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Colostomy closure device, prototypes available

[Category : - HEALTH]
[Viewed 408 times]

Stoma surgery is a mutilating procedure, requiring the formation of an opening between the intestines or urethers and abdominal wall. In most instances, this opening or stoma is permanent, and patients must apply an ostomy pouch for the collection of urine and/or feces. The significant psychological impact of this procedure and subsequent alteration of a person’s body image can impair quality of life. An innovative one-piece soft device for colostomy reversible continence has been developed in order to improve the quality of life of patients who have undergone stoma surgery. This patent is the result of thirty years research and development of the initial one-by-one handmade stiff model that has been already tested by several patients who have declared that it has improved their quality of life without side effects. Only the device stiffness has been deemed uncomfortable by most patients. That is why manufacturing of an industrial model was considered inappropriate at that time. Recently, elastomeric materials and construction technologies suitable for manufacturing of a one-piece soft model have become commonly available, thus allowing the start of the industrial production. StomAid represents a milestone in stoma continence, meets the needs of ostomy patients, it is effective in providing reversible stoma continence comparable to the physiologic voluntary control of bowel contents, being easy to handle by the patient himself, and allows using ordinary toilets at Stomate convenience. Becomes invisible under any garment, but it can also be camouflaged in a naked patient as it can be coloured at will. Should be used no more than 28 days, daytime only, and, in deflated shape, can easily be inserted and extracted by the stoma to allow the discharge of intestinal contents using a stoma bag during the night. It is made by a compound of silicone elastomer, resistant to acids and to the colonization of bacteria, and as well it is resistant to commonly used sanitizing chemical solutions. It consists of a disk shaped as a flattened dome that remains outside the stoma leaning against the skin. The disk itself being integral with a stem with an inflatable balloon of toroidal shape that is applied at the end. The balloon, once inflated into the stoma beyond the abdominal wall, both provides reversible continence of intestinal contents and holds the device in place. The inflating pressure is extremely low and the balloon is elastic. 100 pieces industrial production Pilot Run are available to undergo pre-clinical trials addressed to achieve CE classification and marketing license

Financial information

StomAid®)
The project requires financial partners willing to finance the completion of the project until the achievement of the following listed objectives step by step

Assuming StomAid®) potentially substitute stoma bags market:

Italian ANNUAL STOMA BAGS DEMAND is:
Est. living colostomates n° 21,500
Est. Stoma Bags monthly consumption/pers n° 30 to 60
Est. Stoma Bags annual consumption/pers n° 360 to 720

ANNUAL STOMA BAGS SALES
Est. Stoma Bags annual expenditure /pers - € 1,080 to 2,160
Est. Stoma Bags business volume/year - € 23 to 46 millions

REFINANCING THE COMPANY
Budget (rough)
a) Skills ~ € 276,000.00
b) Device
i) Body no. 100 items ~ € 00
ii) Balloon, n. 100 items, ~ € 17,500.00
iii) Filters (New model)n. 100 items ~ € 17,500.00
iv) Assembly, packaging, sterilization n. 100 items ~ € n.a.
c) CE ~ € 200,000.00
______________________________________________________________ Budget Sub TOTAL ~ € 511,100.00

Sundry payables ~ € 1,428,000.00
______________________________________________________________
ENTRY-FEE (i.e.proprietary capital employed) ~ € 1,939,100.00
______________________________________________________________

MEDICEA MEDICA SRL-
To date, the activity carried out by the company is that of research in the field of biotechnology as it is developing a prototype for enterostomized patients with the Stomaid brand and it is for this reason that the company is still inactive; once the prototype has been defined and the experimentation completed and the CE certification has been obtained, the company will be able to start the production and sale of the device.
-The production will be completely outsourced while the management of order collection and sales will be managed directly by the company.
-The prototype in the definition phase derives from the granting of the license to the company of a patent owned by Dr. Bencini.
Considered to have a purely technological and innovative vocation, the company's assets consist exclusively of intangible fixed assets listed below:
-Start-up and expansion costs:
*these are the costs of setting up the company.
-Development costs:
*made up of the costs incurred for the development of the prototype. -Patent License:
*This is the registered patent relating to the medical device, which
value is quantified on the basis of the licensing agreement.
-Trademark:
*these are expenses incurred for the registration of the StomAid trademark.
-The aforementioned intangible fixed assets, as required by the national accounting standards, are valued at cost, but it is easy to understand that, once the production and distribution of the StomAid medical device has begun, seen at its revolutionary extent in terms of the quality of life of the enterostomized subjects, both the patent and the trademark will have a much higher market value considering
above all the fact that this patent has been registered at an international level.
-The liabilities, on the other hand, consist of:
*Sundry payables, whose amount of € 1,428,000.00 is equal to the book value of the patent, as regards the amount that the company will have to pay to Dr. Bencini, owner-licensee of the same starting from the marketing of the StomAid®) device; Payables to shareholder Bencini, as Dr. Bencini financed the costs inherent in the experimental phase.
-The additional costs involved in bringing the product to market consist of € 511,100.00
THEREFORE ENTRY-FEE is ~ € 1,939,100.00

Patent publications:

US 20180353319

Asking price:

Above 1 million USD

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Seller:

stomaid (Italy)

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