OpSens’ SavvyWire™ Featured at the Transcatheter Cardiovascular Therapeutics 2021 Annual Meeting in Orlando

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OpSens’ SavvyWire™ Featured at the Transcatheter Cardiovascular Therapeutics 2021 Annual Meeting in Orlando

 Quebec City, Quebec, November 8, 2021 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF),  a medical device company currently commercializing its proprietary sensing technology in the interventional cardiology market, announced that its SavvyWire, developed specifically for transcatheter aortic valve replacement (“TAVR”), was featured in four presentations by leading medical specialists during the Transcatheter Cardiovascular Therapeutics (TCT) 2021 Annual Meeting held from November 4-6, 2021 in Orlando, Florida. The SavvyWire is not yet approved for commercialization.

“We are extremely pleased to have been so prominently featured at this year’s TCT Annual Meeting by an esteemed group of physicians as they presented their findings on the potential benefits of our technology for the TAVR market,” commented Louis Laflamme, President and Chief Executive Officer of OpSens.

 

The Future of TAVR Hemodynamics

Presented by Dr. Philippe Genereux

On November 4, 2021, Dr. Philippe Genereux, interventional cardiologist, world-renown for his innovative research, and Director of the Structural Heart Program at Morristown Medical Center in New Jersey, led a panel of key opinion leaders to discuss the future of TAVR hemodynamics brought on by OpSens’ SavvyWire. The discussion focused on current unmet needs in the field of structural heart interventions, especially related to the need for more efficient, safe and optimal way to assess procedural results during TAVR, and the unique solution provides by the OpSens SavvyWire. The symposium featured international physician experts including Dr. Thomas Modine from CHU Bordeaux, France, Dr. Hemal Gada from UPMC Pinnacle, Pennsylvania, USA, and Dr Reda Ibrahim, from Montreal Heart Institute, Canada.

The session can be viewed at https://opsens.com/investors/events-presentations/.

 

A Validation Study of the OpSens LV Pressure Guidewire

Presented by Dr. Philippe Genereux

 

On November 5, 2021, Dr. Philippe Genereux presented for the first-time data validating the robustness of the OpSens SavvyWire algorithm in assessing pressure gradient before and after TAVR procedure compared to different diagnostic modalities during two presentations at TCT.

Dr. Genereux, said “Hemodynamic assessment derived from the OpSens OptoWire III and its new TAVR algorithm demonstrated excellent correlation with measurement derived by 2 pigtails and transducers, both before and after TAVR. Integration of this unique technology within a dedicated TAVR wire with live hemodynamic assessment could bring meaningful value to TAVR operators. I am expecting that sensor-guided TAVR procedure using the OpSens SavvyWire will become the new standard of care in the near future”.

The session can be viewed at https://opsens.com/investors/events-presentations/.

 

Evaluation of the OpSens OptoWire III and its Novel TAVR Algorithm to Measure Pressure Gradient before and After TAVR Compared with Hemodynamic Value Derived by Catheterization and Echocardiogram

Presented by Dr. Philippe Genereux

The session can be viewed at https://opsens.com/investors/events-presentations/.

 

A Pressure Wire for Valve Implantation and Continuous Hemodynamic Monitoring During TAVR Procedures: Initial Experience with the SavvyWire

Presented by Dr. Josep Rodés-Cabau

On November 5, 2021, Dr. Josep Rodés-Cabau, cardiologist and hemodynamic specialist at Quebec Heart and Lung Institute in Canada joined Dr. Genereux and other key opinion leader physicians to discuss innovation trends in TAVR technologies. Dr Rodés-Cabau reported on his experience with OpSens’ SavvyWire, as one of the lead investigators conducting a human study with 20 patients currently taking place in Québec and Montreal.

The session can be viewed at https://opsens.com/investors/events-presentations/.

 

About the SavvyWire

The SavvyWire, a new dedicated structural guidewire, with integrated pressure monitoring and pacing capability, aims at improving procedural efficiency, safety, and clinical outcomes during structural procedures such as TAVR. This device has been designed to support and optimize the minimalist TAVR approach which has been growing among structural heart physicians. With the SavvyWire, physicians can expect to diagnose and implant the percutaneous valve over the same device while getting continuous and accurate hemodynamic measurements.

OpSens’ SavvyWire is not available for commercial use.  OpSens is targeting the commercial launch of its SavvyWire in calendar year 2022.

TAVR Procedure Evolution

Aortic valve stenosis occurs when the heart’s aortic valve narrows, which prevents the valve from opening fully, restricting blood flow from the heart into the main artery (aorta) and onward to the rest of the body.

Initially, the TAVR procedure was only indicated for inoperable patients and then for high-risk surgical patients. Clinical programs like PARTNER or COREVALVE, have since shown better or equivalent clinical outcomes in intermediate and low-risk patients. The TAVR procedure is now evolving quickly with a minimalist approach that allows the procedure to be faster and the patients to be discharged earlier, sometimes on the same day.

The TAVR procedure is on the rise, driven by an aging of the population and recent studies that demonstrate its benefits to patients of all conditions. The TAVR market is currently estimated at US$5 billion and is expected to reach US$8 billion by 2025.

 

About OpSens Inc. (www.OpSens.com or OpSensMedical.com)

OpSens focuses mainly on products for cardiology. OpSens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 150,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

 Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

For information, contact

Louis Laflamme, CPA, CA, President and Chief Executive Officer or

Robin Villeneuve, CPA, CA, Chief Financial Officer at 418.781.0333

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