Gx InPuls® - On-body Infusor Platform
Freeing your patients to continue with their day
Our Gx InPuls® rechargeable subcutaneous on-body infusor is compact, lightweight and easy to use. It discreetly accompanies patients through their day while gently, accurately delivering their therapy.
The platform concept allows for flexible tailoring to your specific small or large molecule drug and even complex dosing regimens can be defined in a volume of up to 3 ml. The two-part design with all electronics in the re-usable unit supports sustainability through the value chain. Patients simply click the two units together and begin infusion with one button press.
Your new on-body infusor
When you choose our Gx InPuls® infusor, you can be confident of a reliable, patient-friendly device that can be adapted to your specific small or large-molecule formulation.
The Gx InPuls® technology has a proven track record with a combination product based on the infusor is approved by the US FDA. You can also rely on our expertise and experience in development, testing, regulatory support, and manufacturing at scale.
Benefits
Simple for patients
1-button operation with easy injection monitoring & safety features
Eco-design concept
Sustainable two-part design with multi-use, rechargeable unit
Reduced risk & time-to-market
Platform concept with proven technology for fast adaptation to different drug volumes & viscosities
Full-service partnership
Proven experience in development & manufacturing
Gx InPuls® Features
Rechargeable and recyclable electronics unit does not need to be sterilized
Pre-filled cartridge holds up to 3 mL of liquid drug
Sterile disposable unit containing the fluid path and delivered in a blister pack
Safe and intuitive self-administration
The intuitive design and safety features of our Gx InPuls® on-body infusor empowers patient independence by enabling them to receive their therapy at home.
- Assembling and attaching the compact, lightweight device with an adhesive patch is quick and straightforward
- There is reduced risk of needle-stick injury and needle anxiety due to the concealed needle
- Single button operation is straightforward for patients
- The needle is automatically inserted once the device is activated and retracted at the end of the infusion
- Occlusion detection with alert as well as visual and audible signals guide the patient
Easy assembly and on-body application
To support the patient and the environment, we developed a sustainable two-part concept for our Gx InPuls® on-body infusor. The patient simply slides the prefilled cartridge into the sterile, disposable unit and easily clicks this together with the rechargeable, reusable unit. An adhesive patch enables the lightweight device to be easily attached to the abdomen.
Gentle at-home therapy
Patients can simply click together and apply the on-body infusor at home and continue with their daily life while it gently, gradually infuses their therapy.
- Medication is released over a period of up to 5 hours which may be better tolerated than an IV infusion
- The lightweight, discreet design remains comfortably on the body and enables patients to move freely while the drug is delivered
Precise, controlled drug delivery
Reliable, gradual, controlled delivery of a therapeutic drug in basal and bolus regimens is assured with our novel SensCore micropumps.
- Our patented micropumps deliver accurate dosing at low increments and can also handle high flow rate for large molecule delivery
- The valve structure in the SensCore pump mechanism provides double protection against free flow as there is only ever one valve open and when the pump is inactive both valves are closed simultaneously
- Your therapeutic drug is gradually infused over a pre-defined time period
Large molecules delivered with ease
Delivering biologic drugs subcutaneously in a home-care setting can be challenging. Sensitive biomolecules and viscous formulations place demands on device technology. We have tested and optimized our novel SensCore micropumps which form the heart of the Gx InPuls® platforms to confirm effective delivery of large molecule formulations at varied flow rates.
Customizable for complex therapy regimens
The on-body infusor is an ideal solution for treating chronic diseases as even complex dosing profiles are handled with ease.
- SensCore technology combined with the software and electronics allows full control of dosing profiles, enabling even complex bolus or basal regimens to be accurately programmed
- The RU is rechargeable and can deliver at least 48 treatments which simplifies use when managing a long-term health condition, streamlines supply chain, and supports sustainability
Sustainability built in
Useability and sustainability go hand-in-hand in our infusors. The two-part eco-design concept has a reusable unit (RU) housing electronics and a sterile disposable unit (DU) containing the needles. Patients benefit from sustainable device that can be assembled in a few seconds and worn comfortably throughout their day, without needing to travel to receive therapy.
Reduce – Size, weight & number of components have been minimized
Reuse – Cost & waste is reduced as the electronic components and batteries are housed in the rechargeable which is not part of medical waste
Recycle – At the end of its life, the RU is recyclable
Rethink – Only the DU needs to be sterilized
Quickly adaptable for reduced time-to-market
The platform concept from Gerresheimer decreases time-to-market and development risk, thanks to:
- Quick tailoring to specific drug and therapy
- Full-service from Gerresheimer including manufacture and supply of primary ISO cartridges
- Customizable colors and options for company and product branding
Full-service partnership
As a leading systems and solutions provider for the pharmaceutical industry, Gerresheimer can support the full device dvelopment process including supplying primary packaging.
We reduce your workload as we manage the project from initial device definition and testing, through risk management, medical device documentation, sterilization, manufacturing, and volume production at one of our worldwide facilities.
We also support the regulatory submission process to US FDA or other bodies for your combination product
Specifications
| Drug suitability | Large and small molecule drugs |
Primary container | ISO 3 mL cartridge |
Fill volume | 1 – 3 mL fill volume |
Patient needle | 25, 27, or 29 G |
Needle system | Automatic insertion and retraction |
Needle protection | Safety shield covers needle before & after use |
System type | SensCore micropump |
Contact the expert
Andrew Moore
Global Director of Product Management & Systems Integration
