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GRENOBLE, France, May 11, 2022 (GLOBE NEWSWIRE) —  UroMems, developer and manufacturer of UroActive™, the first active medical implantable device for treating stress urinary incontinence, today announced the elevation of Steffen Hovard, currently on UroMems’ Board, to Chairman of the Company’s Board of Directors. Mr. Hovard is a medical device industry leader in the U.S, with a successful track record in urology. As chairman, he will be focused on increasing UroMems’ financial, clinical development and commercial footprint in the U.S.

“I joined UroMem’s Board in 2020 because I believed that the UroActive™ device is truly innovative and potentially transformational treatment for the millions of men and women worldwide who suffer from stress urinary incontinence or SUI,” said Mr. Hovard. “Now as we approach the initiation of clinical trials in the U.S., I was offered the opportunity to increase my involvement with UroMems by taking on the responsibility as Chairman of the Board. I hope to further assist the Company in reaching its goals of increasing U.S. investors’ interest, launching clinical trials and anticipating the commercial launch in the U.S. and other geographies.”

For more than 20 years, Mr. Hovard has been a prominent leader in the medical device industry especially in urology. He has held multiple leadership roles at subsidiaries of Coloplast, a publicly traded global medical device company. Most recently, from 2011 to 2019, he served as the President of the global Interventional Urology business, a global $300M fast growing business with a broad portfolio of both single use and implantable devices. Mr. Hovard currently serves on a number of medical device company Boards. Having worked internationally throughout his career, and now living in the U.S., Mr. Hovard brings a geographical and business perspective to UroMems, giving a solid foundation for the company’s transformation to the next stage, as it prepares for clinical trial and eventually commercialization.

“The U.S. is an important geography for UroMems because a large percentage of urological procedures occur there,” said Hamid Lamraoui, Chief Executive Officer and co-founder of UroMems. “This is also the opportunity for the company to bring on board of U.S.-based investors involved in emerging innovative medical device companies. In addition, Steffen has been a key contributor to the Company’s development since he joined our Board in 2020. We are grateful that he has accepted the additional responsibility as Chairman of our Board of Directors. His strong reputation within the medical device industry will be of great assistance as we transition from being a French emerging medical device company into a global, clinical stage medical device company.”

About UroActive™
UroActive™ is an active implantable electronic artificial urinary sphincter that compensates for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique mechatronic platform using embedded smart, AI-based, digital & robotic systems which, based on data collected from a patient, creates a treatment algorithm that is specific for each patient’s needs. The UroMem’s technology platform is protected by more than 100 patents and is designed to overcome the limitations of current solutions by optimizing safety and performance, patient experience and surgeon convenience.

About UroMems
Founded in 2011 by Pr Pierre Mozer, Hamid Lamraoui and Stéphane Lavallée, UroMems aims to restore the quality of life, dignity and self-esteem of millions of men and women worldwide suffering from untreated chronic conditions by the commitment to change the perception that these disorders are inevitable as one grows older and is simply something to endure with no real solution. The first challenge for the company will be applying robotic methods and smart systems for treating urinary incontinence: designed by urologists and collaborating scientists and engineers, UroActive™ will present a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

Since the inception of the company, significant investments have been made for the development of UroMems’ first product. This includes 2 financing rounds totaling $30 million, led by Wellington Partners, Bpifrance, Supernova Invest, Cita Investissement, btov Partners, Hil-Invent and Financière Arbevel. The company has been awarded by several renowned innovation prizes including the Prix Galien Award Medstart’up, and the Worldwide Innovation Challenge initiated by the French government. For more information, please visit www.uromems.com

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Media: Robert Flamm
Burns McClellan

BERLIN, BOSTON, REYKJAVIK, 05 May 2022 – International digital therapeutics leader Sidekick Health (www.sidekickhealth.com) today announces that it has raised $55 million in Series B funding. The round was led by London-based venture capital firm Novator Ventures, with additional participation from Wellington Partners, Asabys Partners, and Frumtak Ventures, as well as a US-based strategic investor that will be revealed at a later stage.
Sidekick is on a mission to develop and deliver effective, personalized digital therapeutics that prevent suffering and add millions of quality life years to people around the world. Digital therapeutics are the next generation of therapeutics designed to prevent, treat and help people manage a wide range of medical disorders or diseases.

“By harnessing the power of technology we have a unique opportunity to deliver personalized treatments via smartphones and other mobile devices, empowering people to take control of their own health,” Sidekick’s chief executive officer and co-founder Dr. Tryggvi Thorgeirsson said.

“The major challenge facing the world’s healthcare systems is how to support and treat people who are dealing with with two or more chronic conditions. The cornerstone of Sidekick’s approach is our multi-chronic digital therapeutics platform, and this funding will allow us to scale even faster the production of a new generation of clinical treatments across all major chronic diseases,” Thorgeirsson added.

