• Pre-assembled mechanical, ready-to-use, fully integrated, mechanical wearable injector

• Incorporates BD Neopak primary container technology

• Customizable flow rate

• Optional smart functionality enables connectivity to the healthcare network

• User friendly app

Wearable bolus injectors, also known as large volume injection (LVI) devices, represent a new
and innovative sector within the injectable drug delivery market. They provide the
opportunity to deliver large (>1-2 mL) volumes of drugs subcutaneously together with the
many associated benefits this offers to drug developers, clinicians and patients.

for delivery of high volumes, but such devices are also seen as a means of extending the
lifecycles of drugs nearing the end of their patent life by, for example, reformulating from IV
to SC.

growth in the biologics market that is thought to be one of the key drivers that will forge the
emergence of LVI devices

make them safer to use, reduce the injection workflow and facilitate selfadministration

easy-to-use device, with improved compliance a likely result

A mechanical drive system, like that found in BD Libertas™, provides a robust, industrytested
method of delivering medication. Purely mechanical systems provide reliable and known
mechanisms for administration, which may help to reduce risk and increase reliability. In
contrast, electromechanical devices typically require pumps, which may introduce technical
complexities and unknown sources of error

provide reliable and known mechanisms for administration, which may help to reduce risk and
increase reliability

devices typically require pumps, which may introduce technical complexities and unknown
sources of error

may deliver more comfortable injections compared with electromechanical devices, as they are
responsive to tissue back-pressure

As fluid diffuses into the subcutaneous space, pressure in the tissue slowly builds, which may
induce pain at the injection site

simply the absence of electronics from the core device. This is particularly beneficial when it
comes to device disposal.

The device permits slow release of the drug which minimises the risk of infusion site reactions

 Wearable large-volume injectors (LVI) are a type of wearable injector that typically
hold at least 2 mL of a drug
 Large-volume medicines have traditionally been infused or administered IV
due to the challenges of getting the required volume of drug into a patient’s
bloodstream. Large volume wearable devices have been most applicable for
biologic drug administration where viscous formulations and higher volumes
are common,
o Cancer Treatment
o Auto-immune Treatment
o Blood Disorders Treatment
o Some others
 Patient self-administration of large volumes using traditional devices such as
autoinjectors, pens or prefilled syringes has been unsuccessful for several
reasons, and require patients to travel to hospitals for treatment
o difficulty for a patient to hold a device in place for the required
amount of time
o the high viscosity of the drugs to be administered
o inability of subcutaneous tissues to absorb large drug volumes
 Enhanze® drug delivery technology from Halozyme have been upstream
changes that have met with the downstream desire of patients to have more
influence over their disease management. These two technology
advancements have allowed larger volumes to be administered
subcutaneously, over a longer period, in a non-clinical setting by ensuring user
requirements are at the heart of the patient experience
 major vendor/manufacturers in the market:
o West
o Unilife
o CeQur
o Sensile Medical
o BD Medical
o Enable Injections
o Roche
o ScPharmaceuticals
o SteadyMed
o J&J
 Large volume wearable injectors offer numerous benefits
o Ease of use
o reduced chances of dosing-related errors
o integrated safety mechanisms
o negligible risk of needlestick injuries
 LVWI types:
o Electronical injectors- typically require pumps, which may introduce technical
complexities and unknown sources of error. electromechanical devices are designed
to deliver medication at a constant delivery rate regardless of tissue back-pressure
o Mechanical injectors- eg: BD Libertas;
 robust
  mechanical systems provide reliable and known mechanisms for
administration, which helps to reduce risk and increase reliability
 deliver more comfortable injections compared to electromechanical devices,
as they are responsive to tissue back-pressure
 absence of electronics from the core device. This is particularly beneficial
when it comes to device disposal
o Any other?

Examples:
1. BD Libertas large-volume wearable injector
 BD Libertas is a pre-assembled, fully integrated, mechanical WI
designed to deliver 2-10-mL doses of high-viscosity biologics of up to
50 cPBD
 unique design and user friendly interface with minimal steps and
little complexity
 It does not require user assembly or filling, reducing the potential
for human error and contamination
 BD Libertas comes completely pre-assembled and ready-to-use out
of the package, eliminating the human interaction,incorrect
assembly
 The WI will be available in two volume formats, 2-5 mL and 5-10 mL,
 The Translational Sciences Center of Excellence at BD Technologies
has partnered with BD Pharmaceutical Systems to provide in vivo
testing of BD Libertas. This collaboration provides valuable insights
to directly impact device design, and offers early information on
performance in a living system

https://drugdeliverysystems.bd.com/products/self-injection-systems/libertas-
wearable-autoinjector
file:///C:/Users/mgupta/Downloads/BD_Libertas_Clinical_Trial_completion_
press_release_20200213.pdf

