Blood all over your underwear. Cramps so bad you nearly pass out. Terrible nausea, awful migraines, and constant fatigue.
This probably doesn’t sound unfamiliar to most women.
The trauma that has been inflicted on all women in some regard is something we will never be able to forget. The unbearable pain, unlike anything we’ve experienced, is incomparable.
It has scarred millions of women and girls all over the world, both emotionally and physically.
Women and girls in modern society are accustomed to the insurmountable effects that an imminent biological process has on our bodies during menstruation or an individual’s period.
However, women face these issues and many others, conceding to the repercussions they have on our lives on a monthly, weekly, and daily basis.
The repercussions extend beyond menstruation. For many women with reproductive disorders, the pain is simply exacerbated during menstruation.
Even on a societal scale, we view the unbearable effects of menstruation and reproductive disorders on our bodies and our mental and emotional health as an inherent part of being a woman. Women are told that it’s “normal” and “expected” to have cramps. Just take a couple of Tylenols, get a heating pad, and stop complaining so much.
In reality, the circumstances are more alarming than they might seem. Society views menstruation through a narrow lens; one in which a woman starts bleeding once a month, faces slight discomfort, takes medicine, and goes about her day. What more is there to it?
But that doesn’t represent the conditions of all women.
In fact, it’s not even close.
Society shelters women from the image of unbearable pain. The image of women throwing up, passing out, unable to move, and going to the ER, only to be given morphine to handle the pain.
Occurring not just once a month, but for years and decades on end.
Most reproductive disorders stem from menstrual pain and discomfort. A level of pain and discomfort that isn’t “normal” by any definition.
In 2019, a survey was conducted on 42,879 women across the world. It found staggering results.
85% of the women in the study experienced dysmenorrhea, or intense menstrual cramping, on a consistent basis, in addition to pelvic pain during their period. 77% reported some sort of psychological complaints, and 71% reported extreme tiredness.
When menstruating, 38% of all women reported not being able to perform all their regular daily activities.
However, out of all of the women that were unable to complete their usual tasks due to their symptoms, 48.6% told their family that menstrual symptoms were the reason.
Periods don’t seem prevalent. Sudden pain once a month doesn’t seem unbearable.
However, countless reproductive disorders stem from this pain. In fact, they are the cause of much of this pain. Pain that is prevalent not only during a woman’s period but before, during, and after it.
It is not normal for women to be facing such extreme amounts of pain. Menstrual pain and discomfort, to some extent, are unavoidable. But we are pushing the limits much too far.
There is almost always an underlying reason.
Reproductive Disorders. Namely, endometriosis, PCOS, and uterine fibroids.
While these disorders are beginning to become more addressed in modern society, many issues remain. The work that is being done on these disorders is minimal.
You might be familiar with these disorders. Or they might be completely unfamiliar to you. Regardless of if you know it or not, you likely know at least several women who suffer from one of these disorders.
Take endometriosis, a disease affecting 1 in 10 women worldwide, in which the tissue lining the uterus grows in other parts of the abdominal cavity, such as the ovaries, fallopian tubes, or tissues lining the pelvis, and can even spread to other organs, including the lungs.
This endometrial tissue becomes trapped and has no way to exit the body during menstruation, and can become trapped causing cysts to form, as well as irritating surrounding tissue and forming scar tissue and adhesions.
Or uterine fibroids, noncancerous growths in the uterus which distort and enlarge the uterus, resulting in heavy and long-lasting menstrual periods and intense pelvic pain. They can range from the size of a pea to over 20 pounds. And well over 25% of women in their reproductive years will develop one.
Meanwhile, PCOS, or polycystic ovary syndrome, is a condition that also affects approximately 1 in 10 women between 15 and 44. While PCOS doesn’t involve the growth of the tissue itself, it alters womens’ hormonal levels, causing women to produce excess amounts of male hormones.
