NASAL PROTECTION AGAINST AIRBORNE VIRUSES.
Taffix ™ is legally marketed in Europe (CE- DE/CA09/0760/N18/001) with the following Indication for Use:
TaffiX ™is indicated for use as a protective mechanical barrier against allergens and viruses within the nasal cavity.
Taffix ™ is approved in Israel (Amar: 33010001) with the following Indication for Use:
Taffix ™ is intended for use to block inhaled viruses and bacteria within the nasal cavity.
Safety of Taffix reaffirmed
A leading biopharma company and makers of rapid delivery innovation for life-saving medicines – Nasus Pharma – stands behind its nasal spray, Taffix, reassuring the public of its safety and clinical efficacy. Taffix is built on an existing, proven, medical technology, which is already used in many nasal sprays to combat allergies and the common cold viruses.
Contrary to the wording in an email regarding Taffix Nasal Spray sent to customers in some countries by a retail company selling the product, Taffix is totally safe and legitimately available for sale in Europe by reference to its valid European Conformity market.
Dr Dalia Megiddo, co-founder and chief executive officer of Nasus Pharma, stresses: “Taffix is safe and legally marketed in Europe under CE certification as an over-the-counter general medical device product. It is indicated for the use as a safe, protective mechanical barrier against allergens and viruses within the nasal cavity. Manufactured to the strictest of compliance to all regulatory
requirements, Taffix has been used by hundreds of thousands of people across the globe and there have been no health or safety concerns reported in relation to its intended conditions of use.
“Confusion has arisen because the Spanish authorities have taken the view that Taffix should be classified as a Medical Device Class III and not Class I product in Spain. This opinion is not consistent with the classification position of the countries within the European Union (EU) and of every country in the world that has approved Taffix. While we respect the Spanish Ministry position, we do not agree with it. Guided by all the experts we work with; we do not accept the validity of the Spanish Agency’s assessment and will be working closely with the authority on this matter.” Dr Dalia Megiddo adds: “As a company, safety and clinical efficacy is best practice which is why we have tested Taffix thoroughly. ” 1 Sold in over 20 countries across Europe, America, Asia and Africa, Taffix is not a replacement for masks, it is an additional layer of self-care protection, particularly useful in high-risk settings such as any enclosed space.
*Taffix should be used in addition to wearing a face mask, practicing social distancing, washing your hands regularly and complying with government restrictions.
General
While the COVID-19 pandemic brought the economy to standstill world-wide, protection of the civil population is critical to overcoming the infection.
The next phase – “Back to Normality” is the primary objective of governments and public health focused organizations. Preventing a “second wave” while returning gradually to normality will necessitate strict preventive measures.
The Taffix™ (Powder) Spray Device is indicated for use against allergens and viruses within the nasal cavity.
A prospective clinical post marketing users survey demonstrated that Taffix™, was able to reduce infection rate of SARS-CoV-2 virus after super spread event by at least 4 fold.
Nasus’s user survey was conducted in Bney Brak- a city that tops Israel’s list of COVID-19 infection and mortality. Members of a synagogue community were offered the use of Taffix and instructed to use it when approaching a highly populated environment. The survey was planned ahead of Rosh Hashana ( the Jewish new year) – an event that involved many hours spent in close proximity among prayers for at least 7 hours each day for 2 consecutive days and was defined as a super spread event. Users and non users among the synagogue community were followed up to 14 days after the event.
Rate of infection among non users was 10% ( 16/160,) while rate of infection among Taffix users was 2.4% ( 2/83 ITT, p=0.037) or 0% ( 0/81 PP p=0.002). At the same time period the general infection rate in the city of Bney Brak increased by some 60%,
* Klang Shmuel, Megiddo Dalia, Lapidot Tair & Naparstek Yaakov (2021): Expert Review of Anti-infective Therapy, DOI: https://doi.org/10.1080/14787210.2021.1908127
The nose is the primary route of virus infection through airborne droplets that contaminate mainly the nasal mucosa
Respiratory viruses and coronaviruses are sensitive to acidic pH. Acidification of the nasal mucosal microenvironment through acidic solution or acidic gel proved to be highly effective in Influenza and Rhinoviruses
Lamarre A, Talbot PJ. Effect of pH and temperature on the infectivity of human coronavirus 229E. Can J Microbiol. 1989;35(10):972–974. doi:10.1139/m89-160
Treatment of nasal mucosa in acidic saline reduced viral load within 1 minute in 3 log cycle. Acidified nasal gel reduced viral load in 5 log cycles P. Rennie, P. Bowtell1, D. Hull1, D. Charbonneau, R. L-Williams and J. Oxford; Low pH gel intranasal sprays inactivate influenza viruses in vitro and protect ferrets against influenza infection. Respiratory Research 2007, 8:38 doi:10.1186/1465-9921-8-38
HPMC – a well-known and safe pharmaceutical excipient is known to create a thin gel over mucosal surfaces, and is used in artificial tears as gel forming protection and as nasal powder against allergic rhinitis
Nasus unique technology creates uniform small
microspheres that create an even thin gel over the nasal
mucosa.
The Taffix™ (Powder) Spray Device is indicated for use against allergens and viruses within the nasal cavity.
Efficacy of Taffix™
The efficacy of TaffiX™ – HPMC gel in blocking viral invasion into cells have been researched by Nasus. Our results demonstrated that Taffix™ is able to block viruses from infecting cells and thus preventing infection.
Laboratory Studies:
In a series of in vitro studies Nasus tested the efficacy of Taffix™ in preventing viruses from infecting cells
Taffix proven effective against respiratory viruse
1
Taffix protected healthy cells
2
Virucidal Activity of Taffix
Figure 4: MDCK cell viability – H1N1 influenza virus:
Taffix™ reduced cell death caused by H1N1 influenza virus by 90%: MDCK cells were treated with H1N1 influenza virus and their viability was tested. Viruses were pretreated by Taffix™ or saline for 5 minutes or 30 minutes prior to infection. The results show the highly protective effect (90%) of Taffix™ in maintaining cell viability.
*Taffix should be used in addition to wearing a face mask, practicing social distancing, washing your hands regularly and complying with government restrictions.
3
High efficacy
In another study, the efficacy of Taffix™ was tested in preventing viral invasion into HEK293T cells. In this study, GFP lentivirus was used based on its ability to insert a GFP fluorescent gene into infected cells thus enabling the identification of virus-infected cells.
Taffix Technology Advantages
