Tag: Indiana angel investing

  • Meet Our April Pitch Presenter: Diana Caldwell of Amplified Sciences, Amplifying Trace Enzymes for Earlier Diagnosis

    Meet Our April Pitch Presenter: Diana Caldwell of Amplified Sciences, Amplifying Trace Enzymes for Earlier Diagnosis

    I first met Diana Caldwell when she was the co-founder and CEO of Pearl Pathways. Pearl was among VisionTech’s corporate sponsors and an invaluable commercialization resource for our life sciences portfolio companies. It didn’t take long for Diana to become a member of VisionTech Angels, giving us deep bench strength as a subject matter expert in drug development and FDA regulatory paths. When she co-founded a new diagnostics startup with pancreatic cancer as its first target, Amplified Science, I was eager to learn more. Pancreatic cancer is the third most deadly cancer, killing 74 of 100 patients within a year of diagnosis, largely because it is rarely discovered early enough to treat successfully. I invited Diana to meet with the VisionTech Angels Screening Committee earlier this month. The group was impressed with Amplified Sciences, its novel technology, progress to date, and invited her to present at our April 27 virtual pitch events. Here’s a preview.

    BP: Tell me a little about yourself. Is this your first startup?
    DC: This is actually my second startup. I was also a co-founder of Pearl Pathways. After earning an MBA at the IU Kelley School of Business, I joined Lilly where I held commercial and cross functional roles for the next 16 years. Lilly really gave me a broad foundation of experience in leadership and developing teams in the biotech space. Eventually, a desire to be an entrepreneur and get back into product development for unmet clinical needs brought me to the startup space.

    BP: What’s the backstory on Amplified Sciences? How did you connect with your co-founder, Dr. V. Jo Davisson?
    DC: I was working at the Purdue Foundry as an entrepreneur-in-resident, helping a half a dozen startups and shopping for IP for my next startup. While I was there, I met Jo,  a Purdue faculty member and biochemist with 30 years of experience in drug and diagnostic discovery and development. He had invented a chemistry reagent platform for the early detection of debilitating diseases, had founded the company, and was looking for a CEO with deep business experience. For the next nine months we had the opportunity to work alongside each other—Purdue has this great knack of pairing entrepreneurs with scientists! In the summer of 2019, I became a co-founder and CEO with Jo as our CSO, and we got to work. 

    BP: What is your product and how is it different?

    DC: Our lead product is a diagnostic reagent for accurately detecting a biomarker that is an indicator of potential malignancy for pancreatic cancer.  Amplified Sciences’ chemistry reagent platform is a suite of patented reporter dyes that amplify biomarker signals. What’s novel about our technology is the ability to detect indicators of disease at a much lower concentration – up to 10,000 times improved limits of detection – than comparable technologies.  Our ultrasensitive dye probes work particularly well when there is a low abundance of the target biomarker and when there is a low volume sample involved. These features are important when you’re working with low volume samples such as with a cyst or when a disease is in its very early stages.

    BP: Let’s discuss your lead assay, PanCystProTM. Why pancreatic cancer? Where are you in its development?
    DC: We chose pancreatic cancer for our lead assay for several reasons. First, because of the deadly nature of the disease—roughly three out of four patients are dead within a year of diagnosis—and the unmet medical need for early-stage diagnostics to help increase survival rates. Pancreatic cancer is a “silent cancer” in that symptoms don’t show up until late stage if they show up at all. By then it’s too late to treat effectively. Early detection is the only way to significantly change outcomes.

    Here’s an example for you. Supreme Court Justice Ruth Bader Ginsburg had colon cancer. It was caught early, and she survived. Later, when she was undergoing a full body scan, an early-stage cyst was found on her pancreas. She was treated with a surgical removal of that cyst, and survived for years. It was only by chance that her pancreatic cancer was found when still treatable.

    Why is it so hard to find? For one thing, the pancreas is deep within the body, behind the stomach, so it’s hard to see in imaging. Most of these cysts are found by imaging incidentally meaning they are found in a cat scan or MRI when doctors are looking for something else .

    Our PanCystPro™ assays test the fluid from these cysts, which are very small so fluid sample sizes are small. This works in our favor because of the ability of our technology to operate with very small sample volumes. Our initial PanCystPro assay is a minimal sample assay for protease biomarkers and is a “rule out” test to determine if the cyst is benign. At +90% sensitivity and specificity, it is more accurate than competing tests.

    We have additional assays in this disease state in development.  I’d also like to mention that we were just awarded a Phase 1 SBIR grant of $400,000 from the National Cancer Institute. This will help accelerate development of our second assay for pancreatic cancer. The award validates the huge clinical need for this test.

    BP: Where are you in development?

    DC: We are making steady progress. The PanCystPro test has been used in clinical samples and is ready for translation to a clinical lab and to enter the regulatory process. Our team, which includes three Ph.D. scientists, is set to expand soon. Research and development on additional assays are underway and this includes active institutional review board (IRBs) studies with three premier research universities.

    BP: What is your total addressable market?
    DC: The in-vitro diagnostics market is huge, about $88 billion. For initial market entry, we are focusing on the pancreatic cancer diagnostic market, which is $2.2 billion including imaging. Drilling down to our real value proposition, more accurate diagnosis of patients with pancreatic cysts, the market is $300 million with a potential market share of $80 million. Pancreatic cancer in-vitro diagnostics is just the start so keep in mind, this is a platform technology that will be leveraged to other disease states.

    BP: What kind of intellectual property protection do you have?
    DC: We have a suite of global composition of matter patents exclusively licensed from Purdue. We are adding patents on our individual products.

    BP: What round is this?

    DC: This is our Series Seed Preferred Round. We completed a previous Series Seed convertible note round in early 2021, raising $1.78 million. In this round, our goal is to raise $3-3.5 million. We have two co-leads, Elevate Ventures and OCA Ventures, that have done their due diligence. They, alongside two other venture firms, closed $1.5 million in Wave 1 of the open round on March 3, 2023. We’d like to raise another $1.5 to $2 million so there’s still plenty of room for VisionTech Angels.

    BP: What is your planned use of funds?
    DC:  The largest portion will be directed to research and development on two additional assays, followed by CLIA regulatory approval, targeted launch with key opinion leaders, clinical utility and trials, sales and marketing, and capital equipment.

    BP: Give me three reasons why VisionTech Angels members should invest.
    DC: First, this is an opportunity to help us build a great diagnostics company focused on earlier, mor accurate detection starting with pancreatic cancer. Second, others believe we are up to the challenge. We already have two respected investors leading the round, Elevate Ventures and OCA Ventures, both of which have invested in diagnostics companies in the past and are familiar with the space. Third, we are a clinical stage company making measurable progress and are planning our commercial launch by end of year. I’m going to sneak in a fourth: we have identified multiple paths to exit and are working hard on the milestones needed for a near term exit.

    VisionTech Angels’ April Pitch Events will be virtual on Thursday, April 27 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com

  • VisionTech Angels Invest $242,000 in Indiana-Based Adipo Therapeutics

    VisionTech Angels Invest $242,000 in Indiana-Based Adipo Therapeutics

    INDIANAPOLIS, Indiana (April 11, 2023) – – VisionTech Angels, among the Midwest’s most active angel investing networks, has invested $242,000 in Adipo Therapeutics, with 29 individual members participating in the round. With the investment, Adipo has closed its seed round, raising $2.8 million with participation from VisionTech Angels, Purdue Ventures, Elevate Ventures, IU Ventures, Racine Medical Angels, and other angel investors.

