BIOFEST INVEST APPLICANT

Eisana Corp

Company Contact:

Legal Entity Type: C-Corp

Company Type: Medical Device

Company Stage: Development

No. of Employees: 1

Desired Financial Amount: $2000000

Background

Company Background

I have a PhD in Biophysics and an MBA and have spent over 25 years in the life science industry, mostly working for startups, bringing Oncology products to market. In 2017, my professional life collided with my personal life when I was diagnosed with Stage 2b breast cancer. While I knew about the evidence-based protocols and knew I would survive, I was surprised to learn about all the side effects, and even more surprised to learn that some of the most devastating side effects can be prevented. I discovered that something as simple as cooling could prevent one of the most common side effects from chemotherapy, nerve damage in hands and feet (peripheral neuropathy), and assumed there would be good patient-centric solutions available to me. Unfortunately, I discovered the solutions were far from ideal. It was hard for me to reconcile using baggies of frozen corn to keep my hands and feet cold on the day of chemotherapy, at MD Anderson, a global leader in cancer care. Independent qualitative market research with oncologists, nurses, and patients, confirmed an unmet medical need for an easy-to-use, portable cooling device for hands and feet, that didn’t stop a patient from normal functions like walking or using their phone. Eisana was founded to bring products to market to prevent side effects from cancer therapy, starting with a cryo-device to prevent nerve damage in hands and feet. We own 100% of our technology.

Management

Our team is experienced and diverse, each with more than 20 years of relevant experience. Carole Spangler Vaughn, CEO, has a science PhD and an MBA. She has been in the life science start-up industry for decades, mostly bringing oncology products to market, and is also a cancer survivor. Lisa Malina, CFO, is a licensed and registered CPA with extensive experience managing finances for both non-profit and for-profit entities. She began her career at Price Waterhouse and transitioned into consulting, serving CFO roles for start-ups. Thomas Moore, VP Engineering, has a PhD in Biomedical Engineering and has extensive industry experience bringing medical devices to market. Kelly Elliott, Director of Clinical, began her career as a nurse and moved to regulatory and clinical, with a focus on medical devices. Not only does each team member have relevant experience but each shares the same strong work ethic, kind and thoughtful personality, and a passion to help all cancer patients live a more pain-free and full life following treatment. And, we really enjoy working together.

Board of directors

Martin A. Simonetti (Board Chair) recently served as President and Chief Executive Officer of VLST. From 1999 to 2005, Mr. Simonetti was employed at Dendreon Corporation, most recently serving as Chief Financial Officer, Senior Vice President Finance and Treasurer. From 1991 to 1998, he was employed at Amgen Inc., serving as Vice President Operations and Finance of Amgen BioPharma and its Director of Colorado Operations. From 1984 to 1991, he worked at Genentech, Inc., first as a scientist in its Medicinal and Analytical Chemistry Department and later as a financial analyst and group controller. Mr. Simonetti received an M.S. from the University of California, Davis and an M.B.A. from the University of Santa Clara. Ann Tanabe (Director), the current Chief Executive Officer of BioHouston has over 15 years of experience working in numerous roles in the Biotechnology Industry. Ann Tanabe, was promoted to CEO of BioHouston in October 2015 after serving four years as the company’s COO. Prior to joining BioHouston in 2011, Ann served as VP of Investor Relations at Synthesis Energy Systems, a publicly traded energy company from May 2008 to December 2010. Preceding her success at both BioHouston and Synthesis Energy Systems, Ann served as VP of Corporate Communications & Investor Relations after serving as the Director of Investor Relations at Encysive Pharmaceuticals, previously known as Texas Biotechnology. The third director is Carole Spangler Vaughn.

Product / Service

disease area / application

Oncology

product / Service

While cancer survival rates continue to improve, side effects remain a significant issue, increasing healthcare costs and reducing quality of life. Chemotherapy-induced peripheral neuropathy (CIPN) is common, debilitating, and often not reversible. Without a cure, the best you can hope for is help tolerating the symptoms. Some Oncologists worry about a lawsuit should their patient become permanently disabled. Oncologists are constantly weighing the impact of CIPN versus survival without any definitive guidelines. In independent qualitative market research, we verified that oncologists, nurses, and patients are all very concerned about CIPN. Current solutions to prevent this devastating side effect include having patients put their hands and feet in ice or frozen vegetables, or in bowls of ice water. Ideally, cooling should be continuous, for several hours, but current methods are uncomfortable and can cause tissue damage. In addition, patients frequently stop cooling for comfort, and to use hands and feet. There is an opportunity for a disruptive product to address this unmet medical need. Our patent pending oncology cooling system solves all the problems of current technologies. We are using smart engineering (thermoelectric cooling) which is light weight and small, making it easy to carry and completely portable. We have three power sources (AC, DC – car, rechargeable battery) to keep our device running just about anywhere. Our cooling gloves and boots are easy to use, comfortable, and allow the patient to have some functionality in their hands and feet to allow continuous cooling.

