Stock Markets
Theraclion Announces Major Advances and Reports First-Half Financial Results
On the strength of its progress on its 2023 and 2024 priorities (access to the US market, R&D and China), Theraclion is planning its commercial ramp-up for 2025 and 2026.
- Pivotal study for access to the important US market: treatments completed in June 2024 as planned;
- R&D and product development: the SONOVEIN is reaching a new level of maturity in clinical effectiveness, as recently highlighted by numerous KOLs;
- Preparing for the commercialization of SONOVEIN in Europe and the Middle East.
MALAKOFF, France–(BUSINESS WIRE)–Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy for the treatment of varicose veins, reports on the implementation of its strategy for the first half of 2024 and the start of its commercial ramp-up.
Martin Deterre, Theraclion’s Chief Executive Officer, states, “During the first half of 2024, we achieved major milestones in Theraclion’s strategy based on access to the US and Chinese markets and on advances in SONOVEIN ® technology and clinical performance. This strategy is paying off: with over 2,700 veins treated and clinical efficacy demonstrated in the daily practice of numerous KOLs across Europe and publicly presented, SONOVEIN has reached a new level of maturity. Theraclion intends to pursue its efforts in these strategic areas, with further concrete advances expected in 2025 in regulatory and product development aspects.
In parallel, and given the product’s current performance level, the company is already preparing the next stages of its development, with commercialization ramp-up set to begin in 2025. This gradual targeted commercialization, with measured resources, will begin in Europe, where we are focusing on recurring revenues thanks to our installed base (sale of consumables), and in the Middle East, a buoyant market for system sales. We are aiming for a turnover of €2.5 million in 2025 and €5 million in 2026. After 2026, once FDA approval has been obtained, we expect sales to accelerate in particular through the search for a strategic partnership in the United States.
Access to the US market: a key stage in the FDA approval process for SONOVEIN ® achieved on schedule
In the United States, treatments in the pivotal FDA (Food and Drug Administration) approved study for SONOVEIN ® ended on schedule in mid-June, marking a key stage in the approval process. A total of 70 patients took part in the clinical trial, conducted at four leading centers in the United States and Europe. A 12-month follow-up period has thus begun, and final results should be available in summer 2025. The marketing authorization application should be submitted to the FDA in the second half of 2025, with approval expected in early 2026. These steps will pave the way to the largest market in the world and to high-impact strategic partnerships.
The maturity of SONOVEIN ®’s clinical performance has been highlighted at leading medical conferences and in scientific journals:
- Professor Paolo Casoni and his team reported a 98.3% efficacy rate for SONOVEIN ® on 188 treated limbs followed up for 12 months. Their results were published last April in Phlebology, The Journal of Venous Disease, a leading vascular pathology journal.
- Last June saw SONOVEIN ®’s inclusion in the American Venous Forum guidelines, thanks to an article by Dr. Steve Elias in the prestigious Handbook of Venous and Lymphatic Disorders, Guidelines of the American Venous Forum.
- During the first half of 2024, 12 presentations by 10 opinion leaders practicing in 5 different countries took place during international conferences in several countries (USA, UK, Italy, Spain, Greece and Canada), based on follow-ups of up to 3 years with success rates in the order of 90 to 100% on cohorts comprising up to several hundred patients treated in routine activity1.
A strong commitment to R&D and product development
Major progress has been made in recent months on specific SONOVEIN ® functionalities, particularly in Artificial Intelligence, acoustics and 3D robotics, aimed primarily at significantly increasing treatment speed. These improvements will enable greater adoption by treatment centers and a sharp increase in the addressable market, ensuring that Theraclion’s long-term growth prospects are both significant and sustainable.
Subject to the timely granting of new regulatory approvals, the deployment of these technological improvements in the field is scheduled for 2025 and 2026, underpinning the commercial development expected over this period.
First-half 2024 results
In €K | 30/06/2024 | 30/06/2023 | Var. % |
Turnover | 442 | 981 | |
from equipment sales | 108 | 597 | -82% |
from sales of consumables | 287 | 314 | -9% |
from sales of services | 46 | 69 | -33% |
Subsidies | 138 | 0 | |
Other products | 38 | 0 | |
Write-back of depreciation and provisions | 11 | 0 | |
Total operating income | 628 | 981 | -36% |
Purchases of goods and stock variation | 170 | 532 | -68% |
Gross margin | 271 | 449 | -40% |
% Gross margin | 61 % | 45% | |
Other purchases and external expenses | 1 640 | 1 115 | 47% |
Purchases of goods and external charges | 1810 | 1647 | 10% |
Salaries and social charges | 1 661 | 1 957 | -15% |
Depreciation expenses | 102 | 103 | -1% |
Allocations to provisions | 41 | 424 | -90% |
Other expenses | 30 | ||
Other operating expenses | 1 805 | 2 514 | -28% |
Operating income | -2 987 | -3 179 | -6% |
Financial result | 84 | -65 | 228% |
Extraordinary result | 16 | 263 | -94% |
Research tax credits | 525 | 504 | 4% |
Net income | -2 363 | -2 476 | -5% |
Average headcount (FTE) | 28 | 30 |
These accounts have been subject to a limited review by the auditors.