Novator Ventures general partner and founder Birgir Mar Ragnarsson joins Sidekick’s board of directors in conjunction with the closing of the Series B financing.
“It has been impressive to follow the rapid growth of the company from the close of its A round 18 months ago. The company may have begun in the Nordics, but I am proud to say that Sidekick is now a globally-recognized digital therapeutics player,” Ragnarsson said. “Novator Ventures recognizes the immense opportunities presented by third generation therapeutics and Sidekick’s ability to scale and operate at the global level. We look forward to working closely with the Sidekick team to transform how healthcare is delivered.”

Sidekick operates its platform in partnership with some of the biggest names in healthcare, including leading US-based health company Anthem Inc. to offer a digital-first care programs, as well as global pharmaceutical majors such as Pfizer and Bayer, to develop integrated combination therapeutics consisting of a molecular drug and a digital therapeutic.

In 2019, Sidekick entered into a strategic partnership with Bayer to provide a digital therapeutic to patients with Peripheral Artery Disease (PAD). In 2020, Sidekick then secured a deal with Pfizer addressing five inflammatory diseases across Europe and beyond.

Following this, during the height of the pandemic, Sidekick assisted the Government of Iceland by providing the remote triaging, remote monitoring and management of people infected with COVID-19. Shortly after, the company raised a $20 million Series A led by Wellington Partners and Asabys Partners. Over the past year Sidekick has further
increased its commercial footprint in the US, including a collaboration with Anthem to support members dealing with COVID-19, Crohn’s disease, and other chronic conditions.
Amidst this backdrop of this rapid growth, the company is now looking to further diversify its portfolio by expanding its chronic disease treatments across even more therapeutic areas, bolstering existing partnerships and forging new alliances with key stakeholders across the healthcare ecosystem.

About Sidekick Health

Sidekick is a digital therapeutics innovator, founded by two passionate medical doctors on a mission to improve the health of humanity. Sidekick is driven by a vision to bring healthcare into people’s everyday lives, empowering them to take control of their own health. Sidekick’s therapeutics are developed and delivered with digital technology, addressing the same endpoints as traditional treatments – such as small molecule drugs and biologics, but with the added benefit of giving people the opportunity to be actively involved in their own treatment. When combined with traditional treatments, the overall efficacy can be strongly increased. That is why Sidekick partners with the world’s most innovative companies across the healthcare spectrum. Sidekick has offices in Berlin, Boston, Reykjavik and Stockholm.
www.sidekickhealth.com

For media inquiries
Please contact
Sidekick
Gulli Arnason, CMCO

+354 660 0053
Sam Hearne

0044 (0)7308 889 791

Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. In the last decade minimally invasive catheter-based solutions have been developed for other heart valve diseases, but none have been designed specifically for the tricuspid valve.

Tricuspid regurgitation is a frequent and serious disease for which open heart surgery and symptomatic pharmacologic treatment are the current standard treatment options. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99 % of patients with tricuspid regurgitation. The prognosis for patients without surgical repair is poor, with 2.2 years median survival. As such, there is an urgent need for minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.

Topaz is an innovative device designed specifically to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is the result of a French and German collaboration and is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.

Today’s announcement marks the successful first in human implantation of Topaz in a patient in Germany, which was done as a compassionate use treatment.

The procedure in Germany was performed for a 76-year-old woman with heart failure due to massive tricuspid regurgitation that recurred despite a previous suture annuloplasty of the tricuspid valve in 2014. The patient has a history of multiple cardiac surgeries like mitral valve replacement and bypass surgery, and has numerous risk factors that made a surgical treatment too hazardous. The successful implantation of the Topaz tricuspid heart valve replacement system took place at University Hospital Mainz in Germany, on 8 April 2022, and was performed by Prof. Ralph Stephan von Bardeleben. Prof. Hendrik Treede, cardiac surgeon at University Hospital Mainz, and Prof. Ulrich Schäfer, interventional cardiologist of the military hospital in Koblenz, Germany proctored the procedure. After an implantation time of 25 minutes the Topaz prosthesis anchored safely in the significantly enlarged ventricle and achieved complete correction of the tricuspid regurgitation. The patient recovered quickly from the intervention and was discharged from hospital after eight days.

In total nine implantations of the Topaz tricuspid heart valve replacement system have been performed to date across Europe.

Building upon the success of these procedures, TRiCares is preparing a clinical study in the coming months to confirm the value of its Topaz tricuspid heart valve replacement system for these types of patients, who until now have had no satisfactory treatment option.

Prof. Dr. Ralph Stephan von Bardeleben, Head of Heart Valve Center Mainz at University Hospital Mainz, commented, “I am delighted to have conducted the first implantation of the Topaz tricuspid valve replacement system in Germany. This patient, like the vast majority of patients with tricuspid regurgitation, had no other viable treatment options. It is tremendous to have successfully treated her using the innovative Topaz system, which provided perfect seating and valve functionality, and I hope this will be available in future for all patients in need.”

