TSO3 Provides An Update On Regulatory Activity
Published: Sep 27, 2017
QUEBEC CITY and MYRTLE BEACH, SC, Sept. 27, 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company has received correspondence from US regulators pertaining to its submission for extended claims for the STERIZONE® VP4 Sterilizer in relation to the terminal sterilization of duodenoscopes, which are used in endoscopic retrograde cholangio-pancreatography (ERCP) procedures.
In their correspondence, US regulators requested clarification on certain aspects of the Company's proposed labeling consistent with the reprocessing of specific duodenoscopes using the STERIZONE® VP4 Sterilizer. In addition, acknowledging recent challenges that have impacted ERCP scopes, regulators have also asked for specific testing to be documented pertaining to what they describe as "challenge features" of the identified devices. This includes testing the integrity of the adhesive seal found at and under the distal endcap of the duodenoscope after sterilization processing.
"We are encouraged by the response." stated R.M. (Ric) Rumble, President and CEO of TSO3. "US regulators have clearly stated that improving the safety of duodenoscopes is a top priority for them, and they are encouraging companies to continue to pursue innovations that will help reduce the risk to patients. TSO3 is doing our part in creating an improved standard of care by offering terminal sterilization solutions for devices that have previously been processed with less robust high level disinfections processes. The Company feels that focusing our efforts on the market leading scope to gain initial claims is likely the most efficient use of resources. Once cleared, the Company will subsequently establish a method to sequentially add additional devices on an ongoing basis."
The Company is preparing a notice for the regulators addressing specific questions, as well as outline intended actions for their comment. The Company's goal is to provide a complete and final response within the 180-day limit established by regulators.
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/.
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, business or operations) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, 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.
SOURCE TSO3 Inc.