KoreClient Spotlight: Peter Kassel, CEO and Co-Founder of HealthySole

Peter Kassel is the CEO and co-founder of Healthysole, a remover of 99.99% of infectious bacteria, viruses, and spores that are tracked on your shoes. As the co-founder of HealthySole Peter has been with the company for its entire journey, which began in 2011. We recently sat down with Peter to discuss his company, the growing Medtech space, and the use of capital raising in this field.

Q: Tell me a little about your experience, company, and your company’s impact on clients and the Medtech space.

A: I have been working in the Medtech space for ten years as CEO and co-founder of Healthysole. Ten years ago, my family started this company on the simple concept that shoes and floors are dirty. We are now hoping to make a significant impact on the Medtech space. My family and I decided to address this issue when a family member acquired a near-fatal infection during a standard medical procedure. While Hospital Acquired Infections and Infection Control are prevalent issues, we found that shoes and floors were regularly overlooked as potential contributors to the problem.

Once we pivoted our product towards the Medtech and healthcare space, top leaders in the field contacted us to test their hypothesis and push the narrative of better protecting the patient and healthcare provider. We see that there is greater value and response for this product within the healthcare setting and beyond. We view the product as simple as washing your hands for the soles of your shoes. When people wash their hands with greater frequency, the environmental presence of pathogens decreases; HealthySole PLUS safely and unobtrusively applies the same principle, only to the soles of shoes in just 8 seconds. This helps limit the pathogens on one of the dirtiest parts of a hospital, shoes. HealthySole can be implemented to lower the amount of infectious pathogens responsible for hospital-acquired infections by addressing and limiting pathogens on your soles.

Q: What excites you most about the sector?

A: It’s one of these examples of a market sector where innovation has very little potential of downside. When working in the Medtech space, you’re trying to improve the experience of patients and healthcare professionals while lowering the chance of infection, better preventing illness, and reducing the spread of germs in facilities.

Q: How do you see the LSI Medtech event having an impact on your company?

A: We have been around for ten years. Once we proved out the device and had momentum, we felt we had a viable tool. Groups that adopted our product to deal with disease infection rates from patient to provider saw the benefits. At the very same time, all these world-shattering events kept occuring, putting a startup like ours at a disadvantage. When we want to put out our results, there’s lots of international news and we are unable to rise above the noise. LSI gives us the opportunity to speak directly to the medical community at large about the threat shoes and floors pose and how HealthySole PLUS can easily and effectively address it.

Q: Now that your company will be using Reg A+ for your next offering, how do you see it impacting your company?

A: It’s night and day. Medtech companies have a very hard time raising money, you need the talent to sell it, but you also need capital to support those sales efforts. Capital is needed for manufacturing at a greater scale, international advertising, researching, and Reg A+ helps us do all these things.

Q: Why do you think education on topics like regulation A+ play such a vital role in expanding access to capital for Medtech.

A: Every human interacts with a medical device, in a multitude of ways, numerous times throughout their life. Medicine is something every human must encounter. As a society, we want better outcomes, and this will never stop. We see during unprecedented events like COVID that the healthcare systems are incomplete. They work during times of calm, but can find it difficult to adapt to rapid change. Investing in a simple, yet effective product within the Medtech space provides an excellent prospect for investors, giving them the opportunity to financially benefit while changing the world of medicine to improve health outcomes all around the world.

Q: How do you see Regulation A+ impacting Medtech companies?

A: I see it transforming medicine as we know it. Medical innovations such as products, procedures and software come with a high cost and a number of difficult regulatory hurdles, leading to large investors’ hesitancy. With Reg A+, we can spread the risk and the reward so the general population can put their money towards a future they want to see. I see the renewed access to capital and alongside the ability for everyday investors to invest in products they believe in, changing the medical industry for years to come.

Q: What advice would you give a young MedTech entrepreneur as they begin their journey through capital raising and building their company?

A: It’s similar to being an entrepreneur in any company. You will need more capital than you expect because the world of medicine moves very slowly. Anything you do will take three times longer, and if it takes three times longer, it will be three times more expensive as well.

 

Regulation A Disclaimer

This communication may be deemed to be a solicitation of interest under Regulation A under the Securities Act of 1933, in which case the following apply:

  • No money or other consideration is being solicited, and if sent in response, will not be accepted;
  • No offer to buy the securities can be accepted and no part of the purchase price can be received until the offering statement is qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date;
  • A person’s indication of interest involves no obligation or commitment of any kind; and
  • An offering statement, which would include a preliminary offering circular, has not yet been filed with the SEC.

