Cycle Clarity | Dr. John Schnorr | Follicle Measurements Ultrasound

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Cycle Clarity receives FDA Clearance for an AI Platform that will revolutionize the Fertility Industry

Dr. John Schnorr

Founder/Chief Executive Officer

Cycle Clarity

https://cycleclarity.com/

Contact:

John Schnorr, MD

843-883-6200

john.schnorr@cycleclarity.com

Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine

Published – April 25, 2022

CEOCFO: Dr. Schnorr, what is the overall vision behind Cycle Clarity?

Dr. Schnorr: I am a reproductive endocrinologist who is a doctor trained in OBGYN followed by a fellowship in reproductive endocrinology. My career is dedicated to helping women with infertility and miscarriage problems. The primary focus of infertility treatment is a process that involves giving women fertility medications to get additional eggs to grow in the ovary. Physicians monitor the response to medications primarily with ultrasound measurements of the ovary. The eggs grow in pockets of fluid within the ovary called follicles. Follicles are 3-dimensional structures that are traditionally measured with 2-dimensional ultrasound which is time consuming and inaccurate. These are transvaginal ultrasounds that are uncomfortable and typically take between 10 to 15 minutes per patient.

We have been able to harness the power of artificial intelligence through a recurrent neural network that allows us to use a 3-dimensional ultrasound probe that completes a 3D ultrasound of the ovary in about ten seconds per ovary. Our Cycle Clarity AI application then instantly detects and measures each of the follicles that are present so the clinical team can better understand when the medication treatment is complete and when optimal egg numbers and egg maturity has occurred. There are many benefits to allowing AI to analyze the ovary including speed. An ultrasound normally takes ten to fifteen-minute and now with artificial intelligence takes ten-second ultrasound per ovary resulting in significantly less discomfort and a tremendous time savings for patients. It is also a benefit to the doctor and the clinical team as they can do the ultrasound much quicker giving them additional time to spend with patient education and support.

Probably the biggest benefit at the end is going to be the ability to standardize measurements across the industry. Right now, measurement variation between ultrasonographers is about 20% but with artificial intelligence performing the measurements the error rate between ultrasonographers is 1.4%. Through this technology a Medical Assistant performing the ultrasound will have the same measurement accuracy as a Reproductive Endocrinologist. The resultant information is transmitted directly to the electronic medical record with artificial intelligence-based prediction algorithms providing the clinical team with predictions of the optimal time for ovulation.

CEOCFO: I understand the AI part but how are you able to do it more quickly? Why is the scan better?

Dr. Schnorr: Right now, a human manually takes measurements of each of the follicles in two dimensions and reports the average of the two. In total it takes the human probably a minute per follicle to take the measurement. The AI platform does it in a second per follicle because it is computationally faster, it is able to see it and measure it at computer level speeds.

CEOCFO: You mentioned 3-D as opposed to 2-D; what piece did you need to put together to be provide a 3-D view?

Dr. Schnorr: We had to teach artificial intelligence what a follicle looked like on an ultrasound image. To make it accurate we taught artificial intelligence with over 19,000 de identified patient images identifying 90,000 follicles. We then digitally outlined each of the 90,000 follicles in a process referred to as annotation. This is a manual, very time-consuming process showing the computer what follicles looked like 90,000 times from many different patients so that it learned repetitively and acquired a high degree of accuracy and precision.

CEOCFO: Would you tell us about the recent FDA clearance?

Dr. Schnorr: The federal government appropriately feels that software that reads a medical image is a medical device. As a result, the FDA regulated us as if we were a medical device. It is called Software as a Medical Device, which is a category of the FDA. The FDA is very detailed in its analysis of a medical device application with the primary focus being patient safety. Our device is considered a category II device and we conducted a variety of clinical trials that ultimately demonstrated patient safety and accuracy with follicle measurement.

CEOCFO: What was the biggest challenge in putting this all together; what were the stumbling blocks?

Dr. Schnorr: The biggest challenge is that this is the first software application in the world in which artificial intelligence has been able to measure and see these follicles. We started with proof of concept to show that artificial intelligence could identify follicles which then led to the second challenge which included the training with annotation of over 90,000 follicles to obtain the accuracy and precision. Annotating is a very “mind numbing” process and I will be forever grateful to our annotators.

CEOCFO: What has been the response from people in the medical community who are aware of follicle clarity?

Dr. Schnorr: They simply call it a disruptive technology, a technology that is really going to significantly change what we do now and in the future. I think that is probably the greatest compliment you can give any new device or piece of software. The software provides patient convenience, clinical efficiency and measurement accuracy all at once.

CEOCFO: Where does cost come into play?

Dr. Schnorr: Cost does come into play. There is a fee to use Cycle Clarity; it is a consumption-based fee. We charge for each ultrasound which is read, but we charge a fraction of the amount of money collected by the center for that ultrasound. Then, of course, we are increasing the throughput by about four or five-fold so they can be doing the ultrasounds much quicker than they were ever able to before at much higher patient comfort and convenience.

