illumiSonics is developing PARS® microscopy-based solutions 
for specific application fields. 

Mohs Surgery Solution

illumiSonics «Hermes 1»​

THE PROBLEM WE SOLVE

Mohs requires 1-6 tissue removal steps. Each step requires a frozen section pathology confirmation that takes approximately 30 minutes. The procedure currently takes approximately 4 hours, which amounts to time and resource inefficiencies.

SOLUTION BENEFITS

The PARS® solution enables the surgeon to directly examine and confirm each sample without any tissue processing or frozen section pathology, saves approximately 30 minutes at each tissue removal and delivers more reliable results. Since the surgery can be performed using a single diagnostic instrument, the entire process is streamlined. PARS® eliminates histology lab work, frees up time and resources and increases surgical throughput.

Current status: Finalising product for admission process

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In-Surgery Solution for Breast and Head & Neck Cancers

illumiSonics «Hermes 2»

During surgery, analysis of the frozen samples takes 30-60 minutes per sample, with a false negative rate of 14%¹. During analysis, the surgery is paused and the patient remains under anaesthesia. Final pathological analysis occurs only after the operation has been completed. It takes 3-14 days to find out if the surgery was successful. This delay leads to reoperation rates of between 15-32%². Additionally, between 0.5-3.5%³ of tissue samples are mislabelled during the handling process.

SOLUTION BENEFITS

The PARS® solution delivers final diagnostics during surgery. It will enable an on-site or remote pathologist to directly examine and confirm each sample without further processing or handling. Repeat operations are no longer necessary. All diagnostics are automatically documented and tissue samples traced. Finally, tissue sampled can still be processed for conventional histological analysis if necessary.

Current status: Product in development

Key Findings Breast:
¹ 14% false negative rate1 frozen sections (Toshiki Tsuboi, Makoto Ohori, Kentaro Kuroiwa, Victor E. Reuter, Michael W. Kattan, James A. Eastham, Peter T. Scardino, Is intraoperative frozen section analysis an efficient way to reduce positive surgical margins?, Urology, Volume 66, Issue 6, 2005, Pages 1287-1291, ISSN 0090-4295, https://doi.org/10.1016/j.urology.2005.06.073.)

² Conservative studies state 15.5% reexcision rate (RE) (Adams  BJ, Zoon  CK, Stevenson  C, Chitnavis  P, Wolfe  L, Bear  HD.  The role of margin status and reexcision in local recurrence following breast conservation surgery.  Ann Surg Oncol. 2013;20(7):2250-2255.)

because of left positive margin other studies show 32.5% RE rates (Piper, M.L., Wong, J., Fahrner-Scott, K. et al. Success rates of re-excision after positive margins for invasive lobular carcinoma of the breast. npj Breast Cancer 5, 29 (2019). https://doi.org/10.1038/s41523-019-0125-7)

​³ 0.5% - 3.5% mix up rate of tissue samples (Weyers W. Confusion-specimen mix-up in dermatopathology and measures to prevent and detect it. Dermatol Pract Concept. 2014;4(1):27-42. Published 2014 Jan 31. doi:10.5826/dpc.0401a04)

(Dtsch Arztebl 2012; 109(50): A-2555 / B-2095 / C-2047)

Key Findings Head & Neck:
Post surgery: 2.6% of the patients had positive margins, 16.3% had close margins which lead to significant lower 5-year survival rate (63%, 52% compared to 80%) (Fridmann E et al. The role of adjuvant treatment in early‐stage oral cavity squamous cell carcinoma: An international collaborative study. Cancer, Onlinevorabveröffentlichung am 14. Mai 2018, https://doi.org/10.1002/cncr.31531)

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FURTHER APPLICATIONS ARE UNDER DEVELOPMENT.
​MORE INFORMATION COMING SOON.

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our products and solutions?

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