Home Xinli Medical Nominated for Prix Galien USA 'Best Startup' with Clinically Validated, FDA-Recognized Innovations

Xinli Medical Nominated for Prix Galien USA 'Best Startup' with Clinically Validated, FDA-Recognized Innovations

Aug 18, 2025 22:16 CST Updated 22:16
magAssist

Developer of Extracorporeal Artificial Heart Devices

Last weekPrix Galien USA Announces the Annual Galien Award Nominees. This Time, It's a Little Different from Previous Years, with Almost Every...Galen Prize AwardsThe presence of Chinese companies can be seen everywhere. First of all, the medical device industry has been most significantly impacted.Best Medical Technology"In the awards, Chinese enterprises achieved a breakthrough -- for the first time, a Chinese medical device product has been nominated --This shows that the innovation capability of China's medical device companies is in line with those in Europe and America. Secondly, in "Best StartupThe award nominations also feature several Chinese startups, such asmagAssistTherapy,Hope Medicine,RealTime Bio. Among themmagAssistTherapy is the only one selected for "Best Startup"The nominated Chinese medical device companies represent the future of innovation in China's medical device industry."
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As more and more enterprises and products in China are selected into "Best Medical Technology" and "Best Startup"Nomination: Chinese medical devices are no longer just 'me too', but are moving towards...fFirst-in-class transformation.Xi'an Dami andmagAssistTherapy has set a good start for the innovation of China's medical devices, and it is expected that more domestic medical device companies in China will embark on the path of innovation.The Road to First-in-Class: Let China's Innovative Devices Go Global.
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Although the topic everyone pays most attention to every year is "Best Medical Technology", representing the most impactful biopharmaceutical technologies and medical device products of the year, but "Best Startup"but represents medical devices, pharmaceuticalsFutureDirection of development. Once approved by the FDA for marketing, "Best Startup"Enterprise Innovation Products Will Be the Future"Best Medical Technology"One of the strongest contenders for the award.

Therefore, to be selected "Best Startup"Startups need to have strong internal energy and meet the following conditions:
  • PossessOriginal technology that has already undergone preliminary feasibility verification
  • Clarify Patient Benefits, Targeting Major Disease Areas
  • FDA Approval or Breakthrough Designation is a Rigorous Requirement
  • Global Patent Layout, Technical Barriers
  • Top Scientific Team, Renowned Industry Collaboration

magAssistTherapy Selection Instructions, has already met the Prix Galienn USA's "Best Startup"Selection criteria. This also demonstrates the magAssist product."Not only is it original and clinically validated, but it also received FDA recognition (its interventional cardiac pump---pVAD-NyokAssist® obtained FDA"Breakthrough Device" Designation).

magAssistTherapeutic Innovation Technology
  • Extra VAD®-MoyoAssist®(Approved for marketing by NMPA)

China's only fully magnetically levitated extracorporeal artificial heart, bridging patients to recovery, heart transplantation, or other destination therapies.

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Full Magnetic Levitation Technology:Eliminate blood damage caused by mechanical contact, achieving the "gold standard" of blood compatibility.

Diverse intubation methods:Can provide left heart, right heart, or biventricular support, meeting clinical needs in various scenarios such as operating rooms, emergency care, and patient transfer.

Significant clinical effects:Patient Survival Rate From33%Increase to 60%, no major device-related adverse events.

Commercialization Progress:First-year sales approximately3,000Tens of thousands, with an expected growth exceeding50%

  • pVAD-NyokAssist®(World's Smallest Artificial Heart)
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Foldable Technology:Interventional Size9Fr, Running Size>21Fr`, taking into account both low trauma and high flow support.`

External Motor:Avoid hemolysis and thrombosis caused by the heat generated from the built-in motor, providing excellent blood compatibility. Meanwhile, it is reusable, offering greater health economic benefits.

Significant Clinical Benefits: The 9Fr interventional size offers substantial clinical advantages, reducing surgical trauma, minimizing the risk of puncture bleeding and lower limb ischemia, and facilitating hemostasis due to the smaller incision. It broadens the range of applicable patients, providing a safe solution for those with thin or narrowed blood vessels. Preliminary clinical trial data presented at international conferences.TCT2024Published, no major adverse events.

The latest generation of international interventional pumps, such as Impella ECP, Magenta Elevate, Supira, etc., generally adopt a similar collapsible design concept to minimize vascular injury and enhance patient safety and comfort.

  • ECMO-BreathMo®(The host has been approved for marketing by NMPA)

The only ECMO driven by a fully magnetically levitated heart pump, equipped with a long-lasting oxygenator, was featured in the "5G Emergency Unit" at the 2023 Hangzhou Asian Games.


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Full Magnetic Levitation Technology:AndExtra VAD®Shared Full Magnetic Levitation Heart Pump, adopting platform-based design for multiple uses.

High-Efficiency Oxygenator:Pressure Drop≤40mmHg, closer to the "natural lung" artificial lung.

Significant clinical effects:Patient survival rate from20%Increased to 70%`, no major adverse events related to the device`


Introduction to magAssist

magAssist (Suzhou) Co., Ltd. was founded in May 2017 by Dr. Bo-Ling Xu, a member of the National Talent Program, the first Chinese committee member of the International Society of Mechanical Circulatory Support (ISMCS), and a distinguished professor at Soochow University. The company was co-founded with a top expert team from home and abroad who have long been engaged in the development of artificial organs, committed to creating a new generation of extracorporeal life support platform for critical care scenarios.

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