    Adipo, a pre-clinical stage company seeking to transform treatment of type 2 diabetes and obesity, was founded in 2016 by Meng Deng, Ph.D., an associate professor of Agricultural and Biological Engineering, Biomedical Engineering, and Materials Engineering at Purdue University. Adipo’s breakthrough technology stems from Deng’s strong commitment and interdisciplinary collaboration in the development of biomaterials-based translational technologies for cellular and regenerative engineering. The company is led by CEO Karen Wurster, who spent 25 years with Eli Lilly developing, launching and commercializing blockbuster diabetes treatments prior to joining Adipo in 2020.

    Adipo’s novel method of action seeks to fundamentally transform how type 2 diabetes and obesity are managed by changing energy-storing white fat cells into energy-burning brown fat cells. The metamorphosis of adipose tissue through browning has the potential to use the body’s own physiology to increase energy expenditure, reduce adiposity and improve insulin resistance.

    Commenting on the announcement, VisionTech Executive Director Ben Pidgeon said the group’s investors were impressed by the enormity of the technology’s human impact and market potential in reversing serious conditions that have reached epidemic proportions in the United States and globally. “By 2025, 37 million American will be diagnosed with type 2 diabetes while 64 percent of the U.S. population will be either overweight or obese. Both conditions often lead to complications that include heart disease, stroke, blindness, and death. Adipo’s goal to use the body’s fat to reverse course and help people live healthier lives would be a tremendous breakthrough.”

    He added, “Adipo is initially targeting a segment of the U.S. type 2 diabetes treatment market that involves injections and is estimated at $1.7 billion. The platform technology can potentially be leveraged to treat obesity and other metabolic disorders, significantly increasing market value.”

    Adipo is VisionTech Angels’ 63rd portfolio company and the first of 2023. Wurster is pleased with the strong support her company has received from VisionTech and other Indiana-based venture groups, which helps advance a much-needed solution for people living with type 2 diabetes. “I am thrilled to be leading a team to realize the potential of this groundbreaking science to improve the treatment of millions of people suffering with type 2 diabetes and obesity. We are appreciative of the support we have received as an Indiana startup from VisionTech, Elevate Ventures, IU Ventures, and Purdue Foundry and look forward to moving our product to the next phase of development.”

    Adipo is using the funds to continue to de-risk their technology, while preparing for a Series A fundraising round that is anticipated to begin later this year.

    About VisionTech
    Founded in 2009, VisionTech is a privately held company that links investors to high-potential, early-growth companies. Based in Indianapolis, VisionTech’s angel investing network includes more than 130 active members across Indiana and Ohio. As of November 2022, 175 VisionTech member investors have deployed more than $24.8 million in capital, investing in 63 portfolio companies from across the United States. Membership is open to accredited investors. Those interested in joining are encouraged to contact VisionTech.

    About Adipo Therapeutics
    Founded in 2016, Adipo Therapeutics LLC, is a privately held biotech company focused on localized conversion of energy-storing white fat to energy-burning brown fat for the treatment of obesity and type 2 diabetes. Adipo’s lead product, ADPO-002-NP, is in pre-clinical development.  For additional information, visit our website.

  • VisionTech Angels Invest $190,000 in Seneca Therapeutics Follow-on Round

    VisionTech Angels Invest $190,000 in Seneca Therapeutics Follow-on Round

    INDIANAPOLIS, Indiana (March 21, 2023) – – VisionTech Angels, among the Midwest’s most active angel investing networks, has invested $190,000 in Seneca Therapeutics with 16 members participating in the follow-on round. With the investment, Seneca has raised $2.8 million to date in its bridge round, with Keiretsu Capital leading the round and participation from VisionTech Angels and multiple other angel investors.

    Seneca, based in Blue Bell, Pennsylvania, is a clinical stage biopharmaceutical company focused on developing novel immunotherapeutics and derivatives for difficult to treat solid cancers. Their first candidate is an oncolytic immunotherapeutic called Seneca Valley Virus (SVV) that eliminates tumor cells in which it can replicate. In October 2022, the company received FDA clearance to begin a Phase I/II clinical study utilizing Seneca Valley Virus (SVV-001) in combination with a checkpoint inhibitor in 2023.

    VisionTech Angels made its first investment in Seneca in 2021 when 34 investors wrote checks totaling $327,500. The group’s total investment in the biopharmaceutical company is $517,500.

    Commenting on the announcement, VisionTech Executive Director Ben Pidgeon said, “VisionTech Angels is excited to continue to support our portfolio company Seneca. Their novel therapy of oncolytic viruses has the potential to identify and treat immunotherapy-resistant tumors. The management team has met several milestones after our initial investment, a significant one was FDA approval of a Phase I/II study. The first oncolytic virus as therapy—Imlygic, now owned by Amgen—was approved in 2015, and there have been recent successes with Replimune, CG Oncology and Tilt. The oncolytic virus immunotherapy market is an exciting space with an expected compound annual growth rate of 12 percent through 2029.”

    Seneca CEO James Hussey said he is pleased with the strong support his company has received from VisionTech across two rounds of investment. “VisionTech has been a great investor and supporter of Seneca Therapeutics over the last few years. They are one of the premier angel groups in the United States and we are excited to partner with them on this follow-on round.”

    About VisionTech

    Founded in 2009, VisionTech is a privately held company that links investors to high-potential, early-growth companies. Based in Indianapolis, VisionTech’s angel investing network includes more than 130 active members across Indiana and Ohio. As of March 15, 2022, 200 VisionTech Angels member investors have deployed more than $27.5 million in capital, investing in 63 portfolio companies from across the United States. Membership is open to accredited investors. Those interested in joining are encouraged to contact VisionTech.

    About Seneca Therapeutics, Inc.
    Seneca Therapeutics was founded to capitalize on the profound tumor specificity of SVV and further the development of SVV-001 in several upcoming clinical trials and the creation and testing of armed derivatives selectively expressing gene product(s) that are inserted into the genome of SVV-001 that create additional anti-tumor effects. Learn more.

    CONTACT: Melanie Lux at Melanie@Lux-writes.com or 803-331-4794

  • 5 Reasons Startups Should Go Local, Return to Personal Banking Relationships

    5 Reasons Startups Should Go Local, Return to Personal Banking Relationships

    On Friday, March 10, 2023, Silicon Valley Bank (SVB), the flagship of the startup banking world, collapsed, causing the FDIC to take over the bank. The failure is the largest since 2008, and it caused a firestorm among customers, the startup and venture ecosystem, policy makers, and politicians. Fanning the flames were  media and social platforms, raising the bar on histrionics. It was no wonder that many people dreaded the Monday after. And yet SVB reopened on Monday under the control of the newly created Deposit Insurance National Bank of Santa Clara. Insured depositors with up to $250,000 in their accounts were able to access their money.

