BIOFEST INVEST APPLICANT

Eisana Corp

Company Contact: Carole Spangler Vaughn

Legal Entity Type: C-Corp

Company Type: Medical Device

Company Stage: Development

No. of Employees: 1

Desired Financial Amount: $600,000 of which $475,000 is remaining as Convertible Notes

Background

Company Background

I have spent over 25 years in the life science industry, starting in R&D at Bristol-Myers Squibb and moving over to Business Development for startups. As it happens, most of those years were spent developing Oncology products. In 2017, my professional life collided with my personal life when I was diagnosed with Stage 2b breast cancer. I knew about the evidence-based protocols, and knew I would survive, but was surprised to learn about all the side effects, and even more surprised to find out that some of the most devastating side effects could be prevented. Through my own personal journey, I learned that the number one pain point for Oncologists is chemotherapy-induced nerve damage (peripheral neuropathy) and the number one pain point for patients is hair loss. Oncologist are pleased with increasing survival statistics but are very unsatisfied with leaving patients with a life-long disability. Chemotherapy-induced peripheral neuropathy causes loss of feeling in hands and feet, as well as pain. In addition, there is no cure. Hair loss is rated as the most traumatic side effect of cancer treatment, so much so that up to 8% of patients will refuse life-saving chemotherapy because of it.

Several studies have demonstrated that cooling can solve both problems. Cooling constricts blood vessels, slows cellular metabolism, and slows the uptake of drug into the cells. However, I discovered that the current solutions are less than ideal, and some are very expensive. There is no FDA cleared device for cooling hands and feet during chemotherapy, so I used baggies of frozen corn that I rotated on dry ice. This was cold and I was unable to keep my hands and feet continuously cold because sometimes I need to use them, to use my phone, or walk. For my hair, I used gel caps that I rotated on dry ice every 20 minutes. That was extremely cold, did not hold a constant temperature, and was a lot of work. There are also circulating cold water baths on the market for hair loss prevention but they are not easy-to-carry and are expensive, starting at $2,000, which is only for the wealthiest patients. Recognizing that there are poor solutions for significant medical needs signaled a business opportunity to me. I did customer discovery interviews and found that Oncologists and Neurologists also saw this as an incredibly important mission, to develop affordable, tech-enabled devices to prevent chemotherapy-induced peripheral neuropathy and hair loss. I then founded Eisana. We are exploiting thermoelectric cooling because it is light-weight, small, inexpensive, and very durable. We filed an extensive patent through the Patent Cooperation Treaty in January of 2021, and all rights are assigned to Eisana.

Management

Dr. Carole Spangler Vaughn (CEO) holds a Ph.D. in Biophysics (Johns Hopkins University) and an MBA (University of Washington). For over 25 years, she has worked for large and small entities, in the laboratory and in business development, including Bristol-Myers Squibb, University of Washington (Office of Technology Transfer), Dendreon Corporation, and Clario Medical Imaging. She owned and operated MediVet Hawaii, a veterinary regenerative medicine franchise. She was a Strategy Consultant/Interim CEO for Emtora Biosciences. She has also consulted several life science companies on strategy, partnering, fundraising, sales, and marketing.

Lisa Malina (CFO) is a licensed and registered CPA with over twenty years of experience. Lisa has a wide range of experience including corporate, not-for-profit, and public accounting. She has given accounting and tax presentations at corporations and not-for-profit national conferences, and is a frequent panelist and speaker on accounting issues. She has served in many roles for the Illinois CPA Society, including: President of the North Shore Chapter, Chairman of the Young Professionals Group, Vice President of the O’Hare Chapter, and as a Legislative Contact. In 2012, Lisa was honored with the “Women to Watch” award from the Illinois CPA Society and the American Institute of Certified Public Accountants (AICPA). Nominated by her peers, this award honors women who have made significant contributions to the accounting profession and to the development of women as leaders.

Kelly Elliott (Director, Clinical and Regulatory) has held executive level positions at multiple medical device companies, successfully designing and executing clinical trial strategies which resulted in new device approvals, new indications, and dozens of publications in peer-reviewed medical journals. Through vast experience, Kelly has learned that high-quality work and well designed and well executed studies are the foundation for achieving the results that companies need to expand their product portfolios. Kelly’s strong clinical background as a registered nurse in the medical-surgical and open heart ICU cardiac catheterization lab, has enabled her to design and conduct successful clinical trials in a large variety of applications.

