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Primer tornillo óseo sin implantes sintéticos para tratamiento quirúrgico de fracturas, mala posición y enfermedades de los huesos

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOAT20180326001
Publicado:
27/04/2018
Caducidad:
28/04/2019
Resumen:
Una pyme austríaca ha desarrollado los primeros tornillos funcionales para fines médicos y quirúrgicos que están hechos de material óseo biológico humano. Estos tornillos se emplean para reconectar o estabilizar huesos dañados en caso de fracturas óseas o artrosis de manos, codo, rodilla o pies (osteosíntesis) sin necesidad de implantes metálicos. De esta forma, el tornillo mejora el proceso de cicatrización y el bienestar del paciente, a la vez que permite reducir costes. El tornillo óseo combina las ventajas de un tornillo con las de la matriz ósea humana. La empresa busca socios con el fin de establecer acuerdos de comercialización, licencia y fabricación.

Details

Tittle:
Worldwide first bone screw without synthetic implants for surgical treatment of bone fractures, malpositioning and diseases
Summary:
An Austrian SME has developed the first functioning screws for medical and surgical purposes which are made of human biological bone material. These screws are used to (re)connect or stabilize injured bones in the case of bone fractures or arthrosis without the need for metal implants. In this way an improved healing process and an improved welfare of patients can be reached while costs are reduced.
The company is looking for commercial, licence and manufacturing agreements.
Description:
An Austrian company with a surgical background developed (within the past 10 years) the worldwide first functioning screws for medical and surgical purpose which are made of human biological bone material. These screws are used to (re)connect or stabilize injured bones in case of bone fractures or arthrosis of hands, elbows, knees or feet (osteosynthesis). In Austria alone about 40,000 osteosyntheses of injured bones are conducted each year.

State of the art technologies use metal screws and plates for osteosynthesis which can irritate the biological matrix and cause inflammations. This may lead to (chronic) pain or suboptimal healing of the treated regions. Furthermore these implants often have to be removed in a subsequent operation resulting in costs and bothering the patient. Alternatively materials based on magnesium or plastic can be applied for osteosynthesis. These materials are intended to dissolve while the surrounding bone is regrowing but commonly they dissolve to quickly or too slowly. Consequently the physical stability can become insufficient and bones can move. Furthermore the rebuilt material is not bone material but fascia and dissolving materials may be carcinogenic.

The bone screw combines the advantages of a screw with those of the human bone matrix: The bone screw itself ensures stability while the body´s own tissue is growing through the bone screw within several weeks. Already about one year after implantation the bone screw can not be detected anymore on x-ray images since it is transformed into endogenous bone material.
The bone screws are available with diameters from 3.5 mm to 5.0 mm, a length of 35 mm and a 1/100 mm precise fine thread. Once implanted the screw head is milled off whereby the screw length can be shortened to the desired length. Within the first 2h after insertion the transplant swells by 2% which enhances its stability in the surrounding bone material. Operation instruments such as drills, tap and die sets or sterilization containers are supplied by the Austrian company.

Quality -Y- Safety:
1) Quality management:
- Certifications DIN EN ISO 13485 and DIN EN ISO 9001
- Each donor is screened for diseases as there would be no sterilization following
- Bone material is sterilized as there would be no screening in advance
- Total traceability of all transplants
2) Human transplants fulfill high regulatory and legally defined requirements
3) Experience with more than 350,000 transplants. With none of these transplants a transfer of microbiological or viral infections was attested after implantation.
4) All bone transplants are free from antibiotika, and animal constituents
5) For sterilization of the bone screw a peracetic acid-ethanol procedure is applied in clean rooms (class A), so no gamma sterilization is necessary.
6) The bone screws are sterile packed and storable for 5 years at 25 °C.
7) Clinical case studies show advantageous results as explained above.

Awards:
National award with the focus on efficient and strategic handling of innovations and IPRs to develop marketable products.

Partner sought:
1) Potential partners should be capable of distributing the technology and should ensure a professional support for surgeons and operating staff. The Austrian company expects the cooperation partner to be in close contact with surgeons to get direct feedback from operating staff for further product developments. A licence agreement or a commercial agreement is sought for this type of cooperation, depending on the state of the actual patenting process in the targeting country.

2) The company is open for cooperation with tissue banks, which are capable to supply sterilized bone tissue. A manufacturing agreement is sought for this type of cooperation.
Advantages and Innovations:
The main advantages of the bone screw are:

1) Improved healing process, improved welfare of patients:

- Bone fixation without metal implants
- Biocompatible -> less complications, no immunologic reactions causing inflammations
- Perfect fit -> screw can be milled off easily if it is protruding -> decreased inflammation risk
- Transformation of the implant into endogenous bone material within a year
- Postoperative pain reduced to a minimum
- New solutions for difficult indications
- Faster healing
- No follow-on operation necessary (removal of metal implants)


2) Cost reduction:

- Less complications -> 434 Euro savings per complication / re-op in Austria
- No need for removal of metal implants -> 141 Euro savings per operation in comparison to state of the art technologies (in Austria).
- Small instrument set -> Easy sterilization
- Storable for 5 years at 25 °C -> reduced storage and sterilzation costs -Y- ad hoc ready for operation
- Decreased need for postoperativ medication-> less costs
- Faster healing -> decreased period of sick leaves
Stage of Development:
Already on the market
IPs:
Secret Know-how,Patent(s) applied for but not yet granted,Patents granted,Trade Marks
CommeR Statunts Regarding IPR Status:
Several patents are pending at different stages of internationalization. European patents are granted and world patents (PCT) are published.
Patent protection can be provided in all European countries and beyond.

Partner sought

Type and Role of Partner Sought:

1) Potential partners should be capable of distributing the technology and should ensure a professional support for surgeons and operating staff. A (exclusive) licence agreement or a commercial agreement is sought for this type of cooperation, depending on the state of the actual patenting process and the cooperation partner in the targeting country. Therefor the company should:
a. have an existing distribution network with direct contact to orthopedic specialists and emergency surgeons as well as to other operating staff.
b. have basic knowledge of the classification and regulatory environment of tissue products in the respective country.
c. be in close contact with orthopaedic specialists and emergency surgeons. Based on this close contact the Austrian company aims to gain feedback on the existing products and ideas for new developments.

2) The company is open for cooperation with tissue banks which should supply / manufacture pre-treated (and sterilized) bone tissue. The final processing of the tissue will take place in Austria. In this sense a manufacturing agreement is sought.

3) The Austrian company will provide any support to enable potential partners and surgeons to distribute and to apply the bone screws:
- Initial training of distributing personal (up to 1 week depending on pre-experience of the partner)
- Technical support
- Videos of real surgical operations to guide surgeons into this technology. Based on these videos surgeons should be able to implement operations by themselves.

4) Distribution in Austria and Switzerland is done by the Austrian company itself since the company is interested in keeping direct contact to clinical staff to get better insight into their needs. No distribution partner is needed in these countries.

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
German

Keywords

Technology Keywords:
06001024 Biomateriales médicos
06001017 Cirugía
06001020 Fisioterapia, tecnología ortopédica
06001002 Investigaciones clínicas, ensayos
06001013 Tecnología médica / ingeniería biomédica