and while living alone. Issues such as loneliness and falling over are both exacerbated by the ongoing staffing crisis in the care industry and, with no new influx of care staff on the horizon, the children of elderly parents should be looking for solutions that provide them with the best possible care and dignity in their old age.”

Getting up from the floor after a fall is a challenge for the elderly. According to a study on the effects of falling among elderly people[1], even when not injured, 47% cannot get up without assistance. Remaining on the floor after a fall for a prolonged period increases morbidity and mortality, with an early study [2] finding that half of those who remained on the floor after a fall for an hour or longer passed away within 6 months. Another study [3] showed that 60% of those who were on the floor after a fall for more than an hour were admitted to the hospital in the follow-up year.

Kepler Vision’s Night Nurse solution is designed to alert relevant staff or carers immediately to elderly people that have experienced a fall, ensuring that they get assistance within minutes not hours, reducing the chances of further injury and health complications.

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Source: https://infomeddnews.com/decreased-mobility-during-lockdown-elderly-suffer/

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British Columbia First Province to Cover Dexcom G6 Continuous Glucose Monitoring System for People With Type 1 and Type 2 Diabetes on Intensive Insulin Therapy

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BURNABY, British Columbia–(BUSINESS WIRE)– Dexcom, Inc. (NASDAQ: DXCM), a leader in real-time continuous glucose monitoring (CGM), announced today that people with diabetes who are on intensive insulin therapy, age two years or older, may now be eligible for provincial coverage of the Dexcom G6 CGM System through BC PharmaCare. This coverage expansion is in line with Dexcom’s mission to make it easier for people living with diabetes to experience the benefits of using a CGM system for their diabetes management.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005428/en/

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

“Improved access to CGM technology elevates diabetes management for everyone in a patient’s circle of care. As an endocrinologist and medical director at a clinic specifically dedicated to diabetes care, I am appreciative that today’s announcement will benefit so many people in the province,” said Dr. Tom Elliott, Medical Director of B.C. Diabetes. CGM leads to better glycemic control for patients1,2 and gives physicians better insight into patients’ glucose levels to make treatment decisions. CGM use may lead to fewer trips to the emergency room by helping users avoid severe hypoglycemic episodes.4

British Columbia joins Yukon, Quebec and Saskatchewan to offer public coverage of CGM systems under provincial health plans. In addition, Prince Edward Island and Manitoba have also recently announced plans for funding based on their 2021 budget platforms. For coverage in B.C., patients must meet the coverage criteria, be enrolled in eligible PharmaCare plans, and meet any deductible requirements. Today’s announcement marks a significant accomplishment in increasing access to life changing technology used in the management of diabetes and recognizes the impact CGM technology can have on those who require intensive insulin therapy to manage their type 2 diabetes as well as those living with type 1 diabetes.

“As a BC-based company, we are thrilled by today’s announcement and the province’s commitment to the diabetes community,” says Laura Endres, Vice President and General Manager of Dexcom Canada. “We have seen the impact of improved access to CGM to truly change lives, and we look forward to continuing our work toward access for all those impacted by diabetes across Canada.”

The Dexcom G6 CGM System includes a small, wearable sensor that measures glucose just below the skin; a transmitter to continuously and wirelessly send glucose levels to a display device; and a compatible smart device* or receiver that displays real-time glucose data to users without the need for fingersticks or scanning. And with real-time alerts, including a predictive Urgent Low Soon alert, the Dexcom G6 can warn the user in advance of hypoglycemia — allowing time to take appropriate action before it happens — day or night. As part of the BC PharmaCare coverage program, users will now be able to pick up their Dexcom CGM supplies through a participating local pharmacy.

For more information about the coverage criteria for BC PharmaCare, please visit https://www.dexcom.com/en-CA/public-coverage and BC PharmaCare’s website section related to Diabetes Supplies.

About Dexcom, Inc.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California in the United States, and with operations in Canada, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

* For a list of compatible devices, please visit dexcom.com/compatibility

Dr. Tom Elliott was not compensated for any media work. He has been a paid speaker for Dexcom Canada, Co.

References


1 Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. JAMA 2017;317(4):371-8.

2 Welsh JB, Gao P, Derdzinski M, et al. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther 2019;21(3):128-32.

3 Roze S, Isitt J, Smith-Palmer J, Lynch P. Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor Versus Self Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Poster presentation presented at: 2020 Canadian Association for Population Therapeutics; October 27, 2020.

4 Mulinacci G, Alonso GT, Snell-Bergeon JK, Shah VN. Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. Diabetes Technol Ther 2019;21(1):6-10.

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Source: https://www.biospace.com/article/releases/british-columbia-first-province-to-cover-dexcom-g6-continuous-glucose-monitoring-system-for-people-with-type-1-and-type-2-diabetes-on-intensive-insulin-therapy/?s=93

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Medical Devices

Orthofix Announces Participation in Upcoming JMP Securities Life Sciences Conference

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June 11, 2021 11:01 UTC

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced that President and Chief Executive Officer Jon Serbousek and Chief Financial Officer Doug Rice will participate in a fireside chat during the upcoming JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 11:00 a.m. ET. The conference will be held in a virtual format, and one-on-one meetings will be held before and immediately following the fireside chat.