PCOS causes women to produce higher amounts of androgens, and lower amounts of progesterone, resulting in small, fluid-filled sacs growing inside of the ovaries, never maturing enough to trigger ovulation. This results in women having irregular menstruation, excess facial and body hair growth, infertility, and acne.
However, PCOS is also correlated with infertility and an increased risk of diseases including Type 2 Diabetes, Heart Disease, High Blood Pressure, and Stroke. Moreover, the prevalence of infertility within women with PCOS ranges between 70 and 80%.
But the most shocking part is that most women with PCOS don’t even know that they have it.
Diagnosis remains the biggest issue.
Less than 25% of women with PCOS have actually been diagnosed. This is largely because women and their health care providers tend to look at the wide variety of symptoms individually rather than collectively. And the women who do find out often only do when trying to have a child.
These diseases are clearly prevalent in society, garnering a much larger presence in underprivileged communities, yet remaining a global issue.
An issue that is taking away from the healthspan of women. Women of all ages, backgrounds, and socioeconomic classes. All women, falling under the burden of undeniable pain and suffering beyond our control.
The biggest issue remains in the diagnosis of such disorders. The average woman in the United States will suffer from endometriosis for up to 10 years before actually receiving a diagnosis. In places where healthcare is government-funded, the wait for a diagnosis can take even longer, compared to healthcare that is self- or insurance-funded.
Endometriosis goes undiagnosed for years because the abdominal pain associated with the condition is mistaken for menstrual cramps. To get officially diagnosed, a woman often has to undergo a surgical procedure that identifies the endometriosis lesions.
Women have to actually convince their doctors that their symptoms aren’t just “horrid cramps,” a task that proves to be nearly impossible.
Over 61% of endometriosis patients have been told by health care providers multiple times that nothing was wrong with them.
For patients with PCOS, there is no definitive answer. When diagnosing PCOS, a doctor might assess medical history, weight fluctuations, and menstrual periods as well as a pelvic exam or blood test. It can take women years and several doctors to receive a diagnosis.
As Marianne Legato, FACP, professor of clinical medicine and Colombia University and a specialist in gender-specific medicine reported in regards to PCOS:
“To be diagnosed, patients would have to report hirsutism or difficulty conceiving or irregular menstrual periods, which they often don’t, and many doctors don’t inquire about those things, either….Many of these women are also obese, so anything that’s unusual just gets written off to their obesity.”
For women with uterine fibroids, invasive diagnostic methods are frequently used. Often, a transvaginal ultrasound is used, in which doctors are required to insert an ultrasound wand, or a transducer, into the vagina and turn it slowly to generate images for up to 30 minutes.
Sometimes, a saline infusion sonography is used, in which sterile salt water is dissolved into the uterus to detect abnormalities and stretch the uterus even further before the examination.
Other invasive methods are also often used in patients with uterine fibroids, from a hysteroscopy, in which a lighted tube is inserted into the vagina to examine the cervix and uterus, to a laparoscopy, a surgical procedure in which incisions are made near the navel to insert a laparoscope, view the organs, and sometimes even to collect tissue samples.
While transvaginal ultrasounds are commonly used over much more invasive methods, this type of imaging doesn’t always reveal all existing fibroids. The size and location of uterine fibroids vary greatly, and extremely small fibroids, submucosal fibroids, and small fibroids that are hidden behind larger tumors aren’t always detectable through a routine transvaginal ultrasound.
Women with reproductive disorders such as uterine fibroids struggle immensely from such treatment options, not to mention the wrath of the disease itself. Here’s what women with uterine fibroids had to say about it in the past year:
“Every doctor wanted to give me a hysterectomy, which infuriated me because there were no other options” -Nichet Smith
“It’s to the point where I hate making plans because then the pain will start and I’ll often cancel.” -Les Henderson
“My fertility has been hijacked by the fibroids in my body” -Gail Anderson
However, the problem with reproductive disorders gets even more complicated.