Prof. Dr. Treede, Director of the Department of Cardiac and Vascular Surgery at the University Medical Centre in Mainz, who proctored all Topaz procedures that were performed until now, commented, “I am very pleased to have attended all of the implantations of the Topaz tricuspid heart valve replacement system, which represents a significant improvement in the treatment of patients with tricuspid regurgitation.”

Helmut Straubinger, CEO of TRiCares, commented, “I am very glad to announce the first successful implantation of our Topaz tricuspid heart valve replacement system in Germany. I am proud of our team for developing an innovative treatment possibility for severely ill patients suffering from tricuspid regurgitation with no other treatment options. This successful implantation together with the results of further eight compassionate use cases give us confidence in our development and in taking the next steps.”

About TRiCares
Founded in 2013, TRiCares is a medical device startup company headquartered in Paris, France, with its operating location in Munich, Germany. The team’s vision is to bring to the market a transfemoral tricuspid valve replacement system to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The company is supported by leading European life science venture capital firms: Andera Partners, BioMedPartners, Credit Mutuel Innovation, GoCapital, Karista and Wellington Partners.

About Tricuspid Regurgitation (TR)
The tricuspid valve is the heart valve that regulates the blood between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution to help patients suffering from severe TR.

About the Medical Need
Heart valve diseases are among the most serious cardiac complications affecting more than 12.7 million patients in Europe. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no such solutions exist due to anatomic, functional and technological challenges specific to this so-called “forgotten valve”. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments currently represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, cardiac surgeons are urgently seeking minimally-invasive, low-risk solutions to improve clinical outcomes in TR patients with no other viable treatment option.

For further information please contact:

TRiCares SAS
Helmut J. Straubinger,
President and
Chief Executive Officer

Consilium Strategic Communications
Matthew Cole
T: +44 (0)20 3709 5700

EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—April 13, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces Lara Smith Weber will join the company as its Chief Financial Officer and Zouhir Mechta will join the company as its Vice President Operations

Hennigsdorf/Berlin (Germany), April 11, 2022 – Adrenomed AG, the vascular integrity company, today announced that its proprietary sepsis drug candidate Adrecizumab (HAM8101) received a funding commitment of € 7.4 million from the German Federal Ministry of Education and Research (BMBF) as part of the German funding initiatives for the clinical development of COVID-19 drugs and their manufacturing capabilities.[1],[2] The University Medical Center Eppendorf (UKE) Hamburg and Adrenomed will receive funds to conduct an investigator initiated Phase II clinical trial with Adrecizumab in hospitalized patients with moderate to severe COVID-19, which has received regulatory approval by the German federal agency, Paul Ehrlich Institute (PEI). Additionally, the BMBF will support financially the manufacturing of GMP Phase III clinical trial material.

Adrecizumab, a first-in-class antibody targeting the vasoprotective peptide adrenomedullin, is currently being developed for the treatment of loss of vascular integrity in sepsis and septic shock. Dysregulation of the endothelial barrier appears to be a common feature of COVID-19 patients and sepsis or septic shock patients. The deteriorated endothelial barrier function leads to vascular leakage and severe impairment of lung and other organ functions. In a novel precision medicine approach, patients with elevated adrenomedullin levels will be treated with Adrecizumab to restore and maintain the endothelial barrier and to avoid further organ dysfunction. At the same time, another biomarker (dipeptidyl peptidase-3, DPP3) is used to exclude patients with an additional competing pathophysiology. The UKE has initiated a national, multicenter, biomarker-guided, placebo-controlled Phase II trial to evaluate the efficacy of Adrecizumab plus standard of care (SOC) and plans to enroll more than 200 patients with moderate to severe COVID-19 and elevated adrenomedullin levels.[3]

Prof. Dr. med. Stefan Kluge, Director of the Department of Intensive Care Medicine at UKE, said: “We urgently need effective drugs for the treatment of hospitalized COVID-19 patients. Particularly important are therapies that can be used in severe cases and can be given at later disease stages. Adrecizumab could potentially be a therapy that can address this treatment gap. In a previous named-patient program with critically ill COVID-19 patients treated with Adrecizumab, we have already observed a rapid improvement in organ function. Based on these results and the positive signals from the AdrenOSS-2 study in septic shock, we will now evaluate a precision medicine approach with Adrecizumab to treat COVID-19 patients with deteriorating endothelial function and increased risk of organ failure and mortality.”

