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Item 1. Business

2023-03-15 compared with 2022-03-30 · 93 added, 114 removed, 123 unchanged (63% of the section changed)

Volition is a multi-national epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including certain cancers and diseases associated with NETosis such as sepsis and COVID-19.

Our mission is to save lives and improve outcomes for millions of people and animals worldwide.

Early diagnosis and monitoring have the potential to not only prolong the life of patients, but also to improve their quality of life.

Our tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

We are primarily focused on human diagnostics and monitoring but also have a subsidiary focused on animal diagnostics and monitoring.

We have five key pillars of focus:

Nu.Q ® , Nu.Q ® NETs, Nu.Q ® Capture, Nu.Q ® Discover and Nu.Q ® Vet, all of which use the same proprietary Nu.Q ® platform to commercialize in different areas.

Our research and development activities are centered in Belgium, with an innovation laboratory in California, and additional offices in Texas, London, and Singapore, where we focus on bringing our diagnostic and disease monitoring products to market.

Volition is a multi-national epigenetics company powered by Nu.Q ® , its proprietary nucleosome quantification platform.

Through its subsidiaries, Volition is developing simple, easy to use, cost effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19.

Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.

The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

We have five key pillars of focus, all of which use the same proprietary Nu.Q ® platform to commercialize in different areas:

Nu.Q ® Vet - cost-effective, easy-to-use cancer screening blood test for dogs and other animals.

Nu.Q ® NETs - monitoring the immune system to save lives.

Nu.Q ® Cancer - detecting cancer early to save lives.

Nu.Q ® Capture - capturing and concentrating samples for more accurate diagnosis.

Nu.Q ® Discover - a complete solution to profiling nucleosomes.

Our product development and manufacturing activities are centered in Belgium, with innovation and U.S.

operations in California, and additional offices in Nevada, London, and Singapore, where we focus on bringing our diagnostic and disease monitoring products to market.

Volition’s Solution and the Science Behind It

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as explained below, chromosomes consist of the genetic material (DNA) wrapped in a coat of proteins and other molecules.

All the tests in our portfolio detect various characteristic changes in nucleosomes that occur from the earliest stages of disease, enabling early detection and potentially a better way to monitor disease progression and the patient’s response to treatment.

All the tests in our portfolio detect various characteristic changes in nucleosomes that occur from the earliest stages of disease, potentially enabling early detection and a better way to monitor disease progression and the patient’s response to treatment.

Unlocking Epigenetics

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Volition’s Epigenetic Approach

Through our Nu.Q ® (short for nucleosome quantification) family of tests in our five key pillars, we aim to offer a new, convenient and cost-effective approach to the detection, diagnosis and monitoring of diverse diseases from a simple blood test.

Through our Nu.Q ® (short for nucleosome quantification) family of tests in our five key pillars of focus, we aim to offer a new, convenient and cost-effective approach to the detection, diagnosis and monitoring of diverse diseases from a simple blood test.

Highlighting abnormalities

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We aim to replace unpleasant, invasive, and often expensive screening and diagnostic tests such as colonoscopies and biopsies with Nu.Q ® blood tests, helping to save lives and to reduce overall healthcare costs.

Population screening

Our technology and tests could potentially play a game-changing role in early detection of disease in asymptomatic people via routine, population-wide screening.

We believe that simple, cost-effective, and accurate tests are the “holy grail” of an effective screening program.

Risk stratification and diagnostic aid

In addition to being highly informative in their own right, Nu.Q ® tests have the potential to improve the sensitivity and specificity of other clinical tests.

Our tests could also reduce the number of people needing invasive biopsies and other diagnostic procedures, which can be expensive and harmful.

Disease and treatment monitoring

Nu.Q ® tests may act as an early warning system by monitoring treatment response, disease progression and remission.

Improving Outcomes for Patients

We have five key pillars of focus:

Nu.Q ® , Nu.Q ® NETs, Nu.Q ® Capture, Nu.Q ® Discover and Nu.Q ® Vet, all using the same proprietary Nu.Q ® platform.

Nu.Q ® - Detecting cancer early to save lives.

We are developing a simple, cost-effective blood test for cancer.

Cancer is a devastating disease that touches many peoples’ lives, accounting for approximately 10 million deaths worldwide each year.

Early diagnosis is the best way to improve someone’s chances of surviving cancer;

however, current population-wide screening tests (such as mammograms and colonoscopies) are often invasive and unpleasant.

They can also be expensive, causing many people to miss routine screening.

