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Dr. Jennifer Hintzsche, Ph.D. • Chief Executive Officer
Dr. Jenn was diagnosed with unexplained infertility in 2017 and was told expensive fertility options were her only chance at conceiving. Hintzsche and husband Ryan invented and conceived their daughter using their patent-pending PherDal kit. PherDal is the only sterile at-home insemination kit that has already helped over a dozen women conceive. PherDal is located in Dixon, IL and is registered with the FDA as an over the counter medical device.
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Dr. Karla Loken DO OBGYN FACOOG • Advisor
Experienced in:
Medical Device Development and Strategy, Marketing and VOC
FDA and EU MDA experience in CER, CEP and PFCP and COPA
Medical Affairs, Regulatory, Payors , Pharmacovigilance, Medical Education, Device Proctoring, and Medical Marketing and HEOR, PMRP, Good Clinical Practice. Clinical Trail Oversight and Onboarding as well as protocol development. VEEVA, Medra, AGILE, Scrum, and Oracle & Teams experience. Individual career transition coaching. Cross-functional team player. Consulting on non-clinical career transition for physicians. Patient Journey, Payer Ad Board Development. Evidence Generation, GCP, Clinical Research Oversight, Onboarding, and Protocol development. ACOOG gov affairs committee -post. PESC- Graduate Education Review committee - post. Girls Experiencing Medical Science mentor ( Gems) girl-scout camp.
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Dr. Steven R. Lindheim, M.D., M.M.M. • Medical Advisor
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The Fertility Treatment Market size is valued at $14.27 billion in 2020 and is expected to reach $21.7 billion by 2025 (source).
Invented & led by Northern Illinois University’s first recipient of a doctoral degree in bioinformatics, whose clinical research has been cited over 500 times by peers, and was most recently Director of Product for a 15M+ revenue SaaS company.
(source, source, source, source, source, source, source)
Overview
Here at PherDal, we aim to provide a science-based, safe, sterile, and affordable fertility option - all in the privacy of your own home.
(source, source, source, source, source)
In addition to making the fertility journey less invasive, we feel we are a source of support for the LGBTQAI+ community, single parents by choice, and people struggling with infertility. With that, we believe Pherdal offers the only patent-pending, sterile, at-home intracervical insemination kit.
Founded by a couple who has experienced infertility themselves - our company genuinely understands the hurt, frustration, and pain of trying to conceive. After Dr. Jenn and her husband created PherDal, they conceived their first child in the second month of use. It gave them hope that they could help others as well.
The Problem
An additional 1 in 4 have difficulty carrying a pregnancy to term (source). On top of that, many people also struggle to even afford the services fertility clinics offer (source). The need for assisted reproduction technology is growing at a rate of 5-10% per year to meet the demand of increased infertility (source). We think people need access to safe, sterile fertility options to try in the privacy of their own homes - especially before trying more invasive measures.
(source, source, source, source, source, source, source, source)
Intrauterine Insemination, or IUI, is often the first line of fertility treatment and is performed in a sterile environment at a fertility clinic (source, source). However, there is a lesser-known form of artificial insemination called Intracervical Insemination or ICI that can be a great first-line of fertility treatment too (source). A 2015 study showed ICI, like the PherDal kit offers, and IUI have the same live birth rate over a 6 month time period in medicated and natural ovulation cycles (source). Similar results were found in a 2018 study (source).
However, we believe our ICI kit is the first to combine the sterile environment of the fertility clinic with the at home capabilities of artificial insemination. When it comes to the importance of sterile environments for infertility treatments, a 2017 study showed that women diagnosed with idiopathic (or unknown) infertility were proven to have a significant differentiation in the proportion of 3 bacterial species naturally present in the vaginal microbiome (source, source). Since then, there has continued to be more scientific research published about the role the microbiome plays in infertility. So much so that a 2020 review of clinical practice recommendations for fertility specialists called the vaginal microbiome the “new frontier” that would increase the overall knowledge of reproductive health (source).
Therefore, we believe we’re bridging the gap between traditional conception and more invasive options with a sterile ICI option for couples facing infertility, including male factor infertility, single mothers by choice, and the LGBTQ+ community.