KoreClient Spotlight: Dr. Joseph McGinley, Founder and CEO of McGinley Orthopedics

Joseph C. McGinley. M.D., Ph.D. is a highly accomplished musculoskeletal intervention and sports medicine physician with over 15 years of experience in the field. He holds a Bachelor’s and Master’s Degree in Mechanical Engineering and a Ph.D. in Physiology and an MD from Temple University. He completed both his residency and fellowship at Stanford University. Dr. McGinley became the founder and CEO of McGinley Orthopedics, a company that designs, develops, markets, and sells orthopedic medical devices.

We recently sat down with Dr. Joseph McGinley to ask him about his company, the industry’s future, and raising capital for a Medtech company today.

Q: Can you tell me a little about your experience, your company, and your company’s effect on patients and the Medtech space?

A: My background is originally in mechanical engineering and I then went on to obtain a  medical degree and Ph.D.. Following that, I attended Stanford University for both my residency and fellowship in musculoskeletal radiology. After my fellowship, I transitioned into private practice in Casper, Wyoming, where I reside today. My passion for problem-solving and engineering inspired us to create our products. The idea was founded and conceptualized at a dinner meeting with colleagues when I was still in medical training. A surgeon was discussing a case about a teenager with a wrist injury. To repair it,  a screw was inserted, and it inadvertently plunged the bone, subsequently tearing the tendon on the far side of the bone. He reported that due to the inaccuracies of the depth measuring process, surgeries may result in incorrect screw sizes.  We knew if we placed sensor technology in the surgical tools, we could improve the surgical outcomes and reduce the occurrence of these all too frequent results.

The current standard of care when in orthopedic plate and screw surgeries is to manually measure depth and “feel” when to stop on the far side of the bone. This process is prone to errors that can be costly and impact patient outcomes. The IntelliSense Drill Technology® improves the level of care by putting sensors in the tools that simultaneously measures depth, telling the surgeon what size screw to use and has auto-stop features to help prevent plunging past the bone.  It makes it easier for the surgeon to expedite the procedure and improve the patient’s care level. The IntelliSense Drill® has been on the market for 7 years and is currently being used in operating rooms across the country.  As a company, we have continued to create products with the mission to improve the standard of care in orthopedic surgeries. Today our company boasts of over 137 patents in various stages of development.

Q: What excited you the most about this sector?

A: For me personally, it is all about making a difference in patient care. As a physician, we usually help patients on a one-on-one basis. Technology such as the IntelliSense Drill ® improves patient care and outcomes on a much larger scale impacting patient care worldwide. Many of us at some point may also find ourselves on the other side of that care. It is great to help provide a solution to enhance many lives globally.

Q: How do you see the upcoming LSI Medtech event having an impact on your company? 

A: We’re excited to be back at LSI. Last year was our first time attending the meeting, and we met many interesting people in diverse business sectors. It made us think about our company, improve ideas, and how to best set up success. There are a lot of innovators at the conference and I have learned from their expertise. We will use the platform of LSI to reach a variety of unique investors that can help change the standard of orthopedic care and improve the quality of care given to patients with their investment. All our investors are part of our team, and we are looking to tap into the experience of those involved. We are also excited to have a platform to share and get the word out about our products. Because we are addressing a real need in orthopedics, we know our message and goals will resonate with many in attendance.

Q: Since you are using Regulation A+ for your next offering, how do you see that fundraising style impacting your company?

A: We are new to Regulation A+. This opportunity will give us access to a broad investor base and allow us to promote our products on a larger scale. We are excited to share our products with new investors through this platform. Reg A+ allows for us to raise capital without losing control of the company.  It is an exciting time at McGinley Orthopedics. The influx of funding into our company will afford us the opportunity to grow and reach more patients with our technology. The funds will not only benefit our current technologies but allow us to bring to market numerous additional products in our pipeline.

Q: Why do you think education on the topic of Reg A+ plays such a vital role in expanding access to Medtech companies?

A: Until recently, I did not have a full understanding of Reg A+ and how it could help our company. I am excited to share what I have learned about its benefits to educate other companies about this approach. In the investment world, we are not used to a privately held company being able to solicit on a large scale. This approach levels the playing field while benefiting the company and the investor by eliminating the middleman. It has also opened doors to additional resources that I know would benefit other medtech companies.

Q: How do you see Reg A+ impacting the Medtech industry?

A: I think we are at the tip of the iceberg regarding Reg A+ in the Medtech industry. It gives companies the ability to access capital in an early stage a lot more easily. I think we will see an increase in adoption and a shift in private equity to Reg A+ in the future. You will see companies like ours reap the benefits, and it’s great for the entrepreneurial world.

Q: What advice would you give a young Medtech entrepreneur as they begin their journey through capital raising and building their company?