There are no population screening tests at all for some types of cancer, including aggressive forms of the disease such as ovarian or pancreatic cancers.

Unfortunately, many patients are therefore diagnosed too late, when their cancer has already spread, and treatment is more difficult.

We believe that Nu.Q ® can become a cost-effective routine blood test for multiple types of cancer, allowing doctors to check off an extra box along with other routine blood tests like cholesterol during an annual wellness visit.

Nu.Q ® tests have further potential applications in clinical oncology beyond cancer detection.

Being able to use epigenetic information from tumor cells’ nucleosomes could also help physicians select the best treatment for each patient, monitor their response and the disease progression.

We are currently investigating the potential use of Nu.Q ® tests in a range of cancers and clinical settings including:

Nu.Q ® Vet, Nu.Q ® NETs, Nu.Q ® Cancer, Nu.Q ® Capture and Nu.Q ® Discover, all of which use the same proprietary Nu.Q ® platform to commercialize in different areas.

Cancer is the most common cause of death in dogs over the age of two years in the United States.

Nearly 50% of all dogs over the age of 10 will develop cancer in their lifetime.

With approximately 84 million pet dogs in the United States, there are an estimated six million pet dogs diagnosed with cancer each year.

As with humans, earlier detection can save lives and can also improve the quality of life of the dog and its owner.

Yet, as of today, there are few single assay cancer blood tests on the veterinary market.

Currently, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming, and painful for the animal.

We hope to change this with the introduction of the Nu.Q ® Vet Cancer Test:

a simple, cost-effective, easy to use enzyme-linked immunosorbent assay (“ELISA”) based screening blood test which may help streamline the diagnostic process for older or “at-risk” dogs.

For example, findings from a clinical study conducted by Volition and Professor Wilson-Robles and the team at Texas A&M University, peer-reviewed and published in August 2022, reflect that Volition’s Nu.Q ® Vet Cancer Test detected 76% of systemic cancers ( including lymphoma, hemangiosarcoma, and histiocytic sarcoma) at 97% specificity versus control.

Data presented at the European Society of Veterinary Oncology Congress suggests that Nu.Q ® Vet may also serve as a more sensitive measurement of both minimal residual disease and remission and could be a useful monitoring test for dogs with cancer.

We are currently conducting ongoing research regarding Nu.Q ® Vet as follows:

Point of Care platform (in partnership with the Heska Corporation),

Broadening the range of cancers detected,

Differential diagnosis,

Pre-analytics for the use of Nu.Q ® Vet in the feline population, and

Use of the Nu.Q ® platform in NETosis in canines.

Nu.Q ® NETs - Monitoring the immune system to save lives.

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a potent protective force that sometimes overreacts, damaging the body’s own cells and tissues in the process.

We are working to develop tests that will identify people at high risk of poor outcomes/death caused by an immune system overreaction to COVID-19 and other infections.

We are working to develop tests that will identify people at high risk of poor outcomes/death caused by an immune system overreaction to sepsis, COVID-19 and other infections.

The immune system is comprised of many different types of white blood cells with different functions.

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Using our Nu.Q ® nucleosome assays could enable the stratification of patients with a high level of NETs, allow physicians to rapidly triage these patients, and monitor their disease progression and response to treatment.

The focus on sepsis due to the COVID-19 pandemic has accelerated our research on NETs.

Our current programs include:

In May 2022, our Nu.Q ® NETs product was CE marked for the detection and evaluation of NETosis on two platforms (ELISA plates and i-10), enabling clinical use in more than 27 countries across Europe.

In August 2022, we appointed Diagnostic Oncology CRO, LLC (“DXOCRO”), a contract research organization specializing in the commercialization of diagnostic biomarker technologies, to spearhead our clinical product development and regulatory programs in the United States.

DXOCRO is undertaking large-scale finding studies across multiple sites using our Nu.Q® platform to determine clinical utility in sepsis and cancer.

We hope the study will support an application to the FDA’s Breakthrough Device program.

The first phase of the study focused on sepsis has been completed and an application to the FDA’s Breakthrough Device Program is expected to be submitted in the first half of 2023.

Nu.Q ® Cancer - Detecting cancer early to save lives.

We are developing a simple, cost-effective blood test for cancer.

Cancer is a devastating disease that touches many peoples’ lives, accounting for approximately 10 million deaths worldwide each year.

Early diagnosis is the best way to improve someone’s chances of surviving cancer;

however, current population-wide screening tests (such as mammograms and colonoscopies) are often invasive and unpleasant.