2. The Subcuject Wearable Bolus Injector (WBI)

Partnerships:
 Enable Injections Enters into Strategic Partnership with Sanofi-
The Enable enFuse is an on-body drug delivery platform with a
self-contained drug transfer system compatible with standard
syringes or vial container formats. The wearable enFuse
platform is being developed for controlled subcutaneous
administration of large-volumes ranging from 5 mL to 50 mL.
Designed for ease of use, the enFuse has the potential to
provide patients and their caregivers an alternative delivery
method for subcutaneous administration of parenteral
therapies outside of a clinical setting
https://www.prnewswire.com/news-releases/enable-injections-
enters-into-strategic-partnership-with-sanofi-300859890.html
 Enable Injections and Flex announce partnership for
production of advanced wearable high-volume biologics
injectors
https://flex.com/newsroom/press-releases/enable-injections-and-
flex-partner-production-wearable-high-volume-injectors

Outline :
Background
Pipeline
Examples
Recent trend/

Chronic clinical conditions, such as diabetes, cardiovascular disorders, neurological disorders,

autoimmune disorders and various types of cancer, are considered to be among the leading
causes of death and disability across the world. Recently, the Center for Managing Chronic
Disease at the University of Michigan reported that over 50% of the global population is
currently suffering from some form of chronic disease. The past few years have witnessed
ground breaking advances in the process of drug development and introduction of several
innovative pharmaceutical interventions for the treatment of a number of chronic diseases.
However, majority of the available treatment options require parenteral administration,
frequent dosing, involve repeated hospital visits and are associated with multiple other
concerns, such as dosing and medication errors, risk of microbial contamination and
needlestick injuries. These challenges represent a substantial threat to medication adherence
and, thereby, are likely to significantly impact therapeutic outcomes. Over the past few years,
a number of companies have developed advanced therapeutic delivery solutions to alleviate
the pressing concerns associated with the administration of both conventional and novel drug
/ therapy molecules. Amongst modern drug delivery practices, the concept of self-injection
has facilitated advanced medications to be administered beyond the clinical setting. This has
also served to reduce healthcare costs, improv0065 therapy adherence and optimize the
utilization of healthcare resources per treatment.
Currently available treatment options for chronic diseases require parenteral administration,
frequent dosing, involve repeated hospital visits and are associated with multiple other
concerns, such as dosing and medication errors, risk of microbial contamination and
needlestick injuries. These challenges represent a substantial threat to medication adherence
and, thereby, are likely to significantly impact therapeutic outcomes
The concept of self-injection has facilitated advanced medications to be administered beyond
the clinical setting. This has also served to reduce healthcare costs, improve therapy
adherence and optimize the utilization of healthcare resources per treatment. Some notable
examples for self injection devices include prefilled syringes, reusable and disposable pen
injectors, autoinjectors and large volume wearable injectors. Large volume wearable injectors
deliver drug primarily via the subcutaneous route in the home-care setting.
The self-injection devices market is currently characterized by the presence of a myriad of
advanced and innovative drug delivery solutions, equipped with a variety of user-friendly
features. Notable examples of such products include prefilled syringes, reusable and
disposable pen injectors, autoinjectors and large volume wearable injectors. Large volume
wearable injectors are capable of drug delivery primarily via the subcutaneous route and
have become a preferred choice for administration of drugs in the home-care setting.
Variants of these wearable devices have been designed to administer highly viscous drugs
(such as most biologics) in large volumes (more than 1 ml), offering numerous benefits, such
as ease-of-use, reduced chances of dosing-related errors, integrated safety mechanisms, and
an almost negligible risk of needlestick injuries. It is worth highlighting that such devices have
captured the interest of several stakeholders in this industry to deliver various insulin and
non-insulin drugs. Moreover, the field is witnessing emergence of other technological
advancements, such as integrated mobile applications with smart health monitoring and
other interesting features (such as provisions for reminders, and the ability to connect to
web-based portals for sharing medical data with the concerned healthcare providers), visual /
audible drug delivery confirmation notifications, automatic drug reconstitution, and error
alerts.

There are many factors that is fueling the growth of the wearable injectors market. The
different market trends and factors in this market according to an analysis performed by
Market Research Future (MRFR) include upsurge in diabetes and cancer cases, use of cutting-
edge technological products, rise in the incidence of needlestick injuries, growing need for
24/7 monitoring, shift to injectables that can be self-administered and prevalence of diseases
that are lifestyle-associated such as hypertension and diabetes

Large Volume Wearable Injectors market will register a 140.4% CAGR in terms of revenue, the
global market size will reach US$ 6680 million by 2024, from US$ 35 million in 2019.
Wearable devices are changing the way drugs are delivered. The size of the market
opportunity for Large Volume Wearable Injectors (LVIs) alone has been estimated at $8.1
billion by 2025, with over 50% of this driven by devices to deliver drugs for cancer and
associated conditions
Ypsodose prefilled cartridge