Economic and health benefits from use of the HemoSep auto transfusion system to reduce blood transfusions and related complications during open-heart surgery.
Submitting Institution
University of StrathclydeUnit of Assessment
Allied Health Professions, Dentistry, Nursing and PharmacySummary Impact Type
TechnologicalResearch Subject Area(s)
Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences
Summary of the impact
A low-cost, efficient, blood cell salvage technology (HemoSep) has
resulted from research carried
out at Strathclyde between 2008 and 2013. The novel technology has been
patented and licensed
to Brightwake Ltd., who manufacture the device in the UK and market it
through a global
distribution network. HemoSep has now been used in clinical centres across
Europe, North
America, and South Africa since its commercial launch in late 2012. The
use of the device has
been shown to reduce the need for donor blood transfusions in open-heart
surgical patients by at
least 1 unit (450 ml) with an associated reduction in transfusion related
complications such as
heightened inflammatory response and bleeding. The reduction in blood
transfusions associated
with the use of HemoSep has a considerable cost benefit to healthcare
providers (in North America
blood costs up to $1600 per unit). In addition, commercialisation of
HemoSep has led to the
creation of new manufacturing, marketing and sales jobs in the UK and
overseas.
Underpinning research
Context:
Conventional donor transfusion in patients undergoing major surgery has
been shown to be both
costly and to carry risks of inappropriate and heightened immune
responses. Over the past 20
years, auto-transfusion, or re-transfusion of the patient's own blood,
spilled during the course of
major operations has become a standard technique in complex surgery such
as open heart
surgery and major vascular and orthopaedic surgery. This approach has been
shown to
considerably reduce the need for donor blood and given that the patient's
own blood is being
recycled, minimises associated risks of transfusion reactions. This
technique has to date required
very complex machinery, including large centrifuge and pumping apparatus
and skilled personnel.
These issues have restricted the uptake of auto-transfusion in some
clinical sectors. However, with
open-heart surgery currently amounting to over 1 million procedures
annually, and blood
increasingly assuming a direct cost to healthcare providers (up to $1600
per unit in the USA), auto-transfusion provides both cost and health benefits over the use of donated
blood. This work
focused on the development of a simple, safe and cost-effective
alternative auto-transfusion
technology that provided benefits over the large, complex and technically
demanding centrifugal
devices.
Key research findings:
In response to expressed clinical need, staff at the Department of
Biomedical Engineering,
University of Strathclyde, undertook the development of a new approach to
auto-transfusion using
membrane controlled superadsorber technology that removes the liquid
(plasma) component of
blood by a rapid "wicking" process rather than conventional centrifugation
and pumping.
Studies were carried out to establish that this process was viable
through testing of hand- built
prototypes (2008-2009). These studies, using bovine blood in the
laboratory, confirmed process
viability and highlighted the critical factors governing performance;
membrane pore size,
membrane composition, superadsorber configuration and the need for
agitation to avoid
membrane fouling. This early research determined that the auto-transfusion
system should
comprise both disposable and hardware elements. The disposable element
consists of the
superadsorber/membrane system contained within a blood bag, and hardware
in the form of a
fixed rate agitation system capable of ensuring movement of blood cells
across the membrane
surface. These studies formed the basis for the device design file and the
patent filed by the
University in 2009. Subsequent to this technology development phase,
prototype devices were
constructed by the University's technology licensee (Brightwake Ltd) and
clinical trials were
initiated with the world-leading University of Kirikkale Medical School in
Ankara, Turkey under the
direction of Professor Serdar Gunaydin, Professor of Cardiovascular
Surgery and an international
key opinion leader in the field of extracorporeal devices for open-heart
surgical deployment. These
clinical studies, carried out in over 100 open-heart surgical patients,
confirmed that the use of the
HemoSep technology resulted in a reduction in the need for donor blood and
diminished
inflammatory response and post-operative blood loss in patients undergoing
HemoSep supported
surgery when compared with other transfusion modalities.
Key researchers:
Terry Gourlay — Professor of Biomedical Engineering at University of
Strathclyde at time of
research from 2008 to present.
References to the research
1. Gunaydin S, Gourlay T. Novel ultrafiltration technique for blood
conservation in cardiac
operations. Annals of Thoracic Surgery, 2013, 95(6), 2148-51. DOI:
10.1016/j.athoracsur.2013.03.048.
