Building families naturally

baby baby

Building families naturally

When was Rinovum Womens Health founded?

Rinovum Womens Health Inc., founded in the States in 2009, is a medical device company focused on reproductive health to aid in conception in the privacy of the patients home. Our mission is to give couples of all lifestyles, health care products that will assist them in reaching their reproductive goals while impacting and having a positive effect in two targeted populations: individuals committed to building a family and patients diagnosed with infertility who have not been able to afford to participate or have been unsuccessfully addressed with existing alternatives today.

Rinovum was founded when the medical device industry was under extreme duress and surrounded by even greater uncertainty with respect to funding sources, reduced reimbursement options for technology, and unclear guidance with respect to the food and drug administration and overall access to the market. This environment did not stifle the candidate, but inspired him to take a hard look at medicine today, how technologies are evolving, and the clouded path to reimbursement, and of course, the growing limited access to new technologies and innovations by the average candidate consumer or patient.

Youre the founder of Rinovum Womens Health. What inspired you to set up the company?

Born and raised in Delmont, PA, a suburb of Pittsburgh, I went out into the world and made a difference in the diverse fields of defending our nation in the US army to innovations in healthcare. After being away for 26 years, I returned to Pittsburgh with my family to build not only a company, but to create a new industry in womens health.

After the Gulf War, my wife and I wanted to begin building a family, but we soon found out that we were one of the 7.3 million couples in the United States having difficulty in conceiving. After working with a physician, we had our first son, yet this long process began the identification of a need and drove me to look for better solutions for others that faced that same challenge. This moment in time was the foundation of Rinovum Womens Health.

Because the companys approach is taking a medical technology used historically by physicians and introducing it into the privacy of the patients home, this path is constantly riddled with obstacles; everything from physicians to the FDA to international markets. We continue to overcome these, as we launch Rinovums lead technology, The Stork across the globe.

How revolutionary is the Stork and how does it differ from other methods of fertilisation?

The lead technology, The Stork, is a take-home, conception aid system that is designed to address the growing unmet need of delayed and/or unsuccessful natural fertility. The Stork utilises cervical cap insemination, a proven method once available only in the GPs office, now available for use in the privacy of home. The Stork Conception System is a simple, safe, private, effective, non-pharmaceutical, and economical method to help couples expedite and overcome many of the infertility issues of todays patient population. Today, the focus of national and world healthcare economics is towards lower cost, patient-centric alternatives as the first step in addressing general healthcare, which will include infertility.

This technology is the first step in the supported treatment path to conception which could dramatically reduce TIME, EXPENSE, and STRESS, especially in the market place where reimbursement and advance programs like IVF are not real options for every couple.

There is a growing trend to delayed parenthood occurring with women in their mid to late 30s. This factor alone has decreased the rate of fertility and conception worldwide. Males, due to environment and age, also factor into the process with lower sperm counts. These factors have elevated the need for a quick and effective method of evaluating and optimising fertility. Many countries regulatory bodies have approved over-the-counter products over the course of the last few years in supporting the conception process with fertility tests, screening tests for male infertility, ovulation predictors, and fertility monitors; yet none of these actually augment the basic process of conception. There are many large market players in this space, yet to date, there is no market leader in an at-home conception aid technology like this today.

Costs

Existing invasive approaches cost from £700+ (IUI) to £10,000+ (IVF) with no greater than a 25% chance of success. The Stork is a simple, safe, and effective technology that that patient can buy for under £125.00 per treatment.

In the growing era of infertility, currently one in six couples is looking for help in building their families. This population has very few options and most of the available options today are slow, invasive, costly, and frequently awkward for the couple involved. Over the past thirty plus years, the course between natural intercourse and In-vitro fertilisation (IVF) has become somewhat of a vacant path. There are a few procedures that can be performed in the GPs office prior to the final option of IVF. The primary option, intrauterine insemination (IUI) is still quite invasive, expensive, and adds to the natural stress levels of this coupled patient population. More importantly, a similar process, cervical cap insemination, which is quite rudimentary, has been historically proven to be possible and successful in the privacy of the patientâs home, in certain cases. Also, reimbursement for these procedures has becoming more and more limited, reducing the options for the average couple to be able to afford tools to aid in conception. The lead technology, The Stork, is a take-home, conception aid system that is designed to address the growing unmet need of delayed and/or unsuccessful natural fertility. Cervical cap insemination historically has had similar results to IUI. The Stork utilises a similar process that can now be done in the privacy of the home. As you would expect, the Stork® is designed to keep this private act within the confidence of the couple and allows the couple to maintain intimacy and partner-inclusion in the journey to parenthood.

The competitive reproductive market is led by invasive procedures, performed by Ob-Gyns, reproductive endocrinologist, or infertility specialists, such as intrauterine insemination (IUI) and multiple forms of Assisted Reproductive Technology (ART). Unfortunately, the majority of couples cannot afford this expensive, invasive, time-consuming path and insurance is not helping.

What is the success rate?

