TSO3 Achieves Commercial Milestone and Provides Operational Update

MYRTLE BEACH, SC and QUEBEC CITY, Jan. 7, 2019 /PRNewswire/ - TSO₃ Inc. ("TSO₃" or the "Company") (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that during its fourth fiscal quarter ending December 31, 2018, the Company received an order for the 100^th unit of its industry-leading STERIZONE^® VP4 Sterilizer. In addition to announcing this milestone, the Company also provided an update on its 2018 operational and commercialization activities.

Commercial Activities

During the fourth quarter of 2018, the Company received purchase orders from US and Canadian customers for 21 sterilizers, which represents the highest order rate in the Company's history. When including orders received during the quarter, over 100 sterilizers have now been sold to end customers. When adjusted for committed order backlog, the Company's inventory of sterilizers now stands at 205 units.  As of the end of 2018, the Company had 66 sterilizers installed, 24 sterilizers in backlog for future delivery and 12 units which have been shipped but are not installed at end customer locations.

In the fourth quarter of 2018, the Company filled sales positions for all its planned sales territories. TSO₃ now has 11 dedicated sales specialists covering key North American markets offering better oversight and control over its sales process, increased customer touch points and an improved ability to educate and support prospective customers.

Regulatory Update

Over the last three years, TSO₃ has actively been pursuing the field of gastrointestinal ("GI") endoscope reprocessing as a key emerging market for its proprietary technology.  Most recently, concerns associated with current reprocessing methods of endoscopes have been raised by the medical community and regulators are closely monitoring the data being reported.  On December 10, 2018, the US Food and Drug Administration ("FDA") issued a Safety Communication alerting that higher than expected contamination rates in duodenoscopes have been reported.  As the first and only low temperature method cleared and validated to terminally sterilize these instruments, the Company believes that it is well positioned to address this critical unmet medical need.  

Looking ahead, TSO₃ will continue to advocate for improved healthcare practices and work closely with the scientific and medical communities to raise awareness about the benefits of the STERIZONE VP4 Sterilizer. Utilizing its recently hired and trained sales team, the Company is targeting the central sterilization and GI departments of specific North American medical facilities where TSO₃'s industry leading technology can provide a low cost, low risk and easy to use solution for the concerns facing these institutions.   

"After a transformational year for TSO₃, we are entering 2019 as a stronger organization. Our pipeline of identified opportunities continues to grow and our sales process, while still young, is beginning to produce tangible results. Following the successful build-out of our sales and marketing capabilities and increased regulatory scrutiny of the efficacy of legacy low-temperature reprocessing technologies, we believe we are in a good position to accelerate market penetration with our disruptive technology," said R.M. (Ric) Rumble, President and CEO of TSO₃. "With a growing pipeline of promising opportunities, I remain confident that we will see an acceleration of commitments as the year unfolds."

TSO₃'s innovative sterilization system quickly provides efficiencies in traditional healthcare sterilization settings immediately reducing the cost per instrument sterilized while in the GI market, TSO₃ remains the only cleared terminal sterilization technology capable of addressing unmet critical needs in this segment.

About the STERIZONE^® VP4 Sterilizer

The STERIZONE^® VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual sterilants of vaporized hydrogen peroxide (H₂O₂) and ozone (O₃) to achieve terminal sterilization of heat and moisture-sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective sterilization process with error-free cycle selection. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.

The STERIZONE^® VP4 Sterilizer is the only terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes, duodenoscopes and gastroscopes - an industry first for any medical device sterilization process.

The STERIZONE^® VP4 Sterilizer is also the only cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb.  The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity).

More information about the STERIZONE^® VP4 Sterilizer is available through TSO₃'s website, under the Products section.

About TSO₃

Founded in 1998, TSO₃'s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. TSO₃ also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.

For more information about TSO₃, visit the Company's website at www.tso3.com.

The statements in this release and oral statements made by representatives of TSO₃ relating to matters that are not historical facts are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the limited history of sales or distribution of the Company, the evolution in customer demand for the Company's product and services, the ability of the Company to obtain the required regulatory clearances to market its products, general business and economic conditions, the condition of the financial markets, the ability of TSO₃ to obtain financing on favourable terms and other risks and uncertainties. Although TSO₃ believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. The complete versions of the cautionary note regarding forward-looking statements as well as a description of the relevant assumptions and risk factors likely to affect TSO₃'s actual or projected results are included in the Management's Discussion and Analysis for the year ended December 31, 2017, which is available on the Company's website. The forward-looking statements contained in this press release are made as of the date hereof, and TSO₃ does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise unless expressly required by applicable securities laws.

SOURCE TSO3 Inc.

Related Links

http://www.tso3.com