CEOCFO: What about human judgment?

Dr. Schnorr: Our platform is designed to provide additional, more accurate information to the physicians to enhance their decision making. We are not replacing doctors. In fact, the additional information we provide is functionally a second set of eyes enabling the physician to review the entire ultrasound at any time in any location. We are here to help the doctor review more data so that they can make the best decisions for the patient.

CEOCFO: Where are you in the commercialization process?

Dr. Schnorr: We just got FDA approval in January of 2022 so we are just now developing the business side of the practice. We have a COO who has been driving us through the business side of things. We have medical device representatives who have been hired and they are working on helping the product get to market. We are talking to many different customers right now and starting integration where we install the software on the ultrasound machines.

CEOCFO: Can it essentially go on almost any machine?

Dr. Schnorr: We intentionally made our software application device agnostic. You just need an ultrasound machine with a 3-D probe which most physician offices currently have.

CEOCFO: It would seem pretty hard to resist!

Dr. Schnorr: That is our hope that people find it hard to resist. When you combine the convenience to the patient, the increased medical accuracy and the increased clinical efficiency, I think it becomes a transformative product that in a lot of ways is a product that is going to revolutionize what we do in the fertility field.

CEOCFO: How else might the computation AI part be used?

Dr. Schnorr: I think artificial intelligence is a very promising technology that is frankly in its infancy right now. I think we are going to find that AI will be able to complete some of the more routine, time-consuming tasks more efficiently and accurately than humans. AI is going to be able to step in and automate these processes to the benefit of humankind. This will release us from mundane activities and allow us to do more cerebral activities that might require creativity, experience and wisdom to complete.

CEOCFO: What surprised you along the way?

Dr. Schnorr: What surprised me along the way was the globalization of the world in that we have been using computer programmers in the US and Ukraine, along with ultrasound manufacturers in Austria, Germany and China. The team approach from all different countries and continents has been amazing to me.

CEOCFO: Do you think it brings different perspective?

Dr. Schnorr: I think in different places of the world there are different perspectives and different approaches to problems, which are unique and positive in many ways. It shows us that we are all riding along on this one planet together and we need to work together to make the world the best it can be.

CEOCFO: Are you seeking funding, investment or partners as you are doing the rollout and continue to grow?

Dr. Schnorr: We are looking for strategic partners to continue to improve the platform, develop a national and international sales force.

CEOCFO: What do you see for the next year or so?

Dr. Schnorr: I think for the next year or so we want to slowly grow and build-out our client network and learn from their experiences to make our software better. AI has the ability to learn over time increasing the accuracy of the measurements and clinical predictions. We have patents in the EU, Canada, Japan, and China.

CEOCFO: Is a follicle and follicle? Are their variations or things that AI needs to learn other than size and shape? Dr. Schnorr: That is the benefit of the artificial intelligence is that a follicle is not a follicle. There can be immature follicles, mature follicles and low-quality and high-quality follicles. The goal of artificial intelligence is to accurately read the size of the follicle and the growth pattern over the last week to understand which the best follicles are, and what the right time is to take the follicles out.

We do not want to “over-cook” or “under-cook” the follicles. We want the follicles to be just right when they are ready to ovulate out and AI helps us with that.

CEOCFO: Why pay attention to Cycle Clarity; what makes your company important?

Dr. Schnorr: Cycle Clarity is important because 19% of all couples in America and 25% of couples in developing countries have infertility which is treated with medications and is monitored by imprecise ultrasound measurements. Cycle Clarity has now made those measurements more accurate and reproducible so they are now standardized across a physician network and standardized across the world. With this new standardization, the power of Cycle Clarity will provide the world’s Reproductive Endocrinology experience to the individual practitioner and patient.

Cycle Clarity | Dr. John Schnorr | Follicle Measurements Ultrasound | Fertility Treatment | Oocyte Retrieval Recovery Time | Cycle Clarity receives FDA Clearance for an AI Platform that will revolutionize the Fertility Industry | CEO Interviews 2022 | Medical Companies | follicle measurements, predict optimal oocyte retrieval timing, automated follicle measurements, infertility, fertility care, ovarian stimulation, follicle measurement, ovarian ultrasound, reproductive care, fertility center, fertility doctor, ovarian follicle, stimulation monitoring, ovarian stimulation monitoring, AI healthcare, artificial intelligence in healthcare, Cycle Clarity Press Releases, News, Facebook, Linkedin

"Cycle Clarity is important because 19% of all couples in America and 25% of couples in developing countries have infertility which is treated with medications and is monitored by imprecise ultrasound measurements. Cycle Clarity has now made those measurements more accurate and reproducible so they are now standardized across a physician network and standardized across the world. With this new standardization, the power of Cycle Clarity will provide the world’s Reproductive Endocrinology experience to the individual practitioner and patient.”
Dr. John Schnorr

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