Pelvic Lipomatosis

NOVEL ASSAY DEVELOPED USING THE PARSORTIX SYSTEM ACCURATELY PREDICTS MALIGNANCY IN PELVIC MASS Publication of results from ANGLE's pelvic mass pilot study in collaboration with Wilmot Cancer Institute in a high impact journal Study informed the development of ANGLE's pelvic mass triage test for detection of ovarian cancer requiring surgical intervention GUILDFORD, SURREY / ACCESSWIRE / September 12, 2022 / ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce the publication of results from a clinical study undertaken in partnership with the Wilmot Cancer Institute, University of Rochester, NY, US. The Parsortix® system was utilised for cancer detection in 183 women with a pelvic mass who had a range of benign and malignant conditions. The results have been published in the respected, high impact, journal Obstetrics & Gynecology ("The Green Journal"). The population of cells captured from peripheral blood by the Parsortix system were subjected to multiplexed gene expression analysis, and these results were combined with serum protein biomarkers to form a predictive algorithm, referred to as the Malignancy Assessment using Gene Identification in Captured Cells ("MAGIC") algorithm. The MAGIC algorithm successfully and accurately detected malignancy in women with a pelvic mass more effectively than serum biomarkers alone. The MAGIC algorithm's unique grouping of 8 genes and 4 serum biomarkers (ROC-AUC 95.1%, 95% CI = 92.0 - 98.2%) significantly outperformed all individual genes (ROC-AUCs = 50.2 to 65.2%; all p<0.001), the serum biomarker only algorithm (ROC-AUC = 89.6%, 95% CI = 84.3 - 95.0%), and the gene only algorithm (ROC-AUC = 88.0, 95% CI = 82.9 - 93.0%, p=0.005) for the discrimination of benign tumours from all cancers. Importantly, MAGIC was able to accurately identify malignancy for both early stage (ROC-AUC: 89.5%, 95% CI = 81.3 - 97.8%) and late-stage (ROC-AUC: 98.9%, 95% CI = 96.7 - 100%) epithelial ovarian cancer. Furthermore, the algorithm not only detected epithelial ovarian cancer, but also detected non-ovarian primary cancers and metastatic cancers. This research highlights the potential of combining the multiplexed gene analysis of captured cells with serum biomarkers from a simple blood test for rapid and accurate pelvic mass triage. This may help to identify the presence of gynaecological cancers at an earlier stage whilst accurately identifying benign conditions that could be managed locally rather than by a specialist. This successful study was used to inform a clinical verification study which is currently ongoing and from which headline results are expected shortly. Assuming similar results, ANGLE intends to establish this test (referred to as the Landscape+TM Ovarian assay) as a laboratory developed test in its own clinical laboratories. The test has the potential to significantly improve patient outcomes whilst at the same time reduce overall healthcare costs. Approximately 5-10% of women will present with a pelvic mass during their lifetime. For these women, accurate and early diagnosis of malignancy is critical. Around 20,000 women are diagnosed with ovarian cancer in the US each year. Sadly, almost 60% of cases are diagnosed when the cancer has metastasised, resulting in a 5-year survival rate of just 31%. Current diagnosis relies on imaging and elevated levels of serum biomarker CA-125, which has poor specificity. Where malignancy is suspected, patients usually undergo surgical resection. However, there is a need for more accurate and timelier triage of patients with a pelvic mass to enable early detection of malignancy so that these patients can be referred to high volume physicians and institutions. It has been shown that surgical staging and debulking by gynaecological oncologists at these high-volume institutions improves survival for ovarian cancer patients. Dr Richard Moore, Director of the division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester commented: "As a leading translational research team with a focus on gynecologic oncology biomarkers, we are excited to present the results of this important study. Ovarian cancer is difficult to detect in women with an ovarian cyst or a pelvic mass and identifying patients at high risk is critical. Our team, in association with ANGLE plc, created the MAGIC algorithm employing the Parsortix system as a key tool in assisting in the detection of ovarian cancer in patients with a pelvic mass, an area of significant unmet need. I also see this technology as an important tool for prognostic indicators and even diagnosis as further research is developed." Professor Kyu Kwang Kim, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Wilmot Cancer Institute, University of Rochester added: "This hybrid technology explores the versatility of CTC evaluation in combination with serum biomarkers to improve the detection of cancer. The MAGIC algorithm is an exciting advance towards more effective pelvic mass triage." ANGLE Founder and Chief Executive, Andrew Newland, added: "Currently gene expression in CTCs is an emerging field not yet incorporated into existing clinical risk-stratification models for ovarian cancer. This prospective clinical trial employing novel technology introduces the combination of CTC and serum biomarker analysis and is therefore an important milestone towards improving pelvic mass triage. We now look forward to receiving the headline results from an ongoing clinical verification study in this setting, and we anticipate that the Landscape+ Ovarian assay will be ANGLE's first laboratory developed test to be offered from our own clinical laboratories." The research has been published as a peer-reviewed publication in the Journal Obstetrics & Gynecology and will be available online at . ANGLE plc +44 (0) 1483 343434 Andrew Newland, Chief Executive Ian Griffiths, Finance Director Andrew Holder, Head of Investor Relations Berenberg (NOMAD and Joint Broker) Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800 Jefferies (Joint Broker) Max Jones, Thomas Bective +44 (0) 20 7029 8000 FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US) +44 (0) 203 727 1000 +1 (212) 850 5624 For Frequently Used Terms, please see the Company's website on Notes for editors About ANGLE plc ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology known as the Parsortix® system and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins. ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Intended use The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions. The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient. The Parsortix technology is the subject of 26 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. In the United States, the Parsortix® PC1 system has received a Class II Classification from FDA for use with metastatic breast cancer patients. FDA clearance is seen as the global gold standard. ANGLE's Parsortix system is the first ever FDA cleared system for harvesting CTCs for subsequent analysis. ANGLE has applied the IVD CE Mark to the same system for the same intended use in Europe. ANGLE has also completed two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation and a 200 patient clinical verification study has now completed enrolment. ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM platform and is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (AUC-ROC) of 95.1%. ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats. ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 68 peer-reviewed publications and numerous publicly available posters from 31 independent cancer centres, available on our website. ANGLE has established clinical services laboratories in the UK and the United States to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services globally to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management. 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AUSTIN, Texas, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Heralding the beginning of Ovarian Cancer Awareness Month, Aspira Women’s Health, Inc (“Aspira”) (Nasdaq: AWH) will ring the closing bell at NASDAQ on Thursday, September 9, 2021 to signal a call to action for progress in ovarian cancer awareness, access to important risk assessment technology, and research. The closing bell ceremony will begin at approximately 3:45pm EDT. A livestream of the Nasdaq Closing Bell will be available at Despite decades of research, ovarian cancer remains one of the most lethal of gynecological cancers. In the United States, it ranks as the fifth highest cause of cancer death in women, even though its incidence---1.3% of all new annual cancer cases—is relatively low. Unfortunately, the onset of ovarian cancer is usually quite insidious, with symptoms that mimic much less serious conditions, thereby earning it the unsettling nickname of “the cancer that whispers.” It actually does NOT whisper as women often ignore or dismiss the bloating, back pain, appetite loss, vaginal bleeding, or urinary disturbances that can be the “alarm bell” that malignancy is present. In fact, many health care professionals exhibit the same response when alerted to these symptoms by women because they are so generic. The end result is that when ovarian cancer is finally detected in the majority of women, it has progressed to stage III or IV disease, when five-year survival rates can be as low as 27%. Aspira Women’s Health Inc. has been increasing access for women to important risk assessment tools and building awareness of our company’s solutions and its brand thru new guidelines, direct to provider education at the local, regional and national level including participating in a congressional briefing in March 2021 regarding the need to fund diversity trials and support MCIT breakthrough technology at the FDA as well as a presentation given by Kaile Zagger, our Chief Operating Officer, at a FemTech Industry Landscape in July 2021 titled “Changing the story through transformation, A New Paradigm in Early Detection of Ovarian Cancer.” During the month of September---Ovarian Cancer Awareness Month—we are bringing awareness to our solutions and our mission to transform women’s health by participating in and sponsoring several events. September 14-15 - Women’s Health Innovation Summit, Boston, MA, September 27- Ovarian Cancer Awareness Month Congressional Briefing “Aspira continues to make great strides towards goal of developing innovative testing options and bioanalytical solutions to significantly improve women’s healthcare, starting with ovarian cancer,” emphasizes Valerie Palmieri. “Participating in these events during Ovarian Cancer Month, coupled with the tools we are able to provide clinicians, will increase not only women’s overall awareness but health care providers’ awareness of this disease and the new opportunities for early detection.” About ASPIRA Women’s Health Inc.Aspira Women’s Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1® plus combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. ASPIRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans. The next generation of products in development are OVAWatchTM and EndoCheckTM. Visit our website for more information at . Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLCTel 617-430-7577Arr@lifesciadvisors.com

Total Revenue Increased 141% to $1.8 million; OVA1 Volume Grew 85% to 4,553 Accessions New Publication Demonstrates OVA1 Superiority to Standard of Care Expanded Access of OVA1 Through AIM Specialty Health Conference Call and Webcast Today at 4:30 p.m. ET AUSTIN, Texas, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on gynecologic disease, today reported its financial results for the second quarter ended, June 30, 2021. “We are pleased with the volume growth in our products as the economy has somewhat emerged from COVID-19 restriction as well as with the advancement of our preparations for our fourth quarter 2021 launch of OVASight,” indicated Valerie Palmieri, Chief Executive Officer. “We are making positive progress on our product collaboration with the Dana Farber Cancer Institute as we disclosed in the first quarter of 2021. We have also continued to have a positive dialogue with the FDA regarding our planned EndoCheck product.” Recent Corporate Highlights Capital Resources Financial Highlights Highlights Second Quarter 2021 vs. Second Quarter 2020: Highlights of Second Quarter 2021 vs. First Quarter 2021: Conference Call and WebcastAspira will host a call today at 4:30 p.m. Eastern Time to discuss results followed by a question-and-answer period. About Aspira Women’s Health Inc.Aspira Women’s Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women.  Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plusTM combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiXTM testing offers both targeted and more comprehensive genetic testing options with a gynecologic focus.  With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health is delivering a portfolio of pelvic mass products over a patient’s lifetime with our cutting-edge research. The next generation of products in development are OVASightTM and EndoCheckTM. Visit our website for more information at . Forward-Looking StatementsThis press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding anticipated expenses. These statements involve a number of risks and uncertainties.  All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” in Aspira’s Annual Report on Form 10-K for the year ended December 31, 2020. The events and circumstances reflected in Aspira’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.  Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLCTel 617-535-7742