Somer Baburek is co-founder and CEO of Hera Biotech – a US startup addressing unmet needs in the field of women’s health and reproductive medicine.
Health Tech World called up Somer to learn more about the impact of endometriosis and how the company’s MetriDx technology could bring diagnosis and treatment into the 21st century.
Hi Somer. How is endometriosis diagnosed today?
The only definitive diagnosis is via a surgical procedure.
The UK sometimes accepts imaging. But imaging won’t tell you what you’re seeing. It will just show that something is there. But is it a cyst? A tumour? Or just a benign growth?
Unfortunately, the current method leads to a diagnostic delay of about eight years in the US.
Sadly, the hallmark symptom of endo is debilitating pain.
When I say ‘debilitating pain’, some women completely black out from the pain. Many can’t get up or go to work because they’re doubled over in bed.
It’s really frustrating for them because they get dismissed. This creates a fractured relationship between the patient and the medical community.
But the only thing a doctor can actually do is recommend you for a very invasive surgery. And it’s often not done by them but by a laparoscopic surgeon.
The success of that surgery heavily depends on the skill and curiosity of the surgeon.
They’ll take multiple biopsies and about half the time, the biopsies they take are not endo.
And in almost 20 per cent of those surgeries, they open her up, they don’t see anything, and they close her up.
What does that mean for the patient? What happens next?
I think that’s almost worse.
With most diseases, the severity of your symptoms corresponds to the progression of the disease.
But with endo, that’s not the case. An early-stage patient with a few small legions can go through excruciating pain.
These legions can be millimetres in size. And if a laparoscopic surgeon who doesn’t treat endo all the time doesn’t spot them, the patient has an even heavier lift to convince people that there’s something wrong.
How did we get to this point where we have a culture of people being dismissed?
It’s always been a bit that way, hasn’t it?
All women, despite their ethnicity, were always treated like small versions of 150 pound white male.
One reason for that is that societally, we don’t want to talk about your period, vagina, cervix, uterus or your fallopian tubes. It was just considered impolite.
I think that’s how we’ve got to this point. It’s just been exacerbated over many years
OBGYNs are the least paid specialty provider but they manage the highest number of indications, something like 80 or more. And that’s not even considering the foetal medicine part of it.
There are 10 million women in the US living in a county that does not have a practicing OBGYN. It’s a complete mess.
In the 1940s and 50s, cervical cancer was the number one killer of reproductive-aged women.
Then a Greek doctor came along and developed the Pap smear after recognising that we could take cell samples from the cervix and look for cancer.
Over the next few years, the rates of cell cervical cancer killing women dropped by 60 per cent.
Now think about how much we know about cervical cancer. We know that it’s primarily caused by a virus, we have a vaccine for it.
That’s exactly where we are in endo. We need a non-surgical diagnostic to opens the door for an incredible wealth of information about the disease.
In the OBGYN world, they call endo the ‘non-cancer cancer.’ The only difference is it doesn’t grow at this unregulated rate.
A cancer researcher told me when she started working in endo that the space was 30 years behind cancer.
Where do you guys fit into this?
We took an oncology approach to developing an endo diagnostic.
A doctor takes a sample of the endometrial lining in a procedure that’s similar to having an IUD placed. They then ship the sample to us.
We separate that tissue into the two main cell types and analyse the overexpression and under expression of a particular gene set, and those two different cell types.
Where are you in your journey so far in terms of funding and clinical trials and so on?
We did a pilot study comparing ourselves to the histopathology of excise lesions during laparoscopy.
Our test was 99 per cent accurate in diagnosing endo.
We’re now in our second clinical trial where we’re looking to replicate the results in a larger patient set.
We developed a computational model, which will eventually become our algorithm that we use when we go commercial.
We have a little over $1 million (£824,000) in non-diluted funding from places like the NIH and the Endometriosis Foundation of America.
We’ve also raised a $2 million (£1,600,000) seed round to support the second clinical trial.
We’re now looking to raise our next round, which will take us all the way through all the activities associated with our FDA clearance.
We will launch prior to FDA clearance as a laboratory developed test. But we we’re not diverting.
We are going for FDA clearance because we think it’s really important to address the access issue and make sure that OBGYNs and pharmaceutical companies developing drug candidates in this space are capable of using our test to measure efficacy.
Because right now, how do they develop a drug?
You have to know it’s working. Well, how do they know that it’s working?
They have to cut a woman open multiple times during a clinical trial to prove it and no one’s going to do that.
Our diagnostic, definitively tied to the formation of the disease, gives them an opportunity to do that in their clinical trials and hopefully enables drugs to come to market that are disease-modifying.
Right now, there is no disease-modifying drug approved for the treatment of endo, only to reduce pain.
Wat’s your timeline looking like for this?
I would like to see us on the market as a laboratory developed test at the end of 2024 and we’re hoping to have FDA clearance by 2026.
We’re engaged in some discussions with the FDA regarding some expedited approval programmes that would we’re trying to get involved with.
Of course, I’d love for it to be on the market right now.
My sister had a hysterectomy when she was 32. She was not ready to not have children but that was the only answer. But it didn’t do any good because they didn’t get the lesions, they just took out her uterus.
Dr Martin at the Endometriosis Foundation of America suspects that endo might affect as many as 30 per cent of reproductive aged women when you factor in asymptomatic women.
We have the opportunity to impact so many people’s mental and physical health and their ability to operate productively as they want to, if we can get some drugs available to them that can actually treat the disease.
What do you want the future to look like for these patients who have been underserved or ignored in some cases?
I want it to look like it does for cervical cancer, maybe better.
Cervical cancer now affects nine in every 100,000 women and endo affects 10,000 in every 100,000 women. So it’s 1,100 per cent more prevalent.
In the US last year, there were 26 million Pap smears done to catch nine in 100,000. That’s what I want it to look like for endo.
When you have your first menstrual cycle, you get your first pap smear.
Well, you should also be tested for endo, because it completely changes the way that you move through the healthcare system.
Testing would mitigate so much expenditure and time for patients and payers alike.
We estimate that even if you take it down to a five-year diagnostic delay, it costs about $180,000, because 70 per cent of these patients are misdiagnosed first.
They’ll go to specialty providers and do all sorts of things that don’t treat the disease. It’s a huge expenditure and society in general would benefit without having to pay for it.
What is the wider impact of people taking time off to manage their endo?
The average woman with endo loses 11 hours of productivity a week. If you factor in absenteeism and chronic presenteeism and all the associated costs, the economic burden is close to $80 billion in the US.
We’re 51 per cent of the US population and women make up 75 per cent of the healthcare workforce.
So if millions of these women are incapable of performing their duties when we already have shortages, that’s a huge problem for society.
What do you have in store for the remainder of 2023 and into 2024?
We’ll have the results of the proof of concept study that we’re doing at the moment. Hopefully, we’ll have some good news to come out after that.
Then hopefully, we’ll get this round raised. We have a good portion of it soft-committed. We just need a lead investor to set the terms.
After that, we’ll move into the validation trial, which will get us a product launch and then moving onto FDA clearance.
