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CARLSBAD, Calif. — November 4, 2024 — Bolt Medical, Inc., a clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of coronary and peripheral arterial calcification.

Bolt Medical today announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the company’s Bolt IVL^TM Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral arterial disease in patients with moderate to severe calcified lesions. The data from both studies was presented today in the Late Breaking Clinical Trials session at the VIVA 2024 conference and will be used to support FDA and CE Mark regulatory submissions.

RESTORE ATK enrolled 95 subjects in the prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in the superficial femoral and popliteal arteries. The study was led by Principal Investigator Professor Marianne Brodmann, Head of Division of Angiology at the Medical University of Graz, Austria. The primary safety endpoint of the trial was freedom from MAE (Major Adverse Events) within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as residual diameter stenosis <50%. Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation and no clinically driven target lesion revascularization supporting the achievement of both the primary safety and efficacy endpoints in the trial.

RESTORE BTK is a prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in 20 enrolled patients with moderate to severe calcified infrapopliteal arteries. The study was conducted at 3 centers across Europe and led by Principal Investigator Dr. Michael Lichtenberg, Chief Medical Officer and Director of the Angiology Department and Vascular Center at the Arnsberg Clinic in Arnsberg, Germany. The primary safety endpoint of the trial was freedom from MAE within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as acute reduction in percent diameter stenosis of the target lesion. Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation and no clinically driven target lesion revascularization supporting the achievement of both the primary safety and efficacy endpoints in the trial.

“The patients treated in the RESTORE BTK Trial presented challenges to traditional IVL therapy.  The improved deliverability and crossability of the Bolt IVL catheter accessed complex lesions with ease. Moreover, the visible emitters on the Bolt IVL catheter provided me with the ability to directly focus acoustic energy on areas of persistent calcification,” said Dr. Lichtenberg.

“The Bolt team is proud to accomplish these major clinical milestones with the completion of both the RESTORE ATK and RESTORE BTK pivotal trial,” said Keegan Harper, Chief Executive Officer of Bolt Medical. “Bolt IVL is positioned to expand the peripheral market and advance patient care as the company plans regulatory submissions for both peripheral devices in the near future.”

About Bolt Medical, Inc.

Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The Bolt IVL system is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter and will feature increased available therapy, a highly deliverable catheter, and visible, directional emitters to target consistent energy for the treatment of concentric, eccentric and nodular calcium lesions. The company is concurrently studying three catheter platforms for various arterial vessel beds. 

Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.

Bolt IVL™ is the trademark of Bolt Medical, Inc.

Media Contact

Bolt Medical

Media inquiries: [email protected]

www.boltmed.com

CARLSBAD, Calif. — October 28, 2024 — Bolt Medical, Inc., a clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of calcified cardiovascular disease.

Bolt Medical announced the intravascular ultrasound (IVUS) results of 22 patients enrolled in the RESTORE FIH (First in Human) Coronary feasibility clinical trial using the company’s Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions. Matthew J. Price, MD, Professor of Medicine and Director of the Cardiac Catheterization Laboratory in the Division of Cardiovascular Diseases at Scripps Clinic, La Jolla, California, presented the IVUS results of this prospective, observational, feasibility study during the TCT 2024 conference.

Intravascular lithotripsy (IVL) has been shown to be a safe and effective treatment for severely calcified coronary lesions.* IVUS was used to evaluate how the Bolt IVL system facilitated optimal stent implantation. Twenty-two patients enrolled in the RESTORE FIH trial, a prospective, feasibility study designed to evaluate initial safety and effectiveness of the Bolt Medical IVL coronary catheter, had evaluable IVUS images at baseline and post-stent implantation. The Bolt IVL system features the unique CAD360™ design where each emitter station is comprised of 4 emitters equally spaced 90° apart.  IVUS images were evaluated by an independent, core laboratory (VasCore, Boston, MA). 

IVUS results post-IVL and stenting support the efficacy of the Bolt IVL system by achieving a minimal stent area (MSA) of 8.07 ± 2.48 mm² with absolute stent expansion of 101% of expected diameter resulting in MSA > 5.0 mm² in 95% and > 5.5 mm² in 91% of patients.  Stent delivery, implantation and post-dilation were successful in all cases.

Commenting on these results, Dr. Price, said, “The data from the Bolt FIH IVUS study are particularly exciting given the achieved MSA and stent expansion, as it supports the safety and efficacy of a novel approach to deliver lithotripsy energy for the treatment of severely calcified coronary lesions. I am looking forward to the results of the FRACTURE IDE trial, so that the potential benefits of this technology – including a uniform energy profile, more pulses, and ease of delivery – can help address the unmet needs of our patients undergoing complex PCI.”