Researchers acknowledge that an early diagnosis of reproductive disorders is beneficial for women to restore fertility, normalize their menstrual cycles, and protect against PCOS, endometriosis, or uterine fibroid related risks for diabetes, heart disease, and endometrial cancer.
However, it takes years for women to receive diagnoses when something is clearly wrong, due to systemic and structural issues.
Society fails to perceive the impact of these disorders beyond the pain that women face.
We fail to acknowledge the suppressed productivity and potential for growth when nearly half of its population suffers from imminent pain.
Take uterine fibroids as an example.
Fibroids are not just an issue for the millions of women who suffer from their symptoms, ranging from excruciating cramps, and even anemia, requiring blood transfusions and several surgical procedures to alleviate symptoms and attempt to remove the growths.
Fibroids should be considered a public health issue, given the magnitude of the problem and costs of health care for this disease.
A study conducted in 2011 estimated the annual cost of uterine fibroids just in the United States at approximately $17.2 billion dollars annually.
Uterine fibroids have a larger economic impact on society than breast cancer, colon cancer, or ovarian cancer, as up to 70% of white women and 80% of black women in the United States will have uterine fibroids by the age of 49.
However, it is a difficult task to estimate the economic burden of uterine fibroids. Between direct costs, including hospitalizations, outpatient visits, surgical procedures, and medical treatments; and indirect costs, such as the work productivity that has been lost in correlation with the symptoms associated with uterine fibroids.
While the researchers in the study estimated that between $4.1 and $9.4 billion is spent annually on medical treatments for fibroid patients, due to the invasive surgical methods combined with hundreds of thousands of hysterectomies, researchers realized that lost work productivity accounted for the largest societal cost.
Many problems exist within the diagnosis of reproductive disorders, at a societal level, but more importantly, at an individual level.
They remain hard to classify, and between unwilling doctors, surgeries, countless invasive ultrasounds, unbearable pain, and the pokes and prods of machines and humans alike, it remains nearly impossible to receive a fast and efficient diagnosis for any reproductive issues, as well as a system to monitor reproductive health in the long term.
So what can we do about all of this? It doesn’t seem like a very easy problem to solve.
Yet by putting the puzzle pieces together, we might have a shot at a real-world impact. Impacting millions of women with uterine fibroids and other reproductive disorders, whose hope might not be lost after all.
But this all starts with a very tiny piece of technology.
One that we likely wouldn’t suspect.
In 2020, the world’s smallest ultrasound detector was created by Vasilis Ntziachristos, a professor at the Technical University of Munich, and Helmholtz Zentrum München, along with his colleagues.
Dr. Ntziachristos’ team developed an extremely sensitive device that could image structures smaller than individual living cells.
This technology would be made inexpensive through silicon-on-insulator technology. Researchers believed that with further optimization, this technology could be mass produced to be used in applications beyond anything we could have imagined in the forthcoming years.
But how does the camera work? Well, it’s not as simple as it may seem.
Due to its size, the device doesn’t actually take “pictures” of intercellular and cellular structures. Instead, it utilizes nanoultrasound chips, which contain piezoelectric transducers. These transducers broadcast high-frequency sound, but also pick up sound that has reflected from target objects — using the reflected signal to create an image.
Previous technologies had tried to shrink the size of the transducers in order to achieve a higher spatial resolution. However, this drastically lowered the sensitivity of the system.
But recently, optical detection techniques have worked to avoid the problem. One of the approaches has been to detect changes in the resonance of an optical cavity that could be caused by ultrasound waves. Yet these techniques had not succeeded in confining light to under approximately 50 microns, continuing to lower the plausible resolution that researchers hoped to achieve.
And here’s where silicon-on-insulator technology comes in.
Dr. Ntziachristos’ team has improved on these designs using silicon-on-insulator technology also known as “silicon waveguide-etalon detector” (SWED).
