Subcutaneous
Wearable Bolus Injector (WBI)
for 1-10 ml drug

Low Cost of Goods
Reliable
Versatile

Low Cost of Goods
Reliable
Versatile

Subcutaneous
Wearable Bolus Injector (WBI)
for 1-10 ml drug

Why

The Subcuject Wearable Bolus Injector (WBI) enables longer delivery time for larger, viscous doses compared to auto-injectors

Convenient delivery of biological drugs often requires an injection time over several minutes. The Subcuject WBI allows for self-administration of large doses over a pre-defined delivery period to avoid injection site leakage, local intolerability, injection pain etc. The drive mechanism is very robust towards variations in viscosity, back pressure etc.

Subcuject WBI enables reduced dosing frequency

The convenient self-administration of larger doses with the Subcuject WBI enables a change from delivery of many small doses to fewer larger doses.

Subcuject WBI enables cost saving in hospitals

Administration of pharmaceuticals via intra-veneous (IV) infusion in a hospital is costly. Patient self-administration of subcutaneous injections is expected to save from 30% to 70% of costs. In addition, the patient’s quality of life is improved with a self-administered wearable injector used in the home environment.

Close to 100 biologics (marketed or under development) are suited for delivery via Large Volume Wearable Injectors. These biologics are for treatment of chronic conditions, requiring frequent dosing, and are not currently available in suitable self-administration systems.

Roots Analysis

Platform

The cost-effective Subcuject Platform provides a wide range of advantages:

  • Manufacturing cost comparable to the cost of an autoinjector
  • Pre-filled and pre-loaded
  • Long shelf life – also at cold storage
  • Cartridges in glass – only well known materials are in drug contact
  • Dimensions smaller than state of the art
  • Simple (one button) activation and noiseless operation
  • Inserts needle at activation, and retracts needle automatically after completion
  • Thin needle – designed for G27 or thinner
  • Injects drugs with high viscosities
  • Accommodates high dose volumes (1-10 ml)
  • Injection speed can be pre-defined
  • No electronics or batteries needed for operation

High viscosity requires a high drive force.

Complex and expensive device mechanisms with batteries and electronics are commonly used to achieve sufficient injection pressure at a slow speed.

The Subcuject WBI utilizes the newest forward osmosis technology to generate force. In simplified terms, two chambers of liquid are separated by a semipermeable membrane. Adding a salt to one chamber draws in liquid from the other chamber. Hereby hydraulic/mechanical pressure for driving the plunger in the primary drug container is generated, Simple and at a low cost.

Pending patents cover core and peripheral functionality.

The proprietary Subcuject device platform:
Low cost, reliable and versatile

The Subcuject WBI consists of only few parts and very few moving parts. This, combined with the inexpensive nature of the osmotic actuator results in low manufacturing price – comparable to the manufacturing price of an autoinjector as well as a robust and reliable principle.

Patients, therapies, drug substances and dose sizes are not equal across a product portfolio. This requires device customization. Our modular design enables straight forward configuration of the optimal combination of modules – across the product portfolio.

The Subcuject WBI Platform does not require electronics. Instead, it has the flexibility to accommodate electronics as an add-on e.g. for connectivity or data collection.

Device platform subcuject

Development status

The Subcuject WBI design is currently being finalized

The device performance has been proven in lab tests and is now being finalized for demonstration purposes.

Demonstration devices (up to 3 ml) will be available in 2019.

The image shows a 3 ml cartridge fully functional test device.

Low Cost of Goods

Few components. Injection force is generated by water and salt.

Reliable

No batteries needed. Low complexity of mechanism. Very few moving parts.
Robust towards variations in viscosity, back pressure etc.

Versatile

Primary packaging of glass and rubber.
Uncomplicated adaptation to specific drug requirements (volume, injection speed and viscocity)

Cold storage

The osmotic drive unit is stable at long time storage at cold temperature making it suitable as a prefilled device for biologics.

Proprietary

Pending patents on core and peripheral functionality.

Convenient

Prefilled, preloaded, one button operation. Noiseless injection. Thin needles. Small and handy device.

Eco-friendly

Component materials are environmentally compatible resulting in higher acceptance for single-use

Collaboration

We welcome you to contact us for a dialogue on how the Subcuject WBI Platform can accommodate your need for patient-centric, cost-effective and proprietary wearable injection devices.

We focus on collaboration opportunities aimed at development and commercialization of the Subcuject WBI Platform.

Contact:

Jesper Roested
jr@subcuject.com

About

Subcuject develops an innovative and proprietary device platform for Wearable Bolus Injection.

Subcuject is organized as a virtual organization and development is done in close collaboration with one of the global leading device CMOs in order to ensure manufacturability and documentation standard.

Our management team and board has decades of experience and track record in medtech, pharma and drug delivery.

We are financed by the Danish venture funds VF Venture and Capnova.

Management

Jesper Roested

CEO
+45 2122 7772

20+ years experience in business development, management and venture financing within medtech and life sciences.

