Stood up over our two main and already developed medical devices, our ultimate goal is to develop an integrated system that allows couples (or single women) to perform sperm selection and intrauterine insemination comfortably at home. As simple as: collect the sperm (or thaw it), load it into our device, incubate it for a few minutes and perform the insemination with our medical device as well.
At the moment, we have already developed two minimum viable products which are being validated at early clinical stages. One of them is a sperm selection device which is starting the road to be regulatory approved in our country. The other medical device is an assisted insemination device which is being validated "in-situ" within patients with their consent.
None of them are on the market yet but they are totally working products already. To have our products on the market, being in the HealthTech sector, we must overcome regulatory approval.
In the first place, People Trying to Conceive (PTtC) need an ART performed by a professional. These people could be couples, women alone and the LGBT community.
Complementary, clinics, and medical practitioners performing the ART must perform a sperm selection.
In different stages and levels, clinics, medical practitioners, and people trying to conceive are going to be our buyers.
Moreover, in a bottom-up approach and evaluating our sperm selector device, there are around 100 clinics performing ART in our country. They serve about 53.000 IUI cycles per year. LATAM region is carrying-out more than 150.000 cycles per year. European and the USA markets, we know there are around 2.5 M and 800 thousand cycles per year, respectively. Finally, at China and Japan (within Asia), there are over 3.5M cycles performed per year.
In conclusion, over 6.5M cycles are performed per year worldwide. It is traduced as a >1Bn USD market value.
As for the home IUI device, all the IUI procedures described above can be performed at home. In this case, the market value is above 3Bn USD.
Problem or Opportunity
Infertility is a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Nowadays, there are 70 million infertile couples worldwide, which means that about 1 out of 5 couples (20%) of couples in childbearing age have fertility problems. The Male factor is involved in approximately 40% of infertility cases. The increasing prevalence of this decease has led the World Health Organization (WHO) to declare it as a public health issue. Media news and data show that population trend would halve by 2100 (https://www.bbc.com/news/health-53409521).
The treatment of this disease relays on so-called Assisted Reproduction Techniques (ART). These procedures, in increasing order of complexity, are Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF), and Intra Cytoplasmic Sperm Injection (ICSI).
Couples need to go to a Fertility Center to be practiced an ART.
On the other hand, no matter the ART applied, it requires a sperm selection.
The total number of healthy spermatozoa in a sperm sample directly influences the success rate in the procedure. So the first stage in the appliance of an ART is to pre-select the sperm through a separation process that selects the best available spermatozoa. Performing the commonly used sperm sample procedure (such as the density gradient method or swim-up) requires highly trained personnel and expensive facilities and equipment.
Solution (product or service)
In Selectivity we are focused on universalizing the access to fertility treatments. We are developing better performing and cost saving Assisted Reproductive Techniques (ART).
First of all, based on our patented technology, we developed a sperm selection device that naturally and non-invasively isolates the healthiest and most mobile spermatozoa for use in ART. With this device, we eliminate the need for complex equipment and facilities, making it possible to perform the sperm selection procedure outside of specific laboratories. The result is a fast and straightforward method that allows the consistent selection of spermatozoa with greater mobility, better morphology of a sample, minimizing the generation of ROS during the process and, therefore, less DNA fragmentation.
As a second step, we have developed an assisted insemination device that helps the user perform intrauterine insemination (IUI) procedures. The device has an optical system that, through image recognition, allows the detection of the cervix. The device is coupled wirelessly with a computer (Cellular, Tablet, or Laptop) at which runs the interface application that assists the user during the procedure. The application also can stream images online in real-time, allowing for remote assistance from a professional. Also, we will add another functionality to this device in order to be able to perform a cervix cancer study remotely with the possibility of performing a Papanicolau study from home as well.
As an ultimate goal, we pursue the objective of developing an integrated system that allows couples (or single women) to perform sperm selection and intrauterine insemination comfortably at home. We are going to join both previously described devices in only one, giving the possibility to perform the treatment comfortably at home.
Summarizing: Selectivity is bringing technology to the farthest places, reducing the waiting time and lowering the total treatment costs for the patients.
Regarding sperm selection device: Zymöt, clinics and laboratories. Related to Zymöt they are trying to conquer market share but we do not exactly now how much they own already. Clinics and laboratories have all the market share because the actual technique applied has more than 30 years being performed.
Regarding the assisted insemination device: Stork OTC and The Inseminator both as an aid to conception (extra-uterine) and fertility clinics. However, once we show our device to medical practitioners they are excited to start using it due to the benefits they find, as: work in a more comfortable position, having a guide to insert the cannula and the AI applied to detect the cervix.
Thinking of a complete home IUI kit, we do not have competitors yet. There is nothing in the market nowadays that can be bought to perform a sperm selection and an insemination totally at home.
Advantages or differentiators
Our competitive advantage is our technology. A biomimetic membrane with a specific geometry, which simulates the natural barriers that spermatozoa must overcome to fertilize the egg. It is a non-invasive technology which allows the self-selection of the healthiest and highest motility spermatozoa without the use of neither harmful chemicals nor centrifugation and taking care of the integrity of the DNA. Technology as unique as being intellectual property patented with favorable PCT opinion.
