registration approval of CE certification;
-- Thoracoabdominal Artery Stent Graft System (consists of the G-Branch$(TM)$
Thoracoabdominal Aortic Stent Graft System, SilverFlow(TM) PV Peripheral
Vascular Stent Graft System and Aortic Extension Stent Graft System) and
Aortic Arch Stent Graft System (consists of the Ankura(TM) Plus Aortic
Arch Stent Graft System and CSkirt(TM) Aortic Arch Branch Stent Graft
System) have completed pre-marketing clinical enrollment and are
currently under clinical follow-up in China;
-- Concave Supra-arch branched stent-graft system, X-Clip(TM) Mitral Valve
Clip System and X-Clip(TM) Steerable Guide System have fully completed
the clinical study on the first in man ("FIM") in China;
-- Cera(TM) PFO Occluder and Cinenses(TM) Lung Volume Reduction Reverser
System are currently at the stage of the pre-registration clinical
enrollment in China;
Iron-Based Absorbable Material Technology Platform: Financing Facilitating the Development
In September 2023, Biotyx Medical (Shenzhen) Co., Ltd., ("Biotyx Medical") a subsidiary of the Company, received an over RMB200 million in Series B financing, boosting its post-investment valuation by 173%.
Biotyx Medical specializes in researching, developing, producing, and marketing of bioabsorbable metal materials for medical use. The company has broken new ground with the invention of the first-ever iron-based bioabsorbable material technology. The material could have a wide range of application in the medical field. The first three offerings of the company are aimed at the treatment of coronary artery stenosis, infrapopliteal artery and pulmonary artery stenosis, with significant market potential or with the condition of hugh unmet clinical needs.
The financing effectively facilitated the clinical and commercialization process of the three innovative devices. The clinical data preliminary proofed advantages of the devices.
-- IBS(TM) Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System has
completed the clinical enrollment in the China Prospective Multicenter
Single-arm Target Study (the "Phase III"). Currently, the five-year
follow-up of the FIM clinical study has been successfully completed, the
Phase II and Phase III are also at the stage of clinical follow-up, and
its CE registration application has been submitted. The device has been
implanted in a total of more than 1,100 patients in all 3 phases clinical
trials in China. The operation success rate is 100%. The Target Lesion
Failure $(TLF)$ and stent thrombosis is at a low level, both in line with
the expectation.
-- IBS Titan(TM) Sirolimus-Eluting Iron Bioresorbable Peripheral Scaffold
System has successfully completed the first clinical enrollment in Europe,
its CE registration application has been submitted. The device was
approved by the FDA in the United States for "Compassionate Use", which
has been successfully implanted.
-- IBS Angel(TM) Iron Bioresorbable Scaffold System (the only absorbable
stent product suitable for children globally) obtained CE MDR
certification. The device has received Malaysia market registration, and
the device was also approved by the FDA in the United States for
"Compassionate Use", which has been successfully implanted several cases.
Financing from the capital market is expected to significantly speed up the process of bringing the novel iron-based bioabsorbable material medical devices from clinical trials to markets. The move not only promises to introduce the unprecedented, effective, and safe treatments to patients worldwide as early as possible but also facilitates Biotyx Medical to seek further financing in the capital market independently, thus to enhance the overall value of the Group.
Patents
Intellectual property is an important intangible asset of the Group, and is also an internal driving force for improving the core competitiveness in the medical device market. As at 31 December 2023, the Group had filed a total of 2,147 valid patent applications, of which 942 patents were registered and valid.
The Chairman and CEO of Lifetech, Mr. XIE Yuehui said:
Despite encountering numerous challenges throughout 2023, LifeTech has achieved consistent progress in research and development, expansion of global distribution channels, and enhancement of product sales. Anchored by the strategy that emphasizes both innovation and globalization, the Company has extended its sales network to nearly 120 countries and regions worldwide, delivering original research and novel medical products. The effort has solidified the Group's status among domestic peers as a leader in expansion into global markets. LifeTech remains confident that the enduring benefits of innovation will equip it to overcome future challenges, sustain momentum for breakthrough development, and facilitate ongoing expansion in the global market.
Looking ahead, LifeTech is committed to leveraging innovation to invigorate its robust business dynamics and untapped market potential globally. Guided by a pragmatic attitude, rigorous and effective management practices, and a sustained business development strategy, the Company aims to expedite the growth of its existing business within the global marketplace. Simultaneously, LifeTech intends to proactively identify and capture new opportunities for development, integrate and leverage beneficial resources from both inside and outside of the Company, to expedite the attainment of the Group's strategic ambitions in the global healthcare industry.
About LifeTech Scientific Corporation:
Established in 1999, LifeTech Scientific Corporation (Stock Code: 1302.HK) is committed to the R&D, manufacture, and sales of minimally invasive interventional medical devices for cardio-cerebrovascular and peripheral vascular diseases. The company provides patients with innovative solutions in the treatment of structural heart diseases, peripheral vascular diseases, and bradycardia, and the Company also expands its business scope in respiratory interventional business, neuro interventional business and interventional oncology business. As of 31 December 2023, over 2,100 patents have been filed of the Company, and its sales network has penetrated nearly 120 countries and regions around the world.
View original content:https://www.prnewswire.com/news-releases/lifetech-scientific-corporation-announced-2023-annual-results-international-business-achieved-a-robust-growth-innovation-at-the-core-to-drive-the-solid-development-302105908.html
SOURCE LifeTech Scientific Corporation
/CONTACT: Di Xiang, xiangdi@lifetechmed.com
(END) Dow Jones Newswires
April 02, 2024 10:10 ET (14:10 GMT)
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