1. What is the problem?
Implantable medical devices suffer high rates of bacterial colonization (between 40-90% depending on the device during the first 3 days and the first month). This complication causes an infection of the patient, which can lead to sepsis, morbidity and death.
2. What is the oportunity?
Currently, around 5 million people a year (between the US and EU) suffer from nosocomial infections, considered the 4th cause of death in the US, being the urinary and respiratory infections two of the most common. Directly, 70% of these infections are caused by implantable medical devices.
Current palliative treatments addressed to solve the problem of bacterial colonization are not effective, as they are only aimed to treating the symptoms. Antibiotic blisters only reduce the symptoms of the patient's infection, but do not eliminate (or prevent) colonization of the infected device which acts as a bacteria reservoir. In addition, the associated cost of these treatments addressed to mitigate the complications of the infections supposes an annual health cost overrun between 30-40 billion dollars per year between the US and EU.
3. What is the solution?
Tractivus has developed the PHOBOSTech™ technology that consists of a superhydrophobic coating that self-protects the medical device preventing bacteria from adhering and colonizing the device. PHOBOSTech™ does not act on the patient but prevents the device from colonizing and prevents the device of being a source of infection.
4. Has Tractivus a technology or products?
Tractivus has developed PHOBOSTech™, a coating technology that prevents bacterial colonization of medical devices. However, this technology has been implemented in two medical devices, a urinary catheter and a tracheal stent. The two products have been validated both in vitro and in vivo, showing excellent results compared to commercial gold standards. Currently, both devices are in the manufacturing phase of preclinical batches for subsequent validation.
5. Why Tractivus is different?
Tractivus and PHOBOSTech™ have been developed over the years as a solution to the current problems of medical devices. The technology is the result of a collaboration between two highly prestigious research groups, GEMAT (IQS) and IDIBELL (Hosp. Univ. De Bellvitge). Tractivus combines the experience of the research groups and a unique solution designed to root out the colonization of the devices through a micro- and nano-structured coating that protects the device from adhesion and bacterial colonization. The team has worked on all aspects of the development: material selection, regulatory strategy, risk reduction, clinical trials, partners, clients ... with the aim of maximizing the success of both the project and the investors.
6. What is the market?
in 2017 - $ 4.8B in 2025) and the tracheal stents market ($ 100M in 2016 - $ 105M in 2025). However, the technology is intended to be applied in other devices such as central intravenous catheters ($ 0.8B in 2016 - $ 1.2B in 2025), the rest of non-vascular stents ($ 816M in 2016 - $ 857M in 2025) or endotracheal tubes ($ 1.6B in 2016 - $ 2.5B in 2023). Only the coatings market dedicated to medical devices consists of $ 0.6B in 2015 - $ 1.2B in 2020.
7. Who are the competitors?
The competitors are medical device companies such as Bard, Rüsch, Covidien, Coloplast (urinal) or Stening, BESS, Hood Laboratories (tracheal). However, none of the tracheal companies have an anti-infectious solution and the rest (the urinary companies) do not have an anti-infectious solution or use antibiotics or bactericides without effective results and with a high manufacturing cost.
8. What is the business model of Tractivus?
Tractivus has decided to focus on its own capabilities and not invent the wheel. For this, Tractivus has designed its strategy based on its technology development capabilities and aims to outsource to third parties (large medical device company) the distribution and sale, through a license / sale model of the company (or technology). It is a common strategy of this type of companies and products and, recent acquisitions (7 years) of products / technology in medical devices by large companies in the sector showed about $ 100-150M average sale.
9. Will be Tractivus going to manufacture?
Initially, Tractivus will manufacture the first batches for regulatory validation and then, it will depend on the type of agreement with the licensee. Mainly, the sales strategy of Tractivus does not include manufacturing, since technology would be integrated into the structure of the third party. However, there is a possible licensing scenario in which Tractivus could manufacture the coating for the licensee.
10. Who will be your clients?
The customers are directly companies that manufacture medical devices.
11. Do you have connections with future clients?
Tractivus has initiated contacts and relationships with third parties for the possible acquisition of the technology and products.
12. Do you have a regulatory strategy?
Of course, from the beginning we have been working on the regulatory strategy and how it affected the development, costs and schedule. A regulatory strategy based on the properties of the structural coating has been defined and, therefore, the classifications of the medical devices are not altered. This fact and the type of devices make it possible to obtain the CE mark through a preclinical validation and a human safety study. The study / clinical validation is considered to be carried out post-marked CE to present clinical evidences and to be able to introduce the products in the market with guarantees.
13. Do you have an IP of your technology?
The PHOBOSTech™ technology and the resulting products with the described characteristics are protected by patent. Currently, the patent is validated in the EU, Australia and national phases are being processed in the US and the rest of the designated countries. In addition, technology derivatives are being worked on.
14. What is your development strategy?
As detailed, the strategy of Tractivus consists in the preclinical validation of the products, obtaining the CE mark and the subsequent clinical validation. This fact allows to generate value in each one of the different steps. Currently, work is being done on the manufacture of preclinical batches and it is expected to obtain the CE mark by the end of the 2020 beginning 2021.
15. When will you get your products to the market?
According to the plan outlined, the products can go to market in 2021.
16. Do you have an exit strategy?
Of course, two scenarios are contemplated, a first scenario at the beginning of 2021 (once the CE mark has been obtained, through a capital increase or through the sale of the company) and a second scenario after carrying out the CE and the post-marked clinical validation (through the sale / license of the company).
17. Do you have a plan B?
Always. Initially, the first scenario consists in the validation of the technology through preclinical, CE and clinical validation with the objective of maximizing the profitability of the investment. However, alternative scenarios are contemplated, such as the company sale before clinical validation, the technology license being Tractivus the supplier of the coated devices to the third-party and their variants.
¿Do you know about TRACTIVUS? If not, we attach a brief FAQ to analyse the potential of the project and to solve some doubts.