Why We Invested in Biota

PFAS are known as the “forever chemicals”, a class of unnatural compounds defined by having carbon-fluorine bonds - “unnatural” because they never existed on earth until modern synthetic chemistry arrived. Consumers enjoyed PFAS-containing products for years - the fluorine atoms tend to make materials quite slick and non-sticky - think Teflon and Scotchgard. Industry has enjoyed the unique properties of PFAS as well - in applications ranging from the production of semiconductor chips to flame retardant materials to firefighting foams. PFAS became pervasive and polluted the environment before we knew it - and our food and drinking water - and our bodies and essentially all life on earth. The public learned far too late that some PFAS are carcinogens.

The carbon-fluorine bond is strong and difficult to break. PFAS are essentially immune to being decomposed by metabolic processes in human, animal, or plant life. PFAS molecules look a bit like fatty acids do, which are naturally produced by all cellular life, and because of that resemblance, many PFAS bind strongly to the proteins in blood and tissues that normally carry fatty acids. But because our bodies weren’t ever meant to ingest PFAS and can’t break them down, they bioaccumulate. There is essentially a 100% chance that you have PFAS in your blood.

PFAS became a public problem in 1998 when a cattle farmer in West Virginia had ~150 of his animals die after drinking from a creek that ran past a DuPont landfill. DuPont was forced to turn over its files that showed the company had studied the toxicity of a PFAS chemical (PFOA) for decades but had stayed silent. Sixteen years later, in 2014, a resident of Hoosick Falls, New York, started asking why so many people he knew had rare cancers, including his father, who died of kidney cancer after decades at the local Saint-Gobain plant. He suspected that PFOA, a cancer-causing PFAS used to make Teflon, might be the cause. He paid out of his own pocket to have the village tap water tested, and it came back at 540 ppt against an EPA advisory limit at the time of 400 parts per trillion (ppt). It then took more than a year of pushing before residents were told to stop drinking it. The EPA limit for PFOA and PFOS in drinking water today is 4 ppt. 

Part of the challenge in addressing PFAS is that we don’t exactly know the levels at which it can exist in water or food before it is toxic to human, animal or aquatic life. The US EPA has taken action, first requiring every drinking water utility periodically to test for PFAS, with initial monitoring to be completed by 2027, and then requiring utilities whose PFAS levels are too high to install removal technology by 2029, though the EPA has proposed allowing systems to request an additional two years, to 2031. And some water utilities with very high PFAS levels are being proactive and installing treatment before they are required to.

Another challenge with PFAS is that it is a category that includes ~10,000 separate chemicals - some have short fluorinated carbon chains and some have long fluorinated carbon chains. And there are different subclasses, including perfluoroalkyl carboxylic acids (such as PFOA), perfluoroalkyl sulfonic acids (such as PFOS), fluoroether carboxylic acids (such as GenX), and fluoropolymers such as PTFE (ie, Teflon) and PVDF.

Quantifying the level of PFAS is a necessary first step in understanding the magnitude of the problem and also in developing the removal processes and validating removal effectiveness. In other words, we can’t really understand the scope of a problem without being able to measure it. But PFAS, being a complex mixture of chemicals, and typically being very dilute in environmental samples, on the order of parts per billion to parts per trillion, is hard to measure. The trusted PFAS measurement method today is US EPA method 1633, performed in a laboratory using a procedure that isolates PFAS in a solid phase extraction (SPE) step that can take hours, followed by elution of the PFAS and then analysis using LC-MS/MS, a sophisticated measurement instrument that averages ~$500K installed. 

The PFAS level in the field is determined today by grabbing a sample, paying ~$500/test, shipping it to a lab to run the 1633 test, and waiting 2-3 weeks for the results; paying a ~300% rush charge can cut the time to ~3-5 days. Some firms that test a lot of PFAS samples actually invest in their own staffed laboratories and perform the testing internally.

