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

Project Information

VACS-D

Grant agreement ID: 954909

DOI

10.3030/954909

Project closed

EC signature date 22 April 2020

Start date 15 June 2020

End date 14 June 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 976 250,00

EU contribution

€ 683 375,00

Coordinated by

SORANUS ARGE VE DANISMANLIK HIZMETLERI SANAYI TICARET ANONIM SIRKETI
Türkiye

Periodic Reporting for period 2 - VACS-D (Vaginal Arco-ColpoSuspension Device for the treatment of Urinary Incontinence in Women)

Reporting period: 2021-06-15 to 2022-06-14

Summary of the context and overall objectives of the project

Urinary incontinence refers to unintentional loss of urine.Stress incontinence happens when physical movement or activity (coughing,sneezing,heavy lifting) puts pressure (stress) on the bladder.Stress incontinence is the most common type of urinary incontinence.Invasiveness is reduced with the advent of MUS which associated with less blood loss,less pain,fewer complications, faster recovery and better cosmetic results.The mid-urethral sling procedure was rapidly adopted due to technical convenience following the success of treatment similar to abdominal colposuspension.Its popularity equaled the abdominal colposuspension approach within only 5 years and accounted for 90% of all total urinary incontinence operations.However use of sling material (polypropylene synthetic mesh) may cause graft-related complications.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.Meshes have the same structural features as the mid-urethral sling but have a wider surface area.Use of mesh has led to rising of side effects related to mesh erosion which isnt seen in other surgical practice.VACS-D will disrupt existing applications for treatment by lowering the costs of healthcare, making it more accessible to 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 the population as "women" are NOT only important for themselves but also for the sustained quality of motherhood as they raise the next generation.VACS-D is a patent-pending surgical support device facilitates a new operation approach for treatment of Urinary Incontinence in Women.It is eliminating the need for mesh through a native tissue repair approach.Its a minimally invasive method requiring only one incision.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Under WP2 we found a specialized company in medical design to improve the architecture of the device.It helped us to identify different bottlenecks and obstacles with the device and to improve them.We collaborated with different companies to select the best materials to improve the quality of the product and produce the device more economically.To further improve the device, we created a Scientific Community with 12 gynecologists and urologists from different hospitals/universities in Turkey.We organized workshops to collect feedback and all 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 safety for doctors and patients.Final version of the device composed of 14 different pieces works efficiently.Together with solution providers our engineers developed a new needle fits with device.To load the needle efficiently and easily into the mouth of the device,a special Suture Loading Apparatus was designed,developed and produced.In addition a safety mechanism was added to the device to control the needle transfer from one side to other successfully.While working on the improvements of the device,a contract was signed with a CRO to conduct cadaver and clinical studies (WP3).The research team carried out cadaver studies with the very final product and the results were 100% satisfactory.In collaboration with CRO, its prepared all ethical paperwork and applied for necessary permissions for clinical studies (WP6).After successful and positive feedback from cadaver studies with an 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 which successfully obtained in the third week of May 2021.The clinical study was realized in two different centers in Turkey (WP3).The first one was Ege University Hospital and the second one was Istanbul University Hospital in Istanbul with 60 patients. Based on the researchers' feedback the duration of operation,length of hospitalization,and recovery time are the same in the two groups (VACS and TOT).We will have the 6 months outcome in December 2022, and one-year results in June 2023.After all we successfully received investments from two Angel investors and joined into the Soranus board with valuation of 15 million USD.We proudly acknowledge that EIC support helped us to create a 15 Million USD valued company in two years’ Main results achieved;Improved design and usability of the device,Enhanced durability with a strong safety mechanism,Successful production of the final version of the device,Design and development of special needle,Design and development of suture loading device,Application of a new utility and design patents,Successful caver studies,Successful clinical study,Obtained CE Mark,Receiving investment

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Functionality:The device has been improved with a new mechanism and complementary apparatus.This brings good trust to a medical device with CE Mark which will gain trust both from doctors and patients and this will create high demand for the device. Being unique in the market:The device has been projected by applying for utility and design patents in the US, Canada, EU, China, Japan and Turkey. As of today, there are no similar patents and technology available in the market.This makes our device unique and attracted the interest of many medical device manufacturing companies and VCs. From the business side, this interest shows the future business potential of our device.Commercialization strategy: We are working on three different commercialization strategies.First is production and sales by the name of Soranus.The second is licensing the production to other international companies and receiving a royalty from sales.The third and final strategy is the exit from big medical device manufacturers.Market size and revenue generation: It is estimated that the total available market for MUS is over 500.000 units per year but the actual market can be higher since due to unavailable permanent treatment many patients aren't included in this market.We expect that our device, which is based on natural tissue repairing (no mesh) will naturally increase the size of the total available market as soon as it is introduced into the market.Our device is targeting the market which has been growing and with no competitors.In the first 5 years,we're targeting to sell a minimum of 1.250.000 units. Job creation: VACS-D is a value-added device and its production requires knowledge in biomedical,mechanics,design and quality control.Therefore the mass production process requires highly skilled employees.The marketing of the device also requires special expertise and good sales skills in the medical device sector and network.Third the collaboration with different stakeholders such as regulatory offices,government bodies,solution partners,distributors and even competitors requires expertise.Our company will hire people from different backgrounds and from different countries which will be well educated, highly skilled and with international experience.We are targeting to hire 5 engineers,10 sales and marketing experts,3 regulatory officers and 25 employees for the production activities in the first 2 years after the product launch.

CE CERTIFICATE

Cadaver Studies and Process-5

Cadaver Studies and Process-7 Closure

Cadaver Studies and Process-3

Cadaver Studies and Process-6

Cadaver Studies and Process-2

Cadaver Studies and Process-4