They can also be expensive, causing many people to miss routine screening.

There are no population screening tests at all for some types of cancer, including aggressive forms of the disease such as ovarian or pancreatic cancers.

Unfortunately, many patients are therefore diagnosed too late, when their cancer has already spread, and treatment is more difficult.

We believe that Nu.Q ® Cancer can become a cost-effective routine blood test for multiple types of cancer, allowing doctors to check off an extra box along with other routine blood tests like cholesterol during an annual wellness visit.

Nu.Q ® Cancer tests have further potential applications in clinical oncology beyond cancer detection.

Being able to use epigenetic information from tumor cells’ nucleosomes could also help physicians select the best treatment for each patient, monitor their response and the disease progression.

We are currently investigating the potential use of Nu.Q ® Cancer tests in a range of cancers and clinical settings.

Nu.Q ® Capture - Capturing and concentrating samples for more accurate diagnosis - Locating the needle in a haystack.

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Serve as a quality control tool to reduce the rate of clinical test failure, saving time that is especially valuable for people whose test results are being used to inform their treatment,

Aid the discovery of new biomarkers.

Aid the discovery of new biomarkers, and

Allow the complete profiling of nucleosomes.

The use of Nu.Q ® Capture technology in the field of transcription factors has led to the successful isolation of tumor derived transcription factor-DNA complexes from blood samples obtained from cancer patients.

As transcription factor binding to DNA is cancer and tissue specific, this technology may, in principle, provide the basis for blood tests for cancer in general as well as blood tests to identify the organ or tissue affected by cancer.

Development is ongoing.

Another novel method utilizing Nu.Q ® Capture and mass spectrometry was published in 2021 and demonstrated the detection and quantification of histone modifications present in the circulating nucleosomes in the blood of cancer patients.

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Nu.Q ® Discover - A complete solution to profiling nucleosomes.

Nu.Q ® Discover gives clinicians, patients, and researchers access to a range of state-of-the-art assays, built on our proprietary Nucleosomics™ platform, for rapid epigenetic profiling in disease model development, preclinical testing and clinical trials.

Our H3.1 assay is also available for purchase as a Research Use Only kit.

Our assays run in our Silver One facility in Belgium or on site and can be used to answer clinical questions, such as measuring treatment efficacy, or on-target and off-target effects in drug development.

Applications include biomarker discovery in oncology, inflammatory conditions, diabetes and more.

Existing and potential customers include both pharmaceutical companies and academic research institutions.

Nu.Q ® Vet (through Volition Vet)

Cancer is the most common cause of death in dogs over the age of two years in the United States.

Up to 50% of all dogs over the age of 10 will develop cancer in their lifetimes.

With approximately 77 million pet dogs in the United States, there are an estimated six million pet dogs diagnosed with cancer each year.

As with humans, earlier detection can save lives and can also improve the quality of life of the dog and its owner.

Yet, as of today, there are few single assay cancer blood tests on the veterinary market.

Currently, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming, and painful for the animal.

We hope to change this with the introduction of the Nu.Q ® Vet Cancer Screening Test:

a simple, cost-effective, easy to use enzyme-linked immunosorbent assay (“ELISA”) based screening blood test which may help streamline the diagnostic process for older or “at-risk” dogs.

Data have been published in peer-reviewed journals demonstrating Nu.Q ® Vet’s detection of common canine cancers such as lymphoma and hemangiosarcoma.

More recently, data have been presented at the Veterinary Cancer Society Annual Conference suggesting that Nu.Q ® Vet may also serve as a more sensitive measurement of both minimal residual disease and remission and could be a useful monitoring test for dogs with cancer.

We are currently conducting ongoing research regarding Nu.Q ® Vet as follows:

Broadening the Range of Cancer Detected

We have conducted work in other canine cancers and anticipate a further peer reviewed publication in 2022.

Although thus far the Nu.Q ® Vet Cancer Screening Test has been marketed as a screening test for lymphoma and hemangiosarcoma, this Test may be useful in detecting other forms of cancer as well.

The Nu.Q ® Vet Cancer Screening Test performs best for tumors that are more systemic (higher metastatic rate) or have a high cellular turnover rate.

We are also working to incorporate additional histone modifications into the Nu.Q ® Vet Cancer Screening Test that will help to better differentiate between various cancer types.

Differential Diagnosis

We are currently developing additional assays to add to the Nu.Q ® Vet Cancer Screening Test to better differentiate inflammatory and other conditions from cancer.

