Cardiovascular disease remains the leading cause of death in all developed countries. It is caused by atherosclerosis, the progressive thickening and hardening of blood vessel walls due to the buildup of plaque.

The buildup of plaque is a drawn out and cyclical process whereby fat cells accumulate in the vessel walls causing inflammation, immune cells arrive to save the day, the immune cells have trouble "eating" the fat cells and end up becoming part of the debris itself, signaling for more immune cells to arrive to scene as backup in a troubling cascade that slowly reduces the diameter of the blood vessel. Over time, the inflamed debris calcifies into a more or less permanent fixture on the vessel wall.

In addition to narrowing the vessel, plaques that have yet to fully calcify can rupture and cause severe blockages that lead to stroke and heart attack. Unfortunately, 23 million people suffer one of these events each year.

Given how much we know about the disease, it would be natural to assume that we’d be pretty good at assessing patient risk, diagnosing and treating the disease. But we’re not even close - a  shocking 70% of patients who had just had their first stroke or heart attack were previously labeled as “low-risk” by current standards! 

Low risk?! Umm... clearly, we have a long way to go.

Today’s Standard of Care is Wasteful

While there has been some progress in recent decades with cardiovascular therapeutics, the same cannot be said about diagnostics. This is especially unfortunate because the majority of stroke and heart attack events are preventable if the disease is identified early and properly managed.

Today's methods largely center around stenosis, which is measuring the extent of narrowing of a blood vessel. The theory goes, the more narrow a vessel, the higher risk of an event. While not entirely false, the 70% statistic above tells us that we’re not quite getting the full story.

Without adequate tools and methods to assess the risk of an event, a lot of time, money, and resources are expended unnecessarily.

The first assessment is generally imaging based (e.g. CT scan or SPECT) and reserved for patients deemed "high risk". This is because the tests are only 50-70% accurate. Despite this, 35 million of these are ordered per year.

The next step is an invasive procedure where clinicians insert a catheter tube into a patient's blood vessel and perform a series of tests intended to determine the risk of an event. The problem is that these procedures are time consuming, expensive ($4,000 per analysis), and less than 75% accurate at determining the risk of heart attack. Still, 5 million of these tests are ordered each year. It is estimated that 50% of these are unnecessary.

Despite having taken patients through two rounds of assessments, clinicians still do not have enough information on hand to make an accurate risk assessment and determine the best therapeutic approach (stent vs. drug A/B/C). 

As a result, clinicians are generally left with limited options: either intervene using a stent (highly invasive, costly, and unclear efficacy) or with broadband therapeutics (statins first, then intensive therapeutics based on results). 

Better Data Needed For Drug Development Too

Developing new cardiovascular therapeutics, like all other pharmaceutical programs, is time consuming and expensive. However, because these therapeutics are targeting an inaccessible lesion, quantifying a drug’s efficacy is an even bigger challenge. Unlike other conditions where you can simply take a blood or tissue sample to understand if a drug is working or likely to work, you cannot do the same with lesions around the heart - blood contains very limited signals regarding what is happening at the wound site itself and taking a tissue sample could potentially cause the same type of catastrophic event that we’re trying to prevent in the first place.

Combined, this leads to therapeutics that are under-utilized with patients and generally disincentivizes further therapeutic development where proving efficacy is required for adoption and a deeper understanding of which patients are most likely to respond, increases usage and efficiency.

The world is in dire need of better diagnostic tools that can more accurately assess patient risk as well as offer insight into which treatments a patient is most likely to respond to.Elucid Bio is building a first-of-its-kind precision medicine platform for heart disease.

Elucid's foundational technology was based upon the insight that not all lesions and plaque deposits should be treated the same. Rather, certain types, those lesions that are especially large or plaques rich in fats (lipids), are the most likely to break off or rupture, and therefore of the highest risk to patients.

This insight had come to be widely accepted across the physician community, however no existing technologies could easily provide this information, let alone do so non-invasively. 

Elucid hypothesized that, leveraging AI, they might be able to use CT imaging data to digitally render and analyze the lesions and plaques present inside a patient. If successful, it would be as if a pathologist had the tissue under a microscope. They could more accurately determine event risk than existing methods on a wide range of patients with suspected heart disease. And they have done just that...

From a routine, non-invasive CT scan, the Elucid platform (vascuCAP) uses AI to digitally characterize lesions and plaque composition, an exciting new source of data detailing what’s actually occurring inside each individual patient’s body. Leveraging this data, Elucid can accurately determine the patient’s event risk as well as provide a patient-specific response model, predicting which treatment option is best suited for them.

More exciting, in recent studies, the Elucid platform has proven to be significantly more accurate at predicting stroke and heart attack risk, outperforming today's standards by 40% and 30%, respectively!

Pharma companies are excited about this as well. Elucid's proprietary technology enables a streamlined method to track plaque progression (and regression!) in the presence of drug therapeutics, enabling companies to quantitatively measure therapeutic response over time for use in clinical trials and patient care.

FFR-CT Analysis

In addition to lesion and plaque characterization, Elucid has validated a novel method to conduct an FFR-CT analysis from the same imaging scan. FFR-CT stands for Fractional Flow Reserve – Computed Tomography. It is a computational analysis that creates a 3D model of a patient's coronary arteries (arteries that supply blood to the heart) and aids in identification of potential blockages. 

FFR-CT was first commercialized by HeartFlow. As a first-mover in the space, HeartFlow established the market and completed several clinical studies validating the technology’s ability to avoid 83% of unnecessary cardiac catheterization procedures, saving $4,000 per patient and $8B annually. These efforts resulted in a lucrative reimbursement rate ($950 per analysis), $600M in funding, and company valuation of $1.5B (as of 2018). 

