- Strong growth in sales driven by the $3m (~€2.8m) milestone
payment from NuVasive during H1 2023
- Acceleration in sales of the Kheiron system (+40% vs. Q4
2022) thanks to the ramp-up of surgeries in the United
States
Regulatory News:
SMAIO (Software, Machines and
Adaptative Implants in Orthopaedics – Euronext
Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA) (Paris:ALSMA), a
French player specialized in complex spine surgery with a global
offer comprising software, adaptative implants and related
services, today published its annual sales for the year to December
31, 2023.
Philippe ROUSSOULY, Chairman and CEO of SMAIO, said: “In
2023, we achieved several key milestones that enabled us to deliver
operational performance and initiate our commercial expansion in
the United States. Obtaining FDA 510(k) clearance for the
customized version of our surgical planning software was an
important first milestone, leading to a $3 million payment from our
U.S. partner, NuVasive. Besides, we continued our efforts to train
surgeons in the United States on our technologies and philosophy,
in order to spread our offering in the world's leading spine
market. Through our U.S. subsidiary SMAIO USA, we performed 27
surgeries in 2023, of which 24 in the fourth quarter alone with our
Kheiron and K-rods implants and customized planning solutions. We
intend to build on this momentum, by increasing the number of U.S.
hospitals in which our solutions will be registered in 2024, and by
intensifying our training initiatives on our technologies for
surgeons practicing in these hospitals or expressing significant
interest in our offerings."
2023 annual sales
In € thousands
December 31, 2023
December 31, 2022
Change
SMAIO SA (parent Company)
7,623
2,442
+212%
- intra-group sales
(2,574)
-
N/A
SMAIO SA (excluding intra-group
sales)
5,049
2,442
+107%
SMAIO USA
334
-
N/A
SMAIO Group
5,383
2,442
+120%
of which France
1,110
1,101
+1%
of which milestone payment
2,765
-
N/A
of which international
1,508
1,341
+12%
* Unaudited data
In 2023, SMAIO SA’s sales amounted to €7.6
million, up +212% compared to 2022. When excluding intra-group
sales of implants between SMAIO SA and its U.S. subsidiary SMAIO
USA, and considering only the hospital implant sales conducted by
the latter, SMAIO Group’s sales came to €5.4
million1, reflecting a +120% growth compared with 2022.
Excluding the NuVasive milestone payment, SMAIO Group’s sales
primarily consisted of sales of the Kheiron system, comprising
customized implants and rods, amounting to €2.5 million over 2023.
The latter were particularly strong in the last quarter of the year
(+40% vs. Q4 2022), due to implants in the U.S. market following
the gradual registration of 4 new centers initiated during H2 2023.
As a result, 27 surgeries were performed in the United States in
the 2nd half of 2023, including 24 in the last quarter,
demonstrating the strong momentum of Kheiron system adoption by
North American surgeons.
In addition to sustaining the performance achieved in the fourth
quarter of 2023 over a full year in 2024, SMAIO expects to complete
several registrations, currently underway, in other hospitals where
surgeons who participated in the training programs organized in
Dallas (November 2022) or San Diego (November 2023) are practicing,
which should accelerate the Company's sales growth in the United
States in 2024.
Upcoming financial publication
- FY 2023 results: April 16, 2024, after market
About SMAIO
A precursor in the use of clinical data and imaging of the
spine, SMAIO designs global solutions for spine surgery
specialists. The Company has recognized expertise thanks to KEOPS,
its Big Data management software that has become a global reference
with more than 100,000 patient cases documented.
SMAIO offers spine surgeons a comprehensive platform, I-Kontrol,
incorporating planning, implants and related services, enabling
them to treat spinal pathologies in a safe, effective and lasting
way.
SMAIO is positioned at the forefront of innovation with the
ambition of providing surgeons with the first active robotic
solution enabling a high level of performance and repeatability to
be achieved.
Based in Lyon, France, SMAIO benefits from the skill and
expertise of more than 40 highly specialized staff.
For further information, please visit our website:
www.smaio.com
Listing market: Euronext Growth Paris ISIN:
FR0014005I80 Ticker: ALSMA
Disclaimer
This press release contains non-factual elements, including, but
not limited to, certain statements regarding future results and
other future events. These statements are based on the current
vision and assumptions of the management of the Company. They
incorporate known and unknown risks and uncertainties that could
result in significant differences in results, profitability and
expected events. In addition, SMAIO, its shareholders and its
affiliates, directors, officers, counsels and employees have not
verified the accuracy of, and make no representations or warranties
about, statistical information or forecast information contained
within this news release and that originates or is derived from
third party sources or industry publications; these statistical
data and forecast information are only used in this press release
for information purposes. Finally, this press release may be
drafted in French and in English. In the event of differences
between the two texts, the French version will prevail.
__________________
1 The financial statements published relate to the SMAIO SA
corporate entity, as the company does not yet publish consolidated
financial statements. However, in order to provide accurate
financial information, the Company is reporting its sales on the
basis of SMAIO SA's sales after elimination of intra-group sales to
SMAIO USA, and increased by sales generated by SMAIO USA directly
to its hospital customers,
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240123279495/en/
SMAIO Philippe Roussouly Chief Executive Officer Renaut
Fritsch Chief Financial Officer investors@smaio.com
NewCap Dusan Oresansky/Aurélie Manavarere Investor
Relations smaio@newcap.eu Tel.: +33 (0)1 44 71 94 92
NewCap Arthur Rouillé Media Relations smaio@newcap.eu
Tel.: +33 (0)1 44 71 00 15
SMAIO (EU:ALSMA)
過去 株価チャート
から 10 2024 まで 11 2024
SMAIO (EU:ALSMA)
過去 株価チャート
から 11 2023 まで 11 2024