Studies are underway at five U.S.

university hospitals to collect data comparing a variety of concomitant conditions including:

Inflammatory conditions

Immune mediated disease

Endocrinopathies

Point of Care Test

We are in the process of developing a point of care test to aid the timely provision of diagnosis and treatment response.

Over the next 12 to 24 months, we are planning to explore and evaluate the potential use and early detection efficacy of our Nu.Q ® Vet platform in cats (related to cancer), horses (related to disease and performance fitness), and cattle (for feedlot disease).

Nu.Q ® Discover empowers drug developers and scientists through access to a range of state-of-the-art assays for rapid epigenetic profiling in disease, model development, preclinical testing, and clinical studies - from discovery to market ready.

Identify potential drug targets by measuring levels of specific histone modifications

Screen and identify lead compounds that modulate the levels of specific histone modifications

Monitor changes in histone modification levels to assess the efficacy and Mechanism of Action (MoA) of compounds

Monitor target engagement to determine the pharmaco-dynamics (PD) of drugs in patients

Support regulatory submissions and help demonstrate drug safety and efficacy

Manufacturing Capabilities and Strategy

Our Silver One site in Belgium offers cutting edge, purpose-built manufacturing and processing facilities.

We currently manufacture our own plates and large-scale manufacturing of our antibodies on beads.

Our expert team is on hand throughout, to offer guidance and support and to fulfil customer needs.

Our objective is to establish long-term mutually beneficial commercial relationships.

We are currently focusing on manufacturing our key components such as the antibodies and positive controls at Silver One, as well as ELISA kits.

We have also outsourced a portion of the production of our ELISA kits to a third-party manufacturer in the U.S.

to facilitate logistics and to aim for large-scale production.

Commercialization Strategy

We are guided by three underlying principles to our commercialization strategy – ensuring our products:

Result in low capital expenditures for licensors and end users and low operating expenses for Volition,

Are affordable, and

Are accessible worldwide.

We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, Nu.Q ® could potentially be used throughout the world.

We have developed and are continuing to develop a large portfolio of intellectual property (“IP”), centered around the science of identifying and measuring nucleosomes in the bloodstream.

We call this science Nucleosomics™.

Our technologies have a large range of applications, both in humans and animals, to screen, diagnose, and risk stratify patients, and to monitor treatments, disease progression and potential remissions.

While we initially focused on cancer, we have now broadened the range of indications to include several diseases associated with NETosis, including sepsis, which is estimated to be responsible for one in five deaths worldwide.

Our launch sequence is largely determined by the regulatory hurdles we face;

consequently, we aim to initially launch in Europe and Asia, and subsequently in the United States.

We aim to remain an IP powerhouse in the Nucleosomics™ space and expect to monetize our IP and technologies through licensing and distribution contracts with companies with established distribution networks on a worldwide or regional basis, in both human and animal care.

The first series of products we expect to launch, following the roll-out of our canine cancer screening test, are:

a canine cancer monitoring test;

a NETosis related screening and monitoring test;

Nu.Q ® Discover;

our biomarkers for research purposes and to support clinical trials;

Cancer tests for humans in Non-Hodgkin's Lymphoma, colorectal cancer and lung.

Our Nucleosomics™ technology is transferable to multiple platforms such as ELISA 96-well plates, bead-based chemiluminescent and we are currently working on transferring our technology to the widely-utilized homogeneous immunoassay or HIA platform and several point of care platforms to enable rapid turnaround of results in clinic/the doctor’s office.

Additionally, we are working on complete nucleosome analysis with our Nu.Q ® Capture technology.

The goal of this project is to investigate ways to specifically target circulating tumor DNA (“ctDNA”).

The ability to enrich ctDNA will allow us to use mass spectrometry to analyze histone and DNA modifications, and moreover to sequence the DNA present around the nucleosomes.

This information might enable cancer diagnosis to identify the tissue of origin of that given cancer.

We aim to remain an IP powerhouse in the Nucleosomics™ space and expect to monetize our IP and technologies through licensing and distribution contracts with companies that have established distribution networks and expertise on a worldwide or regional basis, in both human and animal care across platforms (centralized labs and point-of-care).

To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”), a leading global provider of advanced veterinary diagnostics.

In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q ® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing and is eligible to receive up to an additional $18.0 million based upon the achievement of certain near and mid-term milestones.

In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q ® Vet Cancer Test in kit format for companion animals through Heska’s network of central reference laboratories.

Subsequent to year end, in February 2023 Heska commenced pre-orders of the Nu.Q ® Canine Cancer Screen and Monitor Test to veterinarians at the point of care through Heska.

