Vivasure Medical Announces First Large Hole Venous Patient Treated with PerQseal Elite Vascular Closure System

Investigational technology designed for patients undergoing emerging large bore percutaneous catheter-based venous interventional procedures

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The first successful implant was completed by Prof. Nicolas Van Mieghem, M.D. Ph.D., Clinical Director of Interventional Cardiology at the Thoraxcentre, Erasmus Medical Centre in Rotterdam, The Netherlands, as part of the company’s ELITE Venous Clinical Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of the vascular closure system.

Leveraging Vivasure Medical’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.

“Current venous closure methods are not indicated for large hole venous access applications like Transcatheter Edge-to-Edge repair (TEER), TMVR and TTVR. As these procedures become more common, there’s a need for closure options that can effectively address these emerging clinical applications,” said Prof. Nicolas Van Mieghem, principal investigator of the ELITE Study. “I’m looking forward to further study the PerQseal ELITE technology for venous closure and assess its performance for patients.”

The PerQseal Elite vascular closure system is placed from inside the vein, making deployment simpler and more controlled than conventional closure techniques and returning the vein to its natural state without leaving materials like collagen, metal implants or sutures behind, as commonly seen in other closure technologies.

“Cardiovascular procedures have increasingly adopted minimally invasive approaches, but conventional venous closure techniques have presented risks for vascular complications,” said Andrew Glass, chief executive officer of Vivasure Medical. “We’re encouraged by the early progress we’ve seen in clinical studies of the Elite vascular closure system to address this unmet need. I’m grateful to Prof. Van Mieghem for treating the first patient in this study and look forward to following the outcomes from other patients in this study.”

Vivasure’s Elite Venous Clinical Study will enroll up to 97 patients at up to 12 European investigational sites. Completion of the study is expected this year, and results will support CE mark and pre-market approval submissions.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal® is not available for sale in the United States.

Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study

PATCH Clinical Study will evaluate the safety and efficacy of Vivasure’s PerQseal Closure Device System for large-bore vessel punctures

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System. The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.

"We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology," said Andrew Glass, Chief Executive Officer of Vivasure Medical. "This marks an important milestone for Vivasure as it brings us closer to our goal of demonstrating PerQseal’s potential in supporting successful percutaneous cardiovascular therapies."

Large hole arterial access is required for clinicians to perform numerous life-saving percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.

PerQseal is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success.

The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe. The company intends to use the clinical study results to support an FDA pre-market approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

PerQseal® and PerQseal®+ are not available for sale in the United States.

Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

• Pivotal study expected to be completed by year-end 2023 and set the stage for commercialization of PerQseal® system for large hole vessel closure

• Company announces €30 million strategic investment from Haemonetics as part of its previously disclosed Series D financing

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal® Closure Device System.

The PATCH pivotal study will enroll up to 188 patients across the U.S. and Europe. The company intends to use the clinical study results to support an FDA pre-market approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.

The company also announced that Haemonetics Corporation (NYSE: HAE) (“Haemonetics”) invested €30 million in the company as part of its Series D financing, the initial tranche of which closed in May 2022. Haemonetics is a global healthcare company providing innovative medical products and solutions for interventional cardiology and electrophysiology procedures, the surgical suite, hospital transfusion services, and blood and plasma component collection. The strategic investment by Haemonetics includes an option to acquire Vivasure Medical upon completion of certain milestones. Large hole arterial closure represents a high growth global market opportunity currently estimated at over $300 million annually, with double-digit growth.

“We are excited to be moving forward with this multi-center pivotal study which we expect will affirm the safety and effectiveness of PerQseal for large hole arterial closure. Moreover, we are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure,” said Andrew Glass, Chief Executive Officer of Vivasure Medical. “We strongly believe in the potential of our fully absorbable patch-based approach to large hole closure, and these steps mark important progress toward fulfilling our mission of enabling safe and effective advanced structural and percutaneous cardiovascular therapies.”

“Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large hole percutaneous procedures,” said Stew Strong, President, Global Hospital at Haemonetics.

Large hole arterial access is required for clinicians to perform numerous life-saving percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.

PerQseal is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success.

