MYCOR & SYGNAL — Frequently Asked Questions

Question 1

What is the SYGNAL algorithm?

Accepted Answer

SYGNAL is an algorithm-based Software as Medical Device (SaMD) developed by MYCOR GmbH that screens for cardiac amyloidosis by analyzing standard 12-lead ECG data. It achieves >85% sensitivity and 89% specificity, delivers results in under one minute, and integrates via cloud API into existing hospital ECG infrastructure without requiring additional hardware.

Question 2

What is cardiac amyloidosis and why is it so frequently missed?

Accepted Answer

Cardiac amyloidosis is a progressive cardiomyopathy caused by misfolded protein deposits (amyloid fibrils) in the myocardium. It frequently mimics HFpEF (heart failure with preserved ejection fraction). The average time to correct diagnosis is 6.1 years for wild-type ATTRwt and 5.7 years for hereditary ATTRv. Approximately one-third of patients initially receive an incorrect diagnosis.

Question 3

How does SYGNAL detect cardiac amyloidosis from an ECG?

Accepted Answer

SYGNAL uses a deep-learning algorithm trained on large clinical datasets to analyze morphological, temporal, and voltage patterns in a standard 12-lead ECG. Key hallmarks include low QRS voltage despite ventricular hypertrophy, pseudoinfarct patterns, and characteristic rhythm abnormalities. The algorithm generates a structured screening report flagging high-risk patients for confirmatory workup.

Question 4

What performance metrics does SYGNAL achieve?

Accepted Answer

In internal validation studies, SYGNAL achieves >85% sensitivity and 89% specificity. Results are returned in under one minute. CE marking is pending under EU MDR Class IIa.

Question 5

What are the treatment options for cardiac amyloidosis?

Accepted Answer

Approved treatments include Tafamidis (Vyndaqel, 33% mortality reduction, EU approved), Vutrisiran / AMVUTTRA (EU approved June 2025), and Acoramidis (EU approved March 2025). CRISPR-based gene editing is advancing to Phase III. Early detection is critical — all therapies are most effective before significant cardiac remodeling.

Question 6

How does SYGNAL integrate into existing hospital workflows?

Accepted Answer

SYGNAL integrates via a cloud-based API into existing ECG devices and hospital IT systems. No new hardware is required. ECG data is securely transmitted to MYCOR's cloud platform, analyzed in real time, and a structured screening report is returned in under one minute. All data is processed end-to-end encrypted and GDPR-compliant.

Question 7

How common is cardiac amyloidosis — and who is most at risk?

Accepted Answer

Up to 25% of patients over 80 show transthyretin deposits in the heart. Up to 13% of HFpEF patients over 60 are affected by ATTR-CM. Up to 16% of TAVI patients have concurrent ATTR amyloidosis. Globally, an estimated 3 million patients are affected — yet only around 10% receive a correct diagnosis.

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