In late May 2024, Peijia Medical successfully held its 2024 Corporate Day and the 4th Investor Day at its new global headquarters located in Suzhou Industrial Park. The event comprehensively showcased the exceptional strength and enormous potential of Peijia Medical in the commercialization, operations, and R&D. Senior management of the company, cardiovascular specialists from home and abroad, and industry experts gathered to discuss product development and the latest industry trends with investors and analysts. Additionally, the company's middle management team provided in-depth analysis of operational and cost control management to give attendees a clearer understanding of the company's overall operations. Through this Corporate Day, Peijia Medical not only displayed its strong commercialization and R&D capabilities but also conveyed its firm and clear vision for the future.
TaurusTrio : Transcatheter Aortic Valve Replacement System for Aortic Regurgitation Indication) / In-licensed Trilogy JenaValve Trilogy Transcatheter Heart Valve System
Duane Pinto, M.D., CMO of JenaValve, reviewed the one-year clinical results of the ALIGN-AR trial of the JenaValve Trilogy , which were published in THE LANCET. The incidence of the 30-day primary safety endpoint was 26.7%, the incidence of the 1-year primary safety endpoint was 7.8%. Both the primary safety and primary efficacy endpoints met the prespecified non-inferiority criteria (40.5% and 25.0%, with a non-inferiority margin of 1.35). Echocardiographic follow-up presented good EOA and low transvalvular pressure difference, with 0% incidence of paravalvular regurgitation at 1 year, and sustained improvement in patients' cardiac function and quality of life, along with good improvement in ventricular remodeling, such as LVESD, LVEDD, and left-ventricular mass. As enrollment progressed and procedural experience was gained in the study, the incidence of pacemaker implantation in the last third of enrolled patients (patient 121-180) decreased to 14% compared to 30% in the first third of enrolled patients (patient 1-60). The ALIGN-AR results demonstrate that the Trilogy System, with its unique valve design and release mechanism, has a reliable clinical performance and provides stable clinical benefit in patients with PAR.
The multi-center, registration clinical trial of TaurusTrio in China completed patient enrollment by the end of January 2024. Professor Guangyuan Song from Beijing Anzhen Hospital of Capital Medical University, the principal investigator of the clinical study, presented the 30-day post-operative follow-up data of all patients to investors. The TaurusTrio registration clinical trial is a prospective, multicenter, single-arm study, designed consistent with the ALIGN-AR PMA trial for the JenaValve Trilogy Heart Valve System in the U.S. Between July 2023 and January 2024, 116 patients with moderate to severe and severe aortic regurgitation were enrolled. The mean age of the study population was 71.9 (SD 6.0) years, with 40 (34.5%) being female and 76 (65.5%) male.
All 116 patients achieved immediate technical success. There were no deaths at 30 days, no disabling strokes, and 1 (0.9%) non-disabling stroke (N=116). All patients had mild or less perivalvular leakage (N=116), and the new pacemaker implantation rate was 11.2% (N=116). Additionally, significant improvement was shown in hemodynamic valve performance, aortic regurgitation, postoperative left ventricular reverse remodeling, and functional quality of life compared to preoperative levels. The excellent early results of the registration clinical trial of TaurusTrio are encouraging. At the end of the presentation, both Dr. Zhang Yi and Prof. Guangyuan Song expressed their eagerness for the follow-up results and the application of TaurusTrio in clinical practice.
TaurusNXT®: Non-glutaraldehyde Crosslinked Dry-tissue Transcatheter Aortic Valve Replacement System
TaurusNXT®, the third-generation non-glutaraldehyde crosslinked long-lasting dry-tissue in the Taurus series, was presented at the event with a more detailed introduction and 30-day follow-up data from the pivotal trial. In addition to the innovative leaflet processing technologies such as "nonglutaraldehyde crosslinking" and "cryogenic vacuum freezing" that investors are familiar with, Mr. Yanchi Wang, Senior Director of Clinical Medicine of the Company’s TVT Business, also introduced the design features of radiopaque marker and delivery systems to investors for the first time in detail, providing attendees with a comprehensive understanding of TaurusNXT®.
By the end of February 2024, all patients were enrolled in the multi-center, registration clinical trial of TaurusNXT®. Prof. Daxin Zhou from Zhongshan Hospital of Fudan University, the principal investigator, released the 30-day post-operative follow-up data of all patients in the registration clinical trial of TaurusNXT®. The clinical trial was a prospective, multicenter, single-arm study that enrolled 150 patients with aortic stenosis. The mean age of the enrolled patients was 75.4 years (SD 4.6), of which 71 (47.3%) were female and 79 (52.7%) were male. The BAV ratio was close to 50%, aligning with real-world distribution, and the average STS score was close to the cut-off for high procedural risk. Most patients had severe or extremely severe calcification, complicating the procedure and increasing the risk of PVL. The immediate postoperative device success rate was 94.7% (N=150), the procedure success rate was 93.3% (N=150), the valve-in-valve rate was 4.7% (N=150), and the 30-day all-cause mortality was 2.0% (N=150). Preliminary clinical data showed that the system has ideal safety and efficacy, and the data are superior to previous generations of the product. The launch of this product will open a breakthrough in durability challenges for currently commercialized valve products in China, benefiting more patients.
