On March 26, 2025, Supira Medical announced that it had successfully completed its oversubscribed Series E financing round, raising a total of$120 million (approximately 870 million RMB)。
At the same time, the company has also completed its U.S. SUPPORT I Early Feasibility Study (EFS), evaluating the efficacy of its percutaneous ventricular assist device (pVAD) in treating high-risk percutaneous coronary intervention (HRPCI) patients.SSupira MedicalSeries E financing was led by new investorsNovo HoldingsAndQatar Investment Authority (QIA)Led the investment, with two undisclosed strategic investors participating.Dr. Christopher Shen, Partner at Novo Holdings, has also joined the company's board of directors.Existing investors also participated, including COrmorant Asset Management, The Capital Partnership (TCP), 415 Capital, AMED Ventures, PA MedTech VC Fund, and Unorthodox Ventures.Supira Medical plans to use the funds to expand its clinical programs for HRPCI and cardiogenic shock (CS), including the SUPPORT II U.S. pivotal study for HRPCI, using evidence from the study to support U.S. FDA premarket approval (PMA).
# Supira pVAD Interventional Cardiac Pump
Supira pVAD through itsSmall-size design, self-expanding impeller with flexible cannula, high flow output, rapid exchange delivery system, and integrated pressure sensor, etc.Innovative features significantly enhance the performance and safety of interventional cardiac pumps.Compact Design:Adopt10Fr (1Fr = 0.33mm) small size design, making it easier for the catheter to pass through blood vessels, reducing damage and irritation to blood vessels, allowing for closure with a single suture, simplifying the surgical operation process, and improving surgical efficiency.Strong stability:Combined withSelf-expanding aortic impeller and flexible cannula`, the diameter of the tube can be expanded to`22FrThe self-expanding impeller can better adapt to the anatomy of the aorta, providing more stable blood flow support.
The flexible catheter design reduces shear forces on the blood, thereby lowering the risk of hemolysis (red blood cell rupture).
High Flow:Can provide up to5.5 L/minThe blood flow, the device is able to simultaneouslyMeet the treatment needs of patients with high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS), without the need to replace equipment.At the same time, high flow can better maintain the patient's blood circulation, improve blood perfusion of peripheral organs, and reduce organ damage caused by cardiac insufficiency.
Quick Exchange:Adopt0.018-inch Rapid Exchange (RX) Delivery System, the delivery of the catheter within the blood vessel is smoother, and the doctor can adjust the position of the catheter more flexibly.Integrated Pressure Sensor:The device integrates aortic and left ventricular pressure sensors, providing real-time data during HR-PCI procedures."Decoupling" (Auxiliary Effect) Feedback, helping doctors better evaluate and adjust treatment plans.Therefore, the Supira pVAD not only meets the treatment needs of patients undergoing high-risk percutaneous coronary intervention and cardiogenic shock, but also provides doctors with more precise surgical support through real-time monitoring and feedback functions, thereby improving patients' clinical outcomes.In November 2024, Supira Medical launched the U.S. Early Feasibility Study (EFS), announcing the initiation of its U.S. EFS and the successful completion of patient enrollment.This multicenter, prospective, single-arm clinical study will evaluate the safety and feasibility of Supira Medical's innovative low-profile, high-flow percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention (HRPCI).The U.S. EFS procedure was performed by Dr. David Kandzari, the principal investigator in China for this study and the director of the Piedmont Heart Institute.The company has expanded its clinical projects toMore than 70 patientsThese patients had previously been treated in the first-in-human (FIH) and feasibility studies conducted in South America. The EFS study results will be used to support the submission of the pivotal study IDE application for Supira Medical to the FDA.# Interventional Cardiac Pump Competitor OverviewAccording to data from the U.S.-based market research firm Grand View Research, the global ventricular assist device market size was $1.8 billion in 2020.It is expected to grow at a compound annual growth rate of 17.6% from 2021 to 2028.. Among themThe left ventricular assist device (LVAD) segment dominates the VAD market, accounting for the largest share of 80.5%.。The percutaneous ventricular assist device (pVAD) is a medical device used for cardiac support, particularly suitable for patients with acute heart failure and high-risk percutaneous coronary intervention (PCI).Impella Series (Abiomed）：The Impella heart pump, produced by Abiomed, is a globally recognized interventional heart pump product. It includes several pump models with different flow levels, such as the Impella CP, Impella 2.5, Impella 5.0, and Impella ECP.The Impella series is renowned for its high flow, low shear stress, and adaptive regulation features.。
November 2022,Johnson & Johnson Announces $16.6 Billion Acquisition of Abiomed, Leader in Artificial Heart TechnologyIn 2023, contributed revenue of $1.306 billion.Aortix™ pLVAD：Procyrion's Aortix is a percutaneous arterial pump that can be inserted through the femoral artery to provide cardiac support within the aorta and is currently undergoing clinical trials.