The lack of an inexpensive, rapid, PFAS screening test that can be done in the field is a real pain point in the industry - arguably the single biggest need in addressing the pervasive PFAS problem. That gap is a nightmare for environmental remediation firms, engineering companies, landfill operators, chemical companies, and treatment developers who need high volumes of tests. Just imagine an environmental remediation firm trying to understand the scope of PFAS pollution in an area, drilling a grid of soil samples to define the problem and where the PFAS hot spots are, but having to limit the number of samples because the high cost per test can quickly overwhelm a testing budget - and then having to wait weeks for the data before they can continue mapping the area and home in on the problem.

Rose Nash found this opportunity by setting out to build a diagnostics company that would solve a real unmet need in environmental monitoring rather than to commercialize a particular technology. She saw water monitoring as an overlooked area where diagnostic technologies and approaches could have significant impact. Her first idea was automated virus monitoring at wastewater treatment plants, which made sense given that she was employee #1 at GT Molecular, where she helped build a leading wastewater-based COVID surveillance platform. She interviewed ~100 wastewater utilities and then killed the idea because the pain wasn't acute enough to build a business on.

She kept looking for a large problem to be solved, ran well over 100 more interviews across testing labs, environmental engineers, and remediation firms, and landed on PFAS screening. She drilled deeper to find precisely where pain was most acute, set aggressive targets for cost and speed that would open a market rather than merely serve one, and only then went and built technology to hit those targets. We call that a ‘right to left’ approach, and it's the opposite of what many founders do, which is to start with a technology and then go looking for customers.

The market needs a fast, affordable, in-field PFAS test. And that’s what Biota is on the cusp of delivering. We’re thrilled to have led their Seed round. Rose and the entire Biota team: welcome to Burnt Island! Here’s more on why we invested.

Two technologies that work together

Biota is developing two technologies that can stand alone or work in concert. RapidTest is the PFAS detection technology, based on proprietary chemistry that specifically binds the PFAS (something hard to do since PFAS are so non-sticky), causing a change in fluorescence - which is measured with an inexpensive fluorometer. The entire test takes ~10 minutes, and is less than 10% of the cost of the 1633 test (we’ll let Biota share the pricing themselves) - and that’s with excellent margins for Biota. RapidTest gives people who need to make decisions the immediate information they need: where to drill next, whether the carbon bed has broken through, whether the destruction tech is achieving its goals, etc - accurate answers in minutes instead of weeks, at a cost that lets them test comprehensively rather than sparingly.

The second technology, MagnaPrep, is for isolating and concentrating PFAS from a “matrix” (a fancy term for a complex sample). If the PFAS are not joined by many other contaminants, MagnaPrep might not be needed. But PFAS are often in real samples that have a lot of other things in them, and that’s where MagnaPrep shines. Biota places special PFAS grabbers on very small magnetic particles, then a magnet is used to isolate the particles and the PFAS are eluted off (similar to how PFAS are removed from the SPE column in the incumbent method 1633), for detection by RapidTest. When MagnaPrep and RapidTest are combined, the result is a workflow that is robust to matrix variability and provides a higher degree of sensitivity.

MagnaPrep also has the potential to replace the SPE step in method 1633, with significant advantages - and method 1633 explicitly encourages improvements to it. SPE is labor-intensive as flow through the SPE column is slow, and is especially prone to clogging by complex environmental samples. SPE is also poor at capturing short-chain PFAS, with recovery on compounds like PFBA falling into the low single digit percentage, a known weakness that is accepted. Biota's testing shows that relative to SPE, MagnaPrep provides more than a 10X reduction in labor and short-chain capture at >90%. For a lab running high volumes of PFAS samples, where throughput and labor affect its economics and accuracy is paramount, MagnaPrep offers a dramatic improvement.

Biota has filed broad patent applications spanning the sample prep chemistry, the detection method, and their integration.