The waveguide guides the ultrasound waves with minimal loss of energy by restricting the transmission of energy to one direction. The waveguide is contained within a periodic arrangement of Bragg gratings, refractive fibers, which reflect certain wavelengths and transmits others.
The Bragg gratings are separated by spacers, but with one grating replaced by a cavity. A reflective layer of silver is then deposited on the end of the waveguide.
When Ntziachristos and colleagues pumped a continuous-wave laser into the SWED, they found that the ultrasound that produced waves could induce characteristic intensity variations in the light reflected off the silver layer.
The SWED had a sensing area that was 220 nanometers long and 50 nanometers in length.
The improvement in both sensitivity and resolution allows the SWED to fit on a chip only a half micron in size.
Not only does this allow us to make immense improvements in medical and industrial imaging, but with further optimization, the dense ultrasound arrays could be mass-produced to pick out ultra-fine details in biological tissues and cells.
What if we were able to use this chip for another application? What if we were able to use it to detect reproductive disorders in the uterus?
And that’s where Sona comes in.
Sona.bio is working to eradicate the lack of and misdiagnosis of all reproductive disorders, from PCOS to uterine fibroids, allowing women healthier, happier, and more productive lives.
Sona, a smart tampon, allows women to know what is going on in their reproductive system simply through a smartphone.
Sona harnesses nanoultrasound technology in order to diagnose these disorders. Sona is inserted as a normal tampon, from then the nanoultrasound technology is able to go through the vagina and cervix to enter the uterus, where it scans the body and updates the user in real-time.
Before even using the Sona tampon, the user will use the Sona app to fill out relevant information about herself, her reproductive background, and her lifestyle. These questions include:
“Have you had uterine fibroids in the past?”
“Does anyone in your family have a history of uterine fibroids?”
“How painful were your last several menstrual cycles on a scale of 1 to 4?”
By collecting the user’s input, the diagnosis made by Sona and the AI used to diagnose the images taken can be cross-referenced with the user’s answers.
Based on the user’s history and pain scale, a separate algorithm will be used to analyze their answers, which can be compared with the diagnosis made by an ML model.
The Sona tampon itself will be inserted on a woman’s third or fourth day of her period when she is nearing the end of her menstrual cycle. This allows the woman to insert Sona without having to pull it out dry, which is incredibly painful. This also eliminates the heavier flow and discomfort that often occurs at the start of the cycle allowing the ultrasound device to take clearer pictures.
Once Sona is inserted through the vaginal opening like a regular tampon, the applicator pushes the tampon further in. Then, the user pulls on the tampon string, which ejects the nano ultrasound device, which is connected to the tampons by a nanothread.
As the nano ultrasound device enters up the vagina, through the cervix, and into the uterus, the ultrasound devices will image within the uterus for approximately one hour. The information is sent to the user’s phone instantaneously, through electrical signals.
The ultrasound chip works similarly to its bigger counterpart. The chip sends out sound waves and uses the transducer part of the chip to pick up the sound that is reflected from the structure.
Normal ultrasounds then use piezoelectric crystals to convert the sound waves to electrical energy for devices to pick up, however, this ultrasound chip monitors the changes in light intensity propagating through the photonic circuits and sends that to the phone.
This allows for even faster, nearly instantaneous, images that record extremely fine details.
Once the tampon has been inserted for approximately an hour, it will then reel in the nanothread and the ultrasound that is attached, allowing the user will be able to pull the entire device out.
These images on the user’s phone will then be run through a convolutional neural network in order to identify any irregularities. The CNN will be trained using supervised learning.
Without supervised learning, the model will just analyze the images without any end goal. The supervised learning tells the model what this structure could be. In this example, the model would be able to tell if an image was showing an image of uterine fibroids or healthy tissue growth within the uterus.
The supervised learning will be conducted by taking various images of the uterus through the nano ultrasound.