Existing investors include Fountain Healthcare Partners, Orchestra BioMed Holdings Inc. (Nasdaq: OBIO), LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital. Vivasure Medical has also received support from Enterprise Ireland and the European Investment Bank.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

PerQseal® and PerQseal®+ are not available for sale in the United States.

Contacts

Media contact:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
612.770.0359

Vivasure Medical Announces Series D Financing to Advance Portfolio of PerQseal Vessel Closure Devices

Funds will support clinical development and regulatory approval of fully absorbable percutaneous closure devices for large-bore vessels

Vivasure Medical® (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the closing of the first tranche of €22 million ($23M) as part of its Series D financing round that could reach up to €52 million ($54M) in total. Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones. Other participants in this Series D financing round include a second strategic corporate investor as well as existing investors, Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.

The financing will support the U.S. and European clinical development and regulatory approval of the Company’s portfolio of fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures, including PerQseal® and PerQseal+ for arterial closure and PerQseal Blue for venous closure. Vivasure’s innovative PerQseal technology consists of a proprietary bioabsorbable intravascular patch that seals the vessel from the inside, returning the artery or vein to its natural state without leaving behind the remains of any materials such as collagen, metal implants or sutures commonly used in other closure technologies.

Vivasure Medical’s PerQseal device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe for use in transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). The Company’s next-generation PerQseal+ device has an enhanced bioabsorbable patch designed to address more complex patient anatomies and is currently under clinical evaluation in Europe and the U.S. Vivasure is also developing PerQseal Blue, designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.

“As minimally invasive approaches have become the standard of care for cardiovascular procedures, conventional vessel closure techniques have proven to prolong recovery and lead to bleeding complications for patients. This funding represents an important milestone for our company that will help to further advance our portfolio of novel PerQseal sutureless and fully absorbable vessel closure devices in the U.S. and Europe,” said Andrew Glass, chief executive officer of Vivasure Medical. “We are encouraged by early clinical progress from leading heart centers participating in studies currently underway for PerQseal+ and PerQseal Blue, and we look forward to initiating a U.S. pivotal study for PerQseal+ later this year that will support our submission to the FDA.”

“While tremendous progress has been made for minimally invasive structural heart procedures, vascular issues related to the closure of the procedure remain the most common complication of these interventions,” said Azeem Latib, M.D., section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System. “The novel PerQseal technology is designed to address these shortcomings and has tremendous potential to improve patient outcomes and enhance procedure efficiency.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is a medical device company developing advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

PerQseal®, PerQseal®+ and PerQseal® Blue are not available for sale in the United States.

Contacts

Sierra Smith
408-540-4296
sierra@healthandcommerce.com

Vivasure Medical Begins Clinical Evaluation of Next-Generation PerQseal+ Device

Vivasure Medical® today announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal®+, the next generation of the company’s PerQseal® device. The patient was enrolled by Dr. Fernando Gatto, head of cardiac catheter labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany and investigator of the study. The study will evaluate the company’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies.

The company’s PerQseal device is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), that require large-bore vessel access. The enhanced PerQseal+ device is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore closure.

“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” said Dr. Gatto. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”

“The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large bore closure,” said Dr. Christian Frerker, head of structural heart disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, and principal investigator of the Frontier V study. “This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”

“Enrolling the first patient in the Frontier V study is an exciting milestone in Vivasure’s mission to ensure success for percutaneous cardiovascular therapies,” said Andrew Glass, CEO of Vivasure. “The original PerQseal device has been well-received by clinicians since it became available in Europe because it helps address the complications and risks associated with access-site management for large-bore procedures. The enhanced PerQseal+ device promises to build on that success by enabling even better patient outcomes.”

Vivasure Medical Announces Development of Sutureless Venous Closure Device for Use in Percutaneous Transcatheter Procedures

• Investigational PerQseal Blue designed to be the world’s first and only fully absorbable device for large-bore venous closure

• Development program funded by €2.5 million grant awarded by the European Innovation Council Accelerator

Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced its development program for PerQseal® Blue, the company’s new investigational product. PerQseal Blue is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such transcatheter mitral valve repair or replacement (TMVR) and transcatheter tricuspid valve repair or replacement (TTVR). The PerQseal Blue technology is based on PerQseal, the company’s vascular closure device approved in Europe for use in femoral arteries.

