March 7th, 2019
Leading manufacturer C.R.Bard has announced that the company exits the vaginal mesh market for urinary incontinence.
Februar 6th, 2019
The first injection moulded parts have arrived from our suppliers. All look good. The silicone parts will arrive in April, whereafter we can assemble, pack and sterilize all 2.500 devices for the final long term clinical trial.
December 5th, 2018
Tooling has started for the silicone and plastics parts. We will manufacture 2.500 devices, needed for the final long term clinical trial.
October 10th, 2018
Today, the National Institute for Health and Care Excellence (NICE), in the United Kingdom proposed new guidelines for stress urinary incontinence. “A full range of non-surgical options should be offered to women for stress urinary incontinence or pelvic organ prolapse before any operations, NICE has said.”
Timing and positioning for our non-surgical medical device, Obtinu, looks better than ever.
Read more on the NICE webpage: https://www.nice.org.uk
September 25th, 2018
Clinical Trail 3 is now completed, as the 20th and last test user passed by at the urogynecological clinic. A 42year old lady gained full continence, when using the Obtinu device during a cough-and-activity test. Before using Obtinu, she leaked 13 ml when doing the same series of exercises.
All is set for preparing the long term clinical study together with the doctors at the Copenhagen University Hospital.
September 3rd, 2018
Things look good! Clinical Trail 3 is in good shape, closes soon, and we have decided that a long term study is justified. This study will be initiated in Q1 2019 and will provide us further clinical evidence and most importantly quantify, what market traction to expect.
We welcome new investors for this exciting part of the journey! Business Angels are welcome!
Also this study will take place at the Copenhagen University Hospital, whose support and professional approach to all clinical matters is as always highly appreciated.
July 21st, 2018
We proudly present our new packaging. Each package contains a day's use, i.e. one Obtinu device, a sachet of lubricating gel and a set of flow tubes.
June 8th, 2018
Check our new company video in the top menu. There you learn more, about how important it is that our solution gets available for those who need it.
May 31st, 2018
Also our second patent is now granted in China. A good day.
April 20th, 2018
The intermediate results for Clinical Trial 3 are promising.
More than 90% of the women tested so far got leak tight, when using our device. This is a remarkable feat, considering that volunteers belong to the most diffucult group of stress incontinent women, namely those who are signed up for and ready to risk sling surgery. Further, and just as remarkable : Our one-size-fits-all approach seems feasible. We will strengthen the statistics and include more test users in the coming two months.
Please note, that all test persons in Clinical Trial 3 are recruited among the patients already in treatment at the Clinic for Urogynecology, Copenhagen University Hospital. We cannot sign up any via this website, sorry.
November 9th, 2017
All approvals are in place, all devices are manufactured, and we have now started Clinical Trial 3 at Copenhagen University Hospital. This study will focus on women who are signed up for sling surgery, so that test users are those who have the worst cases of incontinence.
August 23rd, 2017
We have decided to do a third clinical trial, in which we will include a larger group of users than in the previous tests at Copenhagen University Hospital. This new group will evaluate our one-size-fits-all device. All moulding tools are made, and testing is scheduled to start in November.
July 11th, 2017
Copenhagen University Hospital has finialized the clinical trials, which confirmed our expectations: The device is efficient, safe and the comfort is good. No complications were observed. A very positive observation is that a one-size-fits-all seems possible. We have tested four different sizes of our device, and can now conclude, which dimension will fit all.
This means, that our public fund project with Innovationsfonden, announced May 12th 2016, is now finished. All milestones are succesfully met. Our second public project support, from Markedsmodningsfonden, announced October 28th, continues in the year to come and supports our work on obtaining the CE-mark.
March 10th, 2017
We have today started recruiting volunteers for a series of clinical trials at the Copenhagen University Hospital in Denmark. If you suffer from stress incontinence, live in Copenhagen, and are interested in participation, then please visit www.forsøgsperson.dk for more information and contact details.
November 1st, 2016
It is a pleasure to welcome Kristian Uggerhøj as the MagCath's new CEO. Kristian Uggerhøj has a long career in sales and marketing of medical devices.
Niels Erikstrup continues as our CTO, responsible for all technical matters, which includes product development, manufacturing and regulatory affairs.
October 28th, 2016
We are pleased to announce that Markedsmodningsfonden will support DKK 2,1 million to MagCath ApS. The funds are dedicated a DKK 5,5 million project, covering clinical trials and the CE-marking of our device.
September 21st, 2016
Today, the European Patent Office officially granted us a patent for our device.
May 12th, 2016
It is now official, that MagCath ApS receives support from Innoboost, sponsored by Innovationsfonden. Innoboost will provide a total of DKK 474.760 to our product development.