...
Read More
Jesper Roested

CEO

20+ years experience in business development, management and venture financing within medtech and life sciences. MSc. In Medical Electronics & Physics.
Previously Partner at VF Venture investing in- and development of medtech companies. CEO of DDD-Diagnostic (nuclear medicine scanners), multiple positions at Novo Nordisk (in drugs and devices) and McKinsey & Co.

Claus Schmidt Møller inventor, Founder and CTO

Claus Schmidt Møller

Inventor, Founder and CTO
+45 2773 6420

B. Sc. Mechanical Engineering. 20+ years of track record in innovation of drug delivery devices.

...
Read More
Claus Schmidt Møller inventor, Founder and CTO
Claus Schmidt Møller

Inventor, Founder and CTO

B. Sc. Mechanical Engineering. 20+ years of track record in innovation of drug delivery devices. Inventor of Novopen 4 & 5 and co-inventor of Flexpen and Flextouch for Novo Nordisk. Several inventions of various medical devices made for or licensed to major Pharma and drug delivery companies. Mentioned as inventor or co-inventor on 60+ patent families.

Jesper Roested

CEO
jr@subcuject.com

20+ years experience in business development, management and venture financing within medtech and life sciences. MSc. In Medical Electronics &

...
Read More
Jesper Roested

CEO

20+ years experience in business development, management and venture financing within medtech and life sciences. MSc. In Medical Electronics & Physics.
Previously Partner at VF Venture investing in- and development of medtech companies. CEO of DDD-Diagnostic (nuclear medicine scanners), multiple

Claus Schmidt Møller inventor, Founder and CTO

Claus Schmidt Møller

Inventor, Founder and CTO
csm@subcuject.com

B. Sc. Mechanical Engineering. 20+ years of track record in innovation of drug delivery devices. Inventor of Novopen 4 &

...
Read More
Claus Schmidt Møller inventor, Founder and CTO
Claus Schmidt Møller

Inventor, Founder and CTO

B. Sc. Mechanical Engineering. 20+ years of track record in innovation of drug delivery devices. Inventor of Novopen 4 & 5 and co-inventor of Flexpen and Flextouch for Novo Nordisk. Several inventions of various medical devices made for or licensed

Board of Directors

Lars Guldbæk Karlsen

Chairman of the Board

Senior Quality Advisor, Novo Nordisk A/S. M.Sc. and Ph.D. in chemical engineering. 30+ years of pharma

...
Read More
Lars Guldbæk Karlsen

Chairman of the Board

Senior Quality Advisor, Novo Nordisk A/S. M.Sc. and Ph.D. in chemical engineering. 30+ years of pharma management experience from Novo Nordisk, hereof sixteen years in SVP positions i.a. positions with global Novo Nordisk responsibility for business development, device R&D, clinical drug development and quality. During nine years Chairman of the Board in Møller & Devicon A/S, special machine manufacturer to pharma industry

Paul Jansen

Member of the board

Former Global Head of Medical Device Development for Sanofi. Professional Engineer with more than twenty-five years

...
Read More
Paul Jansen

Member of the board

Former Global Head of Medical Device Development for Sanofi. Professional Engineer with more than twenty-five years of experience in medical devices. Extensive experience in the design, development, manufacturing and lifecycle management of medical devices, including Lantus SoloStar. Active member of the International Standards Organisation and currently co-chair of TC84.

Morten Nielsen

Member of the board

Former CEO of Medicom Innovation partner (acquired by Philips Medisize) a leading innovation player within Drug

...
Read More
Morten Nielsen

Member of the board

Former CEO of Medicom Innovation partner (acquired by Philips Medisize) a leading innovation player within Drug Delivery device and Connected Health solutions. Previously also leading positions in i.a. PA Consulting Group (Management and Technology Consulting), DGM (notified body) and S&W Medico Teknik. More than 25 years of leadership and operational experience – predominantly within MedTech.

Tonni Bülow-Nielsen

Member of the Board

Managing Partner in VF Venture, invest from seed- to late stage venture capital in IT, MedTech

...
Read More
Tonni Bülow-Nielsen

Member of the Board

Managing Partner in VF Venture, invest from seed- to late stage venture capital in IT, MedTech and Industrial technology.

Tonni has extensive global industry operational experience. Previous positions include being CEO of Nordic Medical Group A/S, President, ELA Medical (Canada & South America) and VP USA, a part of Sanofi, Global Marketing Director for St. Jude Medical (Los Angeles, USA, and Japan), BU Director for St. Jude Medical EEMEA (Brussels, Belgium), Country Manager for Guidant Nordic Area and Sales Manager for Danica Biomedical. Educational background: medical engineering and an executive MBA from Scandinavian International Management Institute. On the board of companies like: Reapplix, Microshade, Advalight, TeesuVac, Evosep, Subcuject and FBC Devices.

