The global leading causes of death are cardiovascular issues (including heart disease and stroke), cancers, Alzheimer´s and other forms of dementia, and hospital acquired infections (HAI).
•5-10% of all hospitalizations result in a type of HAI, resulting in about 5 million patients per year between US and EU.
•All patients are susceptible to HAIs, but certain characteristics such as underlying diseases, implanted medical devices, injections, communicable diseases or recent surgeries increase the chances of HAI.
•Many nosocomial diseases are caused by antibiotic resistant bacteria, fungi, viruses, and other pathogens.
•HAIs also cause infections in the bloodstream, pneumonia, urinary tract infections, meningitis, gastroenteritis, and much more.
•Common HAIs include catheter-associated urinary tract infections (CAUTI), central line-associated bloodstream infections (CLASBI), surgical sit infections (SSI), and ventilator-associated events (VAE).
•These illnesses have a high mortality rate (12-25%) as they can often lead to sepsis and/or death.
Tractivus proprietary patented technology consist of a unique nanostructured metallic coating that creates a superhydrophobic environment where water, mucous and different body fluids are not able to swell or attach. This behavior, similar to a lotus leaf, shows antifouling properties avoiding bacteria attachment with no biofilm formation.
Tractivus has developed PHOBOSTech™, a coating technology that prevents bacterial colonization of medical devices. This technology has been implemented in two medical devices, urinary catheters and tracheal stents. These 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.
Tractivus and PHOBOSTech™ have been developed over the years as a solution to the current problems of medical devices. The technology was born as 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, stakeholders... aiming to maximize the success of both the project and the investors.
The global Medical Implant market is estimated to expand enormously up to USD 171.5 Billion with a CAGR of 7.7% between 2016 and 2023.
US and Europe hold most of the stock as of now, but LAMEA´s and Asia Pacific´s shares will increase as the need for implanted devices increases and the countries continue developing.
The main issues with infected implanted devices can be represented as the following products by demand.
Several illness and diseases are primarily treated with medical implanted devices. The driving force of the market is the increasing need for these devices in patients.
As previously mentioned, the urinary catheters are highest in demand, followed by respiratory devices (endotracheal tube and tracheal stent), and central venous catheter (CVC).
The global medical device market is vast as it consists of standard devices, medicated devices, and coatings for devices. The competitors are medical device companies such as Bard, Rüsch, Covidien, Coloplast (urinal) or Stening, BESS, Hood Laboratories (tracheal). These companies offer one of these services and/or products. Each product aims to alleviate patients of pain and illness, but most times these devices are the cause of HAIs. Standard medical devices do not protect against infections and have to be replaced regularly for that reason. Coated and medical devices aim to avoid infection and reach the expected life of the device in the body, but they use antibiotics to do so. As previously stated, the use of antibiotics in the medical field is often avoided as it decreases the bodies immunity against AMR bacteria.
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.
In order to achieve Tractivus’ goal, a development plan has been designed. Currently, the project has performed all the laboratory in vitro and in vivo validations to create the final product specifications.
One of the main points of Tractivus development consist on the manufacture package where all the technology and products are completely optimized and scaled to be implemented in the manufacture chain of the industry. Therefore, currently the manufacture plan has been implemented into obtain the first regulatory batches at Q3 2019 (according to ISO 13485).
Finally, regulatory strategy has been implemented and in the following months the products will start the validation and certification tests to increase the value and creates the selling package.
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. Aiming to obtain the CE mark through a preclinical validation and a human safety study, we have been carefully study different scenarios. 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.
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.
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.
Over 12-25% of hospital deaths are related to HAIs, results in 210,000 dead patients in US and EU per year.
In addition to cost of initial care in hospital, the treatment for HAIs include hefty health care associated costs. It is approximated that the overrun medical costs for patients of these infections range from $28-45 billion. The implanted devices in the body commonly suffer bacteria colonisation and need to be treated immediately. HAIs are treated primarily with prevention, and to avoid infection, the devices are frequently replaced. However, if a patient contracts one, they are then treated with antibiotics. Unfortunately, bacteria creates a resistance to the antibiotics, decreasing the effectiveness of the drugs.