Key Highlights
- Osprey Medical has received European CE Marking approval for
the 2nd generation DyeVert Power XT device
- Approval of DyeVert Power XT (for automatic injection) means
the full coronary angiography market is now available to Osprey’s
DyeVert franchise
- Device is expected to be a core product in the product
portfolio being commercialised by GE Healthcare
- Publication of clinical literature supporting effectiveness
of Osprey DyeVert technology by renowned cardiologist in Europe (Dr
Briguori)
- Update on GE Healthcare Strategic Alliance
Osprey Medical, Inc. (ASX:OSP) (Osprey or the
Company) is pleased to announce that the Company has received
CE Marking for the DyeVert Power XT 2nd generation device.
The CE Marking approval for its DyeVert Power XT device means
the product can now be marketed and sold across Europe. Europe is a
core market for Osprey and a significant player in the global power
injector market. Our DyeVert Power XT device is expected to form a
core product in the portfolio that is being commercialised by GE
Healthcare.
Osprey Medical President & CEO, Mike McCormick,
commented:
“We are delighted to have received CE Mark approval for our
Power XT device. The CE Mark is a very significant achievement as
it ultimately enables Osprey to target the full coronary
angiography market as our portfolio is now compatible with both
automatic and manual injection methods.
The approval was a critical building block in our European
roll-out and the timing is perfect, following the strategic
alliance formed with GE Healthcare in July. With the CE Mark
ensuring a comprehensive product range, plus a recently published
paper by renowned cardiologist, Dr Briguori; we are confident of a
strong launch in Europe through the GE Healthcare sales force later
this year”
The main feature of the device is its compatibility with
automated power injectors, thus complementing the Company’s
existing DyeVert EZ product which is compatible with manual
injection. The regulatory clearance marks a critical evolution in
Osprey’s DyeVert technology, as the Company now has full coverage
of the coronary angiography market in Europe.
This marks another key milestone in the Company’s European
strategy following the exclusive distribution agreement with GE
Healthcare announced on 30 July 2020.
Clinical update
In addition to the CE Mark approval, recently and important peer
reviewed manuscript was published by Dr Carlo Briguori, a key
opinion leading heart physician in Italy. This study further
validates the effectiveness of Osprey’s DyeVert technology at
improving patient outcomes and lowering hospital cost. This
important publication will form a key part of Osprey’s European
sales strategy with GE Healthcare.
Some of the key findings from this paper included:
- Study Design
- Patients studied had heart attacks (STEMI and NSTEMI)
- 339 control patient’s (no-DyeVert) were compared to 112
patients who received DyeVert
- Hydration (IV fluid administration) protocol was the same in
both DyeVert and no-DyeVert
- Observed, retrospective, propensity matched study in a single
center in Naples Italy
- Results
- 38% dye reduction in the DyeVert group compared to the
no-DyeVert group
- 58% Acute Kidney Injury reduction in the DyeVert group compared
to the no-DyeVert group
- 25% reduction in hospital length of stay in the DyeVert group
compared to the no-DyeVert group
A link to the abstract is available at
https://pubmed.ncbi.nlm.nih.gov/32682348/ .
GE Healthcare update
On 30 July 2020, Osprey announced that it had signed an
exclusive agreement with GE Healthcare to distribute its products
across Europe, Russia, Middle East, Africa, Central Asia and Turkey
(‘the Region’). Osprey can now provide some guidance on the
agreement which is significant to Osprey. Relevantly, the agreement
is expected to contribute materially to Osprey’s revenue over the
4-year contracted period. Previously, the Company’s operations were
primarily in the US with sales outside US (OUS) contributing an
immaterial amount to group revenues. This agreement represents a
significant shift for the company and means that OUS sales will now
contribute materially to Osprey’s group revenues and complement the
existing growth of sales generated within the US.
Under the contract with GE Healthcare, there are prescribed
minimum order quantities increasing each year with further upside
when sales exceed these quantities. Conservatively, under the
minimum order quantities agreed, the distribution agreement is
expected to add +20% to Osprey’s total expected revenues in 2021
with this expected to scale in importance each year, reaching +40%
by the fourth year. Additionally, under the contract, transfer
prices for all products are fixed over the 4-year period whereby
Osprey will experience margin certainty during the contract
period.
