News
August 27th, 2024
We are conducting clinical trials for our valve catheter, Obtinu, at Gyncare in Herlev. For more information on how to participate, please contact Gyncare directly on obtinu@gyncare.dk
Purpose: The trial aims to assess the usability, effectiveness, comfort, and potential side effects of using Obtinu over a 4-week period.
Timing and Duration: The trial involves one physical visit where eligibility is assessed based on medical history, medications, allergies, weight, height, urine tests, and a gynecological exam. If you meet the criteria and choose to participate, the trial will begin in the clinic, including training on how to use Obtinu. There will be a follow-up phone call one week after the start and after the trial ends.
Diary: During the trial, you will need to keep a diary to record your use of Obtinu and answer questions before and after the trial.
July 12th, 2024
The manufacturing transfer to our new facilities north of Copenhagen has progressed well. Last week, we finalized the installation of larger capacity equipment in the clean room. Coating, assembly and packaging went smoothly, so the first Made-in-Denmark batch of devices could be sent to sterilization on Friday afternoon. We now have the capacity we need for initial market launch.
June 13th, 2024
All regulatory formalities are in place for our clinic trial 5, including registration on clinicaltrials.gov . We have met all Good Clinical Practice (GCP) requirements, and our partner, GynCare w/Dorthe Snejbjerg, has been thoroughly trained in onboarding, usage, and documentation procedures.
Calendar booking for trial participants has commenced.
June 7th, 2024
We are proud to announce a significant milestone for Obtinu. Among nearly 1,000 submissions, Obtinu has been selected to present at the ICS conference in Madrid. This marks Obtinu's first presentation in a research context. The presentation will be delivered by Professor Niels Klarskov from Herlev Hospital. ICS stands for the International Continence Society. These accomplishments underscore our commitment to advancing research and improving clinical outcomes.
February 12th, 2024
Obtinu, our solution for female urinary stress incontinence, just got closer to market launch. Last week, our quality management system got audited by the notified body, and MagCath ApS passed Stage 1 for ISO13485 certification. This may sound like a small thing - but do not underestimate the work that was required. A big thanks to all who have contributed to reaching this milestone!
January 18th, 2024
The national Danish Health Authority (Lægemiddelstyrelsen) as well as the national Danish Ethics Comittee (Etisk Komité) has approved the application for Obtinu’s pivotal clinical trials, starting Q1 2024. We expect the first users to enroll in a few weeks.
January 11th, 2024
All devices for the Q1 2024 Clinical Trials are now assembled, packed in secondary packaging, shipper boxes, and ready for sterilization.
December 18th, 2023
A well spent week on site at our key supplier. We inspected injection moulding, coating equipment, clean rooms and held meetings about assembly, packaging and QA.
December 15th. 2023
The Application for our Q1 2024 Clinical Trials in Copenhagen is filed at Lægemiddelstyrelsen and Etisk Komité.
November 30th, 2023
The MagCath ApS annual general assembly was held today. We welcomed new investors as well as new board member, Ms Camilla Harder Hartvig, and new CEO, Ms Marie Ihlemann. Mr Niels Erikstrup hereafter takes the role of CTO.
October 15th, 2023
We are happy to announce that Mr Kristian Worziger will join and strengthen our team, adding solid experience in regulatory affairs.
July 3rd, 2023
A notified body has accepted us for submittal of a Class IIa application.
May 15th, 2023
We are listed as manufacturer at Lægemiddelstyrelsen.
March 1st, 2023
The regulatory compliance company MyBlueLabel assists in elaboration of our Technical File for the CE-marking. We expect this work to be completed around May 2023.
December 15th, 2022
The first batch of silicone mouldings is made. The tools perform according to specifications, and we do not need any adjustments.
August 19th, 2022
Tooling has started for the launch-ready device.
July 15th
Meet our new packaging. Designed by our advisory board and graphic designer Mette Brix.
May 19th, 2022
This week the ISO13485 Quality Management System gets rolled out in the company. This is a mandatory step on the route to the CE-marking.
January 12th, 2022
Meet our advisory board!
December 1st, 2021
Some user feedback regarding usability suggested an easier and more intuitive valve opening. The development work has been successful and the solution is compellingly simple. No changes to the device’s outer dimensions were needed. The handling of the device is easier than ever.
October 28th, 2021
The annual MagCath ApS general assembly was held in Copenhagen.
June 19th, 2021
We are excited about the performance of the device’s new hydrophilic coat. We don’t need a gel anymore! This is a significant step for both use ease and comfort.
November 19th, 2020
The ICS2020 conference has taken a virtual format this year. MagCath ApS Medical Devices takes part, and you may get in touch during the conference chat.