Sara Nelson (Director, Engineering) holds a Bachelor’s of Chemical Engineering (University of Minnesota) and a Masters of Manufacturing Systems Engineering (University of St. Thomas). For over 18 years, Sara has worked in the medical device industry in a variety of roles, spanning R&D (including product and test development), manufacturing, process engineering, and regulatory support. She has worked for both Fortune 500 companies and startups, and for the last several years she has worked as a consultant helping medical device companies of all sizes meet their goals. She is an inventor on several US patents and applications.

Board of directors

Martin Simonetti (Chair) served as President and CEO of VLST from 2005 to 2013. Prior to that, he was employed at Dendreon as the CFO, Senior Vice President of Finance, and Treasurer. He served as the VP of Operations and Finance of Amgen BioPharma and Director of Amgen’s Colorado Operations. He also worked at Genentech, first as a scientist in the Medicinal and Analytical Chemistry Department and later as a financial analyst and group controller. Mr. Simonetti serves on the Board of Directors of Curtana Pharmaceuticals, Nexgenia, EpiThany, and VLST. He previously served on the Board of Directors of Alexandria Real Estate Equities (NYSE: ARE) and Icagen, a Nasdaq company, until its sale to Pfizer. He was also a past member of the Dean’s executive advisory board for the Albers School of Business and Economics at Seattle University and former chairman of the board of Life Sciences Washington. He received an M.S. and B.S. from the University of California, Davis and an M.B.A. from the University of Santa Clara.

Ann Tanabe, the current Chief Executive Officer of BioHouston, has over 15 years of experience in the Biotechnology Industry. Ann was promoted to CEO of BioHouston in October 2015 after serving four years as the company’s COO. Prior to joining BioHouston, she served as VP of Investor Relations at Synthesis Energy Systems, a publicly traded energy company. Ann also served as Director, then VP of Corporate Communications & Investor Relations at Encysive Pharmaceuticals.

Product / Service

disease area / application

Preventing side effects from cancer treatment

product / Service

We are redefining how cancer patients experience treatment because we believe unnecessary pain and suffering should never be the price of survival. Specifically, we are developing affordable, tech-enabled devices to prevent and treat side effects from cancer treatment. For our first product, Oncologists have asked us to develop a device to prevent chemotherapy-induced nerve damage (peripheral neuropathy). Even though several studies have been published proving that cooling the hands and feet is effective, no other company has developed a device for this purpose. For our second product, we are developing a cooling device to prevent hair loss because this is rated as the most traumatic by patients. Since cancer patients need to cool most of the day they receive chemotherapy, it is imperative that these devices be lightweight and easy-to-carry. Our devices are unique in that they use thermoelectric cooling, which is small, lightweight, and very durable. We are disrupting the status quo with unique technology as well as a business model that makes our devices accessible to all cancer patients.

technology / ip

Currently the only options are circulating water baths, or using various materials and freezing them on ice or dry ice. But, to be successful for all drugs, patients need to cool for most of the day they receive chemotherapy. And, for compliance, the method must be very easy and allow the patient to still use their hands and feet. They need to start cooling before their infusion, during their infusion, then for several hours after. And, the cooling needs to be continuous. Circulating water baths do generate a constant temperature but they leak and are not easy to carry or transport by car or bus. Using a manual method of swapping frozen items out every 20 minutes is a lot of work and you can’t guarantee a constant, efficacious temperature. We are unique in using a cold-generating technology that is small and light-weight, to allow patients to easily carry the device. We also allow for three power sources, AC, DC, and a rechargeable battery, to cover every possible place the patient will be on the day of chemotherapy.

Baylor University has completed bench-top proof-of-concept experiments on the primary components as well as a conceptual industrial design. University of Texas at Dallas had a team of senior engineering students in their UTDesign program build a proof-of-concept device for hair loss prevention. We filed an extensive Provisional Patent in January of 2020, then converted that to a full patent application via the PCT. We filed an additional provisional in December of 2021 to specifically cover the proof-of-concept device that was built by the team at University of Texas. Our patent contains several methods of heat transfer and we have received a positive patentability assessment.

distribution channels

Since other predicate devices for hair loss prevention (circulating water baths) have 510(k) clearance, we will pursue that. However, we are going to apply for over-the-counter status so that we don’t need to rely on a physician’s prescription. Patients will buy directly from us, on our website or over the phone. Our marketing will have a two pronged approach. First, we will hire sales representatives to reach out to Oncologists, so that they know to recommend our devices. Most oncologists are organized in cancer centers and we will prioritize the largest cancer centers. In addition, we will publish our validation study in peer-reviewed journals and Dr. Noah Kolb, a thought leader for chemotherapy-induced peripheral neuropathy and the lead investigator on our validation study, will give talks and promote our devices. Second, we will reach out to the general public through marketing. For younger patients and children of older patients, we will use social media marketing. For older patients we will use traditional marketing. Seventy-five percent of diagnoses occur in patients age 60 and up, and the AARP is the most widely read magazine in the US, with 24 million in circulation.