    So what next? Although the fallout from SVB’s failure is still unfolding, VisionTech turned to Stock Yard Bank’s Denelle Key for insight. She offered five reasons why startups should go local with their banking and return to personal banking relationships.  – Ben Pidgeon, VisionTech Executive Director

    BP: How are you handling Friday’s news of Silicon Valley Bank’s crash?
    DK: First off, this is nothing like the Lehman Brother collapse in 2008. My head is still spinning by how quickly SVB went into receivership. I think it’s the direct result of social media commentary, fearmongering and politicization that the FDIC felt it had to move quickly to avoid more devastating consequences. All weekend long I got calls from fearful bank customers and providing reassurance that Stock Yards Bank is sound, and their accounts are protected. Fortunately, the right people are stepping in to manage the immediate crisis of SVB and avoid the collapse of more banks.

    BP: You’ve pointed to the media’s role, but is there another big difference from the financial crisis of 2008?
    DK: Absolutely! There is a huge generational difference in how young startup founders and their teams – particularly those in the tech sector –  have approached banking and the financial side of their businesses. I call them debit card kids. They’ve never handled real money. They don’t see it or deal with it. And they don’t understand the basic fundamentals of banking. They rely solely on the convenience of the Internet and apps for banking services. Most have never stepped foot in a bank. With everything moving so fast in the digital world, it’s easy to lose track of banking and money basics. When a startup CEO has a problem, they head back online as they have no idea what it means to pick up a phone, call their banker and get a real, thoughtful answer from a knowledgeable banker.

    BP: You’re right about that. So what are the five reasons why startups should go local and return to personal banking relationships?
    DK: Reason One is Experience. When you work with a local community bank, you’re working with people who have years of experience advising businesses on the fundamentals of banking, lending and growth. Startups often don’t know what they might need from a banking perspective, and in this environment, the needs change often. Utilizing a small bank allows you to find someone who has working with startups, has experience in your industry, and can speak to the needs of your business. Oftentimes, a startup thinks they need to go to a national bank as they’re going to be doing business on a national or international scale. The reality is that local banks such as Stock Yards is no different than a Bank of America in terms of having the experienced people, products, and services needed to doing business around the world.

    BP: It seems like people automatically think large banks are too big to fail.
    DK: That’s the assumption. Which is why Reason Two is Security. You need to know that your bank, regardless of size, is sound. Take SVB. Its 40,000 customers are mostly tech companies; big companies alike Shopify, Teladoc and ZipRecruiter. They provided services to around half of all U.S. startups. So if you are a startup CEO, it was pretty safe to assume SVB was a good, secure choice. Now we know that wasn’t the case, but why would you think otherwise?

    A CEO of a startup or any other stage company should understand the strength of their bank and expect that their personal banker can speak to the bank’s performance. With a community bank, it’s more likely that you’ll find a well-capitalized, balanced bank with strong loan-to-deposit ratios. And if you don’t know why this is important to you as a startup, that’s okay! Ask questions! You want to ensure that your bank is sound, and your money is safe, as both are critical. You don’t want to come to work on Friday, looking forward to the weekend, and see your bank and accounts crashing.

    BP: We’ve kind of gotten away from relationships with our bankers. Is that a fair assessment?
    DK: That’s point three: We need to get back to connected relationships with our bankers. And I don’t mean connected in the LinkedIn sense. I mean pick up the phone, let’s have lunch, can you help me out here, I have a question kind of connection. Real relationships!

    Startups, regardless of the age of their founder or CEO, need more than just an ATM, the internet, a debit card, and mobile deposit. You may think that banking and the services they provide are commodities, and you can get by with a digital relationship. However, the last three years have taught us that a relationship with a bank will save your company when hard time happen. During the COVID-19 pandemic, Paycheck Protection Program (PPP) funds distributed through large banks took weeks and weeks to process. Many companies didn’t receive funds simply because they were pushed to the end of the line. Community banks like Stock Yard were able to quickly take care of our clients’ needs because every client had a relationship with their banker. No stone was left unturned by bankers to help their customers. People and their businesses matter. While banking online is convenient, it’s also faceless. And that’s a real problem when problems crop up. A chatbot won’t cut it.

    BP: It really get down to that human connection, right?
    DK: Yep, human connection. So reason four is the ability to communicate with a person, and to trust that person. When you have an engaged banker, someone you’re comfortable talking things over with, this person knows your business and is prepared to problem solve for you. Bankers want to know your business, so we understand where you came from and where you want to go. There’s also a big difference between an employee who works at a bank, and a banker that is a true advisor to your startup or business.  Your banker should also be accessible to you, and available to listen to your questions and issues.  Having one person to be able to contact to troubleshoot and also brainstorm is a huge asset to a business owner and help you through them. Your job as a business owner is to generate revenue, not spend your time managing customer service issues with a bank. You should be able to easily reach your banker and trust their counsel.

    BP: And the last reason to go local?
    DK: Personal service from a bank and banker with whom you have an open, honest connection. Find a bank that makes you feel comfortable as a client. Even better, find one that makes you happy and valued to be there! Providing outstanding service in all of the ways I’ve mentioned help create and build strong, engaged relationships. You should feel great about the service you are receiving from your bank, know and trust your banker, know they are interested in helping you succeed, and feel comfortable having them as an advisor to your business. If any of these items fall short, it’s time to consider a new bank!

    ABOUT STOCK YARDS BANK

    Stock Yards Bank’s impressive history began in 1904. Since then, Stock Yards Bank has earned a reputation for personal service, financial strength, and a commitment to the highest standards of business ethics. We have a full range of financial services to meet the needs of each of our customers, regardless of the size or complexity of their needs. We’ve built our business in the simplest and most straightforward way possible: one account at a time, relationship by relationship.

    Our mission statement calls for providing unsurpassed service to our customers and a great place to work for our employees. Our commitment to this philosophy is a key reason our parent company, Stock Yards Bancorp, a publicly traded company (NASDAQ:SYBT), has consistently ranked among the country’s top-performing community banks and recognized as one of the “Best Banks to Work For.” Learn more here.

  • Meet Our February Pitch Presenter: Dr. Evan Unger of NuvOx Pharma, Using Oxygen to Amplify Treatments

    Meet Our February Pitch Presenter: Dr. Evan Unger of NuvOx Pharma, Using Oxygen to Amplify Treatments

    I was introduced to Dr. Evan Unger by Mike Eckert of the NOLA Angel Network in New Orleans. Their group is syndicating an investment opportunity in NuvOx Pharma, a clinical stage pharmaceutical company developing a drug that significantly improves the flow of oxygen from lungs to blood and from blood to tissue. The drug has applications in treating cancer, stroke, acute respiratory distress syndrome, and other fatal diseases. I invited Evan to meet with the VisionTech Angels Screening Committee earlier this month. The group was impressed with NuvOx, its leadership team and board, traction, and the investment opportunity, and we invited him to present at our February 23rd virtual pitch events. Here’s a preview.

    BP: I went through your website and was very impressed by your team, starting with yourself.
    EU: I’ve been busy: board-certified radiologist and inventor; 30 years as a professor of radiology and bioengineering; have 120 issued patents; have founded four biotech companies, the first of which exited to DuPont at a 20x return; and now CEO, president and co-founder of NuvOx. My experience with startups helps me avoid the common pitfalls!

