Magenta Medical announces a $55 million financing round led by OrbiMed, with participation from existing investors New Enterprise Associates (NEA), Pitango VC, and ALIVE – Israel HealthTech Fund, to advance the clinical programs of the company’s product in the United States towards its first FDA approval.
Temporary mechanical circulatory support (MCS) is one of the fastest growing markets in interventional cardiology, encompassing devices that aim to augment the output of a failing heart, in the setting of dangerously low blood pressure, while resting the heart and providing a bridge to recovery over a period of hours or days. Existing temporary MCS devices provide limited flow, require an invasive surgical procedure, or both.
Magenta’s percutaneous Left Ventricular Assist Device (pLVAD) is a powerful heart pump that is initially folded, inserted through the groin using a small puncture, and expanded for activation inside the left ventricle. The flow of the pump is adjusted based on the clinical circumstances of the patient, up to the entire cardiac output, allowing the heart to rest and the patient to recover. Once the Magenta technology is approved, physicians will be able to rely on a single device to treat the full range of MCS patients, thus eliminating the need to escalate therapy to a new device and subject the patient to unnecessary and invasive replacement procedures.
“Magenta is proud to add OrbiMed to its growing roster of leading MedTech investors as a highly reputable partner for innovative medical device companies,” said Dr. David Israeli, CEO of Magenta Medical. “I am confident that together we can build an organization well-equipped to bring to the market high-impact technology that can potentially address multiple unmet needs in the general cardiology patient population, as well as in many under-served patient groups.”
The potential advantages of Magenta’s high-flow, low-profile device were recognized by the US FDA, resulting in Breakthrough Device Designation for two indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).
Magenta successfully completed a HR-PCI first-in-human (FIH) study in Tbilisi, Georgia, the results of which were presented at the recent 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston, MA, by Dr. Duane Pinto of Beth Israel Deaconess Medical Center and Harvard Medical School. Building on this experience, Magenta is now preparing to launch its clinical programs in the US, starting with an imminent HR-PCI Early Feasibility Study.
“Having supported Magenta’s FIH study, I was thoroughly impressed with the unique combination of a low-profile device delivering best-in-class flow,” said Dr. Pinto. “Magenta’s device is inserted with ease percutaneously and can accommodate the full gamut of flows required by MCS patients in the various situations I encounter as an interventional cardiologist. Use of this technology can be mastered by a wide range of proceduralists to better address the unmet needs of contemporary patients, such as those with small or challenging vascular anatomies, especially if high flows are needed.”
“We are excited to have identified the merits of Magenta’s technology, with its strong disruptive potential, and are extremely pleased with the relationships that we have built with management, the founders, and the existing investors,” said Dr. David Bonita, General Partner at OrbiMed. “We look forward to advancing the clinical programs and accelerating the introduction of this important technology to the market in the US and globally.”
Magenta’s proprietary technology miniaturizes a powerful percutaneous Left Ventricular Assist Device to fit an 8 Fr delivery system – the smallest crimping profile of any such device. The pump is inserted percutaneously, over a guidewire, through the aorta and across the aortic valve, using commercially available 10 Fr introducer sheaths. Employing standard catheterization techniques and equipment for placement has important advantages in terms of ease-of-use, safety, physician access, and vascular access closure. 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 – the full cardiac output of an adult – allowing the heart to rest and the patient to recover. With peak flows exceeding 7 L/min, this is the most powerful known percutaneous pump, comparing favorably even with surgically placed catheter pumps that have more than twice Magenta’s insertion profile.