Nanoflex Robotics Receives ISO 13485 Certification

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Nanoflex Robotics Receives ISO 13485 Certification

The innovative medical robotic startup achieved the globally recognized ISO 13485 certification in December 2023

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ZURICH, Switzerland, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, has received the internationally recognized ISO 13485 certification for its quality management system in designing and manufacturing remote robotic devices for endovascular interventions.

The ISO 13485 certification is the global standard for quality management systems within the medical device industry. To become certified, companies must demonstrate that important components are designed and manufactured in accordance with stringent regulatory standards.

The certification represents Nanoflex Robotics’ commitment to upholding high standards throughout its entire operational chain, from the initial phases of research and development to design and manufacturing. It is a step forward in bringing to market innovative remote robotic solutions that are designed to increase access to critical care procedures, such as the treatment of acute ischemic stroke.

"We are thrilled to receive the ISO 13485 certification for our quality management system. It is an important milestone in our journey to revolutionize stroke care and reflects our desire to deliver innovative, safe, and high-quality robotic solutions that make a real difference in patient outcomes," said Matt Curran, CEO of Nanoflex Robotics.

Nanoflex Robotics’ first product will be a compact remote robotics system that utilizes a control unit and magnetism to guide ultra-flexible devices through the body for a range of complex interventions. The company aims to make remote mechanical thrombectomies a reality through remote robotics surgery, thereby shortening the time to treatment and preserving the quality of life for stroke patients.

About Nanoflex Robotics AG

Nanoflex Robotics is building next-generation remote robotic surgical solutions and devices to enhance access to life-saving procedures. The Nanoflex Robotics platform's first target application is to enable remote mechanical thrombectomies in acute ischemic stroke patients where timely intervention is critical.

Nanoflex Robotics’ unique advanced magnetic navigation technology and ultra-flexible endoluminal robotic tools aims to give physicians greater control and dexterity over procedures, allowing for safer and more precise interventions that enhance patient care, reduce complications, and improve overall outcomes.

Additionally, the platform is being developed to facilitate various other procedures that can be executed comfortably and conveniently by in-person physicians. The platform's compact and mobile design enables seamless integration into diverse clinical settings and operating rooms, underscoring its versatility as a robotic assistant tailored for hospital environments.

For media inquiries please contact:

ir@nanoflexrobotics.com

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Nanoflex Robotics Secures CHF 2.9M

The innovative medical robotic startup received CHF 2.9 million in non-dilutive grants in 2023.

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ZURICH, Switzerland, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, announced it has received a second grant from Innosuisse, Switzerland's Innovation Agency this year.
The receipt of the second grant brings Nanoflex Robotics' total non-dilutive grant funding received from Innosuisse this year to CHF 2.9 million. It reaffirms the company's commitment to bringing life-saving procedures to more people through innovative remote robotic solutions.
The second grant, disbursed under the “UK – Switzerland Bilateral: Collaborative R&D” program, is administered by Innosuisse and Innovate UK, United Kingdom's innovation agency. It was awarded to Nanoflex Robotics and Brainomix, a UK-based AI-powered medtech solutions company. As part of the grant, both companies will work together to jointly develop an integrated remote diagnosis and treatment platform for stroke, powered by artificial intelligence. Innosuisse awarded CHF 400,000 to Nanoflex Robotics, while Brainomix received £400,000 from Innovate UK.
“We are truly honored to receive our second funding grant from Innosuisse this year. The Innosuisse grants are a testament to our team’s unwavering dedication in developing cutting-edge remote surgical solutions and devices that bring life-saving procedures to more people across the globe. Our project with Brainomix aims to improve stroke discovery and treatment options, by leveraging the power of artificial intelligence to enhance our magnetic robotic navigation system,” said Matt Curran, Chief Executive Officer, Nanoflex Robotics.
Starting in 2024, Nanoflex Robotics and Brainomix will collaborate to create an artificial intelligence-assisted magnetic navigation system for robotic surgical tools. The project will leverage Brainomix's artificial intelligence-enabled diagnostic imaging capabilities and Nanoflex Robotics’ precise magnetic navigation technology to create an assisted-navigation feature for interventional devices, such as catheters, as it moves through the vascular network. In April, Nanoflex Robotics received the inaugural Swiss Accelerator Grant of CHF 2.5 million in non-dilutive funding.
The Swiss Accelerator Grant supports innovative startups in Switzerland across a range of industries. It aims to foster collaboration and entrepreneurship by providing financial support and expert guidance to promising projects.
Funding from the Swiss Accelerator Grant will be used to further develop Nanoflex Robotics’ remote magnetic navigation system and ultra-flexible guidewires for its first target application – treating acute ischemic stroke.
“Time is critical when it comes to treating stroke patients. Every delay in removing a blood clot reduces the chance of post-stroke functional independence. By enabling increased and earlier access to mechanical thrombectomies through our remote robotics platform, we hope to give more people a greater chance to live independent lives after stroke,” said Christophe Chautems, Chief Technology Officer, Nanoflex Robotics.
Nanoflex Robotics’ first product will be a mobile robotics system that utilizes ultra-flexible guidewires to allow for direct steering control of the tip. This gives physicians precise control and dexterity over a range of complex interventions.
About Nanoflex Robotics AG
Nanoflex Robotics is building next-generation remote robotic surgical solutions and devices to enhance access to life-saving procedures. The Nanoflex Robotics platform's first target application is to enable remote mechanical thrombectomies in acute ischemic stroke patients where timely intervention is critical.
Nanoflex Robotics’ unique advanced magnetic navigation technology and ultra-flexible endoluminal robotic tools aims to give physicians greater control and dexterity over procedures, allowing for safer and more precise interventions that enhance patient care, reduce complications and improve overall outcomes.
Additionally, the platform is being developed to facilitate various other procedures, that can be executed comfortably and conveniently by in-person physicians. The platform's compact and mobile design enables seamless integration into diverse clinical settings and operating rooms, underscoring its versatility as a robotic assistant tailored for hospital environments.
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Nanoflex Robotics Secures Over USD12m in Funding Support