A: I would say it’s hard, and it requires dedication. If you want to be successful, you must think outside traditional approaches. Don’t eliminate any possibility and think of what works best for you. There is no easy path to success. We are an innovative company and sought unique ways to innovate while raising capital.  We innovate with our products, innovate with our sales, and innovate with how we raise capital including this new approach with Reg A+. It will be hard work, but hard work is part of the journey. Try to get varying perspectives, understand the pros and cons, and do what is best for your company.

 

Regulation A Disclaimer

This communication may be deemed to be a solicitation of interest under Regulation A under the Securities Act of 1933, in which case the following apply:

  • No money or other consideration is being solicited, and if sent in response, will not be accepted;
  • No offer to buy the securities can be accepted and no part of the purchase price can be received until the offering statement is qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date;
  • A person’s indication of interest involves no obligation or commitment of any kind; and
  • An offering statement, which would include a preliminary offering circular, has not yet been filed with the SEC.

KoreClient Spotlight: Manny Villafaña, CEO and Founder of Medical21

Manny Villafaña has a long track record of innovation in the medtech space, delivering solutions to improve cardiac care and surgical procedures. In his latest venture, Manny is creating a product that will change the way cardiac bypass surgeries are performed, improving patient outcomes.

 

We sat down with Manny to discuss his company, the medtech space, and how Reg A+ is helping Medical 21 raise money.

 

Q: Can you tell me a little about your company and how it impacts customers and the industry as a whole?

 

A: Medical 21 is the 8th company in a series of companies that I have formed since 1972. The first company I started was a company that made the first long-life pacemakers and was called CPI/Guidant, which was eventually sold to Boston Scientific. Each company has been focused on improving the technologies used in caring for cardiac patients.

 

Medical 21 has developed a small diameter coronary artery graft to be used in heart bypass surgery. Instead of harvesting blood vessels from a patient’s legs, arms, and chest, we developed this synthetic graft. Rather than pulling the needed vessel from elsewhere in the body, surgeons can pull it out of a package. This is an enormous market, larger than all the pacemakers, heart valves, and defibrillators combined. We are at the stage where we are seeking regulatory approvals to begin clinical trials domestically and internationally. 

 

Q: Besides not having to harvest blood vessels, what is the benefit of this synthetic graft?

 

A: Medical 21’s technology helps doctors not need to open up a patient’s body to take vessels out of the legs or arms during bypass surgery. For the patients, this can reduce pain while decreasing infections, and saving the hospital time and money. As a result, more patients can be safely treated in less time.

 

Q: How did you get into creating products for the cardiology field?

 

A: I answered an ad in the papers in the early ’60s for medical sales put out by the world’s largest x-ray company, Picker X-Ray. Their subsidiary, Picker International, was an export agent for small American companies exporting pulmonary, cardiac, and x-ray products. One of the products I was involved with was pacemakers made by Medtronic. Three years later, Medtronic’s CEO flew to New York and hired me.  I began to learn more and more about the heart through the transfer. With a history of heart attacks in my family, I’ve always been interested in the heart and was personally motivated since my father and brothers died from heart attacks. I am also self-taught. When I see a problem, I go after it. I am always aiming to create a product that can help others.

 

Q: What excites you most about this space you are in?

 

A: This is the most exciting work we’ve ever done because it covers so many people, surgeons, and types of surgeries. Our present work is focused on cardiac bypass, but the graft has the potential to be used throughout the body for a variety of applications. With about 800,000 to 1 million bypass surgeries on the heart each year and each patient receiving 3 to 4 grafts, there is a huge market where we can take care of so many patients globally. We are fortunate; because of our track record in the cardiac space, surgeons across the globe are excited to help us. We’re developing a product that’s incredibly needed.

 

Q: How do you see the LSI MedTech event having an impact on your company?

 

A: We were honored to be invited to the conference by Scott Pantel and his team. At the conference, there will be the best selection of financial people and young entrepreneurs looking to learn what the next step is. We are also bringing in one of our advisors, formerly with the Mayo Clinic, to talk about what is happening in the medtech field and what we are doing at Medical21. It’s an excellent opportunity for our company.

 

Q: Why do you think education on the topic of Regulation A+ plays such a vital role in expanding access to capital for MedTech companies?

 

A: In the environment of the 21st century, we must see how we can reach a wider audience for both financial needs and tap into the market of people who want to participate but are excluded by traditional private funding routes. Historically, these people could not invest until the company went public, leaving them unable to get in at an earlier stage. This provides everyday people the ability to invest in technology in the medtech space that will impact many people globally, especially when health is such a personal matter. The government gave these investors the ability to participate from the beginning, whether they were accredited or non-accredited individuals.