2. Gunaydin S, Gourlay T. Clinical evaluation of a novel ultrafiltration
technique for circuit salvage
in high-risk patients undergoing coronary revascularization. Presented at
CREF (cardiac research
and education foundation) Cardiothoracic Surgery Session. San Diego
California, February 29th
2012. http://crefmeeting.com/wp-content/uploads/2012/10/CREF12GunaydinSlides.pdf
Other evidence for quality of research:
The main findings are published in the Annals of Thoracic Surgery, which
is the leading
international peer reviewed journal in the cardiothoracic surgical sector.
The research has been
disseminated at leading international conferences, all of which are peer
reviewed, with a number of
further presentations planned for the coming year, including a keynote
lecture at the forthcoming
Canadian Institute for Military and Veterans Health Research Congress to
be held at Queen's
University, Edmonton, Canada in November 2013.
This work was internally funded in the first instance, followed by
funding in the region of £500k
through the technology licensee, Brightwake Ltd, as the project approached
commercialisation.
The research led to the filing of 2 patents (The HemoSep University of
Strathclyde/Brightwake Ltd -
(WO/2009/141589), 2009. Bag-in-a-bag Brightwake Ltd — (US 2012/0175319
A1)), one covering
the core technology and the second a novel manufacturing process for
forming the bag-in-bag
element of the device that emerged from the manufacturing development
process.
Details of the impact
Process of impact generation from research:
Brightwake Ltd worked closely with the Strathclyde University team to
develop a commercially
viable and clinically suitable device, resulting in significant outcomes
beyond the basic research
stage. The relationship with Brightwake Ltd is enduring with continued
interaction regarding the
development of HemoSep derivatives and other devices. A Knowledge Transfer
Account fellow
was appointed to further exploit some of these opportunities (Dr Alasdair
Walker, Oct. 2011-
Sept.2012) and Brightwake continue to explore commercial opportunities
with the University.
Development of the technology towards a clinically deliverable device
started in 2010. Strathclyde
University were fully engaged in this, providing laboratory test
facilities and expertise. Novel
technology for "bag-in-bag" manufacture techniques emerged from this
research with a patent filed
by Brightwake Ltd in 2012. In 2011-2012 independent verification of the
performance and safety of
the technology was carried out with the Department of Biomedical
Engineering, University of
Strathclyde providing advice on protocol development and analysis. The
successful conclusion of
these studies led to Brightwake Ltd investing in excess of £500k in
infrastructure to manufacture
devices for clinical trial as part of the CE marking process and
subsequent clinical sales.
Types of impact:
Results of clinical trials show reduction in need for donor blood
A key opinion leader (Source B) was identified in July 2011 through the
Strathclyde Institute for
Medical Devices to lead the clinical trials. In 2011, a study protocol and
post study analysis
designed to meet CE mark requirements, was drafted by Strathclyde in
association with SGS Ltd.
Subsequently (2011-2012), studies were carried on high risk heart surgery
patients with a focus on
clinical outcomes relating to blood transfusion and fluid balance issues.
This work confirmed that
the device was effective in concentrating salvaged haemodiluted blood back
to normal values in
terms of all critical factors. Importantly, the HemoSep technique was
shown to return all blood cell
species back to patients, rather than simply red blood cells, a factor
that considerably enhances
the benefits of auto-transfusion in these challenging patients. The
clinical investigators engaged in
the early clinical trials expressed the view that HemoSep is "the simplest
to use Auto-transfusion
device available for open-heart surgery" and subsequently confirmed that
the use of HemoSep
"results in a reduction in donor blood usage of the order of 1 unit per
open-heart patient" (Sources
B and C).
Formation of new company
Having licensed the HemoSep device from the University, Brightwake Ltd
formed a new company,
Advancis Surgical to market this and other medical devices to the
cardiovascular and other
medical communities. Subsequent to granting of the CE mark, manufacture
and marketing was
scaled up. The commercialisation and clinical studies were funded directly
by the commercial
partner Brightwake Ltd. Brightwake Ltd have fully engaged in the
commercialisation of the
HemoSep technology and have worked closely with the University of
Strathclyde in its continued
development and delivery.