    Our leadership team is impressive. Rong Wang is our CFO/COO and is a very strong organizational leader . Prior to joining NuvOx, she was an executive in investor-backed companies and led multiple successful exits. She’s also worked for Fortune 500 companies such as Baxter International. Jennifer Johnson, PhD, is a co-founder and chief scientific officer of NuvOx. She has more than 20 years of deep R&D and regulatory experience, including tenure with Roche. Our skillsets are very complementary, and we form a high performing team.

    I can’t thank our board and scientific advisory members enough. We have physicians, a former Roche executive, biotech CEOs, and the former U.S. surgeon general, Richard Carmona. They provide comprehensive board governance structure, investor introductions, advice and more.

    BP: Explain the unmet need and how your solution, NanO2, addresses it.
    EU: The problem we’re solving is hypoxia, a state in which oxygen is not available in sufficient amounts at the tissue level to adequately maintain normal functions. This lack of oxygen is responsible for death or morbidities in cancer, stroke, heart attack, traumatic brain injury, acute respiratory distress syndrome (ARDS), and other diseases.

    Our solution is NanO2TM. It is a gas-based active pharmaceutical ingredient (API) that is nanobubble emulsified into liquids to reverse hypoxia in specific medical conditions via simple IV injection. It is designed for use primarily as an adjunct treatment that is synergistic with the standard of care and improves the effectiveness of the treatment. Here is an example. Glioblastoma, a malignant brain cancer, is typically treated with radiation and chemotherapy. Cancer tumors have low levels of oxygen, which makes them resistant to treatment. NanO2 is administered 30 to 60 minutes before chemoradiation to bring up the oxygen level in the tumor. This elevates the effectiveness of the therapy because the standard care, chemoradiation, needs the oxygen in the tumor to be effective. In our initial clinical trial, median survival increased by 40%.

    NanO2 can also be applied as an adjunct treatment for ischemic stroke. When it’s administered immediately after stroke in multiple doses, it provides the necessary oxygenation to preserve brain tissue (penumbra ) for about six hours. This exceeds typical door-to-needle treatment window of the American Heart Association, and significantly improved functional independence in our trial.

    BP: Where are you in terms of commercialization?
    EU: Our product has already been developed in formulation, and we are manufacturing it ourselves for upcoming clinical trials. We can easily scale up our manufacturing and at the appropriate time, engage a contract manufacturer. We’ve completed initial clinical trials for glioblastoma with good results and are preparing for a Phase IIb clinical trial for glioblastoma to start in Q1 2023. We have orphan drug status, giving us the advantage of speed to market in the $100 billion oncology market. A second Phase IIb trial in stroke will commence later in 2023. We seek to leverage our active and planned clinical programs with additional non dilutive funding.

    BP: You mention this is a platform technology. In addition to cancer and stroke, that other conditions can potentially be addressed by NanO2?
    EU: While we have clinical evidence in glioblastoma and stroke, we also have pre-clinical evidence in animal models and current or potential grant funding for immunotherapy, heart attack, sickle cell diseases, and ARDS. Other clinicians have suggested applications in wound care such as diabetic foot. There are so many possibilities to leverage our platform, but we remain focused on our clinical programs, so we’re not spreading ourselves too thin.

    BP: What kind of IP do you have?
    EU: We currently have eight patent families that includes seven U.S.-issued patents and their international equivalents that cover China, Europe, Canada, Australia, Japan, and Korea. We plan to file new patents for key excipient, which would give us an additional 20 years’ runway of protection.

    In terms of additional protection, we have two orphan drug designations with seven-year market exclusivity. Our drug is potentially regulated as a biologic, which, if we achieve this regulatory status, comes with 12-year market exclusivity. We have also protected our position with an exclusive supply agreement, control of our key ingredients and proprietary manufacturing know how.

    BP: What investment round is this?
    EU: This is a bridge round following a $10 million Series A. It’s worth noting we’ve been very successful in attracting $13 million in non dilutive funding from the National Institutes of Health, Department of Defense and other government funders.

    BP: What is your planned use of funds from this round?
    EU: We plan to use proceeds of the raise to fund our Phase IIb trials for glioblastoma, which begins enrolling patients very shortly. We also will start a Phase IIb trial for stroke in 2023. That clinical trial is being funded by the United Kingdom government.

    BP: Why should VisionTech Angels invest in your company? EU: We are addressing a massive market with an unmet need with a drug that has been substantially de-risked, has strong IP protection and a clear pathway to commercialization. We don’t have effective competitors in this field and are very capital efficient. A significant benefit for investors is we have secured more than $13 million in non-dilutive funding and are close to securing an additional $4 million. Finally, our leadership team, our board, and our scientific advisors have deep experience in all aspects of drug development and commercialization and have played a critical role in our success thus far.

    VisionTech Angels’ February Pitch Events will be virtual on Thursday, February 23 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com

  • Meet February Pitch Presenter: Lydia Zeller of Flyte, Addressing Incontinence with Confidence

    Meet February Pitch Presenter: Lydia Zeller of Flyte, Addressing Incontinence with Confidence

    I first met Lydia Zeller, CEO and president of Pelvital (dba Flyte) a femtech solution for stress urinary incontinence in women. If you are unfamiliar with femtech, it is a category of software, diagnostics, products, and services that use technology to focus on women’s health. While VisionTech Angels has invested in a wide range of life sciences companies, this is our first femtech company, a sector that’s recently begun experiencing a lot of growth. I invited Lydia to meet with the VisionTech Angels Screening Committee earlier this month. The group was impressed with Flyte, how they are addressing a significant unmet need, the investment opportunity and Lydia, and we invited her to present at our February 23rd virtual pitch events. Here’s a preview.

    BP: Tell me a little about yourself. Is this your first startup?
    LZ: No, I’ve actually been an entrepreneur for 25 years and have a lengthy background in digital health. The last company I founded and where I served as CEO was Kiio, a digital health company in the musculoskeletal space, which exited in late 2021. I was brought onboard at Flyte in 2022 to take a fresh look at the go-to-market strategy. Outside of Flyte, I’m the board president of the Wisconsin Startup Coalition and a member of Women Business Leaders of the U.S. Health Care Industry Foundation.

    BP: What’s the backstory on Flyte?
    LZ:  First, 60% of women suffer from some form of urinary incontinence, so it’s a big problem. Flyte was originally developed by researchers, physicians, and physical therapists at the Arctic University of Norway. They were frustrated by the fact that nothing worked for patients who came in with stress urinary incontinence. Mechanotherapy was being used to treat astronauts who’d lost muscle strength in space. The question was asked, “Can we use this healing modality to revitalize the pelvic floor of women?” That started the effort at Arctic University to develop the technology that became Flyte.

    BP: I didn’t realize incontinence was such a big issue.
    LZ: Most people don’t. And one of the reasons is it’s embarrassing for women to talk about even though one in two have stress or mixed urinary incontinence. It happens when a woman laughs, coughs or bounces during exercise. It can develop after pregnancy. Athletes suffer from it. Incontinence is also part of the aging process. As common as incontinence is, more than 80% of women just put up with it without treatment. Some wear pads or absorbent undergarments, which are expensive. Some do Kegel exercises at home to strengthen muscles. A very small percentage, less than 3%, opt for surgery.  That’s expensive, there’s the risk of complications and it doesn’t always work. A lot of women are frustrated and end up living with leaks.