 

Q: Now that your company is using Regulation A+, how do you see that helping your company, and what impact do you think Reg A+ will have on other medtech companies?

 

A: We need capital, and it’s not easy to initially jump to IPO’s, even though I’ve done seven previous IPOs. Reg A+ can allow us to raise enough money to begin clinical trials. Reg A+ is a step in a company’s financing as it grows, and a successful offering shows that your company can get it done and raise a large sum of money by reaching a large audience. RegA+ is essential for the future of the medical device industry because medical companies need financing for an extended period of time before the product is approved and sold. Before it can get to the point of sales, medtech relies on private investors for development and clinical trials of life-saving products. 

 

Q: What advice would you give a young medtech entrepreneur as they begin their journey through capital raising and building their company?

 

A: I often give a talk entitled “The Trials and Tribulations of the Entrepreneur.” I offer many bits of advice, and one of those is that before you even begin, you need to overcome simple life challenges to become an entrepreneur. In the medtech space, you have to be a “superman or superwoman” because, in addition to developing new technology, you need to do clinical trials in a risk-averse regulatory environment that makes things difficult. However, at the same time, risk must be taken. The greatest hazard in life is not taking risks; you cannot achieve anything if you don’t take risks!  Thank you! Manny

 

Regulation A Disclaimer

This communication may be deemed to be a solicitation of interest under Regulation A under the Securities Act of 1933, in which case the following apply:

 

  • No money or other consideration is being solicited, and if sent in response, will not be accepted;
  • No offer to buy the securities can be accepted and no part of the purchase price can be received until the offering statement is qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date;
  • A person’s indication of interest involves no obligation or commitment of any kind; and 
  • An offering statement, which would include a preliminary offering circular, has not yet been filed with the SEC.

 

KorePartner Spotlight: Paul Karrlsson-Willis, CEO of JUSTLY

With the recent launch of the KoreConX all-in-one platform, KoreConX is happy to feature the partners contributing to its ecosystem. 

 

Paul Karrlsson-Willis is the CEO of JUSTLY, a registered broker-dealer designed for companies to promote their ESG profiles as the demand for socially conscious businesses continues to skyrocket. Nearly a quarter of the $400 billion investments ESG-focused private capital between 2015 and 2020 was invested last year alone. Paul has over 30 years of experience in financial services businesses and has expertise in building out a company’s global footprint.

 

We took some time to speak with Paul to learn more about himself and his firm. Here’s what he had to say. 

 

Why did you become involved in this industry?  

 

When I left school there was major unemployment in the UK so the government came up with the “youth opportunity scheme” which was an intern program at various companies which the government-funded. I was fortunate to be accepted into this program by the London Stock Exchange who placed me with a broker-dealer, Capel-Cure Myers, and never looked back.

 

What services does your company provide for RegA+ offerings? 

 

We can offer everything from front to back for Reg A+, Reg CF, and Reg. D as a result of having great partners such as KoreConX. Our true value is in our ability to work with the issuers and understand their businesses and needs. Our parent company–Ideanomics (NASDAQ: IDEX)–started no different from the issuers we support and still invests in private equity companies. It’s in our DNA.  

 

What are your unique areas of expertise? 

 

Over my 30+ career, I have continually been given various businesses, products, and groups to build or rejuvenate, many have gone on to be leaders in their space. A good example was when Fidelity hired me in the UK to build a global trading product for their retail clients base, knowing I had no experience in foreign equities and this was after 3 previous attempts had failed. We were up and running in 3 months and when they asked me to come to the US to do the same, the UK business was profitable. At Fidelity Capital Markets (US) we went from being only able to do everything in USD, to being fully multi-currency, able to trade in over 47 countries in real-time. As a result, Fidelity retail was the first retail US broker-dealer to offer global trading in real-time. I’ve been very fortunate to have worked my way up through the business and therefore know how things get from A to Z and the issues you will come across.  I love to learn; I hate being the smartest person in the room, which is why I try to make sure I have a team that is knowledgeable and feels empowered. I’m very passionate and treat everything I build as part of me, as I believe it reflects on me personally.

 

What excites you about this industry? 

 

Up until now, not very much. It’s been a job I have always put more than 100% into to support my wonderful family. JUSTLY has given me the ability to build something that can genuinely make an impact and help others. Every day, I think about making a difference and not feeding the machine or massaging someone’s ego. Don’t get me wrong, my job is to generate revenue and make JUSTLY profitable, but by making that difference, we will as they go hand-in-hand.

 

How is a partnership with KoreConX the right fit for your company?  

 

KoreConX has the complete platform, amazing expertise and therefore enables JUSTLY to focus on making an IMPACT! True success is never achieved on your own; you need a team and great partners. There is no better partner in this space than KoreConX.