It works on real-world samples

Many have tried, and are trying, to develop a rapid PFAS screening test, but with limited success. PFAS are often present in industrial matrices with other contaminants and surfactants that make the development of a PFAS screening test much more challenging than determining PFAS level in drinking water. Landfill leachate, soil rinsate, and Aqueous Film Forming Foam (AFFF) samples are complex, and plenty of promising detection methods have failed when used with these real-world samples, leaving a bad taste in the mouth of many environmental firms. What got us over the line with Biota was seeing the technology run on genuinely difficult real-world samples and hold up, and seeing that MagnaPrep gives Biota a path to isolate the PFAS when a matrix is too messy for the detection step alone. 

Customers are waiting to be served

The served market for rapid PFAS screening tests today is near zero - which is scary for the company and for investors! Biota will essentially be creating the market. 

So the best demand signal at this stage would be in market segments where customers’ need for a solution is great enough to overcome the barriers of adopting a first-of-a-kind (FOAK) product. Throughout our diligence, the people who are dealing with PFAS on a daily basis, from environmental firms to treatment companies to the big analytical players, in the US and Europe, were clear that a fast, inexpensive, field-deployable PFAS test that actually works would be a game changer. What we learned through our primary research was exactly what Rose had told us - that there are market segments where people need immediate answers, and want to do significantly more testing than they can get done today. And there are broad regulatory tailwinds in the US, at both the federal and the state level, and in Europe.

Rose and her team hustled their way into exactly those conversations with people ready to adopt and have built a pipeline of customers who have an acute, immediate need and are already spending money on PFAS testing. That's the right beachhead, because the pain sure seems to exist to such a degree that people are willing to try something unproven. Larger, slower to adopt markets like routine monitoring at regulated drinking water treatment plants and performance testing of PFAS removal systems are on Biota’s market migration map.

Optionality and a platform in the making

Launching a brand-new product into a market that doesn't exist yet carries obvious risk, despite the legwork to define customers’ needs and the specs on products that would delight them. So we love that Biota has sharp customer-focus alongside technical agility to quickly iterate on the solution. And the company has built in several shots on goal: two distinct technology platforms (RapidTest and MagnaPrep) that each have roadmaps, as does the combination of the two. And there are some exciting possibilities in PFAS detection on the horizon to satisfy other customer needs.

Biota has a vision to be a platform company with a family of detection products for emerging contaminants, from quick field screens to high-throughput regulated lab tools, positioning them to be a leader in environmental diagnostics. PFAS is the entry point because of the large unmet customer pain. But there are other unmet diagnostic problems to be solved - and we have confidence in this team.

A founder & team built for this

We invest in people first, and Rose Nash is exceptional. She has intelligence, tenacity, customer-focus, and grit - and she has the big picture view and vision for her company, where PFAS is the first bet. What really struck us is her intellectual integrity - Biota isn't a technology hunting for a market. If Rose had not been able to develop a solution that achieves the necessary market requirements, she would have pivoted to something else. 

Rose iterated with her team through a range of concepts and hundreds of formulations to land on RapidTest and MagnaPrep. She has a fast clock speed, turns learning cycles quickly, and keeps her attention on the customer. And she’s a keen listener with a great presence. She's also brought on a strong team, including Dan Feldheim leading chemistry, who previously ran two gene editing startups, one acquired by Editas Medicine in 2017; Tom Wieser on assay development, with a PhD in biochemistry from CU Boulder; and Sydney Ciechanowicz running analytical chemistry. If there's a founder to back in this fast-moving space, we think it's Rose.

Biota is an early-stage company, and creating a new product category and getting it adopted isn’t easy. But the combination of a founder that you want to back, a picks & shovels approach to addressing the huge PFAS issue, a market waiting to be served, differentiated high-margin products, strong and defensible intellectual property, and a platform vision with room to run made this an easy conviction for us. Rose and the whole Biota team, thank you for having us along for the ride.

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