Turn Therapeutics® Update On The Company’s Response To COVID-19
EMERGENCY USE AUTHORIZATION REQUEST FILED FOR THE USE OF HEXAGEN® AS AN INTRANASAL BARRIER TO AIRBORNE PATHOGENS INCLUDING SARS-COV-2/COVID-19
Scientists have determined that SARS-CoV-2 pathogens target cells in the nose. Given the vulnerability of this site and years of documented safety and efficacy of the product, we believe intranasal application of FDA cleared Hexagen® could serve as an important enhancement to traditional personal protective equipment, such as facemasks.
Our Response to COVID-19
Turn Therapeutics® has proposed to FDA that petrolatum-based Hexagen® be applied via sterile swab to the nasal epithelium as extended-wear, intranasal PPE to prevent exposure to such airborne pathogens as SARS-CoV-2 at this highly vulnerable site. Recent research has identified evidence that cells in the nose (goblet secretory cells), lungs (type II pneumocytes), and intestines (absorptive enterocytes) may be particularly susceptible to COVID-19 infection based on their cell-surface receptors, which further supports the use of Hexagen® as an intranasal barrier for non-infected individuals. New research has also corroborated the theory that COVID-19 likely enters the body through the nose, as nasal epithelial cells have the highest concentration of the proteins that COVID-19 targets of any surface in the airway.
Hexagen® vs. Coronavirus
Hexagen is non-irritating, non-sensitizing, and causes zero damage to healthy cells.
Hexagen may provide an additional layer of protection for healthcare workers, first responders, and everyday citizens during the Covid-19 public health emergency.
We're in this together
For every Hexagen product sold, we’ll donate one to others in need, starting by donating our existing supply immediately to healthcare workers and first responders. This is a time to unite to fight and heal, together.
Hexagen and its formulaic twins (CurX® and AtopX®), were initially created and marketed as a non-antibiotic, equally gentle alternative to first aid antibiotics such as Neosporin and Polysporin. The formula’s active ingredient, Benzalkonium Chloride (BZK), is commonly found in other antiseptics such as Bactine and alcohol-free hand sanitizers. The difference lies in Turn Therapeutics’ Permafusion Technology, which permits Hexagen to administer a strong dose of permanently suspended, liquid BZK over an extended period of time, while also being non-cytotoxic, non-sensitizing, and non-irritating to human tissue and mucous membranes.
The use of Hexagen has evolved over time. It was originally produced to be a competitor to Neosporin. In this labeling, it was named CurX and marketed for over the counter use. Over time, wound experts across the country increasingly remarked that CurX had potential beyond the first aid realm. In fact, studies were showing that it was serving as a much-needed replacement for antiquated, standard of care chronic wound products for such conditions as diabetic ulcers, burns, trauma wounds, and more.
As a result, Turn filed for 510(K) clearance to compete in this market with the proper labeling. Upon receiving clearance from the FDA in 2016, Turn withdrew CurX from the OTC market and relaunched it as Hexagen, then made it available to medical professionals for Rx only, acute and chronic wound care.
Hexagen has been certified by FDA as non-cytotoxic, non-sensitizing, and non-irritating to human tissue. Additional, ISO 10993 testing has confirmed it safe on mucous membranes. We recommend anyone with a history of allergies to the ingredients not use it, but we have not received reports of any adverse reactions.
Hexagen was tested using an ASTM 1052E suspension time kill protocol against human coronavirus in an FDA licensed, BSL2 certified laboratory. The full results of the tests can be found here. Hexagen was successful in killing over 80% of coronavirus present within 10 minutes, with a vertical kill curve suggesting continued and increasing kill over time. Given the petrolatum base, Hexagen can be left in the nose/on the tissue for multiple hours, although we recommend 2-3 applications per day to ensure consistent and thorough decolonization. In its chronic wound labeling, the FDA cleared Hexagen to be left on delicate, breached tissue for 72 hours between dressing changes.
Hexagen has been cleared for chronic wound care by the FDA. It’s prior offering, CurX, was offered as an over the counter antiseptic ointment. We have new data that supports Hexagen may be effective as a nasal decolonization ointment against human coronavirus, which is currently being reviewed by the FDA for an Emergency Use Authorization.
Hexagen is not meant to serve as a replacement for masks or any other PPE. You should always follow current CDC guidelines on how best to protect yourself.
Hexagen is available for prescription use for acute and chronic wound treatment, and is the subject of an EUA under review with the FDA for its use as a nasal decolonizing ointment with activity against human coronavirus. Turn is currently working to scale up production of Hexagen to make the product more widely available in the event EUA is granted.