    BP: How is Flyte different?
    LZ: Flyte is a safe, non-surgical, bladder leak treatment for stress urinary incontinence in adult women. It is the only product to apply mechanotherapy to pelvic floor. It is a quick, easy treatment patients can do for just five minutes per day to strengthen their pelvic floor and realize dry or near-dry results in just six weeks.

    Now here’s how the “magic” of mechanotherapy works. The Flyte device is a wand made of soft, medical-grade silicone that is placed in the vagina. During treatment, it delivers a series of gentle pulses while the patient contracts her pelvic floor muscles. This amplifies the benefits of each squeeze—commonly called Kegels—by 39 times. This promotes the healing response in the pelvic floor muscles and restores strength and bladder control. Length of treatment is six weeks. Women can continue to use Flyte to maintain pelvic floor muscle tone if they like.

    BP: You’ve done clinical trials in Norway and the United States, and the results are impressive.
    LZ: Thank you! We have done the largest clinical trials of stress urinary incontinence in the world, with a total of 179 participants. The first trial was done in Norway at one center with 60 women. After six weeks, 83% of the women were continent. After two years, 77% will still continent. A second study was done in the United States with multiple centers and 119 women. After six weeks, 81% had improvements and at 12 weeks, 91% reported improvements. Overall, 71% achieved dry or near dry in two to 12 weeks.

    BP: What are the barriers to adoption and how are you addressing?
    LZ: Among consumers, there’s a lack of awareness that there’s something new available to them and that it works. We’ve also found that women are a little leery. Surprisingly, incontinence is a noisy space. A lot of people are selling snake oil. And even traditional treatments aren’t that effective. Many women who have tried something that didn’t work give up. Being new, we have to create awareness and educate women that our treatment works, and it’s quick. Some women achieve total dryness in two weeks, for others it’s six weeks of more. Increasing our presence on social media and through digital healthcare companies will help us increase awareness.

    B2B partners get it, particularly clinicians who see the problem day-in and day-out, know their patients struggle with current options and are not solving the problem. They are impressed with the results of our clinical trials. Our price point, $395 per device, would be more attractive if covered by insurance or Medicare/Medicaid. So we are working on getting a reimbursement code.

    Interestingly enough, we also have to overcome barriers with potential investors. Femtech is a new category of investing. Men often don’t realize what a debilitating issue incontinence is for women because women hide it so well. Unlike back surgery or a cancer drug, it’s not always easy to explain our return on investment. Incontinence ROI is more complicated. It’s been linked to depression, urinary tract infections, withdrawal from various activities in professional and personal settings, stopping exercise—the list goes on.

    BP: What is your go-to-market strategy and where are you seeing traction?
    LZ: To date, B2C has been our primary focus, and we are making a small profit here. Last year, we concentrated on reducing our customer acquisition cost and succeeded in cutting it in half. Once we close this round, we will be more involved in our B2C outreach through social and digital channels. Where we’re putting more effort is B2B. In the virtual healthcare arena, we are in advanced discussions with multiple partners and have signed a contract with a large Minnesota healthcare system. B2B deals take more time to develop and close but will allow us to scale more quickly.

    BP: What kind of intellectual property protection do you have?
    LZ: Our technology is very well protected, and we did that intentionally. We have 17 patents in all:  seven in North America, four in Europe, four in Asia, and two in Australia.

    BP: What round is this?
    LZ:  We are currently in our seed round and the goal is to raise $4.5 million. Boomerang Ventures is leading the round through their fund.

    BP: What is your planned use of funds?
    LZ:  Our priorities include securing a reimbursement code so we are accessible to more women through private insurance and Medicare/Medicaid; building out our next generation product, a connected device that will enable Cloud capture of data, a mobile apps for users, and features for virtual healthcare companies, health systems and clinicians; and making key hires in sales, marketing and business development that support commercialization. We will also be building our inventory in anticipation of increased demand.

    BP: Give me three reasons why VisionTech Angels members should invest.
    LZ: Do I have to limit it to three? I have five.

    BP: Sure! Go ahead.
    LZ: First off, women’s stress incontinence is a huge market with an unmet need. Second, Flyte is the right product at the right time. At long last, women’s health has become a priority, and this coincides women finally realizing it’s okay to talk to taboo topics like incontinence and demand for solutions for all women. Our timing coincides with the rise of digital health, which thanks to Covid, became mainstream.

    Third, we have a differentiated, patent-protected, novel approach that has been de-risked through clinical trials and has regulatory clearance for over the counter and prescription sales. Fourth, our business model aligns with direct-to-consumer retail and digital health, with women and partners looking for a real solution to stress incontinence. We are that solution. Fifth, we have a great team!

    VisionTech Angels’ February Pitch Events will be virtual on Thursday, February 23 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com

  • Introducing Our 2nd October Pitch Company: PassiveBolt, Pioneering a Web3 Platform for Securing Places + Identities

    Introducing Our 2nd October Pitch Company: PassiveBolt, Pioneering a Web3 Platform for Securing Places + Identities

    I met Kabir Maiga, co-founder of PassiveBolt, through Joshua Tooker of Union Heritage Capital in Detroit and Endeavor. Both were high on Kabir and Passive Bolt and the pioneering use of blockchain, digital wallets, and hardware to transform how places and things are unlocked. Kabir, who “grew up” developing keyless entry systems for cars with Continental AG, a German multinational automotive parts manufacturer, is a visionary with the practicality of an engineer who knows how to get things done. Kabir pitched the VisionTech Angels Screening Committee in early October. The group was impressed with PassiveBolt’s platform and Kabir, and we invited him to present at our October 27th virtual pitch events. Here’s a preview.

    BP: What’s the back story on PassiveBolt?
    KM: In 2016, I was working with Continental on keyless entry systems. As I looked forward, I wondered what the world would be like if all entry systems were keyless. With the proliferation of app-driven smart devices, the world wasn’t getting smarter or easier for consumers. Instead, things were getting more complicated and also risky. Think about it. Nearly every app asks for your personal information, which is then stored on their server and therefore vulnerable to being hacked.

    I began looking into how we could make this feature, keyless entry, more widely available beyond automotive. At the same time, I wanted to do it in a way that protects people’s personal information. I pitched the idea internally at Continental and they liked it so much they sent me and my team to Munich, Germany, for six months to incubate the idea. Ultimately, Continental allowed us to spin out as a standalone company, PassiveBolt, and also led our seed investment round.  

    BP: What exactly is your solution?
    KM: What we’re doing is using Web3 and decentralized identity to unlock an entirely new class of access control and security solutions based on cryptographic credentialing. Our platform is a combination of hardware and software: blockchain, digital identity wallets, attestations for permission granting, and Web3 hardware. We are eliminating the need for passwords, PINs, key cards, brand-specific app, and other traditional means of entry. Consumer data is private, secure and portable. Companies work with consumers’ digital wallets and there is no need to collect and store personal information. Everything is done cryptographically and meets regulatory compliance by design.

    BP: My head’s spinning.
    KM: I know this is a lot to digest. Our website goes into a deeper explanation here.