“The trial data confirms that the Bolt IVL laser-based mechanism of action with unique CAD360™ emitter design led to outstanding results measured by intravascular imaging that confirm the effect of the Bolt therapy on severe calcium,” said
Keegan Harper, Chief Executive Officer of Bolt Medical. “The positive clinical feedback on device performance and outcomes gives us tremendous confidence to move this innovative IVL platform forward in coronary arteries with a planned global IDE pivotal trial.”

*JACC. 2020 Dec, 76 (22) 2635-2646

About Bolt Medical, Inc.

Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The company is concurrently studying three unique catheter platforms for various arterial vessel beds. The Bolt IVL system is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter and will feature increased available therapy, a highly deliverable catheter, and visible, directional emitters to target consistent energy for the treatment of concentric, eccentric and nodular calcium lesions.  

Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.

Bolt IVL™ and CAD360™ are trademarks of Bolt Medical, Inc.

Media Contact

Bolt Medical

Media inquiries: [email protected]

www.boltmed.com

CARLSBAD, Calif. — May 29, 2024 — Bolt Medical, Inc., a clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of calcified cardiovascular disease.

Bolt Medical today announced the results of the first 60 patients enrolled in the RESTORE ATK pivotal clinical trial using the company’s Bolt IVL^TM Above the Knee System for the treatment of peripheral arterial disease with moderate to severe calcified lesions as presented during the LINC 2024 conference in Leipzig, Germany. Principal investigator, Professor Marianne Brodmann, Head of Division of Angiology at the Medical University of Graz, Austria, presented the results from the prospective, single-arm trial designed to assess the safety and efficacy of the Bolt IVL system in 95 enrolled patients.

The primary safety endpoint of the trial was freedom from MAE (Major Adverse Events) within 30 days following the index procedure. The primary efficacy endpoint was procedural success, defined as residual diameter stenosis <50%. Through 30 days, there were no reports of MAE including severe dissection, perforation, or unplanned target limb major amputation and no clinically driven target lesion revascularization supporting the achievement of both the primary safety and efficacy endpoints in the trial. The successful completion of RESTORE ATK with the first 60 patients provides the powered data set for 510(k) and CE Mark regulatory submissions for the Bolt IVL ATK System.

“The RESTORE ATK trial demonstrated outstanding safety and efficacy in the 60 reported patients at 30 days. I am particularly impressed with the device outcomes as the enrolled patients had severe calcification with 26% percent of lesions being chronic total occlusions (CTO). The Bolt IVL system’s increased pulses and targeted therapy provide advancements to address unmet needs of IVL therapy to treat these complex patients with stand-alone IVL therapy, importantly with a low 12% rate of post-dilation required.” stated Professor Brodmann.

“We are thrilled with the results of the RESTORE ATK pivotal trial and thank all who made this possible, especially our physician investigators and research staff as well as their patients,” said Keegan Harper, Chief Executive Officer of Bolt Medical. “The positive safety and efficacy data highlight the advanced features of our laser-based IVL and is another major milestone that will contribute to the company’s first regulatory submission of the Bolt IVL ATK System.”

About Bolt Medical, Inc.

Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The Bolt IVL system is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter and will feature increased available therapy, a highly deliverable catheter, and visible, directional emitters to target consistent energy for the treatment of concentric, eccentric and nodular calcium lesions. The company is concurrently studying three unique catheter platforms for various arterial vessel beds.

Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.

Bolt IVL™ is a trademark of Bolt Medical, Inc.

Media Contact

Bolt Medical

Media inquiries: [email protected]

www.boltmed.com

CARLSBAD, Calif. — May 16, 2024 — Bolt Medical, Inc., a clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of calcified cardiovascular disease.

Bolt Medical today announced the results of the first 28 patients enrolled in the RESTORE FIH (First in Human) Coronary feasibility clinical trial using the company’s Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions as presented during the EuroPCR 2024 conference in Paris, France. Andrius Berukstis PhD, MD, Associate Professor and site principal investigator at Vilnius University Hospital Santaros Clinic, Vilnius, Lithuania, presented the results from the prospective, single-arm observational feasibility trial.

The primary efficacy endpoint was procedural success, defined as successful stent delivery with a residual diameter stenosis <50% and freedom from in-hospital MACE. The primary safety endpoint of the study was freedom from MACE* within 30 days following the procedure. Both the primary efficacy and safety endpoints were achieved in the trial. Importantly there were no reports of severe dissection, perforation or abrupt closure complications adding to the overall safety of the Bolt IVL Coronary System. The safety and efficacy data supports initiation of an IDE pivotal study which will be used to support global regulatory submissions.