technology / ip

We filed a PCT, SYSTEM AND METHOD FOR MITIGATING SIDE EFFECTS OF CHEMOTHERAPY on 1/28/2021, containing several embodiments covering variations in device material, cooling technology, heat transfer, and control, incorporating gaps in current products. The priority date is 1/2020, from a provisional patent application. This patent is 100% owned by Eisana. We had an initial patentability assessment done and it was positive. Based on that, we entered National Phase in July 2022 and filed in US, Canada, EU, China, South Korea, Israel, Japan, Australia, and Brazil. Recently, our Patent attorney took another critical look, and verified that we were investing in patents that had several claims with a good chance of being granted. As development continues, we will be filing additional patent applications. Our first follow-on provisional patent was filed in February 2023, covering the novel design work done in our first prototype. We have a great team at Oblon guiding us on patent strategy and executing on it. In addition, one of our business advisors, Ron Myers, is an IP attorney, who offers us advice (without an invoice attached).

distribution channels

Recent market research project done with International Teams LLC, indicated that the most appropriate business model is to lease equipment directly to patients. This way, all patients can access the devices and not just those who are being treated at larger clinics with budgets to purchase capital equipment. Eisana will lease the cold generating component monthly to accommodate different lengths of time the devices are needed, and sell recyclable attachments for hands and feet. To reach patients, most turn to Google or social media after getting diagnosed, so we will exploit both of those cost-effective avenues for educating patients. While patients are our de facto customers we will also need to market to the people influencing their behaviors: oncologists and nurses. To educate oncologists, we will partner with a medical distribution company that sells equipment into infusion clinics. While they will not be selling our devices directly, they will provide pads of QR codes that will allow patients to get a discount as well as record the name of the sales representative for credit. These representatives will prioritize those centers that already routinely provide baggies of ice for their patients (early adopters). Additionally, we will reach oncologists through conference presentations and peer-reviewed publications from our medical advisors. In our research, nurses were adamant about not having time to help patients with the devices but they all wanted to know about the devices. For that, they suggested a train-the-trainer program.

market size

To calculate a Total Addressable Market, we considered all the patients receiving chemotherapy in countries that deliver quality oncology care: US, Canada, EU, Israel, Japan, South Korea, Latin America, and Australia. To arrive at patient numbers for each country, we calculated a population-based percentage for each country against the US, where there are 650,000 chemotherapy patients per year, and calculated chemotherapy patients in each country. That resulted in 3.3 million patients. At $1,800 per average lease, the TAM is $5.9B. We calculated the Serviceable Available Market by just considering the US market. The SAM is $1.2B. The growth rate is equal to the growth rate of cancer diagnoses, which varies for each type of cancer.

competition

The main competitor is do-it-yourself techniques, such as baggies of crushed ice or frozen vegetables. Some oncologists offer bowls of ice water. If that sounds like a great, inexpensive alternative, try keeping your hands and feet in bowls of ice water, continuously, for 8 hours. Aside from that, Paxman is in the market with a B2B scalp cooling machine, to help patients keep their hair during certain types of chemotherapy. They now have a relationship with a university in Singapore and are starting to enroll a 777 patient Phase III trial for a device to cool arms and legs, to prevent CIPN. Their device has several differences. First it is a wrap that goes from toe to knee, and from finger-tip to elbow. There is no data that suggests this is better than only cooling hands and feet. Second, it does not allow the patient to walk or use their hands (phone, eat, drink, read a book, etc). Third, it incorporates cyclic pressure, which will increase/encourage circulation. This is the exact opposite of what should happen if you are trying to keep the neurotoxic drugs away from the sensitive nerve endings in the finger tips and toe tips. They likely will continue with their B2B model, and have this as an option with their scalp cooling machine. We learned from our qualitative market research that many clinics will not purchase equipment to rent to patients. One infusion nurse said they don’t even own their own infusion pumps. Our business model of selling D2C allows us to theoretically reach all cancer patients, and not just the ones being treated at larger, wealthier clinics.

Financials

Desired financial amount

$2000000

previous funding

We previously raised an $900,000 pre-seed, angel round. In November, 2022, we submitted a proposal to an NIH/NCI SBIR Contract Solicitation for a non-invasive device to prevent chemotherapy-induced peripheral neuropathy. We expect to hear in May, 2023.

current financials

Currently, we have about $200,000 in the bank. Most of our funds are going to our engineering development partner, Veranex Solutions. We have broken up our development efforts into discrete phases, and only progress to the next one if we have cash on hand. Right now, our burn rate is about $40k/month.

financial use

We currently have a functional prototype. The next step is optimizing the design for patients and manufacturing. That is the overall goal of the next funding round. In addition, we will be pursuing our regulatory strategy with a pre-sub meeting, continuing to prosecute patents, and cover operational costs and salaries.

revenue

Since there are no current devices to prevent CIPN, there are no reimbursement codes. Our plan is to get to market as quickly as possible, launching with a 510(k) for generic body cooling which only requires a small, 15-patient human factors study. This will necessarily be self-pay. Once launched and we have revenue, we will run a follow-on study to gather efficacy data for a specific indicated use with the FDA, as well as data for reimbursement.

exit strategy

We believe by 2027 we will have the revenue that would interest an acquirer. In 2018, Boston Scientific acquired Augmenix, a single product company that makes a hydrogel to prevent radiation damage to the rectum in prostate cancer patients. At the time of the acquisition, their revenue projections were very similar to ours. Their sales were $12M, and the acquisition deal was $500M upfront.

Login

Welcome back! Login below