LifeTech Scientific Corporation | September 06, 2022
LifeTech Scientific Corporation is pleased to announce that on 30 August 2022, an FDA-approved investigator-initiated pre-market clinical trial of its proprietary LAmbre™ Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in the United States, meaning that all patient enrollment of the clinical trial will be fully covered by the USA medical insurance. This is expected to facilitate the marketing and registration process of the innovative device in the United States and provide strong clinical data to support the development of the device in the global market.
The investigator-initiated pre-market clinical trial received FDA approval in March 2022. This prospective, randomized, controlled, multicenter clinical trial aims to evaluate the safety and efficacy of the implantation of LAmbre™ Plus LAA occluder in non-valvular atrial fibrillation patients with large and/or irregularly shaped appendages, as compared to oral anticoagulants. The trial is planning to enroll more than 3,000 subjects from up to 75 investigational sites in the United States and undertake more than 1,500 implantations of the LAmbre™ Plus LAA occluders at a fee. After reaching the established clinical objectives and conditions, the company will submit the marketing application of the device to the FDA.
"This is a great milestone in LifeTech's international roadmap. Our LAA occluders had been successfully implanted in the United States on a basis of 'compassionate use', providing a new treatment for non-valvular atrial fibrillation patients with irregularly shaped appendages. Today, the approval for the first ever USA based investigator-initiated pre-market clinical trial and the medical insurance coverage gives us a greater confidence to further accelerate our process for providing this innovative, safe and effective stroke prevention solution to patients in the United States,"
Mr. Xie Yuehui, Chairman and CEO, LifeTech Scientific Corporation
About the LAmbre™ Plus LAA Closure System
LAmbre™ Plus LAA Closure System is independently developed by LifeTech Scientific Corporation. The device closes patient's left atrial appendage through percutaneous occlusion procedure to prevent stroke caused by detachment of thrombus from the left atrial appendage. LAmbre™ Plus LAA Closure System is a structural optimized version of the LAmbre™ LAA Closure System, which is an advanced medical device in the industry in terms of design and technology, and currently it has been widely used in over 40 countries with nearly 20,000 cases in clinical application around the world.
About LifeTech Scientific Corporation
Established in 1999, LifeTech Scientific Corporation (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 has a comprehensive product portfolio in the treatment of structural heart diseases, peripheral vascular diseases, bradycardia, neurological, neoplastic and respiratory diseases, alongside a unique iron-based bioresorbable technology. To date, 14 of the company's products have been approved as innovative medical devices by the National Medical Products Administration, and with a global reach of over 100 countries and regions, the company is currently one of the few domestic companies in China with a highly internationalized business structure.
Sense Biodetection | September 02, 2022
Global molecular diagnostics innovator, Sense Biodetection announced it has entered into a strategic agreement with TECOmedical for the non-exclusive distribution of Sense’s Veros COVID-19, the first test on the rapid, instrument-free, point-of-care Veros molecular testing platform.
The self-contained, single-use Veros COVID-19 product produces PCR-quality results in about 15 minutes, unconstrained by a reader or need for external power. TECOmedical, a Eurobio Scientific Company, is a leading specialty medical distributor with proven success developing new markets with innovative technology. Effective immediately in Germany and Austria, and pending regulatory approval in Switzerland, the agreement is the latest in Sense’s planned EU distribution partnerships as it commercializes its Veros platform.
“We are delighted to partner with TECOmedical to bring Veros COVID-19 to the market, building on the impressive reputation that TECOmedical has established with their customers,” stated Ryan Roberts, Chief Commercial Officer of Sense. “We’re optimistic that by adding the instrument-free Veros COVID-19 to their diagnostic portfolio, TECOmedical’s customers will be able to take advantage of a laboratory-quality molecular test that can enable improved access and faster diagnosis, helping them to provide exceptional care for their patients right at the point of use.”
“We are always looking for innovative technologies that address an unmet need. Being able to offer an instrument free, PCR-quality result in minutes right at the Point of Care reflects our commitment to customers to bring solutions that help them overcome limitations of existing technologies and improve care. We are excited to launch Veros COVID-19 now and are eagerly anticipating an expanded Veros test menu in the future.”
Marieluise Wippermann, CEO of TECOmedical
Veros is the first and only instrument-free, single-use, rapid, point-of-care molecular diagnostic testing platform that produces lab-quality results in about 15 minutes. Using a proprietary, rapid molecular amplification technology, Veros aims to help to improve access to rapid, highly accurate, point of care testing for many more people, and help reduce the spread of COVID-19 with faster, more precise diagnoses.
