Petach-Tikvah, ISRAEL, June 15th, 2023- LuSeed Vascular, the developer of an innovative solution for the treatment of brain aneurysms, has announced that Aline Goldstein has been nominated as QA / RA Director.
Aline present broad experience in Medical Device areas related to quality (establishment and maintenance of QMS, work closely with different functions to assure product quality and continue improvement, leading of QA activities in design project), compliance (implementation of regulatory requirements and support in regulatory audits) and regulations for global registration (support in regulatory submissions including preparation of submission files and communication with regulatory authorities in different territories
Alin holds a Master’s degree in Microbiology and Immunology from the Ben-Gurion University of the Negev.
Mr. Nitzan Hirsh and Mr. Amir Arthur, co-founders of LuSeed Vascular, say that “We welcome Aline aboard to Luseed’s growing team. We have no doubt that Alin’s extensive experience and know-how in the QA/RA field will play a major role as we move ahead in our clinical process in providing a life-saving solution for the treatment of cerebral aneurysm.”
The device developed by LuSeed is a revolutionary implant that is suitable for the vast majority of aneurysms. This implant is simple and easy to use, as the interventionalist can access the aneurysm from different angles without compromising device stability, making it highly suitable for sidewall and eccentric cases. LuSeed’s device is the first if its category that does not have a marker which protrudes into the parent artery, drastically reducing the potential need for long term dual antiplatelet. The Luseed device has a specifically high mesh density which is intended to promote a safe an efficient occlusion of ruptured cases.
LuSeed Vascular was co-founded in 2018 by Nitzan Hirsh and Amir Arthur, experienced entrepreneurs in the medical device field, funded Sanara Ventures, private investors as well as a grants from the Israel Innovation Authority.
The market for interventional treatment of cerebral aneurysms is characterized by rapid global growth and is expected to grow from a volume of $1.6 in 2022 billion to $3.15 billion in 2027.
The company headquarters and R&D are located in Israel.