A live audio webcast will be available on the Company’s website at ir.orthofix.com/events-and-presentations/.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions while partnering with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210611005084/en/

Source: Orthofix Medical Inc.

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Evaluation of the use of midline peripheral catheters for the purpose of blood collection

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Midline intravenous catheters (MCs) have been used in clinical settings since the 1950s and are an alternative for intravenous (IV) access for giving infusions and medications for long-term therapy in patients who have limited IV access and can be used up to one month duration.  Accessing the midline catheter for blood sampling is sometimes used for those patients who have difficult IV access and those with the need for frequent blood sampling for testing.  Studies have reported on the outcomes of using MCs, however, little is known or reported about the procedures used to sample blood from midline catheters or outcomes from using the MC for this purpose. While the Infusion Nursing Society (INS) standards include recommendations for blood sampling from central venous and short peripheral catheters (SPCs), the newest INS 2021 standards indicate that, while midline catheters might be used to obtain blood samples, there was no evidence available regarding the processes or outcomes of performing this procedure.

In general, IV catheters are intended for giving fluids or medications in a forward, antegrade flow rather than a backwards, retrograde flow when withdrawing blood to test for patency or for laboratory testing. The impact of the flow dynamics and effects on IV catheter performance and vasculature when withdrawing blood from MC is not well known and no recommendations or procedures exist for sampling blood from midline catheters, although it is known that this is performed in the clinical setting.

Hemolysis, the injury or splitting (lysis) of red blood cells, is an unintended and unwelcome consequence of sampling blood from intravenous catheters. The release of contents in red blood cells when “lysed” can alter some blood test values, making blood samples unusable for analysis.  This may result in the need to draw another blood sample with potential delays in care, repeated venipunctures and vein injury, and financial impact. Using SPCs for blood sampling is associated with increased hemolysis and may result from mechanical shearing and turbulence encountered during withdrawal of blood. The American Society for Clinical Pathology recommends that hemolysis rates at or below 2%, and reports rates from 3-32% hemolysis occurring in acute clinical settings.

Midline Catheter Design Changes to Improve Blood Draw
Recently, anecdotal feedback from practitioners experiencing hemolyzed samples when withdrawing blood samples from midline catheters prompted a company to develop a change in their midline catheter to overcome hemolysis. After conducting laboratory studies on fluid dynamics when withdrawing blood through the catheter lumen, the company designed the MC with a reinforced tip to reduce hemolysis during backwards flow when withdrawing blood for sampling. This MC (PowerGlide Pro™; BD, Salt Lake City, UT) received 510K clearance from the U.S. Food and Drug Administration in September 2016. However, this MC had not undergone assessment in a real clinical setting to evaluate for performance and rates of hemolysis and was needed.

Given that little to no evidence was found in the literature about procedures or clinical outcomes from using MCs for blood sampling, my  colleagues and I at Orlando Health conducted an observational study to explore the practices used by clinicians and outcomes when using the MC for blood collection.

The purpose of this study was to assess the processes and outcomes of using the MC to sample blood for laboratory testing. We aimed to evaluate the MC in an acute care setting for hemolysis rates when blood was drawn from the MC for laboratory analysis, catheter outcomes, and nurses’ practices and perceptions when sampling blood from the MC. Since only the MC with the reinforced tip was used at this facility, we only studied these outcomes in that particular catheter.

Our study findings were published in the most recent issue of the Journal of the Association for Vascular Access (JAVA), Volume 25, No. 4.

Study Findings
Findings from this study showed that we had very low rates of hemolysis and withdrawing blood from the catheter did not significantly impact dwell time of the ability to complete IV therapy. Since we only tested the one type of MC designed to lessen hemolysis, it is not known if these outcomes would be achieved with other types of MCs or in different settings. We found that MCs were mostly removed at discharge from the hospital, so it was not possible to determine longer-term outcomes from blood sampling or its effects on catheter dwell time if it were to have remained for longer periods of time.  We learned from focus groups with nurses, that they learned how to withdraw blood from MCs from their preceptors or other nurses and tended to use processes recommended for phlebotomy from other types of vascular access devices, such as central venous or short peripheral catheters.  Since there are still no recommendations from the Infusion Nurses Society about using MC for blood withdrawal, more information gained from this study helped inform nurse actions used for blood withdrawal from MCs and opportunities still exist to develop procedures and practices for this purpose.

Recommendations for Practice
This was the first study of this kind known to evaluate the outcomes and processes used for blood withdrawal for sampling from a midline catheter. Thus, more information and studies are needed to develop and evaluate outcomes using other types of MCs and in other settings.  Further, other recommendations are to develop and test procedures for blood sampling from MCs to contribute to and establish standards of practice in this area.

Editor’s Note: The study mentioned in the article was funded by Becton Dickinson. The author has no financial relationship with BD .

Photo: Anastasia Usenko, Getty Images

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Source: https://medcitynews.com/2021/06/evaluation-of-the-use-of-midline-peripheral-catheters-for-the-purpose-of-blood-collection/

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