October 21st, 2020
As a part of the testing, we evaluate a new hydrophilic coat.
May 21st, 2020
The clinical trials are expected to resume after the holidays at Herlev Hospital. The upgraded design with the new high-flow valve will be ready for this.
March 20th, 2020
Lægemiddelstyren has today approved the amendment request filed on March 9th. We have placed an order for injection mould tools for the upgraded parts.
March 9th, 2020
Our clinical trials are on hold due to COVID-19. The time will be efficiently spent on increasing the flow rate through the Obtinu, as our users asked for this. The change was not complicated, and the laboratory testing showed roughly a doubling of the flow rate. We filed an amendment request at Lægemiddelstyrelsen for this design change today.
Devices are shown to scale.
Feb 18th, 2020
Visits to the leading swiss and danish hospitals for paraplegics opens up for a second use for the Obtinu valve catheter. Obtinu may replace Foley-catheters for female users. Foley catheters are conceptually unchanged for the last 50 years and have a long list of issues. Obinu will offer these patients a complete bladder voiding, a natural bladder dynamics, an elimination of bulky valves and tubes and not the least an elimination of the external collection bag. This second market will be considered for a parallel series of clinical trials.
November 18, 2019
We have been awarded the EU Seal of Excellence. The Seal of Excellence is a quality label awarded to project proposals submitted to Horizon 2020, the EU's research and innovation funding programme. Projects which are considered deserving of funding but do not get it due to budget limits receive the Seal of Excellence.
November 7, 2019
Medical Device Developments, 2019 Vol.2 brings a two-page article about the collaboration between Controlled Polymers A/S and MagCath ApS.
October 22, 2019
Our 8 week long tests of the Obtinu devices are about to start. You can find introductory information and contact details under the headline: “Kvinder med stressinkontinens søges(Kbh)” on the website www.forsøgsperson.dk. The tests are coordinated by the urogynecological clinic at Copenhagen University Hospital Herlev, so only women living in the greater Copenhagen area should apply.
August 2, 2019
We proudly present our new packaging, which is both nicer and more compact than the previous packaging. This is good both for storage and shipping.
June 26, 2019
A third entry to the MagCath patent portfolio was made by the filing of an application for “A urine flow device”. This new application covers add-ons to our core technology, which would also appeal also to women who do intermittent catheterisation.
June 6, 2019
Meet us at the Swiss Medtech Day in Bern on June 6th. We will exhibit at stand P-18, so check your calendar and pass by. https://www.swissmedtechday.ch/
May 10, 2019
One more patent is now granted in the USA! The US Patent Office has today granted MagCath ApS the patent rights for auxiliary devices that can connect to our valve catheter.
April 23, 2019
The US Patent Office has today granted MagCath ApS a patent which covers the unique indwelling valve in our medical device for female stress incontinence.
March 7, 2019
Leading manufacturer C.R.Bard has announced that the company is exiting the vaginal mesh market for urinary incontinence.
https://www.icij.org/investigations/implant-files/leading-manufacturer-exits-vaginal-mesh-market/
February 6, 2019
The first injection moulded parts have arrived from our suppliers. The silicone parts will arrive in April, after which we can assemble, pack and sterilize all 2.500 devices for the final long term clinical trial.
December 5, 2018
Tooling has started for the silicone and plastics parts. We will manufacture the 2.500 devices, needed for the final long-term clinical trial.
October 10, 2018
Today, the National Institute for Health and Care Excellence (NICE), in the United Kingdom proposed new guidelines for stress urinary incontinence. NICE stated: “A full range of non-surgical options should be offered to women for stress urinary incontinence or pelvic organ prolapse before any operations.”
Read more on the NICE webpage: https://www.nice.org.uk
September 25, 2018
Clinical Trial 3 is now completed, as the 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 3, 2018
Things look good. Clinical Trial 3 is in good shape and, will be completed soon, and we have decided that a long term study is justified. This study will provide us further clinical evidence, and most importantly quantify what market traction to expect.
June 8, 2018
Checkout our new company video in the top menu! There you can learn more, about how important it is that Obtinu becomes available for those who need it.
May 31, 2018
Our second patent is now also granted in China. A good day.
April 20, 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 difficult 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 subjects 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 9, 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 23, 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 have been made, and testing is scheduled to start in November.
July 11, 2017
Copenhagen University Hospital has finalized 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 successfully 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 10, 2017
We have today started recruiting volunteers for a series of clinical trials at 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.
October 28, 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 21, 2016
Today, the European Patent Office officially granted us a patent for our device.
May 12, 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.