Over 50 years of data and 30+ publications discuss benefits of cervical caps for conception. (By increasing the volume of sperm to the cervix, the chances of conception increase.) Cervical Cap insemination like The Stork has been published to have a 10-20% success rate. Note: A healthy couple has approximately only a 25% success rate of conceiving through natural intercourse each month (depending on the couples age) and IVF has a 20‐25% success rates. 25 % success rate equates to couples likely to conceive in 4 months of unprotected intercourse.

You also produce a line of vitamins aimed at women wanting to conceive. How important are they in aiding in conception?

A healthy diet is the best way for someone to achieve ideal nutrition requirements for their body before, during, and after pregnancy. While many of us try to maintain a healthy diet, we may still be lacking some of the vital nutrients our body will need to help aid with conception. Below is a list of the most essential vitamins and minerals our bodies may need to help with conception.

• Iron: Studies have shown that iron is important in the maturing of the egg in preparation for healthy ovulation.

• Vitamin C: Research shows that Vitamin C may increase fertility in women who have luteal phase defects. This vitamin may also increase hormone levels. • Vitamin D: Low levels of Vitamin D have been found to cause problems with ovulation for some women. Vitamin D helps with calcium absorption and regulation, which may increase her odds of ovulation by helping with the development of her follicles.

• Vitamin B6: Studies have shown that B6 may improve a womans chances for ovulation and is also said to regulate the womans hormones.

• Calcium: Calcium is essential to strengthening your bones in preparation for carrying a baby.

• Folic Acid: Research shows that taking this during your childbearing years will decrease the chances of having a child born with spinal cord and/or brain disorders (neural tube disorders). Women taking a folic acid supplement are said to have less risk of ovulation problems and egg production issues. Taken during pregnancy folic acid may minimise risks of preeclampsia and miscarriage.

• DHA (commonly found with EPA): an omega-3 fatty acid beneficial for neurological health. Taken during pregnancy, they help with fetal brain and eye development. For those trying to conceive, omega-3’s contribute to processes of the body that are important to fertility including those that are associated with women having regular menstrual cycles.

What products do you also have available for men?

For men to date, we offer the CoQ10 vitamins to support healthy sperm and of course, The Stork. Men also must prepare their bodies to optimise health, volume, and motility of their sperm. Men have done well with augmenting their diets with anti-oxidants like CoQ10 which has been well published to support increased sperm counts and mobility of the sperm.

On a personal note what is the most satisfying part of your job?

Supporting couples on the path of Building Families Naturally within the privacy of their home is a huge reward. Letâs face it, the process should be fun and both partners should be able to be involved. One of the greatest rewards is hearing that we were able to œnudge the Stork and help build a family.

About Steve Bollinger, the founder of Rinovum Womens Health

Steve continues to lead with the highest standards of ethics, execution, and principles that he developed as part of his education at the United States Military Academy (graduated in 1987,) Combat Leadership in the Gulf War (1991) and his 22 years of successful management in life sciences commercialization. In the last 10 years, he has successfully grown and sold two companies that he either founded and/or led as part of the executive team. These accomplishments required his expertise with technological innovation, fund raising, clinical execution programs (under the heavily regulated world of the FDA,) and market distribution. Within this same window of time, he has raised over $50M in private financing with over $180M in exits and currently exiting companies. In the very complex world of advancing medical technology, Steve has invented/created four major new technology innovations in plastic and reconstructive surgery, interventional cardiology, vascular surgery, and now, take home fertility aids. With the changing healthcare market and limited earlystage investors, he continues to take risks; advancing new technologies, and identifying new market segments and opportunities within the Over- the Counter (OTC) access model of taking proven medical technologies to market. These technologies were once only used by physicians and are now evolving to be œpatient friendly, affordable, accessible and utilised in the privacy of the patientâs home. Steve has recognised the market potential for these products being purchased for in-home use while obtaining similar if not better results than they traditionally have in the doctorâs office. Instead of building technologies that historically require reimbursement and hit the overcrowded œbottom-line of Healthcare, he approaches this opportunity in a way that it is accessible to the entire market. He also led his company to achieve FDA authorisation to market Q4:2012, has achieved ISO13485 and CE Marking in April 2013 for his Company, so he could begin distributing in both EU and Canada, and he continues to grow his Team with leaders in the industry. Finally, he is launching his first technology the Stork in Q2:2013.

Steve was born and raised in western Pennsylvania. After spending a majority of his career on both the East and West coasts of the USA, he returned to Pittsburgh in 2009 as an Executive in-Residence at the Pittsburgh Life Sciences Greenhouse. In this role Steve has worked with a portfolio of 66 companies developing fundamental business strategy, planning funding strategies and identifying sources of capital, building connections with critical business partners, including corporate collaborators and angel and follow-on investors and assisting with technology transfer, licensing, regulatory issues and initial contracts.

Steve currently holds seven medical patents, with multiple pending. He received his MBA from Oklahoma City University and is a graduate of the United States Military Academy West Point with a BS in mechanical engineering.

For more information, email Rinovum at Stork uk@rinovum.com or go to theStork  forwomen.com