    BP: PassiveBolt was won some impressive awards since the company was founded.
    KM: Yes, we have. We were recognized at the Consumer Electronic Show (CES) as an Innovation Award Honoree in 2020 and 2021. Forbes named us among their Top 7 Unmissable Tech in 2020 and then recognized us again in 2021 as a Forbes NEXT 1000 Honoree. Internet of Things World included PassiveBolt as a Best Consumer IoT nominee in 2020.

    BP: What industries can benefit from PassiveBolt? Why are you initially targeting the hospitality industry?
    KM: Literally any industry that relies on controlled access. Some examples are hotels, rental cars, storage units, office buildings, and other public spaces. In addition to working with the lock and access control industry, we’re selling directly to the hospitality industry because it’s such a natural fit. Hotels and resorts have a constant exchange of access as guests come and go. Even with technology, it’s a labor-intensive process and hotels are collecting a lot of personal information.

    For hotels, our web3 platform enable the manager or reservations department to grant access to rooms with guests’ digital identities rather than collecting all of their personal information such as drivers’ licenses and credit cards. The check-in process and delivery of mobile keys is automated, the guest experience is more seamless, guest identity is automatically authenticated and protected, and the risk to hotels is also minimized because they are no longer handling and storing the personal data of guests.

    BP: What’s been the response from hotels?
    KM: Very positive. We’re currently deploying to 2,000 hotel rooms.

    BP: Where are you in terms of commercialization?
    KM: We are growing rapidly through our partnerships with Tier-1 lock and access control  companies and hotels. In 2022, we have signed a number of agreement and anticipate the traction to continue in 2023.

    BP: What is the size of your addressable market?
    KM: Security services are definitely a growth market globally and technology solutions are a contributor. The overall lock and access control market is estimated at $25 billion. Our current focus, the Tier-1 technology partners and hotels, represents a $16 billion market.

    BP: What is your revenue model?
    KM: Our model is to license or sell our hardware and software as a Tier 1 technology partner to door lock and access control companies. It’s an attractive model for them as they get the best security solution, stay on top of innovation, deploy technology quicker, avoid costs associated with in-house development, and get the web3 technologies they need for security, privacy and regulatory compliance.

    BP: Do you have any IP protection?
    KM: We have three U.S. patents granted and two that are pending. We are evaluating what global patents to pursue.

    BP: What are your competitive advantages?
    KM: Traditional security and authentic solutions simply do not compare to the comprehensive security afforded by PassiveBolt. On the corporate side, businesses no longer have to handle and store people’s personal information, which puts them at risk of being hacked. On the consumer side, individuals own, control, and manage their personal data. There is no more worry or stress about one’s information being “out there” for others to use for nefarious reasons.

    BP: What fundraising round is this and what is your planned use of funds?
    KM: This is a seed plus round and the funds will be used to scale our presence in the hospitality industry.

    BP: Why should VisionTech Angels invest in PassiveBolt?
    KM: As the pioneer in web3 access control, we have a significant competitive advantage as the first mover. We have a solid team of domain experts in access control from the automotive industry and since spinning off from Continental, we have expanded our expertise to Web3 and other areas. Investors can be confident that we have the right team to execute. Lastly, we have traction and are generating revenue.

    VisionTech Angels’ October Pitch Events Featuring PassiveBolt and Adipo Therapeuthics will be virtual on Thursday, October 27 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com

  • Meet October Pitch Presenter #1: Karen Wurster of Adipo Therapeutics, Using Fat to Fight Diabetes + Obesity

    Meet October Pitch Presenter #1: Karen Wurster of Adipo Therapeutics, Using Fat to Fight Diabetes + Obesity

    I first met Karen Wurster, CEO of Adipo Therapeutics, a year ago when she first pitched the VisionTech Screening Committee. The update at the Innovation Showcase in August 2022 was impressive and it was evident that progress had been made. Adipo, a pre-clinical biotech startup out of Purdue, was one of 21 companies vying for the top prize of $10,000. The field was very competitive, but Karen’s pitch was compelling. Adipo won first place for its novel therapeutic approach of turning “bad” white fat cells to “good”  fat cells to treat people with type 2 diabetes and obesity. Intrigued, I invited Karen to meet with the VisionTech Angels Screening Committee for an update. The group was impressed with Adipo and Karen, and we invited her to present at our October 27th virtual pitch events. Here’s a preview.

    BP: You have dedicated a large part of your career to diabetes therapeutics. Tell me about it.
    KW: I have 25 years of experience in the pharmaceutical industry with Eli Lilly, most of it dedicated to the development and launch of diabetes treatments. In all, I was involved in launching more than 10 diabetes products. My roles included new product planning, market analytics, global brand management, and commercialization. This experience really prepared me for the CEO role at Adipo where I’m focused on developing a clear path to commercialization for the technology and cultivating potential collaborators and acquisition partners.

    BP: Tell me about Adipo and the issue you’re addressing
    KW: Type 2 diabetes (T2D) is an epidemic in the United States and other parts of the world. By 2025, 37 million Americans will be diagnosed with T2D. If not well managed, T2D can reduce life expectancy by eight years. This is due to the complications of diabetes and comorbidities like heart disease. While there are oral and injectable treatments available, Adipo’s unique approach of using the body’s own fat to increase energy expenditure has the potential to bring a new treatment that could be used alone or in combination with existing treatments.

    BP: Using fat to fight diabetes?
    KW: Absolutely. Our bodies have two types of fat cells, technically called adipose tissue. White fats cells make up the vast majority of fat and store excess calories in the fat. Brown fat cells act very differently, burning excess calories and lipids, increasing energy expenditure and reducing the risk of T2D and heart disease. Higher levels of brown fat are correlated with younger, leaner adults with good glucose control. So we asked the question: what if we could turn those white cells to brown as a way to get T2D under control? That led to the develop of a platform that harnesses the power of brown fat cells. This is done by injecting Notch-inhibiting nanoparticles into the fat just below the skin. In mouse studies, we have demonstrated weekly treatments result in reducing blood glucose levels and weight loss without changing caloric intake.

    BP: Is this different from other leading T2D treatments?
    KW: Very much so. Our therapeutic acts directly on fat cells, increasing energy expenditure and improving insulin resistance through the browning of these cells. The other important advantage is due to the localized injection there is limited bio-distribution within the body. The nanoparticles pretty much stay where they are injected, reducing the likelihood of side effects.

    BP: I know you’re pre-clinical, but have you talked to doctors about this?
    KW: Yes, and we’re already generating excitement. They like that it’s easy to administer, has low side effects, and works in a completely new way that is complementary to the treatments they are already using.

    BP: How big is the market you’re targeting?
    KW: The U.S. T2D treatment market is $88 billion. Our ideal patient is no longer in control of their diabetes with oral medications and is looking at starting injections. We estimate this market to be a $1.7 billion market.

    BP: What kind of IP protection do you have?
    KW: We currently have three patents that we have licensed from Purdue and provide protection in the United States, China and European Union. We have the option of licensing more.

    BP: What round is this and what’s your planned use of funds?
    KW: Our initial seed round raised a little over $2 million, which we used to establish our own lab, complete initial safety studies and our first meeting with the FDA. This additional raise of $800,000 will be used to de-risk our technology and position us for a much larger Series A round. Most importantly, we will demonstrate proof of concept in isolated human fat cells, conduct pre-clinical safety and seek additional FDA feedback prior to our IND. We have already been in discussions with a potential Series A investor who has confirmed completing these milestones would encourage an investment.

