Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

TAMPA, Fla., Jan. 7, 2025 /PRNewswire/ -- Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports positive outcomes from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) RCT, which show that its sirolimus-coated balloons (SCB) (MagicTouch -PTA) provide patency and functional benefits on par with paclitaxel-coated balloons for patients suffering from peripheral artery disease (PAD). The 1-year data was presented by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late–Breaking Clinical Trials Session (LBCT). Coverage by TCTMD has highlighted these findings, underscoring sirolimus-based therapy as a viable new option in femoropopliteal interventions.

The prospective, multi-center, head-to-head, core lab adjudicated RCT enrolled a total of 482 patients across 25 sites in Germany and Austria and compared the MagicTouch PTA sirolimus-coated-balloon against 7 commercially available paclitaxel-coated-balloons.

Key Results

• Primary Patency: SIRONA concluded that a primary patency of 73.8% was achieved by MagicTouch PTA against 75% of Paclitaxel DCBs showing a mere rate difference of 1.2% and meeting the non-inferiority efficacy endpoint of primary patency.
• Favorable Safety Profile: SIRONA demonstrates no significant difference in cdTLR (clinically-driven Target Lesion Revascularization) at 12 months, 92.9% (MagicTouch PTA) and 95.4% (Paclitaxel group).
• Functional Improvements: SIRONA showcased similar improved functional outcomes with both Sirolimus and Paclitaxel groups with a 0.1 difference between them and 89% improving by ≥1 Rutherford stage and many by ≥2 stages.

"Historically, paclitaxel-coated balloon angioplasty has been the mainstay therapy for PAD, particularly in the femoropopliteal vascular segment, and is based on the 'leaving nothing behind' principle. However, safety concerns remain, so that emerging evidence supports the exploration of sirolimus as alternative drug option in the treatment of PAD. With the SIRONA RCT showing sirolimus to be as effective as paclitaxel, physicians may soon have more personalized approaches to address the wide-ranging needs of PAD patients," said Prof. Ulf Teichgräber.

Prof. Dierk Scheinert, who has been supporting and encouraging the RCT stated after the exciting results, "After several positive signals from pre-clinical studies and smaller single arm investigations with sirolimus coated DCBs, the findings of the SIRONA RCT using the Head-to-Head randomization design represent the first level one evidence to support clinical efficacy of the Magic Touch sirolimus-coated DCB for a broad spectrum of femoropoliteal obstructions."

"Concept Medical has consistently pursued innovation in vascular therapy," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. "The results of the SIRONA trial advance our mission to offer patient-centric, evidence-based solutions that improve the care and outcomes of those challenged by PAD."

About Concept Medical

Headquartered in Tampa, Florida, Concept Medical is a world leader in cutting-edge drug-delivery platforms. Its flagship MagicTouch Sirolimus Coated Balloon (SCB) has reshaped the landscape of coronary and peripheral interventions, reaching more than a million patients globally by continuously investing in rigorous clinical research—exemplified by the SIRONA trial—Concept Medical remains at the forefront of developing next-generation vascular therapies.

For more information on the SIRONA trial or Concept Medical's innovative portfolio of devices, please visit: www.conceptmedical.com

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Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

KAMPONG CHHNANG, Cambodia, Sept. 19, 2026 /PRNewswire/ -- On September 17, the inauguration ceremony of GAC Cambodia KD Plant was grandly held in Kampong Chhnang Province. Cambodian Prime Minister Hun Manet and Chinese Ambassador to Cambodia Wang Wenbin attended the ceremony, while Jiang Xiuyun, Deputy General Manager of GAC Group, and Wang Shunsheng, Deputy General Manager of GAC International and President of the Southeast Asia Regional Center, together with the leadership of TH Group, GAC's strategic partner in Cambodia, witnessed the official launch of the THAM assembly plant for GAC vehicles. This marks a new stage in GAC's development in Cambodia, transitioning from complete vehicle exports to local manufacturing, and stands as yet another achievement of China-Cambodia economic and trade cooperation.

Prime Minister Hun Manet was present in person to witness this important moment. He noted that the official commencement of the GAC KD Plant is a significant achievement of the Royal Government of Cambodia's industrial transformation, helping Cambodia upgrade from labor-intensive industries to capital-, advanced-technology- and high-skill-driven sectors, spurring local industrial development, raising the added value of the national economy, and cultivating new sources of economic growth.

From complete vehicle imports to local assembly, GAC has steadily built its presence in Cambodia. The project was fully launched in 2024, and through close collaboration among all parties, the plant completed all preparatory and construction work and officially entered production. Under this local assembly project, TH Group is responsible for plant investment, construction and vehicle assembly, while GAC supplies complete knocked-down (CKD) kits, technical standards and full-chain technical support. With a designed annual capacity of around 10,000 units.

Strong market performance further validates the results of GAC's deep cultivation. TRUMPCHI has enjoyed explosive growth in Cambodia since 2024, with an average annual compound growth rate of over 300% over the past three years, and ranked first among Chinese automotive brands in Cambodia in 2025, with continuously expanding brand influence.

The production launch of GAC Cambodia KD Plant marks a brand-new starting point for GAC's deep cultivation in Cambodia. Over the past seven years, from channel development to product rollout, from brand establishment to manufacturing upgrading, GAC has been sharing development opportunities with the Cambodian people through tangible capacity, employment and technology.

For further information about GAC, please visit: https://www.gacgroup.com/en or follow us on social media.

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GAC Cambodia KD Plant Starts Production, Setting a New Benchmark for Localized Manufacturing