The AV-Venture investment consortium composed of Italian Angels for Growth (IAG), Doorway and Club degli Investitori, announces that its investee AorticLab, manufacturer of EMBRACE©, an innovative "full body" filter for anti-embolic protection during percutaneous structural cardiology procedures, has successfully conducted the treatment of the first three patients. In this first phase of the Nautilus clinical trial three of the most important Italian centers have been involved: Policlinico di Monza, IRCCS Policlinico San Donato and IRCCS Ospedale San Raffaele. An enlargement to other important European centers is expected soon.
With the latest funding round concluded in May, with subscriptions beyond expectations at 1.4 million, Aorticlab, considering grant, funding and equity, has raised a total of more than 13 million euros that will allow the achievement of important clinical and regulatory milestones already by the end of this year or early 2022.
"First of all, I would like to congratulate the company's team - says Claudio Zuccolotto, one of the IAG Champions and member of the Board of Directors of AorticLab - which reaps the fruits of a challenging work carried out during the months of the pandemic. 2021 is the crucial year for the success of Aorticlab, because the milestones we will soon reach will give a strong international visibility to the project."
"Congratulations to Franco Osta, to the AorticLab team and to the 'Champion' Claudio Zuccolotto for the results achieved and for the closing of this round, also supported by the Club degli Investitori, which thus fulfills its mission to support capable and innovative entrepreneurs, supporting them along the entire growth path" said Andrea Rota, Managing Director of the Club degli Investitori.
"We are particularly pleased with the results of these clinical trials that highlight the validity of the technology and reward the efforts of the Aorticlab team," said Antonella Grassigli, CEO of Doorway. "As a Benefit company we put at the center of our startup selection process the compliance with ESG criteria because we believe that conferring value to the society, in particular with the development of new medical technologies, produces value also for investors. Aorticlab's progress demonstrates the validity of this choice and we hope that these innovations can soon become of daily use in medical practice".
EMBRACE©, thanks to its unique Catch & Flow design, ensures more effective capture of calcified debris that could be released during percutaneous Structural Cardiology procedures and TAVI (Transcatheter Aortic Valve Implant) in particular, without impacting normal blood flow.
"The innate spirit of innovation that characterizes the team of AorticLab, - said Franco Osta CEO AorticLab - has made possible the development of the unique technology 'Catch & Flow', which combines advanced materials with an original design, giving an optimal filtration of debris without increasing the gradient of blood pressure. The EMBRACE© device is the first in a series of cutting-edge solutions designed to increase patient safety and expand effective access to the treatment of aortic valve stenosis."
"I am truly encouraged by our pilot experience with EMBRACE©," says Dr. Filippo Scalise of Monza Polyclinic, "and believe the benefits of this new embolic filter have the potential to better protect patients from the risk of periprocedural stroke through a device that provides comprehensive systemic protection.
"I am favorably impressed," says Dr. Federico De Marco of IRCCS Policlinico San Donato, "by the overall ease of use of the EMBRACE© filter; the device is safely deployed and quickly placed and retrieved, adding negligible time to the procedure. No additional femoral access is required thanks to the 5Fr pigtail integrated into the device's delivery system."
"Although significant improvements have been achieved," says Dr. Matteo Montorfano of IRCCS Ospedale San Raffaele, "in mortality and morbidity rates during TAVI procedures, the risk of stroke and other neurological injuries has not changed and still represents a non-negligible risk for any TAVI patient and a potential procedural complication for treating physicians. Our patients deserve the highest standards of care and I am very pleased that they can benefit from the latest and most advanced technical solutions designed and developed to improve patient safety and protection."
In 2020, 190,000 patients worldwide underwent the TAVI procedure and by 2027 it is assumed that there will be 390,000 cases. The TAVI procedure carries an inherent risk of stroke that may be greater than the 2-4%. EMBRACE © fits perfectly to the aortic wall and makes all aortic procedures safer in terms of adverse events while minimizing the risk of brain damage by covering all three major branches of the aortic arch and the systemic circulation.
(Source: Club degli Investitori | 📷 © AorticLab)