*The above is an image of a proof of concept kit. Final future product is still currently under development and is not yet available on the market.
The Solution
We are looking to make safe and sterile at-home insemination possible. That’s why PherDal at-home insemination kits are designed to be able to deliver the sperm closer to the egg, potentially bypassing any bacterial or anatomical interference.
(source, source, source, source, source, source, source, source)
We feel that PherDal is leading the industry by including 3 sterile syringes and 3 cups, per kit. That means more chances per month at less cost - without reusing anything.
We feel our business model is similar to at-home, over-the-counter, pregnancy tests. But what we think makes us unique is what we see as our unestablished market. We don’t think enough people know that sterile Intracervical insemination (ICI) is an option to try before Intrauterine insemination (IUI) - as a safe, affordable, way to try and build families.
(source)
The Market
The Fertility Treatment Market size is valued at $14.27 billion in 2020 and is expected to reach $21.7 billion by 2025 (source).
Not to mention, almost two-thirds (64%) of couples trying to get pregnant have tried alternative or natural remedies to conceive (source).
We have found a new industry containing an estimated 12.2 million people struggling to conceive each year (source). PherDal has the potential to offer these people a method of artificial insemination option that we feel is safe, sterile, and private - and we think we are the only ones doing so.
(source, source, source, source, source) *The above is an image of a proof of concept kit. Final future product is still currently under development and is not yet available on the market.
Our Traction
Here’s our timeline of how our founders overcame unexplained infertility, and how PherDal helped:
While PherDal started as the founder’s story, our proof of concept kit launched last year - selling out in 90 days. Most importantly, we believe PherDal helped others successfully conceive too. We have now set a goal to be the only FDA-cleared insemination kit offered over-the-counter as a safe and sterile fertility option.
Why Invest
And to us, success is giving people the potential to feel hope on their fertility journey.
In the next 3-5 years, we anticipate PherDal being available in local pharmacies across North America and Europe - potentially providing a safe, sterile option for everyone.
We have already engaged with the United States FDA to initiate the premarket submission process. And with that, we anticipate having PherDal cleared via 510(k) premarket notification by the end of 2022.
Once manufacturing is scaled, we anticipate our PherDal kits to sell for less than $149 with a direct-to-consumer unit gross margin of in excess of 75%.
We believe our patent is on track to be awarded this fall, putting us in the position, we feel, to potentially disrupt the 2023 market with our anticipated, patented, FDA-cleared, OTC medical device.
(source, source, source, source, source, source, source, source)
Maximum Number of Shares Offered subject to adjustment for bonus shares
01.31.24
You did it! Because of your unwavering support and contributions,
PherDal has just received FDA clearance as the first and only sterile, over-the-counter, at-home insemination kit!
And because of your generosity, millions of people now have access to the PherDal Kit, the first and only to combine the sterile environment of the fertility clinic with the at-home capabilities of insemination. Thank you, from the bottom of our hearts.
With news of FDA clearance, we can start accepting pre-orders of the Kit that will be shipped first come, first serve starting at the end of February. While awaiting FDA clearance, we were unable to sell or re-stock our Kits. Now our team is working hard to make the PherDal Kit available as quickly as possible.
Please follow and share our amazing news with everyone you know - 1 in 6 people in the world are impacted by infertility, many of whom struggle in silence. They deserve to know that help is now available, thanks to your support!
Thank you for believing in PherDal and, most importantly, for giving millions of people hope.
With deepest gratitude,
Dr. Jennifer Hintzsche and the PherDal team
Dear PherDal Investors, You did it! Because of your unwavering support and contributions, PherDal has just received FDA clearance as the first and only sterile, over-the-counter, at–home insemination kit! And because of your generosity, millions of people now have access to the PherDal Kit, the first and only to combine the sterile environment of the fertility clinic with the at-home capabilities of insemination. Thank you, from the bottom of our hearts. With news of FDA clearance, we are able to start accepting pre-orders of the Kit. While awaiting FDA clearance, we were unable to sell or re-stock our Kits. Now our team is working hard to make the PherDal Kit available as quickly as possible. We’re also working to launch an affiliate program, for which you will be the first to be invited to join as a small token of our sincere gratitude for your support to get us here. Thank you for believing in PherDal and, most importantly, for giving millions of people hope. We will be back in touch again soon with more updates. In the meantime, we are wishing you and yours a wonderful holiday season. With deepest gratitude,Dr. Jennifer Hintzsche and the PherDal team |
01.29.24
FDA approves first at-home sterile insemination kit to help with infertility: 'Gives me goosebumps'
Special thank you to Fox News for featuring an exclusive story about our historic FDA clearance news!
