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Temporary mechanical circulatory support (MCS) devices augment the output of a failing heart: they are intended to assist with the pumping function of the heart for a period of up to several days, until native heart function can recover to a point where no outside help is needed.
While this is a rapidly growing market, existing solutions are either overly invasive and fraught with complications or provide too little flow/support to the ailing heart, said Dr. David Israeli, CEO of Magenta Medical, the developer of what it says is the world’s smallest heart pump.
"The implications of these issues on the patient are profound, because complications can affect their outcomes," he explained.
"Vascular access complications can lead to otherwise avoidable surgery, or require blood transfusions due to excessive bleeding. Too little flow may result in suboptimal blood flow to vital organs, which may limit or even prevent recovery from the acute episode."
Magenta tackles both problems with its low insertion profile, which translates into less access site complications; now the company will be able to take the next steps toward getting its product approved by the FDA, and on the market, thanks to $55 million in funding it announced on Wednesday.
The round was led by OrbiMed, with participation from existing investors New Enterprise Associates, Pitango VC, and ALIVE - Israel HealthTech Fund.
Magenta's Elevate Left Ventricular Assist Device (pLVAD) is a self-expanding percutaneous catheter-mounted arterial pump that provides temporary mechanical circulatory support for the left ventricle during high-risk percutaneous coronary intervention (HR-PCI) and in patients hospitalized with cardiogenic shock.
The company's technology miniaturizes a percutaneous Left Ventricular Assist Device to fit an 8 Fr delivery system, the smallest crimping profile of any such device.
"A typical device is 14Fr to 24Fr, increasing the risk and complication profile of the insertion procedure. The larger the pump, the more likely the physician is to encounter vascular access and/or bleeding complications," Israeli explained.
The pump is inserted over a guidewire, through the aorta, and across the aortic valve, using 10 Fr introducer sheaths. Once deployed inside the heart, the speed of the pump can be adjusted to provide more than 5 L/min of mean blood flow at physiological blood pressures, aka the full cardiac output of an adult, allowing the heart to rest and the patient to recover.
"Magenta developed proprietary technology to miniaturize the pump, thus allowing it to be folded/crimped during insertion and expand to its full operating size once inside the heart. At the end of the support period, the pump is folded/crimped again to facilitate simple and atraumatic extraction," said Israeli.
"The translation of these attributes into better patient outcomes and fewer complications is intuitive to them and straightforward."
The new financing will be used, among other things, to advance the clinical programs of the company’s product in the United States towards its first FDA approval. That will involve Magenta launching an Early Feasibility Study in the US, to be followed by a pivotal study to support FDA approval for its first indication, HR-PCI.
These studies will build on a HR-PCI first-in-human (FIH) study the company completed in Tbilisi, Georgia, the results of which were presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston.
Once the Magenta technology is approved, physicians will be able to rely on a single device to treat the full range of MCS patients, thereby eliminating the need to escalate therapy to a new device and subject the patient to unnecessary and invasive replacement procedures.
"The ultimate goal is to see this powerful technology enter the market and improve the care of patients who require temporary mechanical circulatory support. Positive feedback from both physicians and patients is what success looks like," said Israeli.
(Image source: magentamed.com)
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