    BP: That’s a fairly small raise. Do you have other funding?
    KW: We have applied for grants with the U.S Department of Defense and a National Institutes of Health SBIR Phase 2. If these are approved, that would bring in $6 million in non-diluted funding. We have also received Indiana Innovation grants.

    BP: Why should VisionTech Angels invest in Adipo?
    KW: First, we have an experienced, high functioning leadership team. Our founder and president, Dr. Meng Deng, is an assistant professor of Biological Engineering, Biomedical Engineering, and Materials Engineering at Purdue and our technology stems from his 15 plus years of experience developing biomaterials-based translational technologies for cell engineering, tissue engineering and drug delivery. Like me, our vice president of operations, Roger Miller, has deep experience in pharma and biotech start-ups, including leadership roles in R&D, manufacturing and corporate business development. We are following a very realistic, capital preserving plan. Lastly, we are confident that our technology, which harnesses the intrinsic power of brown fat, will be of high interest to the leading diabetes companies and mean a world of difference for those living with T2D.

    VisionTech Angels’ October Pitch Events will be virtual on Thursday, October 27 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com

  • Meet September Pitch Presenter #2: Zach Booker of ADHD Online, Accelerating Diagnosis + Treatment

    Meet September Pitch Presenter #2: Zach Booker of ADHD Online, Accelerating Diagnosis + Treatment

    Zach Booker, the co-founder and CEO of ADHD Online, was referred to VisionTech Angels by the Michigan Capital Network. The Grand Rapids, Michigan-based venture capital firm is the lead investor in ADHD Online. With $24 million in annual revenue rate, ADHD Online has far more traction than our typical investment opportunities. Obviously, this is very attractive, but their mission to help the mental health community is well timed. In 2020, the National Institutes of Health reported that one in five adult Americans live with a mental health condition. It’s easy to imagine those numbers have swelled since the global pandemic and resulting social isolation and economic struggles. As the VisionTech Screening Committee delved into ADHD Online, we were even more impressed with ADHD Online and invited Zach to present at our September virtual pitch events. Here’s a preview.

    BP: Some founders have a personal connection to their startup. What’s yours?
    ZB: I have ADHD as does my co-founder and chief innovations officer, Dr. Randall Duthler. Dr. Duthler is a family physician and on the faculty of Michigan State University and has a deep understanding of the challenges ADHD causes for parents, their children and adult patients. Our personal experiences drive our desire to make diagnosis and treatment of ADHD faster, easier and simpler.

    BP: How does someone know they have ADHD?
    ZB: They likely don’t know and that’s a big part of the problem. In adults, you may have a hard time focusing your attention and tasks. Kids with ADHD are more fidgety, impulsive, talk or move excessively. ADHD becomes more apparent once kids go to school because of the structured environment. It’s hard to sit still and be quiet! But these characteristics may not be ADHD. You really need a professional assessment to be sure.

    BP: How are you connecting with potential patients?
    ZB: Patients can be referred by schools, their doctors and health systems. More importantly, people can self-refer. We market across all of our social media platforms along with search engine optimization.

    BP: Tell me about ADHD Online and the problems you’re solving.
    ZB: If you think you or your child has ADHD, you face a bunch of hurdles. First, it will take you about seven months to start the process. That’s an incredibly long time to wait if you or your child are struggling. The system for diagnosis and treatment is very hard to navigate. The complexity of taking time off from work or school for multiple appointments can be challenging. Imagine how tough it was during COVID when in-person services were shut down and telemedicine alternatives were few and far between. It’s also expensive. Expect to spend about $2,000 out-of-pocket even with insurance.

    ADHD Online launched in 2018 as an online assessment tool. For the first two years, we bootstrapped and worked on our platform. During COVID, we expanded our services to assessments, consultations and ongoing treatment. Our clinical assessment tool requires patients answer some 250 questions, which can take 60-90 minutes to complete in one sitting. The patient has an unlimited amount of time to complete the assessment with the option to start and stop as they wish. That, coupled with the dynamic experience of the questions changing as answers are submitted ensures not everyone has the exact same test. The questions vary based on the patient’s answers. We use doctorate level psychologists for the diagnosis. Patients receive their diagnosis in an average of three days. Think about that. You think you might have ADHD. You get online, do our assessment, and in that same week later you have professional results. That’s huge.

    ADHD Online provides congoing consultations via synchronous visits with a board-certified physician or patients can choose to take their assessment to their physician. Either way, the complexity is gone.

    BP: What’s been the patient response to ADHD Online?
    ZB: Whether it’s parents of a child who is having issues at school or an adult, people simply want to know what’s wrong. Once they’ve used our service, the reviews are overwhelmingly positive about the process, the quick results, and the compassion of our psychologists. I would encourage people to visit our website and read some of the reviews.

    BP: What are your competitive advantages?
    ZB: From the patient perspective, it’s the ease and immediacy of access, how quickly they get their diagnosis, the ability to choose how they receive ongoing care, whether it’s through our physicians and telemedicine or through a local physician in a traditional face-to-face setting. Also important to patients, schools, employers, and health systems accept our assessments so people can get special accommodations at school or work.

    For obvious reasons, what we do is highly scrutinized. There used to be multiple competitors in this space. However, in 2022,the U.S. Department of Justice and the Drug Enforcement Administration shut several of them down. Today, there are no other practices that do what we do or use the model we use. We stand alone in the market.

    BP: What kind of intellectual property do you have?
    ZB: we are currently working to secure a process patent for our diagnosis model. Our dynamic assessment questions changes based on answer given, making it a unique product in the mental health system.

    BP: What is your total addressable market?
    ZB: For ADHD, we estimate the total addressable market to be $170 million. However, half of America has something going on with their mental health. We’re front line with our business model and as we expand the platform to include other mental health issues, the market becomes much, much bigger.

    BP: What is your revenue model?
    ZB: It’s pretty simple: fee for service and self-pay. We charge $149 for the assessment, $199 for a 30-minute medical treatment appointment with a physician, and $99 for the follow-up appointment 30 days later. ADHD is a chronic condition, meaning it does not “go away.” Patients can schedule 50-minute teletherapy sessions with a psychologist on a regular or as-needed basis for $99 per session. We use board certified MDs and DOs for our telemedicine services. This is the standard of care for ADHD. Many insurance companies reimburse patients for their care.

    BP: Where are you in terms of commercialization?
    ZB: These quick facts demonstrate where we are. ADHD Online currently serves as many as 650 patients a day. To date, we have assessed more than 90,000 people. More than 35,000 physicians have accepted our diagnosis and continue to treat our patients to this day. We have processed $27 million in credit card payments to date.

    BP: What is your planned use of funds?
    ZB: This is a $5 million bridge round, and we are looking at a fast close. We intend to use the funds to drive growth in three areas. First, we plan to add more dynamic questions in our assessment so that we can identify additional mental health disorders, including anxiety, bipolar, depression, and PTSD. Second, we’d like to establish more partnerships with health systems. There is a tremendous shortage of mental health services, including diagnostics. Partnerships with health systems would allow us to refer patients as well as co-manage with local health systems. Our technology is API first and can easily integrate with electronical medical record systems like EPIC, which is used widely in health care. Finally, we want to establish partnerships with payors, which will support patient access and reimbursement.

