Photo - Native Health
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Native Health

Innovative technologies for skin health using nanotechnology

Brazil
Market: Medicine, Pharmacology
Stage of the project: Prototype or product is ready

Date of last change: 21.06.2021
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Idea

We bring together two concepts to create the ideal method to fight skin cancer: Magnetic nanoparticles and drug delivery of known drugs in combination with new compounds from the Brazilian biodiversity.
Our magnetic nanocarriers are able to direct an encapsulated drug through the attraction and movement generated by a magnetic field, increasing the concentration of the drug in the cancer cells. This treatment can also be applied directly from the skin avoiding the typical overload of drugs dispersed throughout the body and the typical unwanted side effects of chemotherapy.

Current Status

The basic research has been completed and the in vitro results have been positive with a large potential for skin cancer treatment.
We are now moving to complete pre-clinical studies and GMP small batch production to request the permission for clinical trials (phase I).
Several papers have been published in well-know scientific journals proving the potential efficacy of our nanoparticles for cancer treatment.

Market

Skin cancer is the most common form of cancer. 40% of cancer cases. Global market in 2019 was USD 8.19 Billion.
3 million Americans are diagnosed with non-melanoma skin cancer each year. The market will reach USD 14.55 billion by 2027. 1 in 5 Americans are affected by skin cancer. Common treatments include immunotherapy, targeted therapy, chemotherapy and radiation. Many pharmaceutical companies offer the common treatments which may be efficient, but not without strong side effects.
In contrast to most cancer types, melanoma skin cancer also occurs relatively frequently at younger ages. Age-specific incidence rates increase steadily from around age 20-24 and more steeply in males from around age 55-59. The highest rates are in in the 90+ age group for females and the 85 to 89 age group for males.

Problem or Opportunity

Skin cancer treatments are still plagued with strong side effects such as pain, disfigurement, nerve damage or numbness, bleeding, hair and fertility loss, among others.
Both patients and medical professionals are looking for better treatments for skin cancer. Although common treatments can be efficacious to treat cancer, they are still very aggressive with lots of side effects. Such issues have turned away a large number of people who should undergo a cancer treatment.
Our nanotechnology offers a treatment that is efficacious and mild to the patient. By doing so we believe more people will opt for a life saving alternative and therefore we increase the quality of life of patients. We can also predict a reduction in posttreatment remediation costs related to the common drugs and treatments side effects.

Solution (product or service)

Our nanotechnology brings together two important concepts to create the ideal method to fight skin cancer:
1) Magnetic nanoparticles, which movement caused by an external magnetic field promotes cancer cells death, and
2) Together with localized and controlled delivery of known drugs in combination with new compounds from the Brazilian biodiversity to fight cancer.
This combination has the potential to treat skin cancer from the skin surface instead of the common intravenous method.
Because our technology is potentially as efficacious as ordinary treatment, but without the strong side effects, this will encourage patients to join treatment before it is too late.

Competitors

At the first glance we are competing against the established pharma companies that offer chemo and radiation-based therapies. However MagForce, a German based company is our direct competition, since they already have a nanoparticle-based technology for cancer treatment.

Advantages or differentiators

We have however a competitive advantage: MagForce is focused on the potential of magnetic particles to heat up the cancer cell to cause death.
We use the combination of magnetic forces and drug delivery, increasing the efficacy of the treatment.
Our nanoparticles can encapsulate both hydrophilic and hydrophobic drugs and area applied from the outside, not necessarily intravenously.
Moreover, we also have included compounds from the Brazilian biodiversity in combination with known drugs.

Finance

Because of the lengthy regulatory pathway for cancer treatments, we will only start generating money from our nanotechnology for cancer treatment in 2026. But until there we plan to generate cash by selling our innovative line of cosmetics, since cosmetics have a very low regulatory barrier, but a large number of competitors and lower price (below 100 USD) we don't expect large revenue in the first years, but this revenue will be important for us to avoid the need of a new round of finance.
The large revenue will come from our cancer treatment, since the average price for cancer treatment is around 10,000 USD.
See below sales numbers from 2022 to 2026.
Year USD
2022 $380.000,00
2023 $437.000,00
2024 $480.700,00
2025 $528.770,00
2026 $2.331.647,00

Business model

Once we have the necessary data (pre-clinical and clinical safety) we will start talks to enter into a licensing agreement with a large pharma company to move to phase II clinical trial. This agreement will provide us with a large exclusive licensing agreement fee and the first payments from our cancer treatment product. Meanwhile we will commercialize an advanced cosmetics we own, since this is already registered in Brazil and it is ready for commercialization. The sales from this secondary market (advanced skin cosmetics) will allow us to cover our expenses until we start collecting our royalties from the sales of our medicinal products. Our collaboration with the Federal University of Ceara (in Brazil) also gives us the opportunity to use their facilities and personnel to reduce our monthly burn rate.

Money will be spent on

We are looking for 3 Million USD to finance our pre-clinical tests, small batch GMP production and phase I clinical trial.
Moreover the money will be used to finance the market launch of our first cosmetics in the Brazilian, German, Portuguese and US markets.
The money is also required to finance the expansion of our patent portfolio.

Offer for investor

We offer 16.66% of the company for 3 Million USD investment.

Team or Management

Risks

The regulatory process in the pharma industry is among the toughest from all industries, specially when dealing with nanoparticles. All regulatory agencies such as FDA, ANVISA and the notified bodies in Europe demand full documentation to approve a new drug or treatment. This can take time and cost a lot of money.
Other risks: Low efficacy of either delivery system or drug potency.
In either case, we have to solve such issues by constant researching and testing to improve our products.
Change in regulation can make the whole process more complicated. The search for additional markets with less regulated scenario for our technology is also a way to avoid such bad surprises.
We believe however now is the right time to move forward with nanoparticles in the pharma industry. Because we can take advantage of the approval of nanoparticle based vaccines such as Moderna and Pfizer/Biontech. The fear of nanoparticles is basically gone, however we still need to go through the whole approval package.
Dr. Rivelino Montenegro, CEO of Native Health has many years experience in the regulatory affairs of medicinal products in North America, Europe and Brazil. He invented and approved medical-based-products in many countries.

Incubation/Acceleration programs accomplishment

None

Won the competition and other awards

None

Invention/Patent

BR 10 2015 012999 8
BR 10 2016 016795 7
BR 10 2019 016450 6
BR 10 2019 013856 4
BR 10 2018 004126 6
BR 10 2018 004137 1
BR 10 2017 009173 2

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Idea
Current Status
Market
Problem or Opportunity
Solution (product or service)
Competitors
Advantages or differentiators
Finance
Invested in previous rounds, $
Business model
Money will be spent on
Offer for investor
Team or Management
Mentors & Advisors
Lead investor
Risks
Incubation/Acceleration programs accomplishment
Won the competition and other awards
Invention/Patent
Photos
Product Video
Presentation