Turnover for the first half of 2024
In the first half of 2024, sales of consumables to existing customers remained stable, while sales of new systems, which were not a priority, fell by 82% in the first half.
Operating income came to 628K €, including an operating subsidy of 138K € received in the first half.
Until now, Theraclion has focused on supporting centers equipped with SONOVEIN ® in order to improve their experience, rather than on prospecting for new customers. In the first half of the year, the company focused its resources on improving products and treatment protocols, as well as on clinical trials with a view to ensuring the success of the US clinical trial.
From 2025 onwards, given the progress made in clinical trials and R&D, the Company will gradually be devoting resources to its commercial roll-out, with priority given to Europe and the Middle East.
Operating expenses
The increase in gross margin reflects a favorable product mix, with margin-generating services and consumables accounting for 75.3% of sales as against 39.1% in the first half of 2023.
External expenses of 1,640K €, compared to 1,115K € at end June 2023 reflect expenditures linked to the clinical study in the United States (333K €). This increase is partly offset by a 15.1% reduction in compensation and benefits compared to prior year period.
After taking account of allocations to the provisions to the tune of 41.5K €, operating income came to a loss of 2,987K €, down 6% compared with the first-half 2023.
The financial result amounted to €84K due to interest gained from long term bank savings.
After taking account of the Research Tax Credit (Crédit Impôt Recherche – CIR), amounting to 525K €, the net loss comes to 2,363K €, down 4.6% year-over- year.
Evolution of cash flow and going concern
On June 30, 2024, Theraclion had a cash balance of €5.9 million. This cash position will cover Theraclion’s needs until the end of the first quarter of 2025.
Future short-term cash inflows include:
- Short-term cash inflows include payment of the 2023 Research Tax Credit amounting to 1,049K €.
- Second-half turnover forecast up on first-half.
The Company has already taken steps to secure the financing it needs to pursue its strategy and begin its commercial expansion.
About Theraclion
Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.
High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room, leaves no scars, and enables patients to return to their daily activities immediately. The HIFU treatment method concentrates therapeutic ultrasounds on an internal focal point from outside the body.
Theraclion develops the HIFU, CE-marked, platform for varicose veins treatment SONOVEIN ®, which has the potential to replace millions of surgical procedures every year. In the United States, SONOVEIN ® is an investigational device limited to investigational use; it is not available for sale in the U.S.
Based in Malakoff (Paris), the Theraclion team is made up of some 30 people, most of them involved in technological and clinical development.
For more information, please visit www.theraclion.com and follow the LinkedIn account.
Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE – ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29
_________
1 References available on www.theraclion.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20241030713291/en/
Theraclion contact
Martin Deterre
Chief Executive Officer
contact@theraclion.com
Source: Theraclion
JERUSALEM (Reuters) – The population of Gaza has fallen 6% since the war with Israel began nearly 15 months ago as about 100,000 Palestinians left the enclave while more than 55,000 are presumed dead, according to the Palestinian Central Bureau of Statistics (PCBS).
Around 45,500 Palestinians, more than half of them women and children, have been killed since the war began but another 11,000 are missing, the bureau said, citing numbers from the Palestinian Health Ministry.
As such, the population of Gaza has declined by about 160,000 during the course of the war to 2.1 million, with more than a million or 47% of the total children under the age of 18, the PCBS said.
It added that Israel has “raged a brutal aggression against Gaza targeting all kinds of life there; humans, buildings and vital infrastructure… entire families were erased from the civil register. There are catastrophic human and material losses.”
Israel’s foreign ministry said the PCBS data was “fabricated, inflated, and manipulated in order to vilify Israel”.
Israel has faced accusations of genocide in Gaza because of the scale of death and destruction.
The International Court of Justice (ICJ), the United Nations’ highest legal body, ruled last January that Israel must prevent acts of genocide against Palestinians, while Pope Francis has suggested the global community should study whether Israel’s Gaza campaign constitutes genocide.
Israel has repeatedly rejected accusations of genocide, saying it abides by international law and has a right to defend itself after the Hamas attack on Oct. 7, 2023 killed 1,200 Israelis and precipitated the current war.
The PCBS said some 22% of Gaza’s population currently faces catastrophic levels of acute food insecurity, according to the criteria of the Integrated Food Security Phase Classification, a global monitor.
Included in that 22% are some 3,500 children at risk of death due to malnutrition and lack of food, the bureau said.
CARACAS (Reuters) -Venezuela’s economy grew over 9% in 2024, President Nicolas Maduro said, according to a transcript of an interview published by Mexican media outlet La Jornada on Wednesday.