“With Adrecizumab we provide a treatment option that aims at restoring and maintaining the impaired vascular integrity in COVID-19 other than antiviral drugs”, Dr. Jens Zimmermann, Chief Medical Officer at Adrenomed added. “This approach may help to improve the organ function and thus survival rates of hospitalized COVID-19 patients. We are very grateful for this financial support granted by the BMBF which enables Adrenomed to pursue the clinical development of Adrecizumab in the treatment of COVID-19, as well as the manufacturing process.”

Dr. Richard Jones, Chief Executive Officer of Adrenomed, stated: “This funding commitment of € 7.4 million from the BMBF is a significant endorsement of Adrenomed’s innovative bio-marker guided precision medicine approach for patients in the acute care setting. This clinical study further compliments our overall development program of Adrecizumab for the treatment of loss of vascular integrity in sepsis and septic shock in collaboration with our strategic partner, Sphingotec.”

About Adrenomed

Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity and save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate Adrecizumab (INN: enibarcimab) is a first-in-class monoclonal antibody. Adrecizumab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn and Twitter.

Contact                                                                     

Adrenomed AG
Frauke Hein, Ph.D. (Chief Business Officer)
phone: +49 (0)3302 2077814

Media Inquiries
MC Services AG
Eva Bauer / Julia von Hummel
phone: +49 (0)89 21022880

[1]      https://www.gesundheitsforschung-bmbf.de/de/12638.php
[2]     https://www.gesundheitsforschung-bmbf.de/de/13173.php
[3]    https://clinicaltrials.gov/ct2/show/NCT05156671?term=adrecizumab&draw=2&rank=4

EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—April 7, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces an important publication in the New England Journal of Medicine (NEJM), highlighting the use of ONWARD’s innovative approach to treating orthostatic hypotension in a patient with MSA-P, a degenerative nervous system disease.

EINDHOVEN, the Netherlands & LAUSANNE, Switzerland—March 28, 2022–ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today announces two new innovations have been added to its portfolio of license agreements with the Swiss Federal Institute of Technology Lausanne (EPFL), one of the world’s preeminent neuroscience research institutions, and Lausanne University Hospital (CHUV), ranked among the top 10 hospitals in the world.

Hennigsdorf/Berlin (Germany), 15 March, 2022 – Adrenomed AG, the vascular integrity company, today announced the appointment of Dr. Richard Jones as Chief Executive Officer of Adrenomed, effective today. Dr. Jones brings over 25 years of experience in leadership positions in the pharmaceutical and biotech industry with a sustained record of achievements in business, clinical development and commercialization.

“I am delighted to welcome Dr. Richard Jones as the new CEO of Adrenomed. He is a highly achieved life science specialist, who provides a unique combination of strategic, financial, development and organizational capabilities to the Company. Under his leadership, Adrenomed has a strong team in place to lead its first-in-class drug candidate Adrecizumab through late-stage clinical development towards commercialization. Our goal is to bring an urgently needed, effective precision medicine for treating sepsis to intensive care units,” said Prof. Dr. Erich Schlick, Chairman of Adrenomed’s Supervisory Board.

“On behalf of the entire Supervisory Board, I would also like to thank Dr. Wolfgang Baiker, former CEO of Adrenomed, for his contribution to the company and wish him well for the future,” he added.

Dr. Richard Jones, CEO of Adrenomed, said: “I am excited to be joining Adrenomed at a pivotal phase of the Company’s evolution. Sepsis is responsible for between one third and one half of deaths of hospitalized people. This equates to 11 million people worldwide dying each year which is higher than the top 3 cancer conditions combined and represents a significant high unmet medical need. Adrenomed’s innovative biomarker guided treatment approach, with Adrecizumab, is targeting the endothelial barrier dysfunction as a major cause of mortality in sepsis. I look forward to working with the team and advancing the late-stage clinical development of Adrecizumab to provide a new treatment option for critically ill patients.”

Richard Jones joins Adrenomed from Fusion Antibodies Plc, a contract research organization specialized in antibody engineering. As CEO of Fusion Antibodies Plc, Richard successfully implemented a new growth strategy in the global antibodies marketplace. Previously, Richard served as CEO for a number of UK and European private companies as well as SVP, Head of Europe for a US based public company. Before this he gained expertise at Novartis and GSK as VP, Medicines Commercialization Leader Global Haematology at both companies. In these roles, Richard was responsible for three regulatory submissions and initiation of several new drug development programs, plus the planning and execution of three global product launches. Richard also worked with Genzyme Corporation and as International Franchise Director for Shire Pharmaceuticals. He holds a BSc in Biochemistry and PhD in Molecular Oncology from University of Surrey.

About Adrenomed

Adrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate Adrecizumab is a first-in-class monoclonal antibody. Adrecizumab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn and Twitter.

Contact                                                                     

Adrenomed AG
Frauke Hein, Ph.D. (Chief Business Officer)
phone: +49 (0)3302 2077814

Media Inquiries
MC Services AG
Eva Bauer / Julia von Hummel
phone: +49 (0)89 21022880