    BP: Why should VisionTech Angels invest in ADHD Online?
    ZB: Three words: opportunity, demand and growth. We have great traction, and we need to continue to keep the gas pedal down. We are beginning to dramatically change the mental healthcare delivery system by giving more people more access to care, rapid diagnostics, and more convenient ongoing care that is the standard of care. We have proven demand among patients, health systems and schools, and our assessments are profitable. The growth opportunity extends beyond the United States to Canada and the United Kingdom, where there is a two-year backlog for services. We can plug into their systems quickly.  

    VisionTech Angels’ September Pitch Events will be virtual on Thursday, September 29 at Noon and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com.

  • Meet September Pitch Presenter #1: Kilele Health’s Andrew Cothrel, Bending the Curve for Chronic Disease Management

    Meet September Pitch Presenter #1: Kilele Health’s Andrew Cothrel, Bending the Curve for Chronic Disease Management

    Here’s an interesting fact: Andrew Cothrel, CEO of Kilele Health, has been involved with VisionTech longer than I have. In fact, he goes back to the Stepstone days! In addition to being a VisionTech member/investor, Andrew serves on the board of portfolio company Scioto Biosciences and is the former CEO of SonarMed, another portfolio company that successfully exited in 2020. Having a deep background in the medtech industry bringing new products to market has made Andrew an excellent CEO of early-stage medical device and diagnostics companies. When he recently presented Kilele Health  to the VisionTech  Screening Committee, we were impressed and invited him to present at our September virtual pitch events. Here’s a preview.

    BP: Where did the name Kilele Health come from?
    AC: Kilele is Swahili for mountain peak. It reflects our vision of helping patients achieve peak health through improved management of their chronic diseases.

    BP: Tell me about Kilele Health and unmet need you’re addressing.
    AC: The science is complex, but our story is simple. The prevalence of chronic disease in America and around the world is bad and getting worse. By chronic diseases I am referring to conditions like diabetes, hypertension, heart disease, respiratory diseases, stroke, cancer, and obesity. Many of these conditions are intertwined. People with diabetes are also likely to suffer from heart disease. Chronic diseases are very difficult to manage. And from a healthcare payer perspective, the slope of the chronic disease cost curve has to bend, or it will bankrupt us.

    There is already one success story in this space – continuous glucose monitors (CGMs). Patients and physicians now have a way to continuously monitor blood glucose levels and ultimately, better manage diabetes. Today, there are 5.5 million users of CGMs, representing a $5 billion plus market.

    What Kilele Health is doing is following the proven path of continuous glucose monitors but enhancing them to measure other things via Aptamer biosensing. This allows us to leverage the hundreds of millions of dollars that have gone into establishing CGM systems, but the device is now set up to detect other biomarkers or drugs specific to a patient’s chronic diseases and provide real-time monitoring. For example, our CGM+ can monitor drugs or biomarkers related to blood coagulation or congestive heart failure. Having this information allows patients to monitor their condition, make better behavioral choices and better comply with medication regimens. If they notice something wrong, they can contact their doctor. This replaces or reduces the need for in-person appointments to monitor and manage their condition.

    Given how physicians and patients have embraced CGMs, we believe adoption of our CGM+ will have some tailwinds. We also know that the original equipment manufacturers of CGMs are all very interested in adding additional biosensing to their devices. That’s where Kilele Health’s Phase I commercialization plan comes in.

    BP: Explain aptamer chemistry. I had not heard that term before.
    AC: Aptamers have been around a long time. They are nucleic acid sequences like DNA or RNA. They are great for binding a specific target molecule. Historically, the problem has been they just don’t last. That is the “big deal” that Kilele has solved; our aptamer biosensors last a very long time.

    BP: What are your competitive advantages?
    AC: We have several competitive advantages over traditional chronic disease management. The need for  patients to physically go to their doctor’s office, which delays treatment, is costly and inconvenient, goes way down. Physicians get better data that is better managed, and probably get more compliant patients as well.  Payers win because long-term costs of disease management should go down.  And nobody drowns in data. Our algorithms will identify events that are noteworthy of physician attention.

    In terms of advantages over competitors, I mentioned the longevity of our biosensors. Nobody else that we are aware of is even coming close to doing what we have. The other significant advantage is that we’re not reinventing the wheel. We are leveraging the existing CGM platforms and hope to partner with these OEMs to accelerate time to market as well as speed of adoption based on the positive goodwill of physicians and patients toward CGMs.

    BP: What kind of intellectual property do you have?
    AC: The University of Cincinnati has a suite of more than 30 pending patents on the technology with more coming. Kilele Health has exclusive rights to license this patent protection. We want to build a tall fence around Kilele Health and plan to add our own patents going forward.

    BP: What is your total addressable market?
    AC: Any market over a billion is big, and the market for our technology is significant. We believe our Phase 1 market, which is our CGM+ for people with diabetic comorbidities, represents a $5 billion opportunity. Phase 2, which is using those same assays for non-diabetics, may represent $10 billion. Phase 3, which is new medical indications, is at least another $5 billion opportunity.

    BP: What is your revenue model?
    AC: Phase 1 is very likely to be licensing to one or more current CGM OEMs. After that, it’s hard to know exactly. However, by Phase 3, I would anticipate that we will have built our own wearable monitoring system hardware and software

    BP: Where are you in terms of commercialization?
    AC: We are early stage, finalizing our tech and prepared for animal studies leading to human testing and FDA clearance. Our first product is aimed at cardiac comorbidities. Many diabetics have cardiovascular issues, so that’s a natural initial target. That said, we plan to develop multiple sensors in overlapping but staggered tracks. We will be partnering with CGM original equipment manufacturers on development. Already there is strong interest in what we’re doing with aptamers and our CGM+. One OEM is already paying us to do some proof of principle work for their platform.

    BP: This is a $2.25M Series Seed Round. What is your planned use of funds?
    AC: Our use of funds is straightforward. First, we plan to expand team and prove a biosensor life of one week in an animal model. We will be focused on developing aptamers for our top three to five targets. We will also work toward scheduling a pre-submission meeting with the FDA to nail down our clearance submission requirements

    BP: Three reasons why VisionTech Angels should invest in Kilele Health.
    AC: First, our team. Internally, we have global leaders in aptamer biosensors, experienced medtech entrepreneurs, and individuals who have worked directly with potential partners and acquirers. Our external clinical advisors are also excellent.

    I’m a known quantity to VisionTech Angels and will be transparent with our investors. Second, we have identified a hole in the portfolios of the three makers of continuous glucose monitors, Abbott, Dexcom and Medtronic. They are all interested in adding new capabilities to their platforms. We are positioned to provide that to them. Lastly, our commercialization pathway will be very capital efficient and hopefully take us to a quick/high IRR exit.

    VisionTech Angels’ September Pitch Events will be virtual on Thursday, September 29 at Noon ET and at 6 p.m. ET. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page where you’ll find the RSVP links, or email Ben Pidgeon at bpidgeon@visiontech-partners.com.