TSO3 Provides an Operational Update
Jan 25, 2018, 08:59 ET
QUEBEC CITY and MYRTLE BEACH, SC, Jan. 25, 2018 /PRNewswire/ - TSO3 Inc. (TSX: TOS) ("TSO3" or the "Company"), an innovator in sterilization technology for medical devices in healthcare settings, today provided an update on its 2017 operating activities.
During 2017, TSO3 shipped a total of 170 STERIZONE® VP4 Sterilizers to its global distribution partner, Getinge Infection Control. Fifty of those units were shipped in the fourth quarter of 2017. The Company also supported Getinge in the installation of STERIZONE® VP4 Sterilizers into multiple medical facilities in North America and Europe. The Company reported in its third quarter report a total of more than fifty unit deliveries and is awaiting final fourth quarter shipment and installation figures from Getinge. Repeat customers and multi-unit customers continued to increase in the quarter, and in particular, one health system has now ordered more than eight sterilizers which are being scheduled for installation. Lastly, the Company ended 2017 with $14.8 million of cash, cash equivalents and short-term investments and no debt.
During the fourth quarter, as previously reported, the Company corresponded with US Regulators concerning its submission for extended claims on duodenoscopes. The Company has subsequently exchanged documentation summarizing these calls and path forward including a request already made for an additional meeting prior to finalizing the submission. That meeting is expected to be scheduled soon.
In addition, during the fourth quarter of 2017 a team of the Company's senior scientists participated in an interim meeting called by the Association for the Advancement of Medical Instrumentation (AAMI) to advance the working group's revision of ANSI/AAMI ST91 Flexible and semi-rigid endoscope processing in health care facilities. AAMI is considering the evidence presented at its Stakeholder's meeting last September, along with comments from user and manufacturer groups, with the intent of elevating the standard of flexible endoscope processing and improving patient safety. Moving from high-level disinfection to sterilization of flexible endoscopes is central to this discussion, which will continue during AAMI's Sterilization Standards Week in March 2018.
"This year produced significant results in most areas of our business. Given the growing installed base, our direct experience servicing these accounts and our expanded involvement in supporting sales efforts, we feel well positioned for 2018," said R.M. (Ric) Rumble, President and CEO of TSO3. "Our confidence in our product and its ability to favorably impact work flow and reduced costs has been validated repeatedly with documented customer experiences."
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 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 at http://www.tso3.com/en/products/sterizone-vp4/.
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 (including, without limitation, those regarding the timing or outcome of TSO3's regulatory filings, revenue, sales, business or operations) 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 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, 2016, 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.
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