Veros COVID-19’s clinical performance was established in one of the most comprehensive clinical trials in COVID-19 diagnostic testing conducted to date. The multicentre study prospectively enrolled nearly 300 evaluable subjects during both the Delta and Omicron variant surges of the pandemic. All study sites represented near-patient testing / point-of-care environments, with all test operators reporting no prior formal laboratory training or experience. 100% of operators agreed the Veros COVID-19 was easy-to-use, read and understand the results, with minimal hands-on time required from start to finish.
As the virus continues to evolve, Veros COVID-19 has maintained 100% conservation in all Variants of Interest and Concern identified to date by WHO and the US CDC, including all Omicron sub-variants.
About Sense Biodetection
Sense Biodetection is a global molecular diagnostics company focused on empowering patients and transforming healthcare access and affordability by bringing lab-quality results through easy-to-use, rapid, disposable molecular tests without the constraints of an instrument. The company's Veros product platform will enable widespread testing to enhance patient access, improve patient health and lower systemic healthcare costs. Backed by respected investors, such as Koch Disruptive Technologies, Cambridge Innovation Capital, Earlybird Health and Mercia Asset Management, Sense has launched its first product, Veros COVID-19, and is growing rapidly while building a portfolio of tests for other diseases.
The Swiss-based TECOmedical Group, a Eurobio Scientific company, with subsidiaries in Germany and Austria is a leading provider of in-vitro specialty test systems in medical diagnostic, based on Immunosorbent, Immunofluorescence and Molecular methodologies.
HEALTHTECH SECURITY,FUTURE OF HEALTHCARE
Sightpath Medical | November 22, 2022
Sightpath Medical, the leading provider of mobile ophthalmic services for cataract and refractive surgery, announced that it has acquired Accusite Surgical, a cataract surgery equipment outsourcing company.
Founded in 1991, Sightpath Medical delivers custom access to advanced ophthalmic equipment, instruments, and services to facilities and surgeons across the United States. Through its patented technology, the company was the first to mobilize phacoemulsification machines, excimer lasers, the IntraLase Femtosecond Laser, and the LenSx Femtosecond Laser. Sightpath Medical has earned the trust of medical professionals and patients nationwide through the quality of its equipment, the skill of its employees, and the dedication and responsiveness of its staff.
Accusite Surgical is a mobile cataract surgical company that outsources state-of-the-art equipment, technology, and certified staff to surgeons, ambulatory surgical centers, and hospitals. For over 28 years, the company has assisted in more than 200,000 procedures throughout the Southeastern U.S.
In connection with the transaction, D. Lynn Godfrey, Founder and Chief Executive Officer of Accusite Surgical, will join Sightpath Medical as Chief Strategy Officer.
“This strategic combination bolsters Sightpath Medical’s market-leading position and enhances our ability to deliver variable, tailored access to the expert personnel, equipment, and supplies surgeons need to provide critical eye care. We are delighted to begin integrating the Accusite Surgical business into ours and are equally excited to welcome Lynn Godfrey, who is an experienced and creative executive, to our management team. We look forward to growing Sightpath Medical together.”
Joel Gaslin, President and CEO of Sightpath Medical
Mr. Godfrey added, “After 28 years, I began exploring the long-term options for my business and quickly determined that the Sightpath Medical executive team and its financial partner, MGG Investment Group, were the right partners for Accusite Surgical. We are closely aligned on our core mission of helping surgeons and their referring Optometrists provide patients with excellent eye care and, ultimately, better vision. I am thrilled to commence Accusite Surgical’s next chapter as part of Sightpath Medical.”
About Sightpath Medical
Sightpath Medical is the leading U.S. provider of mobile ophthalmic services for cataract, refractive and laser-assisted surgery. Working alongside more than 1,200 surgeons and the staffs of their surgical facilities for more than 30 years, Sightpath Medical is the market-leading choice for surgeons, ASCs, and hospitals due to our proven ability to deliver the staff, equipment, and supplies wherever and whenever they are needed – regardless of geography.
About Accusite Surgical
For nearly three decades, Accusite Surgical has been a leading provider of state-of-the-art equipment, supplies, and support for cataract surgery in the Southeastern United States. Accusite Surgical is a trusted partner to ASCs and hospitals and ophthalmologists for cataract surgery services and is committed to helping surgeons grow their practices while delivering superior outcomes for patients.