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Vaginal Arco-ColpoSuspension Device for the treatment of Urinary Incontinence in Women

Periodic Reporting for period 1 - VACS-D (Vaginal Arco-ColpoSuspension Device for the treatment of Urinary Incontinence in Women)

Reporting period: 2020-06-15 to 2021-06-14

Urinary incontinence refers to unintentional loss of urine. Stress incontinence happens when physical movement or activity such as coughing, sneezing, running or heavy lifting puts pressure (stress) on the bladder.The disease comes in three different forms: Stress UI,Urge UI and Mixed UI,in which the most common is Stress UI. Stress incontinence differs from urge incontinence, which refers to unintentional loss of urine caused by the contractions of the bladder, and is usually associated with increased stress. Stress incontinence is the most common type of urinary incontinence in women.Invasiveness is further reduced with the advent of MUS, which associated with less blood loss,less pain,fewer complications,faster recovery and better cosmetic results.The midurethral sling procedure was rapidly adopted due to its technical convenience following the success of treatment similar to abdominal colposuspension.Its popularity equaled that of the abdominal colposuspension approach within only 5 years and accounted for 90% of all total urinary incontinence operations.However the use of sling material (polypropilene syntetic mesh) may cause graft-related complications, of which the most frequent is vaginal exposure.The warnings were associated with the side effects of meshes placed in the vagina for the surgical treatment of genital organ prolapse.These meshes have the same structural features as the midurethral sling,but have a much wider surface area.The use of mesh has led to the rise of side effects related to mesh erosion which is not seen in any other surgical practice.Erosion is defined as damage to the wall of neighbouring area and mesh replacing the vaginal wall.The rate of erosion due to vaginal mesh in genital organ prolapse surgery has been reported to be 5–8%,whereas the rate of erosion attributed to midurethral sling operations has been reported to be 1–2%, but with lesser severity.VACS-D will disrupt existing applications for treatment by lowering the costs of healthcare,making it more accessible by a larger population and also providing a pain free, long-lasting solution that will also increase the quality of life as the world population age increases. VACS-D helps a major part of population as "women" NOT only important for themselves but also for the sustained quality of motherhood as they raise the next generation.VACS-D is a disruptive innovation, presently novel and patent pending surgical support device developed by our company,facilitates a new operation approach for treating for treatment of Urinary Incontinence in Women.It enables doctors to carry out surgery via vagina,eliminating the need of mesh through a native tissue repair approach.It is a minimally invasive method requiring only one incision.The device will be very popular among women who afraid to have this operation and having a very low quality of life.
The project conducted under 5 WPs.Under WP2 (Micro-architecture and Design improvement) we found a specialized company on medical designing to improve the architecture of the device.This collaboration helped us to identify different bottlenecks and obstacles with the device and to improve them all.We also collaborated with different companies which help us to select the best materials to improve the quality of the product and to produce the device more economically. However, due to COVID situation companies couldn't provide samples and revised products due to factory closes because of Covid positive cases among their staff.The situation caused delay in our initial plan.In order to further improve the device we created a Scientific Community with participants of 12 gynecologists and urologists from different hospitals/universities in Turkey. We organized many workshops to collect feedbacks and all are used for further improvements of the device.Current version of the device provides the highest level of user comfort through advanced industrial design, the best material selection and necessary safeties for doctor and patient. As a result of those joint work,final version of the device composed of 20 different pieces works efficiently. Also,none of the available needles were compatible with our device therefore, together with solution providers, our engineers developed a new needle. To load the needle efficiently and easily into the mouth of device, a special “needle box” designed,developed and produced.In addition, a safety mechanism added on device to control the needle transfer from one side to other successfully.Those additional specifications also added to our patent application.While working on the improvements of the device, a contract signed with a Clinical Research Organization (CRO) to conduct cadaver and clinical studies (WP3).After these permissions, the research team carried out cadaver studies with the very final product and results were 100% satisfactory. In collaboration with CRO, it's planned to prepare all ethical paperwork and to apply for necessary permissions for clinical studies (WP6) but we couldn’t start the clinical trials due to Covid.After successful and very positive feedbacks from very first two cadaver studies with earlier version of the device,we accelerated the process to obtain the CE Mark, Class II a (WP4) We received professional services to prepare technical files for CE Mark application and conduct all necessary tests (biocompatibility, irritation etc.) to apply for CE Mark.The CE Mark successfully obtained in the third week of May 2021. Currently FDA approval process and product registration to Ministry of Health System (WP4) have started. We are preparing necessary files for Clinical studies. It is expected to start recruiting participants in clinical trials at the beginning of October 2021.Main results achieved in Period 1;
a)Improved design and usability of the device,
b)Enhanced durability with strong safety mechanism,
c)Successful production of final version of the device,
d)Successful caver studies with the latest version of the device with good results,
e)Obtained CE Mark.
f)Patent,design and trademark protection in EPO,Canada and US.
In second period,we'll follow up our application to Ministry of Health for permission to sell medical device in Turkey so that Soranus Co.will be able to operate in domestic and external markets.Other critical issue is the FDA approval which allows us to export the device to US and Canadian market.Other important activity is the clinical trials in Turkish hospitals.We expect to have permissions from Ministry of Health in 3 months’ time,FDA Approval 6 to 8 months and first results of clinical studies in first quarter of 2022. We're expecting that our device will be the main instrument for treatment of Urinary Incontinence which millions of women are effected around globe.The mesh-free approach won't have any side effect but provide permanent solutions for patients. This will improve the quality of life of millions of women and help them to socialize and able to live without urine leakage problem.Besides improvements women quality of life,it will create jobs for mainly educated people.Furthermore,the product has huge export potential both in EU and outside the EU as well.In sum,while providing permanent solution for SUI patients,this product will help women to socialise,able to work and remove pad using in their daily life,it will also create jobs for people,generate high revenue for the company and more export for Turkey as well as the EU.
Cadaver Studies and Process-6
EC CERTIFICATE
Cadaver Studies and Process-5
Cadaver Studies and Process-2
Cadaver Studies and Process-3
VACS-D State of the Device
Cadaver Studies and Process-7 Closure
Cadaver Studies and Process-4
VACS-D