The PerQseal Blue development program was first initiated in 2020 and is funded in part by a €2.5 million grant awarded by the European Innovation Council Accelerator (EIC). The EIC was part of the European Commission’s Horizon 2020 program and supports innovative entrepreneurs, small companies and scientists planning to expand internationally. Vivasure Medical was one of only 36 companies to receive a grant award from the EIC, which reviewed 1,852 applications from EU-based companies. Horizon 2020 is the largest EU research and innovation program, with nearly €80 billion of funding available over seven years.

“As transcatheter procedures for mitral and tricuspid valve treatment become increasingly common, there is a growing need for new venous closure options. These minimally invasive procedures require much larger punctures which often result in vascular complications,” said Dr. Azeem Latib, M.D., Section Head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York. “Based on my experience using PerQseal for large-bore arteries in percutaneous endovascular procedures, I am optimistic for the potential of PerQseal Blue to provide a simple and safe option for venous closure that does not leave behind any sutures, metal implants, or collagen.”

Currently, there are no sutureless options for venous closure following TMVR or TTVR procedures. PerQseal Blue has the potential to be the first sutureless, fully absorbable synthetic implant for large-bore venous closure following these catheter-based procedures. Leveraging Vivasure Medical’s PerQseal technology, PerQseal Blue consists of an intravascular patch designed to seal the vessel from the inside, returning the vein to its natural state.

“We’re thrilled to introduce PerQseal Blue to our product development portfolio as a potential new option specifically for large-bore venous closure following percutaneous cardiovascular procedures,” said Andrew Glass, CEO of Vivasure Medical. “We plan to advance our venous program to the clinical stage in 2022 with the initiation of a study to evaluate and optimize PerQseal Blue.”

PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures that require large-bore arterial vessel access, including TAVR, thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). Frontier V, a European multicenter study, was recently initiated to evaluate Vivasure Medical’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies. PerQseal+ is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore arterial closure.

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal Blue development program has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 946304.

Vivasure Medical Begins Clinical Evaluation of Next-Generation PerQseal+ Device

Vivasure Medical® today announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal®+, the next generation of the company’s PerQseal® device.

The patient was enrolled by Dr. Fernando Gatto, head of cardiac catheter labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany and investigator of the study. The study will evaluate the company’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies.

The company’s PerQseal device is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), that require large-bore vessel access. The enhanced PerQseal+ device is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore closure.

“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” said Dr. Gatto. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”

“The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large bore closure,” said Dr. Christian Frerker, head of structural heart disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, and principal investigator of the Frontier V study. “This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”

“Enrolling the first patient in the Frontier V study is an exciting milestone in Vivasure’s mission to ensure success for percutaneous cardiovascular therapies,” said Andrew Glass, CEO of Vivasure. “The original PerQseal device has been well-received by clinicians since it became available in Europe because it helps address the complications and risks associated with access-site management for large-bore procedures. The enhanced PerQseal+ device promises to build on that success by enabling even better patient outcomes.”

EIB unveils financing for Irish innovation as Galway medtech firm Vivasure Medical gets EUR 10 million backing

Vivasure Medical second Irish medtech firm to get EIB Venture Debt financing

EIB and IBEC brief business leaders on new long-term financing for Irish innovation

EIB confirms strengthened direct support for Irish companies

Galway based Medtech Company Vivasure Medical Ltd. is the latest Irish company to agree Venture Debt financing with the European Investment Bank.

The second long-term EIB financing for an Irish medical technology company was confirmed ahead of a briefing for Irish business leaders on new innovation financing opportunities supported by the EU Bank.

IBEC-EIB briefing on new innovation financing opportunities

Company representatives and innovation partners were briefed on new tailor made EIB financing at workshop in Dublin hosted by IBEC and the EIB, part of a series of corporate finance briefings being held across Ireland.

“Ireland is home to world class innovation and the European Investment Bank recognises the crucial need to ensure that research driven companies can expand and succeed in new markets. The new EUR 10 million backing for Vivasure Medical will contribute to efforts to improve cardiology and endovascular treatment through pioneering medtech innovation. In partnership with IBEC we wish to ensure that companies across Ireland can consider how streamlined innovation financing can turn research ideas into commercial success.” said Andrew McDowell, European Investment Bank Vice President.

