Ferrosan Medical Devices
Ferrosan Medical Devices comprises two companies that both provide a range of innovative products used by health care professionals in the fields of surgery and diagnostics. Our technology includes Biomaterials used as haemostatic agent for surgery to control bleeding, and miniature Electromechanics used in devices for minimally invasive surgery and drug delivery.
Optomeditech Oy
Optomeditech Oy develops patent pending breakthrough technology in the field of Intravascular Catheters. The technology uses laser light to aid in placement of the IV catheters, making the process easier, faster, safer and more reliable.
The global IV catheter market is roughly a $2B a year market that is growing 10% a year. Over 30% of first attempts to place IV catheters fail today causing significant costs and discomfort for the patients and caretakers alike. The poor placement of IV catheters is the most common cause of complaints in the hospitals. Optomeditech's product OptiVein has the technology to capture a significant portion of the IV catheter market quickly with the advantages it brings.
Optomeditech Oy has confirmed its regulatory pathway for both its CE mark and 510(k) clearance through presubmission consultation with BSI and FDA respectively and is looking to achieve CE mark by the end of Q1 2014 and 510(k) in the summer of 2014. The company is planning on entering the US market during 2015.
The company is currently conducting a clinical trial at the Helsinki University Hospital in Finland and the results have been very good to date. The clinical trial is scheduled to close at the end of August 2013.