First generation retained sponge prevention technologies, namely barcode and radio frequency technology, have both been commercially available since 2005 and 2006, respectively. Though both have shown the capacity to be clinically effective in reducing retained surgical sponges in the facilities in which they have been implemented, despite being available for over a decade and a half, the vast majority of hospitals in the U.S. have passed on implementing them. We believe this is due to the limitations of these solutions that are the result of the dated technologies they utilize and the impact on the clinical efficacy, cost and user experience with these products.

Tally is designed to be a reliable, easy to use, low cost and more complete retained sponge solution. Tally is designed to provide an accurate count of surgical sponges faster and easier than competitive retained sponge prevention solutions.

Accurate – With unique RFID data programmed onto every sponge, Tally helps prevent the inaccurate counts that lead to retained sponges when a manual count alone is relied upon.

Fast – The technology powering Tally enables scanning of up to 900+ items per second7, dramatically faster than the one at a time process inherent in scanning barcodes and manual counting. Further, unlike barcode technology, Tally’s RFID labels do not require a direct line of sight to be scanned. Barcode labels need to be relatively flat and clean and have a direct line of sight between the barcode itself and the barcode reader, whereas Tally is capable of quickly reading numerous sponges relatively simultaneously without requiring the same handling and effort.

Easy – In addition to faster, easier scanning and counting, Tally’s proprietary “FIND” feature is designed to help users more quickly locate missing sponges. In the event that a count taken prior to surgery does not match a count taken of sponges removed from the patient, Tally’s FIND mode can help guide the user to the exact missing sponge or sponges, helping reconcile the count more quickly. Neither barcode technology nor radio frequency technology has this capability.

In May of 2020 we filed a submission to the FDA regarding Tally. Subsequently, the FDA provided us with a formal response letter to our submission. As opposed to clearing Tally through the Premarket Notification Process [510(k)], in the response letter to us the FDA stated that they believe Tally falls within a device classification type and product code that is exempt from the premarket notification requirement altogether. More specifically, the FDA stated they believe Tally to fall within 21 CFR 880.2740 under product code LWH and therefore is a Class I type device that is exempt from the premarket notifications [510(k)] requirements. Based on this categorization by the FDA, Tally will not require further submissions to seek FDA clearance given the exempt status of the device type and product code.
Tally is designed to be used as an adjunct to a manual count, not as a replacement. We combined our deep clinical, development and technology experience, together with extensive input from operating room clinicians, to design Tally to reinforce recommended practices for manual sponge counts.

By improving the ease and speed of accurately counting sponges and providing the ability to more quickly reconcile counts, Tally empowers clinicians to reduce total case time.

We are initiating an early adopter program in early 2021 that will include the first hospitals using Tally.  We have filled the spots for hospitals we intend to partner with for this program, however if you are interested in learning more about how your facility can participate please contact us.  We anticipate widespread commercial availability of Tally in 2022.

Tally is protected by a broad portfolio of issued and pending patents controlled by Tally Surgical, Inc.  The Company’s IP portfolio includes multiple patents acquired from third party inventors with extensive backgrounds in RFID and retained sponge prevention.

We will be disclosing pricing to interested hospitals upon commercial release of Tally.  Our pricing will reflect our intention to establish Tally as the most compelling retained sponge prevention solution from not just a clinical satisfaction perspective but one of value.