Aortix is very small, with a diameter of only 6 mm and a length of 6.5 cm.Aortix is placed in the descending aorta via percutaneous catheter intervention for up to 7 days, reducing cardiac load, allowing the heart to rest, and increasing renal blood supply.
February 2024,Procyrion Announces Completion$57.7 million's Series E financing, which will be used to support ongoingDRAIN-HF Key IDE Trial，Evaluate the safety and efficacy of Aortix in patients with acute decompensated heart failure (ADHF).NyokAssist™ (XinQi Medical):Supira Medical'sNyokAssist™With the world's smallest interventional size of 9Fr (3mm), it can minimize bleeding., reducing the occurrence of perioperative and postoperative vascular complications, achieving higher flow while operating at lower speeds, and minimizing the damage to blood cells caused by the high-speed rotation of the impeller.
In February 2024, the minimally invasive interventional artificial heart NyokAssist™ received the U.S. FDA "Breakthrough Device" designation and was recognized as an innovative medical device by the National Medical Products Administration (NMPA) within a span of six months.Become the world's only interventional artificial heart to simultaneously obtain "dual innovation" approval in both China and the United States.Magenta Elevate：Self-expanding interventional cardiac pump, used to provide temporary mechanical circulatory support for the left ventricle (LV) in high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS) inpatients.
Elevate ApprovedReduce the pressure and volume of the left ventricle, and alleviate cardiac load., thereby reducing ventricular wall stress, mechanical work, and myocardial oxygen consumption.Magenta's proprietary technology has achievedMiniaturization of Percutaneous Left Ventricular Assist Devices, allowing it to be compatible with a 9Fr delivery system,It is the smallest of such devices.。
July 2024,World's Smallest Interventional Cardiac PumpElevateDeveloperMagenta MedicalAnnouncementComplete a new round$105 million financing (equivalent to 760 million yuan), and the financing will be mainly used to advance itsClinical Research on Minimally Invasive Cardiac Pumps and Ensuring FDA Approval for the Elevate SystemPatients undergoing high-risk percutaneous coronary intervention (HR-PCI)。 
Supira Medical, founded in 2012, is a privately held portfolio company of Shifamed. The company focuses on developing the next generation of percutaneous ventricular assist devices (pVAD) for high-risk patients undergoing interventional procedures.Its core product is the Supira system, a percutaneous ventricular assist device featuring a novel low-profile, high-continuous-flow design.In November 2024, Supira Medical announced that its Supira System received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and initiated the U.S. Early Feasibility Study (EFS).▲ Source of the article: Supira Medical▲Please indicate the above source for reprint.Disclaimer: This article is for informational purposes only and serves as a reference. It does not constitute any advice on investment or treatment; please evaluate carefully. If the content, copyright, or other issues of the work are involved, to protect the rights and interests of both parties, please contact us and we will handle it immediately. If this article is reprinted by any platform, the platform shall be responsible for the article itself; the Medical Device Innovation Network is not responsible for any secondary dissemination caused by the reprint.
