U.S. FDA 510(k) clearance for eZono 4000
eZono AG (“eZono”), a private corporation designing, developing and distributing state of the art tablet ultrasound systems, today announced it received 510(k) clearance from the FDA for its eZono 4000 dedicated procedural guidance system with eZGuide technology, providing any plane freehand navigation.
The eZono 4000 offers excellent image quality and features eZGuide, a revolutionary needle guidance providing needle tip location, with the precision and ease of use that clinicians did not think possible in a tablet style system. “The eZono 4000 with eZGuide, is exceeding our expectations in performance and has been welcomed as game changing technology by many physicians”, says Graham Cox, CEO eZono. “eZono is passionate about bringing practical and affordable solutions to clinicians in their everyday practice and we are delighted to bring this technology to the United States for needle guidance applications. As healthcare costs rise, it becomes imperative for companies to provide quality solutions at affordable prices. eZono addresses the needs of improving patient safety with increased efficiency by making essential equipment more easily accessible with minimal ongoing costs per procedure”.
“The eZono 4000 has revolutionized the way in which ultrasound guided procedures are performed in two ways
” says Dr Jeff Gadsden
, Director of Regional Anesthesia St. Luke’s-Roosevelt Hospital Center, New York “Firstly, knowing where your needle tip is at all times represents a substantial safety advantage, both for in-plane and out-of-plane procedures. The needle localization technology eliminates the guesswork out of ultrasound guided techniques and reassures you that the procedure is not going to end in misadventure. Secondly, we have found the learning curve is accelerated with the eZono 4000 — trainees understand ultrasound guided block techniques more quickly when they are trained on the 4000 and are able to demonstrate better hand-eye coordination skills after several sessions with the machine compared to traditional teaching techniques
eZono appoints Dieter Schwartmann as Business Director EMEA
eZono AG (“eZono”), a private corporation designing, developing and distributing state of the art tablet ultrasound systems, today announced the appointment of Dieter Schwartmann as Business Director of Europe, Middle East & Africa, effective May 13th 2013. Mr. Schwartmann brings 37 years of experience in the medical ultrasound and technology industry including serving as Vice President of Europe for SonoSite and Vice President of ATL Ultrasound, Inc., now part of Philips Medical Systems.
“Dieter brings a unique combination of leadership skills with unprecedented experience in the healthcare industry and we feel very fortunate to have him join our team to head up our business in Europe, Middle East & Africa,” said Graham Cox, eZono’s CEO-elect. “We look forward to working with Dieter to accelerate our growth and build on the launch of our revolutionary new products”.
“eZono has the vision and technology to address the challenges that European health care systems face and I am convinced their products will have a positive impact on healthcare efficiencies,” said Mr. Schwartmann.
Mr. Schwartmann was a co-founder of Sonotron GmbH, an ultrasound distributor and service provider, where he spent nine years as General Manager. He also served as regional sales manager for ultrasound and other medical products at Kontron Medical GmbH. Additionally, he worked with Beckman Instruments in Germany and Carl Zeiss GmbH, a maker of medical optical instruments.
Graham Cox to join eZono as CEO
eZono AG (“eZono”), a private corporation that designs, develops and distributes state of the art tablet ultrasound systems, today announced a leadership transition that will accelerate the company’s growth. eZono’s supervisory board has appointed Graham D. Cox as the company’s Chief Executive Officer effective 1st June 2013. Mr. Cox will succeed Allan R. Dunbar, co-founder and acting CEO of eZono, who remains with the company as Chief Commercial Officer.
“We are very excited that Graham is bringing his skill, experience and remarkable track record to eZono. I firmly believe that, together with Allan and the team, he will enable the company to realise its enormous potential” said Hugo Harrod of MVM Life Science Partners, lead investor in eZono.
“We have been searching for an experienced CEO to capitalize on technologies such as our groundbreaking needle guidance. In my opinion, Graham is the best-qualified candidate in the world to take this role” commented Allan Dunbar.
“eZono has an impressive and unique team with a proven ability to innovate in the field of portable ultrasound. I am very excited to join the company and take these innovations to market worldwide” added Graham Cox.
Mr. Cox is an ultrasound industry veteran with more than 35 years of experience in the field. He joins eZono from SonoSite, a recognised leader in point-of-care ultrasound. At Sonosite, he served as Senior Vice President, Worldwide Sales & Distribution. During his 13 year tenure, annual revenues grew from zero to over $250 Million. Prior to joining SonoSite, Mr. Cox also held senior positions running sales and distribution for ATL Ultrasound (now Philips Medical Systems) and Acuson (now Siemens AG). Mr. Cox received an electronic engineer education and holds an Executive MBA (Hon) from the International Management Centers Association.
eZono AG closes $10m financing round
MVM Life Science Partners leads investment into portable tablet ultrasound platform and novel needle guidance technology Jena, Germany — (Business Wire) — eZono AG (“eZono”), a private corporation that develops portable tablet ultrasound systems, announced today that it has completed an equity financing of up to $10m. The capital increase is led by new investor MVM Life Science Partners LLP (“MVM”). In conjunction with the financing, MVM partner Hugo Harrod will join eZono’s board of directors.In May 2009, eZono launched one of the first tablet-style portable ultrasound systems, the eZono 3000. Due to its touch screen graphical user interface, the eZono 3000 allows ultrasound to be adopted in new applications where the barrier to entry is the users’ lack of experience. Furthermore the eZono 3000 includes CueCards and downloadable multimedia apps which speed up the learning curve for a variety of regional anaesthesia and emergency care procedures. “Having sold more than 450 eZono 3000 systems globally, we now take the next step with our novel needle guidance technology in 2013. Ultrasound guided regional anaesthesia is a key driver for patient safety and reducing cost in surgery but adoption is still slow because of the difficulties inherent in guiding the needle to the nerve. Our needle guidance technology addresses this and should accelerate adoption.” said Allan R. Dunbar, eZono’s Chief Executive Officer.
In contrast to existing solutions, eZono’s needle guidance technology works with a variety of existing standard needles used in regional anaesthesia and is associated with no additional setup time or change to clinical practice. “eZono has one of the most innovative development teams we have encountered and a great platform in the eZono 3000. We have witnessed the remarkable clinical reception to eZono’s needle guidance technology and believe it has the potential to make eZono a global leader in portable ultrasound.” commented Hugo Harrod of MVM.
With the proceeds from the financing, eZono will expand its research and development operations in Jena but also invest significantly in its global sales operations. “Having MVM as a partner, allows us not only to accelerate the introduction of our new technology but also to increase our revenue growth, which was 60% in 2012” concluded Andre Jaekel, Chief Financial Officer of eZono.
eZono AG was founded in July 2004 and is located in Jena/Germany. The company develops and markets tablet style ultrasound systems for emerging markets like regional anaesthesia and emergency care. Its first generation eZono 3000 system achieved CE mark in May 2009 and FDA 510k in July 2011. The eZono 3000 is now sold in more than 30 countries globally.
MVM Life Science Partners LLP is a global venture capital firm that has been investing in emerging healthcare companies since 1998. Its three funds under management total $500m and its team of seven executives is located in London and Boston.