“The RESTORE FIH trial clearly demonstrated that the Bolt IVL Coronary System is able to fracture calcium enabling optimal stent expansion and has an excellent safety profile. Moreover, the catheter design provided excellent deliverability across difficult lesions,” stated Dr. Berukstis.

Dr. Matthew Price, Professor of Medicine, Director Cardiac Catheterization Laboratory, Division of Cardiovascular Diseases, Scripps Clinic and clinical advisor to Bolt Medical added, “The data from the Bolt FIH study are particularly exciting, as it supports the safety and efficacy of a novel approach to deliver lithotripsy energy for the treatment of severely calcified coronary lesions. I am looking forward to the results of the FRACTURE IDE trial, so that the potential benefits of this technology – including a uniform energy profile, more pulses, and ease of delivery – can help address the unmet needs of our patients undergoing complex PCI.”

“This trial data confirms that the Bolt IVL laser-based mechanism of action with unique CAD360™ emitter design led to excellent efficacy and safety results,” said Keegan Harper, Chief Executive Officer of Bolt Medical. “The positive clinical feedback on device performance and outcomes gives us tremendous confidence to move this innovative IVL platform forward in coronary arteries with a planned global IDE pivotal trial.”

About Bolt Medical, Inc.

Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The company is concurrently studying three unique catheter platforms for various arterial vessel beds that will feature highly deliverable catheters, increased available therapy, and visible, directional emitters to direct consistent energy for the treatment of concentric, eccentric and nodular calcium lesions.

Caution: The Bolt IVL™ System is an investigational device, which is not yet cleared for commercial distribution in any country.

Bolt IVL™ and CAD360™ are trademarks of Bolt Medical, Inc.

Media Contact

Bolt Medical

Media inquiries: [email protected]

www.boltmed.com

CARLSBAD, Calif. — April 22, 2024 — Bolt Medical, Inc., a clinical stage medical device company is developing a new generation intravascular lithotripsy (IVL) advanced laser-based platform with inherent advantages over commercially available IVL devices for the treatment of calcified cardiovascular disease. 

Bolt Medical today announced the completion of patient enrollment of the RESTORE ATK pivotal clinical trial using the company’s Bolt IVL^TM Above the Knee System for the treatment of peripheral arterial disease with moderate to severe calcified lesions. The data from RESTORE ATK, which will be presented later in 2024, will be used to support FDA 510(k) and CE Mark regulatory submissions.

The prospective, single-arm trial is designed to assess the safety and efficacy of the Bolt IVL system in 95 enrolled patients. The study was enrolled in 11 centers across Europe and led by principal investigator Professor Marianne Brodmann who serves as the Head of Division of Angiology at the Medical University of Graz, Austria.

“Effective calcium modification remains one of the toughest challenges in treating peripheral artery disease. The RESTORE ATK trial enrolled patients with severe calcification and a high percentage of chronic total occlusions (CTO). Further, female patients, another challenging cohort, were significantly represented within the trial as well. The Bolt IVL system’s unique energy platform, that offers increased pulses and targeted therapy provides a new generation of IVL that advances my ability to treat my patients with calcified lesions.” stated Professor Brodmann.

The Bolt IVL system is designed to fracture intimal and deep calcium by creating acoustic pressure waves inside of a balloon catheter and will feature increased available therapy, a highly deliverable catheter and visible, directional emitters to direct consistent energy for the treatment of concentric, eccentric and nodular calcium lesions.

“Intravascular lithotripsy therapy represents one of the fastest growing medical device markets. Bolt IVL is positioned to expand the market and advance patient care with our unique laser-based energy platform,” said Keegan Harper, Chief Executive Officer of Bolt Medical. “Our team is rapidly innovating the Bolt IVL system for coronary and peripheral arterial disease. We are proud to accomplish this major milestone of completing the enrollment of the RESTORE ATK pivotal trial.”

About Bolt Medical, Inc.

Bolt Medical is focused on the design and development of innovative IVL catheters used in coronary and peripheral interventional procedures, particularly in patients with moderate to severe calcified arterial disease. The company is concurrently studying three unique catheter platforms for various arterial vessel beds.

Caution: The Bolt IVL^TM System is an investigational device, which is not yet cleared for commercial distribution in any country.

Bolt IVL^TM is the trademark of Bolt Medical, Inc.

Media Contact

Media inquiries: [email protected]

www.boltmed.com