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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
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
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment
Over 15,000 visitors to the INCHEON–IFEZ Booth; IFEZ supported a record 50 innovation companies participating in CES 2026.
Participating companies secure a foundation for global expansion, including 20 MoU signings.
INCHEON, South Korea, Jan. 16, 2026 /PRNewswire/ -- The Incheon Free Economic Zone (IFEZ) announced the successful operation of the INCHEON–IFEZ Booth at CES 2026, presenting IFEZ's future-city vision and the technologies of Incheon-based innovators to a global audience.
Under the theme "Destination Incheon — From Smart City to AI City," the booth highlighted a sustainable urban future enabled by Incheon companies' innovations and drew more than 15,000 visitors, according to IFEZ.
During CES 2026, IFEZ also met with the Fairfax County Economic Development Authority (FCEDA) to discuss support measures and collaboration models for helping Incheon startups enter the U.S. market. The two sides plan to develop practical joint programs through continued cooperation.
IFEZ supported a record 50 companies at CES 2026 across multiple participation tracks, dividing them across various exhibition areas: 10 companies in the 'INCHEON-IFEZ' Booth at the Las Vegas Convention Center, 10 in the Korea pavilion (KOTRA) at the Eureka Park, 6 in the Global Pavilion, and 15 as the Incheon Startup Park Delegation and 10 Innovation Award showcase participants.
These companies achieved record-breaking results, conducting 1,419 business consultations with overseas buyers and investors, with the estimated value of export consultations reaching $560 million—more than 400 additional meetings compared to last year. In addition, nine companies signed 20 MOUs, building momentum for global expansion and investment opportunities.
Leadpoint System, a smart manufacturing and industrial automation solutions provider, signed an MOU with Webtronic Labs, a U.S.-based technology R&D company.
emCT, which specializes in fire detection and safety management solutions, signed an MOU with Texas Legacy Realty, a Texas-based real estate development and operations company, to pursue collaboration on applying fire safety and "safe zone" solutions in commercial and residential buildings.
Medicell Healthcare, a regenerative medicine and bio-healthcare solutions company, signed an MOU with the City of Phoenix, Arizona's largest city, and discussed cooperation on technology collaboration and local proof-of-concept initiatives in public healthcare.
IFEZ said 14 supported companies earned 17 CES Innovation Awards, the highest total to date for Incheon, drawing strong interest from global buyers and investors. Deep Fusion AI received a Best of Innovation honor for its radar-based sensor-fusion AI technology, gaining attention in next-generation autonomous driving and robotic perception.
Mayor Yoo Jeong-bok said the CES participation advanced the Incheon–IFEZ AI City vision on the global stage and pledged continued support to expand Incheon companies' international reach and strengthen Incheon as a global business hub.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
INCHEON-IFEZ Booth Wraps Up a Successful CES 2026, Recording $560M in Export Consultations and 17 Innovation Awards
