The Womens Health Story

Daniel Powell [00:00:04]:
I think we have to start by acknowledging that it’s not lost on us that we’re three men talking about women’s health and menstruation today. Our job isn’t to mansplain, but to share an exciting discovery that could have a profound impact on women’s health. Let’s start with the astounding statistics around women in clinical trials.

Alejandro Covalin [00:00:33]:
It’s depressing. When I started reading about this, I was shocked. The first woman with a medical degree in the U.S. was in the late 1800s. Women weren’t included in clinical trials for years because it was considered too difficult to interpret results due to hormonal cycles—which is exactly why they should be included. The FDA only suggested including women in the late '70s. The NIH didn’t mandate it until 1993.

Daniel Powell [00:01:28]:
Not required—just suggested.

Alejandro Covalin [00:01:29]:
Right. And that delay in inclusion left a massive gap in research and healthcare for women.

Daniel Powell [00:02:05]:
I know from personal experience—among us, we’re all married, and we have six daughters. My wife would ask, “Why isn’t more being done for women?” So Navid, take us from the neural tourniquet work to how we got into women’s health.

Navid Khodaparast [00:02:38]:
It began with the neuro tourniquet—applying neurostimulation to help reduce bleeding, initially targeting hemophilia, which affects mostly men.

Navid Khodaparast [00:03:02]:
So we asked: what’s a more prevalent bleeding disorder? That’s Von Willebrand’s disease (VWD), which affects men and women equally. But it’s under-recognized and doesn’t get as much attention as hemophilia.

Daniel Powell [00:03:46]:
I’ve heard it called the forgotten bleeding disorder.

Navid Khodaparast [00:03:48]:
Yes. And when we dug into it, we found that over 80% of women with VWD suffer from heavy menstrual bleeding (HMB). That’s not just a medical issue—it has physical, psychological, and social consequences.

Navid Khodaparast [00:04:42]:
Women with HMB can develop anemia, low platelet counts, even stroke risk. Psychologically, many experience depression, anxiety, PTSD—even suicidality. Teen girls with HMB often miss school, struggle academically, and face stigma.

Navid Khodaparast [00:05:29]:
So we designed a clinical study. And it was ideal—because HMB is predictable. It happens monthly, allowing us to track and treat the bleeding event directly.

Daniel Powell [00:05:57]:
And we’re trying to prove we can reduce blood loss.

Navid Khodaparast [00:05:59]:
Exactly. Unlike spontaneous bleeding in hemophilia, HMB lets us test interventions in a controlled way.

Alejandro Covalin [00:06:33]:
And you found we were helping with more than just bleeding.

Navid Khodaparast [00:06:38]:
Yes. Beyond bleeding, we started seeing effects on pain, depression, anxiety. So let’s talk about pain.

Alejandro Covalin [00:06:49]:
Cramps aren’t just any pain—they’re ischemic. The uterus contracts so much it restricts blood flow. Acetylcholine relaxes the uterine muscles, allowing blood to flow again. Our therapy activates the parasympathetic nervous system, which triggers acetylcholine release.

Alejandro Covalin [00:08:17]:
So, we’re not just masking pain—we’re treating its root cause by restoring blood flow. And we also trigger the brain’s endorphinergic system, releasing endorphins to blunt pain signals.

Navid Khodaparast [00:08:50]:
Endorphins are natural painkillers.

Alejandro Covalin [00:08:55]:
Exactly. So our therapy both addresses the pain source and provides natural pain relief.

Navid Khodaparast [00:09:15]:
Women often use NSAIDs or heat therapy to manage cramps. But regular NSAID use has side effects. Our therapy provides an alternative—non-pharmaceutical, non-invasive, and safe.

Daniel Powell [00:09:50]:
And this isn’t theoretical. Let’s talk about the real results from our pilot study.

Navid Khodaparast [00:10:02]:
In our pilot, women with VWD and HMB used the device twice a day during menstruation. We saw a 50–55% reduction in blood loss.

Daniel Powell [00:10:46]:
And how much blood were they losing initially?

Navid Khodaparast [00:10:49]:
Nearly a liter over seven days, even while on hormone therapy. Our device cut that nearly in half.

Daniel Powell [00:11:14]:
Huge implications for anemia and long-term health.

Navid Khodaparast [00:11:24]:
It aligns with the results seen with hormone therapy—40–60% reduction. Plus, we saw 50% less pain, 50% less time spent in bed, and about 20% shorter periods.

Daniel Powell [00:12:21]:
Then we realized—this isn’t just for women with VWD. There’s a much broader group.

Navid Khodaparast [00:12:43]:
Exactly. We launched a second study with women who had idiopathic HMB—no known cause, no hormone therapy. And we’re seeing similar results.

Daniel Powell [00:13:10]:
And the key difference in this group?

Navid Khodaparast [00:13:13]:
They’re not on hormone therapy. That makes our device a stand-alone treatment—and that matters. Many women want non-hormonal options due to side effects or personal choice.

Daniel Powell [00:14:02]:
So we’re committed—this will be our first women’s health product. But then we asked: what else can we address?

Alejandro Covalin [00:14:23]:
That led us to endometriosis. It’s when uterine cells grow outside the uterus, creating recurring wounds. Research shows women with endometriosis have fewer alpha-7 acetylcholine receptors. Our therapy increases acetylcholine—an agonist for this receptor—which may help reduce inflammation and progression.

Alejandro Covalin [00:15:42]:
There’s solid evidence to support this pathway. We still need to study it directly with our device, but the hypothesis is strong.

Daniel Powell [00:16:36]:
And finally—perimenopause. Hot flashes, hormonal imbalance, and the autonomic system.

Alejandro Covalin [00:16:50]:
Hormonal shifts disrupt autonomic balance—specifically increasing sympathetic tone. Our therapy boosts parasympathetic tone, restoring homeostasis. That could reduce hot flashes and other symptoms.

Daniel Powell [00:17:20]:
As always—it’s about the autonomics.

Alejandro Covalin [00:17:28]:
Exactly. Your autonomic system regulates temperature, digestion, stress—it’s foundational. Our therapy helps bring that system back into balance.

Daniel Powell [00:18:43]:
This is an exciting roadmap. We’ve formed a women-led internal advisory group, and Spark is now 60% women. There’s real energy in our team around transforming care. Thank you both.

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