In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funding, receive regulatory approval, appoint new executives and board members, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Announced that its MRI-guided focused ultrasound system received approval from Health Canada for ablation of uterine fibroid tissue. Arrayus’ focused ultrasound system offers a novel method for non-invasive therapy, utilizing high-precision acoustic energy to treat tissue deep within the body without incisions or general anesthesia.
Successfully completed the first TendMIN™ minimally invasive Achilles tendon repair in the United States. TendMIN is a minimally invasive tendon repair and surgical system aimed at reducing wound size, surgery time, complication rates, recovery time, and infection risk.
Announced that it has been awarded the $525,000 grand prize in the NIH Rapid Acceleration of Diagnostic Technology for Maternal Health Challenge. The company’s flagship product, VitalStreamⓇ, is an FDA-cleared wireless, wearable continuous cardiac output and blood pressure monitor.
Appointed Laurie Hayner as its VP of Clinical Operations. Coramaze develops minimally invasive structural heart solutions, such as its TriPairⓇ System, designed to treat tricuspid regurgitation.
Completed enrollment for the primary arm of its TRIOMPHE IDE clinical study of the NEXUSⓇ Aortic Arch Stent Graft System. The NEXUS system is a CE-marked, off-the-shelf endovascular aortic arch system indicated for several aortic pathologies, such as arch aneurysms and thoracic dissections.
Celebrated the completion of its 100th implant of its Summit Patella Plating System. The system is an FDA-cleared, sterile, single-use procedure kit with built-in soft tissue management indicated to treat patella fractures in adults.
Appointed Stanton Rowe to its Board of Directors and received FDA approval to expand its PreVail-PH2 Early Feasibility Study. The company is developing a minimally invasive ultrasound-based device to treat patients with pulmonary hypertension and associated heart failure.
Announced the establishment of its global headquarters in Miami, Florida. The new location will support the company’s anticipated FDA approval and subsequent U.S. launch and commercialization of its CGuard™ Prime carotid stent system.
Appointed Scott Hoots, Chad Hacker, and Tessa Sphar to its senior executive leadership team and Dr. Jwala Karnik to its Board of Directors. The company specializes in bioelectric protein expression technology intended for regenerative aesthetics and healthspan longevity.
Announced that its global organization has been certified to ISO 27001:2022 and SOC 2. Achieving ISO 27001:2022 and SOC 2 compliance helps the company create a robust data security, privacy, and compliance foundation for its Maestro™ ecosystem.
Entered a collaboration with Dr. Arutha Kulasinghe, PhD, of the University of Queensland (UQ) and the Queensland Spatial Biology Center (QSBC). The partnership aims to develop a highly selective, spatial-biomarker-based companion diagnostic for predicting immunotherapy response.
Announced a 1-for-375 reverse stock split, a convertible note and warrant exchange, and the consummation of a PIPE offering. Sanuwave develops and commercializes energy transfer technology to accelerate wound healing on a cellular level.
Closed its $15M Series A-2 financing. The funds will support the company’s 304-patient Maturation of Arteriovenous Fistula with Automated Sonography Assessments (MAFASA) clinical trials for its EchoMark and EchoSure.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.
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