The funding will drive first-in-human and regulatory clearance of the company’s robotic platform to precisely steer wires and catheters through vasculature using electromagnetic fields.

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Zurich, Switzerland, February 2023 - Nanoflex Robotics AG, a pioneer in magnetically controlled medical soft robotics, today announced that it has achieved an initial $12 million in funding. Nanoflex Robotics will use the funding to bring its first-generation system to market and to accelerate development of new neuro-interventional products.  A first-in-human trial and FDA submission is planned for Q3 2023. 
The financing round is led by Ascend Capital Partners, an international venture capital firm focused on investments in MedTech and Mobility early-stage tech companies. The financing round is supported by European based family offices, including Kinled Holding Ltd, an experienced medical device/robotics investor with a significant track record of identifying successful spin outs from EPFL/ETH Zurich, and Mountain Labs AG, an incubator specialized in funding innovative technology.  
"Nanoflex Robotics aims to revolutionize catheter-based treatment of neurovascular and vascular disease by enabling faster and safer access to target sites in the vasculature. Our robotic system allows precise and flexible steering of magnetically-adapted guide wires and catheters, while potentially decreasing X-ray exposure for the physician," said Matt Curran, CEO of Nanoflex Robotics AG. "We are excited to partner with Ascend Capital Partners, Kinled and Mountain Labs to make our goal of safe remote treatment for acute ischemic stroke a reality."Nanoflex Robotics was founded in Zurich in 2021 by Prof. Bradley Nelson, Dr. Christophe Chautems and Matt Curran. Its proprietary technology to generate and control electromagnetic fields for endovascular navigation of magnetic devices is based on over 20 years of research at ETH Zurich, the Swiss Federal Institute of Technology. The project continues to receive support from ETH Zurich and Wyss Zurich. 
Jerry Hong, CEO of Ascend Capital Partners, who will join the board of directors, commented: "We are excited to support this exceptional team in reinventing the surgical robotic space with remote vascular interventions. We especially recognize its potential to achieve more equitable patient access to timely mechanical thrombectomies, which are very effective for preserving the post-stroke quality of life for patients." 
Nanoflex Robotics’ first product will be a compact and mobile electromagnetic field generator that can easily be moved between hospital interventional suites, requiring no additional infrastructure beyond a high voltage electrical point and access to a water-based cooling system. The system allows direct tip control of magnetically adapted interventional devices, in contrast to conventional procedures where torque must often be transferred more than a meter down the length of devices to control tip direction.  
About Nanoflex Robotics  Nanoflex Robotics, a Zurich (Switzerland) based MedTech start-up, has developed a proprietary robotic platform to navigate magnetic devices in complex vascular anatomy using precise electromagnetic fields. Its portfolio of products is intended to diagnose and treat vascular disease, including acute ischemic stroke, in a timely and safe manner. For more information, please visit Nanoflex Robotics. 
Investors & supporters  Ascend Capital Partners is a leading international venture capital and financial advisory firm committed to working with innovative companies who have potential to grow and expand internationally, particularly in Europe, Asia, and the United States. With extensive regional and international networks and insight into Chinese and Western capital market worlds, Ascend has set itself apart from other pure advisory firms and pure private equity funds. For more information, please visit Ascend Capital Partners. 
Kinled Holding is a partner in four dedicated life science investment companies based in Boston, Vienna, Gibraltar and Zurich, with combined Assets Under Management of $250M. Kinled Holding and the Aisher Family have long believed in fostering academic projects to become commercial businesses. The company has exited 19 investments via IPO and a further dozen through trade sales to strategics such as Astra-Zeneca, Medtronic, Globus and J&J. For more information, please visit Kinled. 
Mountain Labs is an incubator that focuses on early-stage technology investments in Switzerland and Austria. They assist other like-minded family offices and investment companies to better understand the risks and opportunities of investing in early-stage tech and FinTech and have developed a strong network of relationships with national universities and technology transfer offices. For more information, please visit Mountain Labs. 
The Wyss Zurich Translational Center (Wyss Zurich) is a joint accelerator of the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich), which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. h.c. mult. Hansjörg Wyss. It was established to foster translational research focused on developing treatment protocols and clinical therapies, as well as novel technologies and intelligent systems, in the emerging fields of regenerative medicine robotics, and hybrid technologies thereof. Wyss Zurich unites world-leading experts from both institutions in multidisciplinary teams, pooling their knowledge and expertise. For more information, please visit Wyss Zurich. 
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