Up until this point, HeartFlow has had a monopolistic position in the market due to a patent moat limiting competition. However, the Elucid platform uses a different computational methodology to calculate FFR-CT. In addition, Elucid has significantly improved upon the original HeartFlow product offering, solving key design limitations. The stage has now been set for Elucid to capitalize on the path trail blazed by HeartFlow.

Having spent just ~2% of the capital investment that HeartFlow required to get here, not only is Elucid primed to be a successful fast follower, but their solution also has several major advantages over HeartFlow that will enable them to outcompete.

Compared to HeartFlow, the Elucid platform is able to offer more clinical utility, seamless workflow integration, faster runtime, on-site deployment, and better financial incentives. Specifically, Elucid can:

• Analyze results in minutes vs. hours with HeartFlow, meaning the patient does not need to go home as they do today and the customer can run more scans per day

• Complete its automated analysis using standard CT scans vs. a manual processing of specially-acquired scans using highly-trained technologists with HeartFlow

• Process results on-site vs. having to send patient data outside the hospital with HeartFlow. Many major health systems, including the Department of Defense and VA will not work with HeartFlow because they refuse to send information to an external third party. For Elucid, the addressable market expands overnight because they can approach these systems with an alternative as well as super product.

• Better integrate into clinical workflows: fast, easy, auto-upload to EMR

• Deliver high margins vs. no margin with HeartFlow (labor intensive and expensive)

• Provide critical information to the clinician about a patient’s risk of event, which lesions require intervention, and measurement of therapeutic response objectively. 

A New Standard of Care Is Coming

VascuCAP is FDA cleared, CE-marked, and has established reimbursement. Elucid has over 20 clinical & research clients, including several recently launched influential sites: Mount Sinai and MedStar Health, as well as a european hospital system in partnership with GE.

Elucid is in late-stage discussion with multiple strategic partnerships that represent multi-million-dollar opportunities. In parallel, the company has multiple contract research studies focused on stroke/heart attack prediction and modeling patient response to cardiovascular drugs, including PCSK-9s.

Elucid’s FFR-CT data has been recently published. The company generated buzz when it previewed the work at the Radiological Society of North America (RSNA) Annual Meeting in Dec 2020. Having demonstrated superior accuracy to HeartFlow’s system, the company is now focused on finalizing ongoing clinical studies and anticipates FDA clearance in early 2022. 

The company’s work with virtual transcriptomics remains an exciting area of internal R&D with great potential. Their initial manuscript will be published shortly. Having successfully demonstrated proof-of-concept, the next milestone will be a follow-up validation paper as well as integration into a large-scale drug development program. To get there, Elucid plans to continue to work through its proprietary data set to further refine the models & enhance accuracy. From there, they will continue to pursue partnerships with pharmaceutical companies in drug discovery and, ultimately, tailored therapeutics. 

Elucid is developing a truly first-of-its-kind AI-enabled precision medicine for cardiovascular disease platform that will inform not only diagnostic and treatment decisions, but aid in the development of novel treatment options. It has potential to become the new standard of care in the space and improve outcomes for millions of patients each year around the globe.

Intellectual Property

Elucid has comprehensive IP coverage spanning: histological validation, image restoration, FFR derived from vessel wall, and associations with molecular mechanisms and clinical utility. 

Elucid will be the only company able to bring an FFR-CT solution to market that does not infringe on HeartFlow’s patents due to its unique computation methodology.

The company’s IP moat is further enhanced by proprietary data banks, including pathologist annotated tissue samples, gene expression profiles, and patient outcomes data, all labeled and paired with CT images.

Regulatory & Reimbursement

Elucid has successfully obtained FDA clearance and a CE mark for its AI-enabled plaque quantitation methodology to inform risk of stroke and heart attack and inform treatment selection. FFR-CT clearance is anticipated in early 2022.

For hospitals, Elucid's platform more than triples reimbursement of a standard coronary CT scan. FFR-CT is being pushed by U.S. payers due to the dramatic cost savings tied to adoption and has already been established as a standard of care in the UK.

Market

Heart disease is the leading cause of death in the developed world. Elucid will be the only cardiovascular diagnostic & therapeutic development platform able to accurately predict patient outcomes, personalize care, and track progression for 35M patients per year, representing a market opportunity of $35B+.

Hospitals & Imaging Companies

There are over 26,000 CT scanners in markets where Elucid has clearance today, including large health systems, clinics, diagnostics centers, and others. The Elucid platform can be leveraged by a number of specialists at these facilities, including cardiologists, radiologists (diagnostic, interventional & neuro), and vascular surgeons.

In addition to its sales team, Elucid is exploring partnership with CT scanner manufacturers and medical software companies to further scale distribution.

Pharma & CROs

There are ~20 major pharmaceutical companies & CROs involved in cardiovascular drug development that have been validated as prospective customers for Elucid’s platform. Until now, these companies have had limited ability to validate the efficacy of their drugs and more granularly determine the profile of patients most likely to respond. Data stemming from these studies will have the added benefit of improving the underlying Elucid algorithms. 

Team

Scientific Advisory Board

5 Whys: Elucid Bio Manifesto with CEO Blake Richards

Dive Deeper

• Validation study: demonstrating more accurate stroke prediction
• Validation study: demonstrating more accurate heart attack prediction
• Validation study: demonstrating Fractional Flow Reserve (FFRct) accuracy equivalence to HeartFlow
• Validation study: demonstrating reduced risk of heart attack following biologic therapy
• Validation study: demonstrating reduced risk of heart attack following drug therapeutic