The agreement with GE Healthcare includes key provisions of an
exclusive distribution agreement between the parties. The terms
were disclosed in the prospectus dated 3 April 2020 remain, and are
set out below for convenience:
(a) GE Healthcare’s large and dedicated commercialisation team
(in excess of 120) will be tasked with selling products in the
Osprey portfolio in the Region;
(b) GE Healthcare will be granted a right of first refusal to
distribute and promote any new products introduced by Osprey in the
Region;
(c) in order for GE Healthcare to maintain its exclusive
distribution rights it must meet the minimum purchase levels (which
increase on an annual basis during the term);
(d) transfer prices are fixed over the 4-year term and provide
appropriate gross margin returns for Osprey; and
(e) during the term, GE Healthcare will liaise with Osprey in
relation to marketing, business plans and provide sales
reports.
This release dated 13 August 2020 has been authorised for
lodgement to ASX by Mike McCormick, CEO of Osprey Medical.
About Osprey Medical (ASX: OSP)
Osprey Medical’s vision is to make heart imaging procedures
safer for patients with poor kidney function. The amount of dye
(contrast) used during angiographic imaging procedures increases
the patient's risk for dye-related kidney damage known as
Contrast-Induced Acute Kidney Injury (CI-AKI). The Company’s core
technologies originated from research conducted by Dr David Kaye at
Melbourne’s Baker Institute. Its proprietary dye reduction and
monitoring technologies are designed to help physicians minimize
dye usage and monitor the dose of dye real time throughout the
procedure. The Company’s DyeVert™ System reduces contrast while
maintaining image quality in a self-adjusting easy-to-use design
that monitors dye usage. Osprey Medical’s Board and Management are
comprised of experienced and successful personnel with established
track records covering medical device development, regulatory
approvals, sales and marketing, and mergers-acquisitions. Osprey
Medical’s advisory board comprises world-recognised experts in
heart and kidney diseases.
Forward-Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management’s beliefs, assumptions, and
expectations and on information currently available to management.
Forward-looking statements involve known and unknown risks,
uncertainties, contingencies and other factors, many of which are
beyond the Company’s control (including but not limited to the
COVID-19 pandemic), subject to change without notice and may
involve significant elements of subjective judgment and assumptions
as to future events which may or may not be correct.
All statements that address operating performance, events or
developments that we expect or anticipate will occur in the future
are forward-looking statements, including without limitation our
expectations with respect to our ability to commercialize our
products including our estimates of potential revenues, costs,
profitability and financial performance; our ability to develop and
commercialize new products including our ability to obtain
reimbursement for our products; our expectations with respect to
our clinical trials, including enrolment in or completion of our
clinical trials and our associated regulatory submissions and
approvals; our expectations with respect to the integrity or
capabilities of our intellectual property position.
Management believes that these forward-looking statements are
reasonable as and when made. You should not place undue reliance on
forward-looking statements because they speak only as of the date
when made. Given the current uncertainties regarding the impact of
the COVID-19 on the trading conditions impacting the Company, the
financial markets and the health services world-wide, investors are
cautioned not to place undue reliance on the current trading
outlook.
Osprey does not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise. Osprey may not actually
achieve the plans, projections or expectations disclosed in
forward-looking statements, and actual results, developments or
events could differ materially from those disclosed in the
forward-looking statements.
Foreign Ownership Restriction
Osprey’s CHESS Depositary Interests (CDIs) are issued in
reliance on the exemption from registration contained in Regulation
S of the US Securities Act of 1933 (Securities Act) for offers or
sales which are made outside the US. Accordingly, the CDIs have not
been, and will not be, registered under the Securities Act or the
laws of any state or other jurisdiction in the US. The holders of
Osprey’s CDIs are unable to sell the CDIs into the US or to a US
person unless the re-sale of the CDIs is registered under the
Securities Act or an exemption is available. Hedging transactions
with regard to the CDIs may only be conducted in accordance with
the Securities Act.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200813005668/en/
Investors relations Leijie Li Vesparum Capital T: (61) 3
8582 4800 ospreymed@vesparum.com
Company Brendan Case Company Secretary M: (61) 410 442
393 brendan@casegovernance.com.au
Osprey Medical (ASX:OSP)
Historical Stock Chart
From Feb 2025 to Mar 2025
Osprey Medical (ASX:OSP)
Historical Stock Chart
From Mar 2024 to Mar 2025