Here's an excerpt:
Kits are shipping in February and can be pre-ordered at PherDal.com
We are so grateful to our investors and families for helping us achieve this historic success!
-Dr. Jenn
09.08.23
Dear Investors,
It is with immense gratitude that I share the latest strides and developments from the past quarter at PherDal. Here's a comprehensive overview of our Q2 accomplishments:
Quarterly Sales and Expenses:
I am thrilled to announce that, thanks to your unwavering support, we have successfully covered all costs related to our FDA clearance testing. Your commitment has been instrumental in propelling us forward. Moreover, we have proudly unveiled two impactful products aimed at supporting individuals on their journey to conceive. Our eBook, “Empower Your Fertility: Clear Steps Toward Conception”, has been met with enthusiasm. Additionally, we are excited to introduce the limited-time opportunity for 1:1 fertility consulting sessions with the renowned Dr. Jenn.
Team Update:
Dr. Jenn's exceptional contributions have not gone unnoticed. Her participation in the prestigious SXSW Pitch Competition as a finalist in the MedTech category is a testament to her innovation and expertise. Furthermore, Dr. Jenn was invited as a featured innovator at the Life Science Intelligence USA conference, underscoring her leadership in the field.
Dr. Jenn and PherDal have also been featured in reputable media outlets, including:
Industry Update:
We believe in collective vigilance to ensure our emerging industry’s compliance. We urge your assistance in identifying companies that may not be adhering to FDA regulations in women's health. If you suspect unlawful sales of medical devices on the internet without FDA clearance, please submit an anonymous report to the FDA using this link. Your contribution will play a vital role in safeguarding women's health.
Future Plans:
As we embrace the next quarter, our focus remains resolute. We are eagerly awaiting the results from the FDA clearance testing laboratories, a pivotal step toward realizing our vision. Upon obtaining these results, we are determined to submit them to the FDA, a milestone that will pave the way for obtaining clearance for the first-ever assisted reproduction kit offered over the counter, fortified by our patented sterile technology.
Feedback / Intros from Investors:
We continue to seek additional funding avenues to support our product launch and scale production capacity. If you are aware of any interested parties, please don't hesitate to contact investors@pherdal.com.
We also love to connect with each of you and your network too! We would love introductions to be emailed to Support@PherDal.com to you or people you know that can help us in the following areas:
Your enduring support fuels our passion and perseverance. Together, we are making a profound impact in the realm of fertility solutions. If you have any insights, feedback, or suggestions, please feel free to reach out.
Warm regards,
Dr. Jenn
Dr. Jennifer Hintzsche, Ph.D.
CEO & Founder
PherDal Fertility Science, Inc.
12.19.22
We've given it our all.
Thank you for the support investors we can't wait to make you proud.
12.19.22
12.16.22
Thank you for helping us hit $500K! This is the last 3 days before our campaign is over.
12.15.22
OMGOODNESS ❤️ My heart is exploding!!
I just learned about baby number 27 ❤️!! I can't tell you how much it means to me that these families share their stories and journey with me!
From the new mama:
"I wanted to reach out and add a baby to the list! We purchased two Pherdal kits-one in November 2021 and the other in December 2021. We found out we were pregnant in January of this year, and our baby boy was born in September. We are so grateful for your product. I hadn’t even known about it as an option and thought we would have to have expensive and lengthy IUI or IVF procedures. Thanks to google, I found Pherdal and figured we had nothing to lose and tried it. I’m so thankful Pherdal existed at that time because it worked for us! Also, I really appreciated that there were three syringes per kit and that there was information/support included via downloadable guides as well. It made the whole process easier and less stressful for us!"
We need your help to give even more families this same beautiful gift. Invest now!!
12.14.22
Last week Dr. Jenn received the official letter
that PherDal is PATENTED!!
12.13.22