“Access to diversified funding streams help boost the competitiveness, resilience and innovation of fast growing companies in Ireland. Companies across Ireland are securing EIB financing, allowing them to continue to develop, innovate and compete on a global level. Today’s joint event with the EIB allows companies across a range of sectors to gain a direct insight into new innovation financing at our fourth specialist finance briefing” said Danny McCoy, Ibec CEO.

Over the last three years research focussed companies across Ireland have benefited from European Investment Bank Venture Debt financing. These include world class companies developing artificial intelligence, pharmaceutical and telecommunication products.

Expanding development of cardiology treatment for high risk patients

The EUR 10 million new financing will be used by Vivasure to expand research and development of medical devices to provide non-invasive cardiology treatment. Vivasure has developed pioneering non-invasive biodegradable devices to treat cardiology patients with conditions that require vascular surgery.

“Over the last decade Vivasure Medical has developed innovative and easy to use medical devices that transform cardiology and endovascular treatments and avoid the need for access and closure surgery. We welcome the European Investment Bank’s firm support and agreement of EUR 10 million of new financing that will enable Vivasure to accelerate innovation and expand into new markets. This is a vote of confidence in the Irish Medtech.” said Gerard Brett, CEO and co-founder of Vivasure Medical.

Last year the European Investment Bank Group provided EUR 970 million of long-term financing to strengthen higher education, improve healthcare, transform transport and harness clean energy across Ireland, as well as enhancing corporate research and innovation.

Vivasure Medical Announces Launch of the PerQseal® Large-Bore Closure Device

The world’s first fully absorbable, patch-based large-bore percutaneous closure device is now available to European physicians and patients

GALWAY, Ireland - Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the European launch of the PerQseal® closure device for large-bore transcatheter procedures.

Novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), require large-bore femoral artery access. Closure of these large-bore access sites is challenging and has been associated with significant vascular and bleeding complications.

PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore arterial punctures. The PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state.

“Closing the artery has been a concern since we started using transcatheter techniques for valve implantation,” says Prof. Horst Sievert, of the CardioVascular Center in Frankfurt, Germany. “The PerQseal device is a very innovative solution for closing large holes, and we are enthusiastic to make it part of our armamentarium.”

“We’re excited that the PerQseal device is now widely available to European physicians, providing a safe and simple option for the closure of large puncture holes that leaves behind no sutures, metal implants, or collagen,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “This commercial launch is a key milestone for Vivasure as we journey to enable better patient outcomes in fully percutaneous large-bore endovascular procedures.”

“In my first clinical experience with PerQseal, I found the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully,” said Dr. Saib Khogali, Heart & Lung Centre, New Cross Hospital Wolverhampton, United Kingdom. “I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal® is not available for sale in the United States.

Contacts

Vivasure Medical

Sierra Smith, 408-540-4296

sierra@healthandcommerce.com

Vivasure Enrolls First Patient in Frontier IV Clinical Trial

International Trial Designed to Expand Indications for PerQseal Closure Technology
 

GALWAY, Ireland -Vivasure Medical® (“Vivasure”) is pleased to announce the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of its proprietary PerQseal® large arteriotomy closure technology. The patient was enrolled by Dr. Peter Crean at the Blackrock Clinic, Dublin, Ireland.

Large arteriotomies (12F+) are vessel punctures created to facilitate endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), balloon valvuloplasty (BAV) and ventricular assist devices (VAD). PerQseal is the world’s first fully absorbable, patch-based large-bore percutaneous closure technology.

“Driven by clinical and economic outcomes data, percutaneous access-site management has become an increasingly important aspect of TAVR procedures,” said Dr. Christoph Naber of the department of cardiology and angiology, Contilia Heart and Vascular Centre, Essen, Germany, and TAVR principal investigator of Frontier IV. “I strongly believe PerQseal, which is designed specifically to address large arteriotomies, will help improve outcomes for these patients.”

