Shanghai, China, 3 May 2022 — MicroPort CardioFlow Medtech Corporation (CardioFlow Medtech) announced that their strategic partner 4C Medical Technologies, Inc. (4C Medical) recently completed two successful cases using their next generation low profile and fully retrievable transseptal (TS) delivery system. The procedures were performed by Dr. Vlasis Ninios, Director of Department of Cardiology at the Interbalken Medical Center in Thessaloniki, Greece.
These first-in-human cases were completed via compassionate use pathway. Both patients were diagnosed with severe mitral regurgitation (MR) and required treatment to address their heart failure symptoms resulting from MR. These patients were non-surgical candidates and had been previously disqualified from other transcatheter mitral valve therapies due to their challenging anatomies. In both procedures, the AltaValve™ was delivered to the targeted site using the TS delivery system and achieved a clinically significant reduction in MR. The patients were successfully discharged from the hospital with a notable improvement to their cardiac function and quality of life.
The AltaValve™ is a transcatheter mitral valve replacement (TMVR) device designed to broaden the treatable patient population: the device's supra-annular valve placement overcomes the concerns of anchoring and fixation difficulties present in current TMVR technologies. Moreover, the design of the AltaValve™ minimizes the risks of left ventricular outflow tract (LVOT) obstruction, which is a known limitation for other TMVR technologies. In addition, its proprietary, next generation low profile and fully retrievable TS delivery system allows for optimal positioning and deployment of the AltaValve™ at the targeted site. The AltaValve™ is the only known TMVR device that offers full implant retrievability even after its complete deployment and prior to its detachment from the TS delivery system.
“We are proud and honored to have performed worldwide the first-in-human implantation of the AltaValve™ using their novel transfemoral/transseptal low profile delivery system in two of our patients who had no other treatment options,” said Dr. Vlasis Ninios. “4C Medical’s support, training, and dedication to helping these patients was exceptional, leading to fantastic outcomes for our patients. The AltaValve™ technology is straightforward to use and has a great potential to help a broad number of patients suffering from mitral regurgitation”.
MR is a common valvular heart disease, which refers to the mitral valve’s inability to close completely, causing blood to flow from the left ventricle into the left atrium during ventricular systole. In 2019, the population of MR patients was 96.7 million in the world and 10.6 million in China, accounting for nearly 1/9 of the global patients. According to Frost & Sullivan report, with the continuous increasing of market demand of transcatheter mitral valve (TMV) products and the unceasing emerging of innovative TMV technologies, the global TMV market is expected to increase to US$17.4 billion by 2030 and will eventually grow to three to four times of the TAVR market size. However, as the treatment of TMV is very sophisticated and there are certain clinical restrictions on the majority of existing TMV technologies, which is likely to result in complications such as causing obstruction of the LVOT, impairing function of the left ventricle and device embolization, a TMV product that can address the above clinical restrictions is urgently needed to provide safer and more effective medical solutions for TMV patients.
There are generally two access approaches for TMVR procedure, transapical approach (TA) and transseptal approach (TS). TA requires a small incision of about 3-5cm to the left chest whereas the TS requires a small incision to the groin for access. Compared to TA, the TS approach may significantly reduce intraoperative trauma to the patients.
“We are excited by the performance of our next generation low profile transseptal delivery system to treat these patients. These efforts are a continuation of our transseptal experiences as we focus on optimizing our system to treat a broader number of MR patients. We continue to build on our clinical data and confirm the performance of the AltaValve™ to benefit patients with severe MR. Our mission at 4C Medical is dedicated to innovating structural heart technologies to treat both mitral and tricuspid regurgitations,” said Saravana Kumar, PhD, President and CEO of 4C Medical.
In September 2018, CardioFlow Medtech led 4C Medical’s Series A financing round and was granted the exclusive commercial rights to distribute 4C Medical’s AltaValve™ technology for MR in China. In March 2022, CardioFlow Medtech led 4C Medical’s Series C financing, becoming the largest shareholder of 4C Medical, and was granted exclusive commercial rights to distribute 4C Medical’s tricuspid technology in China.
“As an innovative medical device company focusing on the development of transcatheter technology for treatment of structural heart diseases, 4C Medical is working to pioneer some breakthrough technologies in the fields of therapy for mitral and tricuspid regurgitation. The ongoing partnership is beneficial to expand CardioFlow Medtech’s technology portfolio pipeline, thus enhancing our market competitiveness. In the future, we hope to continue strengthening the cooperation between both parties to provide safer and more effective medical solutions for structural heart disease patients worldwide,” said Mr. Chen Guoming, President of CardioFlow Medtech.
About 4C Medical Technologies, Inc.
4C Medical is a medical device company developing minimally invasive technologies for structural heart disease, focusing initially on mitral regurgitation (MR) therapy and subsequently on tricuspid regurgitation therapy. Subject to regulatory approvals, the Company’s AltaValve™ would be the first MR treatment with atrial-only fixation that is designed to minimize known issues associated with current TMVR technologies, which rely on placement and fixation within the native mitral annulus.
About CardioFlow Medtech
MicroPort CardioFlow Medtech Corporation is a leading medical device company in China focusing on research, development and commercialization of innovative transcatheter and surgical solutions for structural heart diseases. On February 2021, The Company was listed on the Main Board of the Stock Exchange of Hong Kong Limited (Stock Code: 2160.HK), the Company’s self-developed first-generation Transcatheter Aortic Valve Implantation (TAVI) product, with its unique product design and outstanding clinical performance, has entered more than 300 hospitals across China and was successfully commercialized in Argentina. The Company’s second-generation TAVI product VitaFlow Liberty™ also the world’s only commercialized motorized retrievable system was approved by the NMPA in August 2021. In addition to the TAVI products, the company has also established a strategic R&D pipeline covering Transcatheter Mitral Valve (TMV) therapies, Transcatheter Tricuspid Valve (TTV) therapies, surgical valve products and surgical accessories via independent development and collaboration with global partners.