We also entered into a licensing and supply agreement with IDEXX Laboratories, Inc.

(“IDEXX”), a global leader in pet healthcare innovation, in October 2022.

This contract provides worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available.

Subsequent to year end, IDEXX launched the IDEXX Canine Cancer Test in January 2023.

Further, we engaged with DNAtech, Portugal, and, through our agreement with Heska, with Scil Lab Europe, to launch the Nu.Q ® Vet Cancer Test to customers in Europe commencing in November 2022.

Our Market Opportunity

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Given the wide-ranging nature of our products in development we believe that our market opportunity is large.

Based on our calculations, we believe that Volition’s annual total addressable market is approximately $70 billion.

Key assumptions for this market forecast are:

Based on our calculations, we believe that Volition’s annual total addressable market (“TAM”) is approximately $70 billion (including distributor and vet/clinician margins).

Key assumptions for this market forecast include:

opportunity is calculated based on canine and feline populations that are eligible for screening and monitoring.

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We anticipate that because of their ease of use and cost efficiency of our tests they have the potential to become the first method of choice for disease detection and monitoring in both humans and animals.

O ur Competition

We anticipate facing competition primarily from other human focused healthcare, pharmaceutical and diagnostic companies such as Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Oncimmune Holdings Plc, Abbott Laboratories Inc., Cepheid Inc., Koninklijke Philips N.V., GE Healthcare, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, and Roche Diagnostics, and from companies such as Mars Incorporated, IDEXX Laboratories Inc., PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.

Our Competition

We anticipate facing competition primarily from other human-focused healthcare, pharmaceutical and diagnostic companies such as Exact Sciences Corporation, Guardant Health, GRAIL Inc., Freenome Holdings Inc, CellMax Life, Archer DX Inc., Foundation Medicine Inc., Oncocyte Corporation, OpKo Health Inc., MDNA Life Sciences Inc., Oncimmune Holdings Plc, Abbott Laboratories Inc., Cepheid Inc., Hologic Corporation, Agilent Technologies Inc., Qiagen Inc., Thermo Fisher, Illumina, Becton Dickinson, BioMerieux, Invitae, Siemens, Gen-Probe Incorporated, EpiGenomics AG, MDxHealth SA, and Roche Diagnostics, and from companies such as PetDx, One Health Company (Fidocure) and Vidium Animal Health focused on the veterinary space.

There may also be other companies developing products competitive with ours of which we are unaware.

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The healthcare industry, and thus our business, is subject to extensive federal, state, local and foreign regulation.

Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations.

Some of the pertinent laws and regulations have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations.

In addition, these laws and their interpretations are subject to change.

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The federal government also has increased funding in recent years to fight healthcare fraud, and various agencies, such as the United States Department of Justice, the Office of Inspector General of the Department of Health and Human Services, and state Medicaid fraud control units, are coordinating their enforcement efforts.

Commercialization of our future products in the clinical IVD market (e.g.

Commercialization of our future products in the clinical in vitro diagnostic (“IVD”) market (e.g.

for patient diagnosis in hospitals, clinics, etc.) requires government approval (CE marking in Europe, FDA approval in the United States, and Chinese Food and Drug Administration (“CFDA”) approval in China).

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A similar system operates in China through the CFDA.

In Europe, IVD medical devices are regulated by the European Directive 98/79/EC (“EU IVDD”), where products not listed in ANNEX II, such as the ones developed by Volition, can be CE marked through a self-certification process.

Under this system, manufacturers must operate a Quality System and build/maintain a technical documentation file demonstrating the conformity of the product with the requirements of the EU IVDD.

This includes the validation of the devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance criteria.

The manufacturer then issues a declaration of conformity and affixes the CE mark logo to the product.

In May 2017, the new European In Vitro Diagnostic Regulation 2017/746 (“EU IVDR”), became effective, marking the start of a transition period for manufacturers selling IVD devices into Europe.

The date of application of the EU IVDR, which replaces the EU IVDD, is May 26, 2022.

After this date, no new applications pursuant to the former EU IVDD will be accepted.

We believe the most challenging changes under the IVDR will be those regarding the classification of products, which will bring almost all IVDs under the direct review and control of designated assessment organizations (“Notified Bodies”), and the performance evaluation of IVDs, which will require extensive clinical and analytical performance studies in addition to a demonstration of scientific validity.