“We are very excited to begin the Frontier IV trial as the next phase in our commitment to build the clinical experience with PerQseal,” said Gerard Brett, co-founder and CEO of Vivasure. “A percutaneous approach has now become the gold standard for procedures such as TAVR and EVAR, driven by clinical outcomes data. As patient volumes increase, access site management and closure has become an increasingly important aspect of complication and cost reduction. The data from this trial will be used to support our goal of expanding the indication range of the PerQseal technology.”

About PerQseal®

PerQseal® utilises a fully absorbable, intravascular patch, which seals large arteriotomies from the inside. It is comprised of a synthetic polymer implant, and an easy-to-use, ergonomically designed delivery system. The implant has a flexible, low-profile intravascular patch and a supporting scaffold. A portion of the scaffold extends through the arteriotomy, and includes a locator which helps maintain the implant in position. After deployment, the implant is rapidly endothelialised and fully absorbed.

About Vivasure

Based in Galway, Ireland, one of Europe’s largest medtech hubs, Vivasure is focused on the development of bioabsorbable implant technologies with vascular applications. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors.

Contacts
for Vivasure Medical
United States:
Jessica Volchok, +1 310-849-7985
jessica@healthandcommerce.com
or
Europe:
Jonathan Neilan, +353 (0)86 231 4135
jonathan.neilan@fticonsulting.com

Vivasure Medical Appoints Robert (Chip) Hance to Company’s Board of Directors

25-Year Medical Device Veteran Brings Deep Industry, Commercialization Experience

Galway, Ireland — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced the appointment of Robert (Chip) Hance to the company’s board of directors. 

Hance is a 25-year veteran of the medical device industry. He is the former CEO of Creganna Medical, a private equity-backed Ireland-based supplier to the minimally invasive medical device industry, which was recently acquired by TE Connectivity. Previously, he served as an Entrepreneur in Residence at the U.S. Food and Drug Administration (FDA) and in multiple executive roles at Abbott including president of Abbott Vascular, president of Abbott Diabetes Care, president of Vascular Devices and divisional vice president of Abbott Diagnostics in Europe.

“I can think of no one better suited than Chip to help lead Vivasure to the next stage in its evolution,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “Chip is a highly respected leader who has done much to advance innovation in our industry and to improve healthcare outcomes for patients around the world. We look forward to working closely with him as we further our mission of developing novel bioabsorbable technologies for percutaneous vessel closure.”

Hance’s appointment follows the recent completion of Vivasure’s Series C financing of €16.2M ($18.3M) to support European commercialization of the company’s PerQseal™ technology and to advance execution of a FDA regulatory study.

“I look forward to joining the Board as Vivasure advances its progress toward European market expansion and securing U.S. approval and commercialization of the company’s first product,” said Hance. “Vivasure’s closure device meets an important and growing clinical need and I am excited about the potential of this innovative technology to improve arteriotomy closure outcomes for patients.”

“On behalf of the entire Board and Vivasure’s investors, we are pleased to welcome Chip to the company’s Board of Directors,” said Bernard Collins, chairman of Vivasure’s Board of Directors. “His guidance will be invaluable as Vivasure moves toward this next stage of accelerated growth and opportunity.”

The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device-related complications. Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021.

Hance holds a bachelor’s degree in chemical engineering from Massachusetts Institute of Technology and an MBA from Harvard Business School.

About Vivasure Medical    

Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com

Vivasure Medical Announces €16.2M ($18.3M) in Financing to Advance Commercialization of Closure Device in European Union and United States

Galway, Ireland —08 September, 2016 — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced that the company has completed a Series C financing of €16.2M ($18.3M). The round was led by LSP (Life Sciences Partners) of The Netherlands, investing from its LSP Health Economics Fund, and co-led by Evonik Venture Capital (Germany), alongside Panakes Partners (Italy) with returning Series A and B investors led by Fountain Healthcare Partners, Ireland. 

The funding will support European commercialization of the company’s PerQseal™ technology to meet the growing demand for absorbable, percutaneous vessel closure products, as well as execution of a U.S. Food and Drug Administration (FDA) regulatory study.
 
The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device related complications. Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021. 

