Needle-free Smartpatch for painless drug delivery

Needles and injections are the most common used drug delivery methods, with over 16 billion yearly injections worldwide. They generate pain, fear and social rejection. Patients and organizations (WHO) are demanding alternative administration methods to help decrease injection related problems and increase adherence. It is estimated that 10% of COVID-19 Vaccine refusals are due to Trypanophobia (needle-phobia). There are over 2000 daily accidental injuries and $3Billion/year in associated costs only in the USA (plus the heavy environmental burden of the biological-needle-waste). 

The Smartpatch opens micropores in the skin using harmless ultrasound waves that increase the size of the natural skin pores temporarily, pushes big drugs to go through and the pores close again when the device stops. 

It relaxes the tight skin cell junctions by generating cavitation bubbles that burst in the epidermal layer. Then the drug is deposited on a small skin area (<1cm2) and another set of ultrasound waves pushes them through the previously permeabilized skin.

It can work with multiple different drugs like heparin, antibodies, insulin or vaccines. 

It has a durable component with the electronics to last over 3 years and a recyclable piece with the cartridge and adhesive. The patient fills it with traditional drug syringes as insulin pens, places it on the arm or the abdomen and activates it. It is completely safe and painless to use and it can be controlled through an app in which the patient can receive guidance about the disease and the doctor can access to relevant data. 

CHRONIC PATIENT WITH PERIODIC INJECTIONS:
20-50 years old (however, our device can work for nearly all age groups), Tech-savy, finds patterns in disease behaviour to use them as actionable insights; Relatively wealthy to afford add-ons to therapy (pain relief)
Likely to have tested sensors and/or infusion pumps. Injects daily or weekly. Looking to improve quality of life.

These patients have

- Limited access to disease information and recommendations, which can be solved through the information section of the app

- Disconnection with the healthcare providers which can be solved with the telemonitoring function of the app

- Difficult access to medication and trials which, counting on patient consent, could be solved through a database shared with potential providers or clinical trials for rare diseases

- Multiple injections that can be solved with the smartpatch

PHARMAS AS POTENTIAL TECH LICENSEES:
About to release a new drug or looking to gain market share on an old one. patient focused CSR.

Co-Founders: 

Dr. Eduardo W. Jørgensen - CEO - Medical doctor, internationally recognized innovator, public speaker, executive officer for different projects (from medical school to his own ideas); he has formed and guided teams to solve complex tasks through lean startup and scientific R&D.

Mr. César de Mercado - COO - Telecom engineer with experience on strategy and IT businesses. He has experience as data analyst and database technician in AVALOND.T.S., holding a managing position that helped him gain operational experience.

Mr. José Carlos Montesinos - CTO - Telecom engineer with experience on medical devices (HW and SW). Passionate about electronics and programming, spends his free time building devices to improve results from previous stat of the art. He has experimented with ultrasounds in several occasions throughout his career. Trustworthy, perfectionist and respected tech team leader.

Ms. Patricia Cremades CSO - Medical doctor, general surgeon. Extensive skills on user experience and customer relationships. She also specializes in handling complex clinical problems, resulting perfect for scientific tasks of development of the device. 

TEAM INFO: 

• Eduardo and Patricia are Medical doctors; César and José are telecom engineers
• Cesar, José and Eduardo are friends from 1st grade.
• Founders take care of overall strategy, operations, technology & scientific affairs.
• Antonio (Data scientist) manages algorithm, he has worked for international governments. Enrique (engineer) comes from MIT and Phillips. Pedro for materials
• Carlos (lead researcher) has wide experience on biological research with devices
• The business team is young but agile, with passion and previous MedTech sales.
• We are now hiring a Senior Business development manager, a Medical director and another engineer to design ultrasound transducers

Our team is our biggest asset, we have 8 full time members and 4 part time + 9 advisors. In this industry it is very hard to acquire and retain the key team capabilities. It requires high level of specializing. However, we already
have the most relevant engineering and clinical validation skills, the team is being rewarded with attractive stock option policies and they deeply believe in the project.

We believe the MIT SOLVE can help us reduce risk and time on: 

- Finishing the preclinical validation to unblock the milestone required for Series A
- Secure pre-market pilots with pharma companies

- Accommodate device specs to the unknown regulatory requirements of a new class of devices

We also consider extremely valuable the cash award, the expertise of MIT on entrepreneurship and the network we would have access to. 

Medicsen ́s product works thanks to an internally developed ultrasound transducer which allows our differential value: WEARABLE, PAINLESS, CONNECTED, STANDARDISABLE & SAFE TRANSDERMAL DRUG-DELIVERY (with possible autonomous dosing or maximum daily dose limitation for opioids).

We have protective IP for the ultrasound transducer, being the first of its kind to have a size of just 2cm and be powered with a traditional battery. We will reach the market first (long R&D for competitors). We have the best team of experts on the matter with passion to solve the social problems of drug delivery. 

During the next year we expect to complete animal trials, fundraise €4M and hire 3 profiles to complete the team

In 5 years time we expect to: 

- Have released the world from 30M injections

- Have solved 10M disease related doubts

- Have saved 9000 years of lifetime for increased adherence and reduced uncertainty

- Have €20M in revenue, with break even on year 4

We are a dynamic and diverse team, 25% of the team are females, with one of them being among the co-founders. The team has all ranges of ages, from 55 to 20 years old.
We have different nationalities, having employed Australian, Polish, and Indian team members among other nationalities.
We don´t care about the gender, age, ethnic or social background of our teammates, we only care about getting people that love what they do and have an attitude of continuous growth.

We will sell the device with a B2C subscription model for a 100 €/m, including monthly delivery of disposables to
the patient ́s house (already validated by sensors as Abbott freestyle libre).
We plan on reaching B2B licenses in specific verticals (as an example, we could sign with Lilly for insulin, with
Pfizer for antibodies...). This could bring pre-loaded cartridges from manufacturing to the patient.
Our device could also be used for cosmetics, opening another potential revenue stream.

PHASE 0: approach the market with campaigns to evangelize KOLs and influencers, also publishing our results and presenting in health and diabetes events as MEDICA or ATTD

PHASE 1: 2024 - start selling in the US, penetrating slowly; 500 monthly active users through 5 key selected accounts in order to ensure a controlled market entry that generates valuable data to improve and scale. We want to nail it before we scale it.

PHASE 2: 2025 - EU expansion, 3000 MAU. This growth is based on our phase 1 data convincing prescriptors and KOLs to promote our solution.

PHASE 3: 2025 - we will reach ASIA, completing our pharmacoeconomic studies and entering reimbursement schemes, 10,000 MAU 

Vernadsky challenge Best technology for Space health 2021 - €30K

MIT TR´s Spanish innovation of 2017 

Forbes 30 under 30 2018 

Mapfre social innovation award 2021 - €30K

Fermina Orduña innovation award by Madrid ́s government 

EIBT Stamp (innovative company based on technology) 

Red Cervera €500K grant + loan 

European Commission H2020 Phase 1 2017 - 50K 

TOTAL FUNDING RAISED

Private equity - €1.5M (33% VC, 33% Family offices, 33% BA) 

Public funding - €1M