The result is a fast and easy to use medical device that eliminates the need of highly trained personnel and complex equipment and facilities in order to perform a sperm selection.
Our unique selling proposition reduces costs, improves time-effort of trained personal, decreasing significantly the complexity and letting them to perform several selections in a row.
As a middle step, we developed an assisted insemination device in order to help medical practitioners improving their insemination procedures.
With this middle step conquered, our ultimate goal is to bring to market a highly efficient medical device, all-in-one, which is going to allow couples (or women alone) with fertility problems to perform a sperm selection and an IUI at home, universalizing the access to early treatments, avoiding travelling to high complexity clinics in big cities, reducing anxiety, fear and anguish.
Today, an IUI treatment at the US cost around $500-$1000 without insurance. We estimate our product will be about $350 for the first trial, adding 200$ for the second and following trials.
On the other hand, to achieve our ultimate goal, we are starting by our innovative medical device to be applied by medical practitioners and clinics to perform simpler and more effective sperm selection. This device reduces process time by 66%, enhance the DNA integrity by 73%, no longer needs of high-level professionals to perform the selection technique and it can be applied outside a laboratory. Also, medical practitioners who do not carry-out the ART because they do not have a third-party laboratory selecting sperm or do not want to invest in expensive equipment or work in a small town will be able to open a new treatment within their offices. We estimate to be cost competitive compared to actual sperm selection technique applied in the present.
With our ultimate goal, PTtC would not have the obligation to travel to fertility clinics to perform an IUI. We will design a complete medical device applicable at home, with the ability to sperm select and inseminate all-in-one. Thus, its main benefits for PTtC will be the reduced costs, the possibility of several trials before accessing medical practitioners or clinics, the lower anxiety, anguish, fear, and finally, the improved success rate due to much better sperm selection. This solution will be transversally enhancing all the market columns: functional, economic, emotional, and social.
We expect to be selling worldwide within five years and conquering 7% of the marketshare.
We offer solutions for four different market segments:
1. For the fertility clinics reducing time and costs
2. For Medical Practitioners, allowing them to perform ART
3. For the Couples, performing an IUI at home
4. Zootech and Vet applications
The market we are targeting is related to fertility products and services which are the product and services taken by people who are not capable of conceiving naturally. These services help single parents, LGBT community and infertile couples to achieve parenthood and start a family. Fertility services include all kind of products and treatments involving the handling eggs and sperm; involve several techniques that are used for treating infertility problems to help in conception.
Analysis and trends show that the global fertility services market is expected to rise from its initial estimated value of 20.4 billion USD in 2019 to an estimated value of 41.4 billion USD by 2026 registering a CAGR of 9.25% in the forecast period of 2019-2026. This rise in the market can be attributed to the changing lifestyle and increasing infertility rates.
Thus, delivering directly to Clinics and Medical Practitioners, we think of a B2B commercial challenge and thinking about families in their homes, we expect a B2C commercial challenge.
The market drivers are:
• Delayed pregnancies in women have increased the fertility services market demand.
• Technological developments regarding fertility treatment in the industry will act as a major market driver.
The market restraints are:
• High cost of ART treatments in developed countries are acting as a major restraint for the market.
• Inadequate reimbursement policies will hamper down the fertility services industry.
Money will be spent on
Being a HealthTech startup you must know resources are fundamental in order to grow. At the moment, with the available resources we have been able to develop our two main products and being under first “in-situ” trials. With the objectives of getting the regulatory approval of both of them, developing the integrated system and increasing the company structure to manufacture and sell globally, the investments will be located in these directions.
Offer for investor
In order to conquer our goals, we know we need 3M USD and we are wondering to give 20% of equity.
The potential risks we are facing are related to difficulties in market penetration.
Regarding the sperm selection device, as a red ocean market, we are going to need to be price-cost competitive compared to present techniques. Thus, if we are not capable of reducing costs quite efficiently, we will be out of the market even when advantages are perfectly described and obtained.
Regarding the assisted insemination device, it is going to be complementary to medical practitioners. Thus, we will need to present it and introduce it to market as it is.
Regarding the ultimate goal, the integrated platform, thinking of a medical device being able to be applied at home by regular people we face a blue ocean market but the fear which could cause auto-selecting the spermatozoa and delivering them with the assisted insemination device might be the principal constraint for the users. Thus, we think of involving medical practitioners to prescribe the use of it, letting the couple or women alone decide whether to perform it at the medical practitioner office or at home.
Incubation/Acceleration programs accomplishment
Selectivity is incubated within CITES. They are our principal investor as angel investor and also at a very early stage. With the received support we have arrived to deliver these advances.
Won the competition and other awards
Unfortunately, we have not been victorious in any competition yet. We hope to break this path here at Unicorn Battle South America.
WO2018154169 - DEVICE AND METHOD FOR SEPARATING MOBILE CELLS