ALTHE

Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive ultrasound therapy, is reaping the benefits of its focus on technology. This progress is reflected in new clinical partnerships, a growing deployment of the latest HD system among practitioners, particularly in the United States, and 4 scientific communications at the International Congress of Phlebology (#UIP2022) in Istanbul.

Enhancing performance

Theraclion continued its efforts to increase clinical performance. ‘Before gaining market share, we focused on technical and clinical performance in renowned sites. This is how we demonstrate on the international stage that we have a clinically relevant product,’ said David Caumartin, CEO of Theraclion.

New partnerships with opinion leaders have recently been signed, such as a few days ago in Latvia (Riga) in one of the three largest European centres for the treatment of varicose veins.

SONOVEIN® HD technology moves forward

Delivered from last May, the third CE marked generation of SONOVEIN® is a success. Already 6 sites in the world are using the HD system. It incorporates the best high-definition imaging system in its class, which allows faster treatments and more complex cases to be managed. ‘This is a true innovation,’ explains Dr. Guillaume Stalnikiewicz, MD, a vascular physician in France and a pioneer of ultrasound therapy worldwide.

SONOVEIN® HD has crossed the Atlantic and is now being used on the American continent by Dr. Steve Elias, MD, Director of the Venous Disease Centre at Englewood Hospital (New Jersey). The clinical trial in the United States is underway and most patients have already been included.

Clinical performance presented at the International Congress of Phlebology, IPU in Istanbul

A key event, the IPU brought together the international players in phlebology from the 12th to the 16th of September. On this occasion, 4 opinion leaders spoke favourably of Theraclion's technology, including Pr. Mark Whiteley, MD, who shared the latest advances of SONOVEIN® HD, complemented by the clinical results of the sites of Pr. Paolo Casoni, MD (Parma, Italy), Pr. Jaroslav Strejcek, MD (Prague, Czech Republic) and Dr. Teresa Reyero, MD (Madrid, Spain) who reported their results respectively. ‘The vein closure rate is at the level of the best thermal endovascular techniques,’ said Dr. Teresa Reyero, MD, vascular surgeon at HM Monteprincipe in Madrid, in her paper on 92 patients without any invasive treatment.

Investment in technology and treatment protocols

In K€

 

30/06/2022

 

30/06/2021

 

Var. %

Turnover

 

347

 

885

 

-61%

Grants

 

4

 

203

 

-98%

Other revenues

 

4

 

11

 

-64%

Total operating income

 

354

 

1 100

 

-68%

Purchase of goods

 

(143)

 

(481)

 

- 70%

External costs

 

(1 746)

 

(996)

 

+ 75%

Personnel costs

 

(1 735)

 

(1 255)

 

+ 38%

Other operating expenses

 

(173)

 

(107)

 

+ 62%

Total operating expenses

 

(3 797)

 

(2 839)

 

+34%

Operating profit

 

(3 443)

 

(1 739)

 

+ 98%

Financial result

 

40

 

(185)

 

- 78%

Non-current result

 

350

 

(1)

 

n.a.

Research tax credit

 

492

 

294

 

+ 67%

Net result

 

(2 561)

 

(1 631)

 

+ 57%

 

 

 

 

 

 

 

Average headcount

 

28

 

30

 

-7%

The first semester’s results reflect the teams’ focus on the launch of SONOVEIN® HD and the finalisation of treatment protocols in existing centres of excellence, with the goal of securing the fastest access to the American market possible. Commercial expansion will be conducted through strategic partnerships.

Theraclion SA had a turnover of 347 K€ in the first half of 2022, a 61% decrease compared to the first half of 2021. Theraclion had sold 4 Echopulse® systems in 2021 compared to only one second-hand system sold in 2022. With all production capacity currently dedicated to SONOVEIN® HD, Echopulse® sales are therefore limited to the availability of second-hand systems. Sales of consumables increased by 45%, driven by sales of consumables for the treatment of varicose veins. The expert centres have a mixed activity of treatment protocol development and commercial treatments.

Operating expenses increased by 38%, reflecting the development of treatment protocols by Theraclion teams and expert sites, the acceleration of the SONOVEIN® HD launch and the search for strategic partners. Salary growth is explained by an unfavourable comparison basis. Indeed, in the first half of 2021, a Collective Performance Agreement was signed, which reduced the payroll by 0.5 M€.

The financial result is a gain of 40 K€ for the half year, mainly due to exchange rate gains.

The research tax credit amounted to 492 K€ for the period compared to 294 K€ a year earlier, due to the increase in research expenses.

The intensification of development efforts in the first half resulted in a loss of 2,549 K€.

In K€

 

30/06/2022

 

31/12/2021

 

Var. %

Cash flow

 

4 806

 

2 462

 

+2 344

Medium-term cash position

 

31

 

31

 

0

Total cash and cash equivalents

 

4 837

 

2 493

 

+2 344

Bank loans

 

-2 610

 

-2 750

 

+ 140

Convertible debt

 

- 184

 

- 184

 

0

Total debt

 

- 2 794

 

- 2 934

 

+ 140

Net cash position

 

2 043

 

-441

 

+2 484

Theraclion has received cash advances from Oseo for an amount of 6,290 K€, including capitalised interest. Its repayment is based on milestones that are not expected to be reached within the next five years. Therefore, the advance is not accounted for as a financial liability.

Theraclion's cash position is 4.8 M€ on 30 June 2022. On March 1, 2022, Theraclion completed a capital increase of 6.5 M€, including issue premium, which should enable Theraclion to meet its cash needs until the beginning of 2023.

About Theraclion

At Theraclion we believe that surgery, as we know it, is outdated. It converts optimistic patients into anxious individuals, brilliant doctors into exhausted system executors and stretches healthcare systems to the limit. We have disrupted this convention by creating extracorporeal treatment platforms. We replace surgery with a robotic treatment from outside the body using High Intensity Focused Ultrasound (HIFU). Our leading edge echotherapy platforms are currently CE marked in non-invasive treatment of varicose veins with SONOVEIN® and of breast fibroadenomas and thyroid nodules with Echopulse®.

Located in Malakoff, near Paris, our employees live and breathe innovation by extensive clinical research and harness artificial intelligence. The market of varicose veins treatment alone requires around 5 million procedures annually. It is a dynamic market in which we change paradigms by making non-invasive echotherapy the new standard.

For more information, please visit www.theraclion.com and our patient website www.echotherapy.com.

Theraclion is listed on Euronext Growth Paris Eligible for the PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

View source version on businesswire.com: https://www.businesswire.com/news/home/20220926005702/en/

Contacts Theraclion

David AUREGAN Chief Operating Officer david.auregan@theraclion.com

Anja KLEBER VP Marketing, Market Access & Sales Francophonia anja.kleber@theraclion.com