Additional requirements will be applied to reinforce the safety of the products such as extended responsibilities of the economic actors of the supply chain, increased post marketing surveillance activities, unannounced audits from Notified Bodies, implementation of an improved traceability and transparency of the devices with the introduction of the Unique Device Identification system and an expanded European Database on Medical Devices.

In January 2022, the EU IVDR was amended.

The May 26, 2022, date of application of the EU IVDR remains unchanged.

Tailored transitional periods have, however, been introduced for devices that must undergo a conformity assessment involving Notified Bodies for the first time under the EU IVDR.

In Europe, since May 2022, IVD medical devices are regulated by the new European In Vitro Diagnostic Regulation 2017/746 (“EU IVDR”).

The most challenging changes compared to the previous Directive are those regarding the classification of products, which brings almost all IVDs under the direct review and control of designated assessment organizations (“Notified Bodies”), and the performance evaluation of IVDs, which requires extensive clinical and analytical performance studies in addition to a demonstration of scientific validity.

Additional requirements are now applied to reinforce the safety of the products such as extended responsibilities of the economic actors of the supply chain, increased post marketing surveillance activities, unannounced audits from Notified Bodies, implementation of an improved traceability and transparency of the devices with the introduction of the Unique Device Identification system and an expanded European Database on Medical Devices.

Tailored transitional periods have been introduced for devices that must undergo a conformity assessment involving Notified Bodies for the first time under the EU IVDR.

The length of the transitional periods depends on the classification of device.

In practice, the conformity assessment procedure for our products will be a combination of Quality Management System (“QMS”) audits and Technical Documentation assessments.

In practice, the conformity assessment procedure for our products requires a combination of Quality Management System (“QMS”) audits and Technical Documentation assessments.

The time needed for a Technical Documentation assessment of a device by our Notified Body (“TÜV SÜD”) is expected to last for nine months at a minimum.

We have already begun discussions with the TÜV SÜD to ensure compliance with the EU IVDR as soon as possible.

To support the conformity to both the EU IVDD and the new IVDR, Belgian Volition has implemented a QMS, conforming to the internationally agreed standard ISO 13485 that sets out the QMS requirements specific to the medical devices industry.

We have already begun discussions with the TÜV SÜD and are in the process to ensure compliance with the EU IVDR in 2023.

To support the conformity to the new IVDR, Belgian Volition has implemented a QMS, conforming to the internationally agreed standard ISO 13485 that sets out the QMS requirements specific to the medical devices industry.

Belgian Volition has maintained its ISO certification since 2015.

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We have used this position to build a growing, broad and strong patent portfolio covering the ability to profile the epigenetic environment surrounding circulating chromosome fragments from diseased cells, including the epigenetic signaling status of nucleosomes, DNA, and other epigenetic chromatin proteins.

Our patent portfolio includes 29 patent families and a total 84 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 14 patents granted in Europe, and a further 58 patents granted worldwide.

Our patent portfolio includes 34 patent families (plus three in-licensed families) and a total 97 patents granted related to our diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 15 patents granted in Europe, and a further 70 patents granted worldwide.

Additionally, we have a total of 122 patent applications currently pending, worldwide.

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Our IP strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries.

The patents on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2031.

As of December 31, 2021, we had 83 full-time equivalent (“FTE”) compared to 60 as of December 31, 2020.

The patent filings on the technologies underlying our products should provide broad coverage for each product, including protection through at least 2043.

As of December 31, 2022, we had 104 full-time equivalent (“FTE”) compared to 83 as of December 31, 2021, reflecting the growth in commercial and production activities.

We continually assess employee turnover, recruitment initiatives, compensation and benefits programs, safety in performing critical laboratory work, diversity and other matters relevant to human capital management, and we review results with our board of directors on a periodic basis.

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Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited, a private limited company formed under the laws of England and Wales (“Volition Diagnostics”), which was formed in November 2015, Volition America, Inc., a Delaware corporation (“Volition America”), which was formed on in February 2017, Volition Veterinary Diagnostics Development LLC, a Texas limited liability company (“Volition Vet”), which was formed in June 2019, and Volition Germany GmbH (formerly Octamer GmbH, or “Octamer” and now “Volition Germany”), a Munich, Germany-based epigenetic reagent company that it acquired in January 2020.

Our principal executive office is located at 13215 Bee Cave Parkway, Suite 125, Galleria Oaks B, Austin, Texas 78738.

Our principal executive office is located at 1489 West Warm Springs Road, Suite 110, Henderson, Nevada 89014.

Our telephone number is +1 (646) 650-1351.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business