“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive percutaneous procedures,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “The Vivasure closure device is designed to be easy to use, allowing the surgeon and interventional physician to provide a complete repair at the access site, without leaving metal implants, sutures, or exogenous tissue behind. Our goal is to facilitate improved therapeutic results for patients over the open-surgery alternative, faster recovery times, and cost savings for the healthcare system.”

“We are excited to support this innovative company and its vision of improving outcomes for patients as it moves into commercialization in the European Union and enters the United States,” said Anne Portwich, partner, LSP. “We look forward to working closely with Vivasure as the company continues to work toward gathering more data through clinical studies that will facilitate expansion of adoption in European markets and drive U.S. approval and commercialization of its first product.”

An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to surgical cut-down and sutured repair via a 3- to 5- centimeter incision for large-bore arteriotomies.  

About Vivasure Medical
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com.

About LSP
LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, LSP’s management has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1 billion of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. The LSP Health Economics Fund invests in innovative products that can increase the quality of health care, while reducing the cost of care. For more information, please visit: www.lspvc.com.

About Evonik VC
Evonik in the context of its venture capital activities wants to invest in total €100 million in promising start-ups with innovative technologies and in leading, specialized venture capital funds. Regional focuses on Europe, the United States and Asia. Currently, Evonik holds stakes in nine start-ups and four funds. More information is available at http://venturing.evonik.com/.

About Panakes Partners
Panakès Partners is a Venture Capital investor that finances medical companies, early stage startup and SMEs, with extremely promising products and great ambition, in Europe and Israel, improving both patient outcomes and healthcare economics. Investments focus on the medical device, diagnostics and healthcare IT fields. Panakès Partners is headquartered in Milan, Italy. www.panakes.it. 

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com.

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Media contacts:

United States:
Jessica Volchok, +1 (310) 849-7985
jessica@nicoleosmer.com

Europe:
Jonathan Neilan, +353 (0)86 231 4135
jonathan.neilan@fticonsulting.com

Vivasure Medical receives CE Mark for First and Only Fully Bioabsorbable Percutaneous Closure Device for Large-Bore Transcatheter Procedures

Sutureless Technology Designed to Facilitate Less-Invasive, Shorter Procedures

GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical today announced Conformité Européenne (CE) Mark approval of the world’s first fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The Vivasure closure device is the first product from the company’s patented PerQseal™ technology platform, and is the only approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.

An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. Large-bore arteriotomies, such as those made to facilitate transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR), have traditionally required a surgical cut-down and sutured repair via a 3- to 5- centimeter incision. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to sutured repair.

“Percutaneous transfemoral access is a key enabler for TAVR procedures, which are rapidly becoming standard of care for patients with aortic valve disease,” said Michael Laule, M.D., cardiologist at Charité University Hospital, Berlin. “The Vivasure closure device is an easy-to-use option that promises to significantly improve the patient experience and shorten overall procedure times by allowing physicians to utilize a fully percutaneous procedure to repair the access site.”

“The bioabsorbable nature of the Vivasure closure device allows the surgeon to provide a complete repair at the surgery site, which helps avoid stenosis and maintains the integrity of the vessel,” said Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic, director of the Scripps Prebys Cardiovascular Institute for Scripps Health, and chief medical officer of Vivasure Medical. “The demand for bioabsorbable solutions is growing as the transient nature of these products continues to demonstrate as good or better therapeutic results for patients.”

“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive procedures that offer improved clinical outcomes and faster recovery times over the open surgery alternative. The Vivasure closure device is intended to further facilitate the less invasive nature of these treatments,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “CE Mark is an important milestone for Vivasure as we continue development of our technology, which we plan to launch in Europe in the coming months.”

The Vivasure closure device includes a delivery system and single-use patch-like device. The system has been evaluated in clinical studies, with patients treated in four EU countries, achieving 97 percent device technical success with no major device related complications. Long-term follow-up data has been collected to 12 months post-procedure.

To view an animation of the Vivasure closure device, please visit www.vivasuremedical.com.

The Vivasure closure device is not currently approved in the U.S.

About Vivasure Medical
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal™ platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com.

Contacts
for Vivasure Medical
Jessica Volchok
424-271-6471 (O)
310-849-7985 (C)
jessica@nicoleosmer.com