22/4/21   FDA Clearance for SOZO Heart Failure Index

Brisbane, Australia – ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximise patient health is pleased to announce the United States Food and Drug Administration (FDA) 510(k) clearance of ImpediMed’s SOZO® device to include a heart failure index (HF-DexTM) as a monitoring tool for patients living with heart failure

•  SOZO HF-Dex analysis provides an objective measure of fluid levels to assist in the clinical assessment of heart failure patients. The HF-Dex analysis is obtained through a simple, noninvasive, easy to administer, 30 second test.
•  HF-Dex, when used in conjunction with other clinical data, can be useful for clinicians to risk stratify heart failure patients with fluid management problems.
•  HF-Dex is presented together with normal fluid volume reference ranges.
•  The results are displayed graphically to enable tracking over time (example below).
•  Reference ranges are provided from grey to dark blue to help visualise increases in extracellular fluid as compared to a normal healthy population.
•  HF-Dex provides medically meaningful and actionable data which allows clinicians to more effectively and efficiently manage heart failure patients

DISC: I hold

SOZO Clinical Utility in Heart Failure Published

Brisbane, Australia – ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximise patient health is pleased to announce that the full peer-reviewed manuscript demonstrating the clinical utility of ImpediMed’s SOZO device in monitoring heart failure patients has been published in Frontiers in Cardiovascular Medicine.

The publication, titled Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy, describes the BIS-derived HF-DexTM values, Extracellular Fluid expressed as a percentage of Total Body Water (ECF%TBW), in a clinically relevant way that can be used by physicians to aid in clinical risk stratification and fluid volume monitoring of heart failure patients.....

DISC: I hold....  I see the results as being a bit ambivalent (but are they?). I think I need another report done more in layman's terms? or at least to give some $ figures (projections)

ImpediMed’s COVID-19 US CARES Act Loan Forgiven

Brisbane, Australia – ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximise patient health is pleased to announce that the Paycheck Protection Program (PPP) loan under the U.S. Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) has been forgiven in full.

In May 2020, the Company announced receipt of loan proceeds of US$1,140,202. Forgiveness of the loan required the Company to file for forgiveness through the Small Business Administration (“SBA”) after meeting certain requirements related to the use of funds. The Company’s request for forgiveness of the PPP loan was fully approved and the SBA loan is now paid in full. All obligations under the PPP promissory note have been satisfied in full.

About the Paycheck Protection Program The PPP is a program administered by the U.S. SBA that awards loans to help businesses keep their workforce employed during the Coronavirus (“COVID-19”) crisis. A borrower can apply for forgiveness once all loan proceeds for which the borrower is requesting forgiveness have been used.

For a small cap this is really good,

Disc: I hold

Revenue Summary:

•  Record period for Total Revenue for 1 st Half FY’21 of $3.6 million, +26% the previous corresponding period (pcp) (1st Half FY’20: $2.8 million).
•  Record period for SOZO® Revenue for 1 st Half FY’21 of $3.3 million, +54% pcp (1st Half FY’20: $2.1 million).
•  Record period for SOZO SaaS Revenue for 1 st Half FY’21 of $2.3 million, +48% pcp (1st Half FY’20: $1.6 million).

              o SOZO SaaS Revenue of $2.0 million from Core Businessi , +25% pcp.

             o The appreciating AUD is underrepresenting the strength of the SaaS Revenue from the Core Business in the translated results. When reported in USD, SOZO SaaS Revenue from the Core Business was +36% pcp.

           o SOZO SaaS Revenue of $0.4 million, when rounded, from Clinical Businessii .

Cash Flow Summary:

•  Cash on hand as at 31 December 2020 of $19.0 million.
•  Cash receipts from customers for 1 st Half FY’21 of $3.3 million.
•  Receipt of an additional $8.0 million, before costs, during 1 st Half FY’21 from the exercise of options issued to subscribers in the entitlement offer. o A total of $9.1 million has been received for the first three expiry periods. o There is potential for up to a further $9.1 million to be raised by 31 March 2021, from remaining options issued in the offer.
•  Net operating cash outflows for 1 st Half FY’21 of $6.6 million, which is significantly better than the forecasted $8.0 million net operating cash outflow announced to the market on 27 October 2020.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02343954-2A1281747?access_token=83ff96335c2d45a094df02a206a39ff4

• DISc: I hold

American College of Cardiology Accepts SOZO HF Abstract

ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximise patient health is pleased to announce that an abstract evaluating the use of ImpediMed’s SOZO® BIS technology in identifying heart failure (HF) patients at risk of hospital readmission at the time of discharge has been accepted for poster presentation at the American College of Cardiology (ACC) 70th Annual Scientific Session on 15-17 May 2021 in Atlanta, Georgia, USA....

“The ACC annual meeting is the leading scientific session for US cardiology and has global reach,” commented Richard Carreon, Managing Director and CEO of ImpediMed. “Presenting data here lends important credibility to our technology and its potential to integrate into existing patient care pathways for the reduction of hospital readmissions. These results will support our commercialisation effort in heart failure, which is one of our three strategic focus areas.”

Disc: I hold