Photo - Monarch Bioimplants GmbH
45352

Monarch Bioimplants GmbH

Giving potency back for prostate cancer patients

Germany
Market: Medicine
Stage of the project: Operating business

Date of last change: 05.03.2020
Min investment
$  250.000
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Total required
$ 2.500.000
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Idea

We have developed a device to solve erectile dysfunction, which is the number one side effect from prostate cancer surgery. Our product is already FDA approved and we just started commercialization in the US.
We are looking for investment to create a sales team and reach as many hospitals as possible to scale up our sales.

Current Status

Our product is finalized and we have already the FDA approval.
We have already obtained the confirmation of 5 hospitals which want to use our device. Among them, the prestigious Mount Sinai in New York.
One hospital in Dallas has already tested and is about to start ordering regularly.
Meanwhile we are waiting for the approval in Europe and building up our sales team in the US to scale up the commercialization.

Market

Our customer is a man who is diagnosed with prostate cancer, typical age above 60.
He is very worried about erectile dysfunction which is the number one side effect fr om the surgery. In Europe 5% of patients will refuse surgery, risking their own lives because of the potential side effect. In the western part of Canada this number reaches 11%.
With an aging population, the number of cases is always growing. The number of new cases each year is growing steadily, in 2020 there will be 1.5 Million new cases. In China the growth of new cases is by 12%.
Prostate cancer is only the first market for our membrane, which can be applied in any surgery wh ere nerve repair is required. Our total potential market including prostate cancer, breast reconstruction, carpal tunnel and traumatic surgery, etc. is 2.8 B$.

Problem or Opportunity

Prostate cancer is the second most diagnosed cancer among males worldwide. More than 10% of new diagnoses occur in men which are younger than 55 years old and the number of new cases each year is growing steadily.
The best treatment option is surgery. However with a horrible side effect: erectile dysfunction because of the damage caused to nerves.
Roughly 70% of patients will only recover potency after one year, if at all. This issue leads to lower quality of life, depression, suicide, etc.

Solution (product or service)

Monarch's flagship product, NeuroShield is the first chitosan based membrane developed to be implanted during the surgery and already proven to accelerate nerve repair. Our clinical trial has shown that 72% of our patients were potent again in 3 months instead of waiting a full year.

Competitors

While close to 8 major companies offer nerve repair solutions that can compete with ours in some areas of application, only 2 companies (Midmex and Axogen) have membranes that can be used in the case of prostate cancer and only 1 (Midmex) has clinical data for this application.
The market is still a blue ocean, because only two products (our own and Midmex) have clinical evidence of the efficiency of such membranes in this application.
Axogen has sold in 2018 80M$ in products for nerve repair, but not in the prostate area, because they don't have results in this area.

Advantages or differentiators

Among other advantages we can mention:
We don't use human tissue as Midmex does, therefore because of ethics issues, they are not allowed to commercialize in Europe, while in the US they only have a "research" sort of status and permission for commercialization, which can be revoked at any moment.
Our production costs is much lower than of the competition, therefore we have more room to play with the price.
We can keep our device in the shelf at room temperature as well during transportation. No need of refrigeration.
We have clinical data and in vitro date explaining the mechanism of action.
Our device is thinner and more resistant than the competition.
Almost all products from the competition are made either from collagen or human tissue, we are the first to bring a different material, a natural Polysaccharid (sugar) chitosan membrane overcoming the typical drawbacks of the old materials.

Finance

Each membrane is sold for 550$ (roughly 500 Euro).
In the next 5 years with a conservative growth rate we believe to have over 37 M$ in sales for prostate cancer only.
The other markets included this number will reach over 100$ in the next five years.

Business model

Our business model is the traditional direct sales to hospitals and clinics.
We plan to use a mix of our own sales force and Independent distributors.

Money will be spent on

Sales and marketing in the US and finalization of CE mark approval process in Europe

Offer for investor

We have used a discounted cash flow model to calculate our valuation which is 18 M$.

Team or Management

Risks

If a new surgery method is developed or any other prostate cancer treatment that causes no damage to the nerves, then there is no need for our device for this specific application. We can however use in the other fields mentioned above.

Incubation/Acceleration programs accomplishment

No incubation was needed. Monarch's team is made by professionals with roughly two decades of experience in Medtech, development and commercialization of medical devices in Europe and North America

Won the competition and other awards

NeuroShield was chosen the best peripheral nerve repair technology for 2019 by the Global Health & Pharma (GHP).
We also were chosen the best investment by FastTrack venture in 2016.

Invention/Patent

US granted patent # 10,328,096
Europe granted patent # 3,266,467
Canada application # 2,971,272

Photos

Photo 1 - Monarch Bioimplants GmbH

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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
Website address