Commercial adoption of new and improved technology
The HemoSep technology has all the advantages of conventional centrifuge
based auto-transfusion systems in terms of process time, but occupies around 10% of
the space commonly
required for a conventional system and can be operated by relatively
non-specialist staff. These
features have resulted in global interest in this device leading to rapid
growth in sales. At the
present time Brightwake has, through a distributor business model,
established distributorships for
HemoSep in Canada, Germany, Thailand, Italy, Australia, New Zealand and
South Africa, and
have already submitted for FDA approval for access to US markets.
Orthopaedic and paediatric
derivatives of HemoSep were launched in July 2013 and are undergoing
clinical trials in UK and
Canadian hospital sites.
Investment and jobs
The company have invested over £1.5 million in the manufacture and
marketing of the HemoSep
technology and have created 11 new jobs in the UK in the manufacturing and
marketing of the
device, together with other new jobs overseas in its international
distribution network (3 full time
sales staff in Canada, 2 in Thailand, 3 in Italy). A total of 25 new jobs
associated with the
HemoSep device had been created internationally by March 2013. (Source A)
In addition to new
jobs, the HemoSep technology has resulted in Brightwake investing in new
plant and
manufacturing technologies at its Nottingham headquarters. These include a
dedicated clean room
for device assembly and unique manufacturing technologies for the
bag-in-bag device assembly
(Source A provides confirmation of the investment details and progress
with HemoSep to July
2013).
Sales
Brightwake made the first sale of HemoSep, and therefore established a new
income stream, in
September 2012. As of May 2013, less than 1 year after CE marking,
Brightwake Ltd has sold
HemoSep hardware and disposables into Canada, Italy, Germany, UK,
Thailand, South Africa, and
Australia. The Director of R&D Brightwake/Advancis Surgical Ltd
(Source A) states that "since we
launched Advancis Surgical Ltd to develop and sell this and other medical
device technologies,
uptake of HemoSep has been very good....UK clinical trials are ongoing at
a number of NHS
centres and we anticipate considerable growth in the coming year."
Total sales of the disposable element of the HemoSep system are in the
many thousands of units
across these territories. Contracts for distribution in other territories
are in negotiation at the
present time. The critical market for HemoSep will be the USA, where there
is a real focus on the
cost and risks of conventional donor blood transfusions. Brightwake has
recognised this as an
opportunity and have already filed for FDA approval for this product.
Sales in the USA are
anticipated to exceed sales in the totality of other territories (Source
A).
Benefits to patients
A number of patient benefits have been confirmed through clinical
deployment of the HemoSep
system to date. The large-scale clinical trial of HemoSep carried out in
Turkey has demonstrated
that the system results in a reduction in the need for donor transfusion
by around 1 unit (450ml) per
patient. This represents around a 50% reduction when compared to patients
undergoing surgery
without the HemoSep system. In addition, these studies have demonstrated a
consistent reduction
in the inflammatory response and bleeding known to complicate the
post-operative recovery of
these patients, leading to reduction in time spent in the intensive care
setting after invasive surgery
(see published results reference 1, Source B, and the statement on
Advancis website, Source C)
The sparing of all blood cell species by the HemoSep system, rather than
just red blood cells as is
the case with conventional centrifugal systems, is the reason for these
major benefits. This overall
reduction in risk of transfusion reaction, blood loss and use of donor
blood goes some way to
rendering open-heart surgery a safer procedure for patients undergoing
these complex
procedures.
Summary
There are a number of beneficiaries from the HemoSep development.
Healthcare providers will
benefit from reduced costs of delivery of open-heart surgery resulting
from the saving of donor
blood and reduced complications in recipient patients. The shareholders
and employees of the
licensee company will benefit from the greater stability and the financial
return that comes from
launching a new and innovative product with genuine downstream development
potential into a
technologically receptive marketplace. Patients will benefit from reduced
complications associated
with donor blood transfusions and improvements in clinical outcome related
to the preservation of
all cell types when the HemoSep technology is employed during their
surgery. Strathclyde
University will benefit financially from the income generated through the
license agreement with
Brightwake Ltd and from the new and close relationship we have with the
company in developing
new medical devices.
Sources to corroborate the impact
A. Statement from Brightwake Ltd on current status of HemoSep program.
B. Statement from Professor of Cardiothoracic Surgery University of
Kirikkale on clinical
experience with HemoSep
C. Website for confirmation of HemoSep status and new developments -
www.advancis.co.uk.