Surgical Medical Equipment Business Plan

Bioring SA addresses the surgical repair techniques which are implemented in open heart surgery. This business is based on a patented product owned by the company, which is the Kalangos Biodegradable Ring cardiac implant.

The Bioring biodegradable valvular heart ring (Kalangos mitral or tricuspid ring) has been developed and designed to diminish or reinforce the valvular orifices of the heart. The ring allows a normal growth of the valve in newborn and babies, avoiding stenosis and multiple surgical procedures.

The ring is dimensioned to the size and natural geometry of the valve, and it is manufactured with a specially designed biodegradable polymer called polydioxanone. Once implanted, through the regular absorption of the ring inside the endomyocardiac tissue by simple hydrolysis, the body creates (by reaction) a scar along the ring, characterized by fibrotic tissue presenting an improved resistance to elongation. Once the ring has been completely biodegraded, the rigidity of the fibrotic tissue of the scar is maintaining the valvular orifice at the desired dimension.

As the residual scar is made of the proper biologic tissues of the patient, there is no predisposition to infection, and furthermore, the scar is able to grow normally during the growth process of the newborn.

The Kalangos mitral ring is available in 11 dimensions, covering all phases of development and all adult sizes. The Kalangos tricuspid ring is also available in 11 dimensions. Sizers have been designed to help the surgeon surgeon to choose the right ring dimension.

3.1 Product Description

 As of June 2001, Bioring SA has 44 products to sell:

• Kalangos Mitral Biodegradable Ring: sizes 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36.
• Kalangos Mitral Sizers: model size 16, 18, 20, 22, 24, 26, 28, 30, 32, 24, 36.
• Kalangos Tricuspid Biodegradable Ring: sizes 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36.
• Kalangos Tricuspid Sizers: model size 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36.

3.2 Competitive Comparison

There are already existing heart rings on the market: Duran, Carpentier, Puig-Masada, Cosgrove, but none of them produce a biodegradable ring. The major benefits of Kalangos rings when compared to existing products available on the market are:

• Avoiding multiple surgical procedures (newborn and babies).
• Lowering the risk of local infection.

And moreover, the ring is attached to a suture-needle system which makes the surgical procedure easier and faster.

3.3 Sales Literature

Bioring advertisements and sales literature are under development.

Bioring is registered on the Web page of the Chambre Vaudoise du Commerce et de l’Industrie. The company intends to have its own presenting page on the Web once the products have been CE marked. 

3.4 Sourcing

Bioring SA manufactures its own products, using its in-house development process. The raw materials are provided by a major chemical supplier, which delivers to Bioring SA a customized polymer.

An injection molding press has been specially designed and installed to inject the polymer into the proprietary molds.

All operations, including the packaging of the final product, are done in a controlled environment: class 100 clean room.

The list of suppliers is considered as proprietary information, which is not disclosed here.

3.5 Technology

Bioring Kalangos biodegradable rings have been internationally protected by patent. A Swiss patent application has been filed in 1997, followed by a worldwide PCT application filed in 2000. Copies are available.

A trademark application is in progress.

3.6 Future Products

The Kalangos biodegradable rings have ben developed following a market need and demand in pediatric surgery. Moreover the present existing rings are subject to very restrictive applications in neonate surgery in USA. This is due to the used material. As a result of this situation, a collaboration between a Swiss cardiac surgeon and a Swiss biomedical engineer led to the creation of Bioring SA. Together, they conceived a new concept which opens new perspectives in the field of cardiovascular surgery. This concept was tested as a prototype, and the achieved results motivated the partners to create the company in order to patent, develop, manufacture and commercialize the new cardiac implant. The long term strategy at five years is to penetrate 35% of the newborn market (40,000)  and 10% of the adult market (200,000). All together, this means around 35,000 biodegradable rings implanted per year.

The development of the biodegradable polymer may meet other very promising applications in the fields of cardiac and vascular surgery. We are presently in the process of writing the extension of the initial patent and testing the very first prototypes of new implants. No information can be given at this stage.