UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence
This initial clinical trial is a key milestone in the development of its UroActive™ System
GRENOBLE, France, Nov. 29, 2022 /PRNewswire/ — UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive.
“This is a historic milestone for UroMems, patients, physicians and the industry as this is a first-of-its-kind fully automated AUS implant designed to treat SUI in both men and women,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “This is the next important step in delivering our novel technology to a large, underserved patient population with unmet needs not addressed by current options on the market.”
The first male patient procedure was successfully completed at La Pitié-Salpêtrière University Hospital (AP-HP, Sorbonne University, Paris, France) by Professor Emmanuel Chartier-Kastler, principal investigator, with approval from the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration).
“We believe this groundbreaking therapy will change the way SUI is treated worldwide, establishing a new standard of care,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder.
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. UroMems is revolutionizing the treatment of SUI with smart active implants, using the latest technological advances in the field of embedded systems and micro-technologies for the development of its groundbreaking solutions.
UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is automatically controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.
“We see a high rate of today’s AUS implants that are revised or removed after three years,” said Professor Daniel Elliott, urologist at Mayo Clinic in Rochester, Minn., and clinical advisor to UroMems. “The potential of being able to personalize the therapy to the patient automatically, post-implantation is very appealing.”
SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. While mild SUI is addressed by pelvic floor re-education and bulking agents, moderate and severe SUI historically have only had two options: mesh sling or artificial urinary sphincter.
UroActive is an active implantable electronic artificial urinary sphincter that has been developed to compensate for sphincter insufficiency in patients, both men and women, with SUI. It is based on a unique bioelectronic platform using embedded smart, AI-based, digital and robotic systems which, based on data collected from a patient, create a treatment algorithm that is specific for each patient’s needs. The UroMems 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.
Founded in 2011 by Professor 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 embedded mechatronics methods and smart systems for treating urinary incontinence: designed by urologists and collaborating scientists and engineers, UroActive intends to provide 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 two financing rounds totaling 46 million euros, led by Wellington Partners, Bpifrance, Supernova Invest, b-to-v Partners AG, Cita Investissement, Hil-Invent, Financière Arbevel and the founders. The company has received several awards for innovation, 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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Boditech Med and SphingoTec close global licensing agreement for kidney function biomarker Proenkephalin A 119-159 (penKid)
- Worldwide licensing agreement signed to develop and offer penKid as test on Boditech’s fully automated immunoassay systems.
- The biomarker penKid adds diagnostic value and addresses current unmet needs in the management of patients suffering from acute kidney injury.
- PenKid’s availability on Boditech’s global network of analyzers will amplify the reach of penKid to the wider critical care community.
Gangwon-do, Republic of Korea and Hennigsdorf/Berlin, Germany, November 15, 2022 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced they have entered into a nonexclusive royalty-bearing license agreement. Under the terms of this agreement, Boditech has obtained the rights to develop and commercialize clinical tests for the kidney function biomarker penKid on its renowned AFIAS and ichroma Point of Care platforms. Through this partnership, Boditech and SphingoTec will make the biomarker penKid available on Boditech’s worldwide installed base with the goal of improving the management of patients suffering from acute kidney injury (AKI).
AKI affects one in five hospitalized patients (1). The critical state is currently diagnosed by standard-ofcare biomarkers when 50% of the kidney function is already lost (1). PenKid addresses these pitfalls, offering an earlier and more precise determination of kidney function in acute and critical care settings (2).
Eui-Yul Choi, CEO, Boditech Med said “Expanding our critical care portfolio with innovation in the field of acute diseases can, in the future, support our customers applying medical advancements and improve patient outcomes. After successfully evaluating the feasibility of penKid on our diagnostic solutions, we are looking forward to working with SphingoTec for the development and commercialization of the new test.”
Jörg Menten, CEO, SphingoTec said “Boditech is a leader in point of care diagnostics with a strong global footprint. The agreement entered into with Boditech marks a significant milestone in SphingoTec’s mission to provide early detection of acute kidney injury to the international acute and critical care community. Our scientific research shows the future potential of penKid to monitor kidney function in further clinical settings such as renal replacement therapy (3) and pediatric AKI management (4,5). We are excited to work with our new partner to bring these advancements to critical care physicians around the globe very soon.”
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References:
1. Kellum, J.A. et al. Acute kidney injury. Nat Rev Dis Primers 7, 52 (2021). https://doi.org/10.1038/s41572-021-00284-z
2. Hollinger A, et al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006.
3. von Groote et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4
4. Smeets NJL, Hartmann O, Schulte J, Schreuder MF, de Wildt SN. Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements. Clin Chem Lab Med. 2022 Oct 27. doi: 10.1515/cclm-2022-0545.
5. Hartman et al (2020), Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury - Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, doi: 10.1515/cclm2020-0381
About Boditech
Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated more than 20 years of business expertise in the field. The company has more than 85 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-valueadded products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia.
About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarker for the diagnosis, prediction and monitoring of acute medical conditions. Sphingotec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for assessment of endothelial function in conditions like sepsis, and Proenkephalin A 119-159 (penKid), a biomarker for assessment of kidney function in critical diseases.
About penKid
Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing the kidney function in acute and critical conditions. The biomarker offers a blood-based alternative for the complex and time-consuming in vivo measurement of true glomerular filtration rate (GFR). PenKid is independent of common comorbidities (e.g. hypertension and diabetes) and the frequently occurring inflammation in critically ill patients. Rising penKid blood levels predict acute kidney injury earlier than today’s standard of care and decreasing penKid blood levels indicate the improvement of kidney function. Scientific evidence shows that penKid also reflects kidney function in children, representing a potential biomarker for pediatric AKI.
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Boditech Med Inc.
Duk Seung Na
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Phone: +821028451778
www.boditech.co.kr
SphingoTec GmbH
Ruxandra Lenz
Email:
Phone: +49-3302-20565-0
www.sphingotec.com