In order to train the model, we will show it various types of uterine fibroids. Researchers have groups fibroids into 4 main categories
Submucosal fibroids: These are the rarest type of fibroids. They grow in the submucosa, which is the inner layer of tissue in the uterus. However, these fibroids can protrude into the uterine cavity.
Intramural fibroids: These are the most common type of fibroid. Intramural fibroids are contained within the uterine wall and can grow very large if untreated. It is also common to have multiple of these fibroids in the same area.
Subserosal fibroids: These fibroids grow on the outside of the uterine wall.
Pedunculated fibroids: These fibroids grow on stalks and stems, which are already attached to the uterine wall. They can either grow outside of the uterus or inside the uterine cavity.
Sona would not only be able to detect the presence of fibroids, but it would also be able to detect which one was present, making the treatment plan and options much clearer for the individual.
We would be able to use Sona to take pictures of all four main types of fibroids and use them to teach the ML model which type of fibroid it was, allowing it to provide the user with specific information.
We can train it to detect the presence of uterine fibroids and the type of fibroid present through consistent training, reaching at least a 95% accuracy rate.
By training it in such a way, and taking into account every possible picture outcome, the ML model can learn to detect fibroids, and eventually cysts and other forms of tissue overgrowth, on its own.
Although Sona plans to start with the detection of uterine fibroids, we plan to evolve the technology to be able to detect various other reproductive conditions, including scarring in the uterus, the formation of cysts, and tissue overgrowth in order to detect symptoms of endometriosis and PCOS.
Sona would be able to detect these disorders through the detection of scarring, cysts, or excess tissue growth. The same process would be used in order to do so. Once the tampon is inserted, Sona would proceed to scan the uterus, however, the images analyzed would be focused on looking for differing signs.
Once the uterus has been scanned, the images will be sent to the phone, where the phone will identify them and cross-reference them with the symptoms of the patient.
In order to do this, we would need to develop AI models that are specific to PCOS and endometriosis, as well as an algorithm to analyze the answers provided by the patient in the questionnaire.
Developing the technology.
However, certain gaps still prevail in the use of Sona’s technology. Sona uses the same nano ultrasound technology developed by Dr. Ntziachristos’ team in 2020. While this device has been shown to develop extremely clear scans, the device itself has not been used for clinical purposes.
While the research is still being developed by the team, who has noted that the “technology showcased is suitable for manufacturing ultra-dense detector arrays (>125 detectors/mm2), which have the potential to revolutionize ultrasonography and optoacoustic imaging,” more research will need to be conducted in a laboratory setting.
Through the developments made in the next several years by Dr. Ntziachristos’ team and other laboratories around the world, there is a large potential for the nano ultrasound device to gain traction for clinical purposes and become a more mainstream device within the medical community.
The research over the next several years will be conducted in a laboratory setting, as the technology behind Sona continues to develop before launching the product itself. Beyond the development of the nanoultrasound chip, further research on the integration of the chip with the nanowires within the tampon will also need to be conducted.
As we continue to develop Sona over the next several years, the price point will be lowered, as the prices of the ultrasound chips decrease and become more mainstream in the medical community.
Within the next two to five years, we expect the price of Sona to easily sit under $100, when combining the cost of the tampon, the ultrasound chips, and the nanothread, as well as costs such as packaging, app development, etc.
As the technology is developed in a research setting, we plan to grow Sona.bio as a brand that is working to empower women.
Fostering a community of women who want to learn about their bodies.
Sona will be available to all women in their reproductive years, 18 and older. Although most women start menstruation earlier, the device can be harmful and may not function optimally in girls whose reproductive ecosystems are still changing and developing.
Sona.bio is working to eradicate the lack of diagnosis and misdiagnosis of all reproductive disorders, from PCOS to uterine fibroids, allowing women healthier, happier, and more productive lives.
Allowing women the opportunity to understand what is happening in their reproductive system, simply through a smartphone.