Regulatory News:

THERACLION (Paris:ALTHE) (ISIN: FR0010120402; Mnemo: ALTHE, eligible PEA-SME), an innovative company specializing in the development of medical equipment for treatment by echotherapy including varicose veins, announced today its sales for the first semester of 2019, closing on June 30th.

David Caumartin, Managing Director of Theraclion, says: "Based on its existing commercial platform, Theraclion is continuing its dynamic development of its Echopulse® treatment solution on its historical pathologies, thyroid nodules and breast fibroadenoma. During the first half of this year, Theraclion sold four Echopulse® units in Germany, allowing total sales close to one million euros, an increase of 12% compared to the first half of 2018. The CE mark obtained in April for the SONOVEIN® varicose vein treatment solution, the adoption of our first trade agreement in May with a UK customer and the number of commercial treatments that have been performed since then confirm our ambition to enter a $ 10 billion1 varicose veins market with our innovative treatment offer: no catheter, no injection of chemicals and no incision. Theraclion is expected to accelerate its sales growth in second half of 2019 to reach between 30% and 50% sales growth this year. This sales growth is expected to carry on the following years to achieve break even quarters within three years.”

Growth in sales of Theraclion SA: + 12%

Theraclion SA achieved a turnover of K€ 962 in the first six months of 2019.

Equipment sales, which account for 76% of the business, were up 11% compared to first semester 2018. In Germany, four treatment solutions were sold against only one in 2018 (H2). This dynamism is part of the broadening of the reimbursement in Germany of echotherapy for the treatment of thyroid nodules and breast fibroadenoma where the current number of insured is now reaching approximately 18.6 million people.

Following CE marking for the SONOVEIN® varicose vein treatment solution in April 2019, the first commercial treatments started in May, generating 12 K€ in consumable sales as of June 30. Sold as a pay-per-use model, the SONOVEIN® solution should, after a ramp-up period, generate close to € 200,000 per year per site, a source of high and recurring free cash flow.

Recurring revenue, consisting of the sale of consumables and services, increased by 46% in the first half of 2019, from 137 K€ to 200 K€.

Annual Sales / K€

2019

2018

Variation

Echopulse® sales

728

653

+11%

Echopulse® rent

36

72

-50%

SONOVEIN® consumables sales (a)

12

0

na

Echopulse® Consumables sales (b)

102

70

+46%

Service sales (c)

86

67

+28%

Total Sales Theraclion Sa

963

862

+12%

1 Millenium research varivose Vein Device Market Study 2015

Growth in the number of treatments in clinical routine: + 21%

The number of treatments in clinical routine (that is, treatments performed outside a Theraclion-sponsored clinical study) increased by 21%. In the first half of 2019, 449 clinical routine treatments were performed. Several reference sites in Germany, Spain and Hong Kong have selected echotherapy as an effective method of treatment of thyroid nodules, which also offers them a differentiating advantage in their reference market.

57 varicose vein treatments were performed in one and a half months, demonstrating the extremely fast adoption of this solution in open centers since the CE marking was obtained in April 2019.

Cash position

At June 30, 2019, Theraclion's available cash position amounted to € 3.1 million2. Given this available cash in hands, expected double-digit sales growth and a tax credit refund, Theraclion estimates that it will be able to cover its cash requirements until the end of 2019.

For the record, Theraclion announced in February the signing of a € 4.8 million financing agreement that can be increased to a maximum of € 11.8 million. This 3-year funding gives Theraclion the necessary resources to implement its strategy: develop a varicose vein treatment solution and demonstrate its commercial relevance. The first tranche (tranche 1) of this € 4.8 million financing agreement was exercised in February at a price of € 0.80 per share, representing a premium of 34% over the closing price of 11th February 2019 (0.596 €).

In the wake of the Annual General Meeting of April 19, 2019, warrants were issued for the benefit of investors involved in the € 4.8 million financing transaction (tranche 1), enabling them to participate via the exercise of the warrants in the additional financing of tranches 2 and 3 amounting respectively to € 3 million and € 4 million maximum. Exercice of tranche 2 or tranche 3 warrants gives right directly or indirectly to Theraclion share at a price respectively of € 0.80 per share or € 1.09 per share. No warrants were executed at this date.

About Theraclion

Theraclion develops an innovative, high-techonology echotherapy solution using therapeutic ultrasound to treat varicose veins non-invasively with its SONOVEIN® product. The SONOVEIN has received the CE mark in April 2019 and uses no catheter, no injection of chemicals and no incisions. No operating rooms are required. It’s based on the company’s previous experience with its Echopulse® solution. Echopulse allows a non-invasive tumor ablation through ultrasound-guided high-intensity focused ultrasound (HIFU) of breast fibroadenomas and thyroid nodules.

Varicose veins are a common pathology and generated 5 million interventions annually, according to the Millenium research Varicose Vein Device Market Study 2015.

Theraclion’s solutions are based on a combination of ultrasound imaging and therapeutic ultrasound, providing accuracy and ease of use to practitioners.

Based in Malakoff, near Paris, France Theraclion has brought together a team of 25 people, 50% of whom are dedicated to R&D and clinical trials.

For more information, please visit Theraclion’s website: www.theraclion.com

Theraclion is listed on Euronext Growth Paris

Mnémonique : ALTHE – Code ISIN : FR0010120402
LEI: 9695007X7HA7A1GCYD29

2 Numbers non audited