market size

There are approximately 500,000 patients receiving chemotherapy that can cause peripheral neuropathy. There are approximately 600,000 patients receiving chemotherapy that cause hair loss. These numbers will only increase as cancer occurrence continues to increase and cancers are being diagnosed earlier and earlier.

competition

For prevention of chemotherapy-induced peripheral neuropathy, patients are taking a do-it-yourself approach using ice bags, frozen vegetables, gel ice packs, and cooling mitts and socks. Because the frozen items warm up and thaw, they must start at much colder temperatures than needed, which is uncomfortable. Also, patients are unable to use their hands and feet, for their phone or for walking to the bathroom, so they have to interrupt treatment, which impacts effectiveness. For head cooling, competitors fall into two categories. Paxman and Dignitana have devices that circulate cold liquid through caps in the infusion center. These companies lease the equipment to infusion centers and also bill the patient directly. The practical limitation is that patients are not allowed to stay in the infusion center long enough for slower clearing drugs, such as adriamycin/cyclophosphamide (AC), which is commonly prescribed for breast cancer. Another company has joined the market, Cooler Heads. They also have a circulating water bath but they put it on wheels so that patients can push it around. However, it is not practical to carry because of its weight. There are also reports of leaking with these circulating water bath systems. In addition, they are all very expensive at $2,000 and up, making them only accessible to the wealthiest of patients. Several other companies (Penguin Cold Caps, Arctic Cold Caps, Chemo Cold Caps, WishCaps) use a manual approach – several gel caps on dry ice that are swapped out every 20 minutes for up to 11 hours for some drugs (AC). This is difficult and uncomfortable, putting -30degF on your head. To solve this problem, you need better technology and a better business model. These are the two areas we will successfully compete against the status quo.

Financials

Desired financial amount

$600,000 of which $475,000 is remaining as Convertible Notes

previous funding

The initial money all came from the Founder, Carole Spangler Vaughn. For the current pre-seed round, Cortex Design is our lead investor, and we have another investor as well.

current financials

We are raising this $600,000 pre-seed round to get to a prototype with the look, feel, and function of the final device, file for 510(k) clearance, and plan a validation study. This money will fund 8 months of operations, which on average is a $75,000 per month burn. Current available cash is $125,000.

financial use

Develop a prototype with the look, feel, and function of final device for preventing chemotherapy-induced peripheral neuropathy.
Evaluate usability of prototype with KOLs and healthy volunteers.
File for 510(k) clearance.
Enter National Phase for PCT patent application.
Plan and start validation study for chemotherapy-induced peripheral neuropathy.
Pay salaries.

revenue

Until we get enough data to apply for a unique HCPCS code, the reimbursement will fall under the Durable Medical Equipment code. At Eisana, we will have customer support agents who can help our customers submit their applications directly to their insurance companies for reimbursement. This is what the Founder was able to do when she went through treatment, receiving approximately 50% back from Aetna.

While we will have 510(k) clearance, the unique twist to our marketing plan is to file for over-the-counter status. This will allow our customers to skip the step of having to get a physician’s prescription streamlining the acquisition process since the time from diagnosis to treatment is often short. Our customers will order directly from our website, or over the phone. We will charge $100/month to lease the base unit, and sell the gloves/socks and caps as disposables. We plan on launching our first product, the device to prevent chemotherapy-induced peripheral neuropathy, in 2024, and our second product, the device to prevent hair loss, in 2025.

exit strategy

Our exit strategy is acquisition. The wearable medical device market is hot right now, as is at-home care products. We fall into both categories. In this area, it appears companies become acquisition targets at around $10M in revenue and receive a good multiple. In 2019, there were two such acquisitions. Pacira Pharmaceuticals acquired Myoscience for $220M ($7.9M sales) for their hand-held cryo-analgesia device for chronic pain management. Hill-Rom acquired Breathe Technologies for $130M ($10M sales) for their wearable ventilator system. In 2021, Boston Scientific acquired Preventice Solutions for $950M ($158M sales) for their wearable heart monitor.

Pitch Video

Login

Welcome back! Login below