Lars Stigel

Member of the Board

CEO of Capnova, a Danish pre-seed and seed investor. PhD. Since 1998 Lars has been involved

...
Read More
Lars Stigel

Member of the Board

CEO of Capnova, a Danish pre-seed and seed investor. PhD. Since 1998 Lars has been involved in starting and investing in around 140 new companies of which 50 are spin out’s from university and hospital research. Before 1998 he among other positions was in charge of the profiling of university research towards the industry and managed a governmental cross institutional environmental research program.

Claus Demant member of the board

Claus Demant

Co-founder and Member of the Board

E*MBA from SIMI, HD (A) from Copenhagen Business School. 25 years of experience in leadership, strategy

...
Read More
Claus Demant member of the board
Claus Demant

Co-founder and Member of the Board

E*MBA from SIMI, HD (A) from Copenhagen Business School. 25 years of experience in leadership, strategy and business development.
International experience from IT, Electronics and MedTech industry. Regional Leadership positions in Creative Labs and SVP position in Daymen Acquisition S.A

Lars Guldbæk Karlsen

Chairman of the Board

Senior Quality Advisor, Novo Nordisk A/S. M.Sc. and Ph.D. in chemical engineering. 30+ years of pharma management experience from Novo

...
Read More
Lars Guldbæk Karlsen

Chairman of the Board

Senior Quality Advisor, Novo Nordisk A/S. M.Sc. and Ph.D. in chemical engineering. 30+ years of pharma management experience from Novo Nordisk, hereof sixteen years in SVP positions i.a. positions with global Novo Nordisk responsibility for business development, device R&D, clinical drug development and quality. During nine years Chairman of the Board in Møller & Devicon A/S, special machine manufacturer to pharma industry

Paul Jansen

Member of the board

Former Global Head of Medical Device Development for Sanofi. Professional Engineer with more than twenty-five years of experience in medical

...
Read More
Paul Jansen

Member of the board

Former Global Head of Medical Device Development for Sanofi. Professional Engineer with more than twenty-five years of experience in medical devices. Extensive experience in the design, development, manufacturing and lifecycle management of medical devices, including Lantus SoloStar. Active member of the International Standards Organisation and currently co-chair of TC84.

Morten Nielsen

Member of the board

Former CEO of Medicom Innovation partner (acquired by Philips Medisize) a leading innovation player within Drug Delivery device and Connected

...
Read More
Morten Nielsen

Member of the board

Former CEO of Medicom Innovation partner (acquired by Philips Medisize) a leading innovation player within Drug Delivery device and Connected Health solutions. Previously also leading positions in i.a. PA Consulting Group (Management and Technology Consulting), DGM (notified body) and S&W Medico Teknik. More than 25 years of leadership and operational experience – predominantly within MedTech.

Tonni Bülow-Nielsen

Member of the Board

Managing Partner in VF Venture, invest from seed- to late stage venture capital in IT, MedTech and Industrial technology.

Tonni has

...
Read More
Tonni Bülow-Nielsen

Member of the Board

Managing Partner in VF Venture, invest from seed- to late stage venture capital in IT, MedTech and Industrial technology.

Tonni has extensive global industry operational experience. Previous positions include being CEO of Nordic Medical Group A/S, President, ELA Medical (Canada & South America) and VP USA, a part of Sanofi, Global Marketing Director for St. Jude Medical (Los Angeles, USA, and Japan), BU Director for St. Jude Medical EEMEA (Brussels, Belgium), Country Manager for Guidant Nordic Area and Sales Manager for Danica Biomedical. Educational background: medical engineering and an executive MBA from Scandinavian International Management Institute. On the board of companies like: Reapplix, Microshade, Advalight, TeesuVac, Evosep, Subcuject and FBC Devices.

Lars Stigel

Member of the Board

CEO of Capnova, a Danish pre-seed and seed investor. PhD. Since 1998 Lars has been involved in starting and investing

...
Read More
Lars Stigel

Member of the Board

CEO of Capnova, a Danish pre-seed and seed investor. PhD. Since 1998 Lars has been involved in starting and investing in around 140 new companies of which 50 are spin out’s from university and hospital research. Before 1998 he among other positions was in charge of the profiling of university research towards the industry and managed a governmental cross institutional environmental research program.

Claus Demant member of the board

Claus Demant

Co-founder and Member of the Board

E*MBA from SIMI, HD (A) from Copenhagen Business School. 25 years of experience in leadership, strategy and business development.
International

...
Read More
Claus Demant member of the board
Claus Demant

Co-founder and Member of the Board

E*MBA from SIMI, HD (A) from Copenhagen Business School. 25 years of experience in leadership, strategy and business development.
International experience from IT, Electronics and MedTech industry. Regional Leadership positions in Creative Labs and SVP position in Daymen Acquisition S.A

Contact

Subcuject ApS

Nordre Strandvej 119, F1
DK-3150 Hellebaek
Denmark

Jesper Roested

CEO
Phone: +45 2122 7772
jr@subcuject.com