“In 2023, we had 5.5% (growth). In 2024, according to all scientific, statistical, and technical data, we will surpass 9% growth in gross domestic product, with a very high level of growth in the real economy, as well as in the hydrocarbons sector,” Maduro told Spanish journalist Ignacio Ramonet.
Venezuela’s economy in recent years has experienced a prolonged crisis marked by triple-digit inflation and the exodus of millions of Venezuelans seeking better opportunities elsewhere.
In 2019, the government loosened controls on the private sector, allowing for an informal dollarization, which provided a lifeline to key sectors of the economy.
However, analysts believe the strategy has not been sufficient for a full economic recovery.
The interview with Maduro is set to air on Venezuelan state television on Wednesday evening.
By Brian Thevenot
NEW ORLEANS (Reuters) -A driver crashed his pickup truck into a crowd celebrating New Year’s Day in New Orleans’ French Quarter and opened fire, killing 10 people and injuring more than 35, in an early morning attack the FBI said was a potential act of terrorism.
The suspect, described by one city leader as being in “full military gear,” died after a shootout with police, law enforcement officials said.
“This man was trying to run over as many people as he could,” Police Chief Anne Kirkpatrick said at a televised press conference on Wednesday. “He was hell-bent on creating the carnage and the damage that he did.”
The incident occurred at 3:15 a.m. (0915 GMT) at the intersection of Canal and Bourbon Streets, a historic tourist destination in the city’s French Quarter known for attracting large crowds with its music and bars.
Kirkpatrick said the driver, who swerved around barricades, fired at police and struck two police officers from the vehicle after it crashed. The officers were in stable condition, she added.
“We know the perpetrator has been killed,” said New Orleans City Councilman Oliver Thomas. “As we search for a motive, remember there is no making sense of evil.”
Officials did not immediately name the suspect.
NBC News, citing three unnamed senior law enforcement sources, identified the suspect as Shamsud Din Jabbar, 42.
NOLA.com, citing one unidentified law enforcement source, reported that same suspect was carrying an ISIS flag in the truck. Reuters was unable to verify the reports and the U.S. Army did not immediately respond to a request for comment.
More than 300 officers were on duty at the time of the incident, police said. The city hosts the Sugar Bowl, a classic American college football game, each New Year’s Day, and will also be the site of the NFL Super Bowl on Feb. 9.
New Orleans Mayor LaToya Cantrell called the incident a terrorist attack.
The FBI said in a statement that it was investigating the incident as an act of terrorism. Initially, Alethea Duncan, an assistant special agent in charge of the FBI’s New Orleans field office, had said it was not a terrorist event.
Duncan said a suspected improvised explosive device was found but provided no further details.
“From what I understand, there is a potential that other suspects could be involved in this, and all hands on deck on determining who these individuals are and finding them,” New Orleans City Council President Helena Moreno told 4WWLTV.
“Information that I received is that this individual was in full military gear, that he is apparently not local, and that he was prepared, and that he was very prepared to inflict horrific pain on the people on Bourbon Street,” Moreno said.
‘HORRIFIC ACT’
Verified video taken by an onlooker shows at least two twisted bodies in the street, with one of them lying in what appears to be a puddle of blood. A bystander is seen kneeling over one of the bodies as a group of uniformed military personnel in green uniforms and carrying firearms runs past.
The injured were taken to at least five hospitals, according to NOLA Ready, the city’s emergency preparedness department.
A couple told CBS News that they heard crashing noises coming from down the street and then saw a white truck slam through a barricade “at a high rate of speed”.
Zion Parsons (NYSE:), 18, told NOLA.com that he and his two friends were leaving a Bourbon Street eatery when they heard a commotion and saw a white car barreling toward them.
He said he dodged the vehicle, but one of his friends was struck, with her leg “twisted and contorted above and around her back.”
“You can just look and see bodies, just bodies of people, just bleeding, broken bones,” he said.
Louisiana U.S. Senator Bill Cassidy said on CNN that despite the attack, law enforcement in New Orleans was ready for the Sugar Bowl on Wednesday night. “The Superdome has been locked down,” he said.
In response to vehicle attacks on pedestrian malls around the world, New Orleans was in the process of removing and replacing the steel barriers known as bollards that restrict vehicle traffic in the Bourbon Street pedestrian zone. The project’s status was unclear at the time of Wednesday’s attack.
Construction began in November 2024 and was scheduled to continue through February 2025, according to a city website.
Last month in Germany, a 50-year-old man was charged with multiple counts of murder and attempted murder after police said he plowed a car through crowds at a Christmas market in Magdeburg, killing five people and injuring scores.
President Joe Biden called the city’s mayor to offer full federal support. President-elect Donald Trump said his incoming administration would help New Orleans as it investigates and recovers from what he called an act of pure evil.
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