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Medical Devices

OpSens Announces Third Quarter Fiscal 2021 Record Financial Results



Conference call on the results to be held today at 11 a.m.

QUEBEC CITY, July 13, 2021 /CNW Telbec/ – OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering diagnostic and treatment solutions based on its proprietary optical technology, today reported its financial results for the third quarter of fiscal 2021, ended May 31, 2021.

Third Quarter Financial Highlights

  • Record total revenue of $9.2 million, compared with $6.6 million for the third quarter of fiscal 2020, a 39% increase;
  • Record sales of coronary artery disease products of $6.2 million, compared with $4.4 million for the third quarter of fiscal 2020, a 41% increase;
  • Cash and cash equivalents at $38.8 million as of May 31, 2021 ($10.9 million as of August 31, 2020);
  • OpSens awarded three-year contract agreement with Vizient, Inc., one of the largest group-purchasing organizations (GPO) in the United States, to provide its members with the Company’s OptoWire;
  • OpSens signs an agreement with Cathmedical Cardiovascular S.A. (“Cathmedical”) for the integration of its coronary physiology algorithms into the Picasso hemodynamic system, initially focusing on the Spanish cardiology market where the Picasso has a dominant market share.

Recent Developments

  • The SavvyWire,™, OpSens’ innovative pressure guidewire, for the percutaneous delivery and assessment of aortic valve stenosis (“TAVR”), is scheduled to be evaluated in a 20-patient study by the end of the summer. This study is one of the last steps before OpSens files for regulatory 510(k) clearance with the U.S. Food and Drug Administration (“FDA”);
  • OpSens surpasses 150,000 procedures with the OptoWire;
  • OpSens Solutions receives advisory and funding support to develop an optical-based fuel monitoring system for aerospace applications, including civil aircrafts with partner.

Management Commentary

“We achieved strong financial performance in the third quarter of fiscal 2021, as we continued to build on our positive momentum, with solid double-digit top line growth,” said Louis Laflamme, President and CEO of OpSens. “We are excited by the continued commercial adoption of our proprietary optical solutions in cardiology to address some of the industry’s most challenging applications. Our OptoWire solution has surpassed the 150,000-procedure mark and is gaining further traction within the U.S. with record sales of coronary artery disease products. Additionally, we continue to expand on the signing of high-quality contracts with U.S. GPOs. Further, with the closing of our $28.75 million bought-deal financing earlier this year, we are accelerating the development of our next generation TAVR product, including the hiring of key technical, clinical, and commercial talent and the conduct of our first in-man study,” Louis Laflamme concluded.

Financial Results – Quarter Ended May 31, 2021

Total revenue reached $9.2 million for the three-month period ended May 31, 2021, compared with $6.6 million for the same period the previous year. This 39% growth is mainly the result of an increase in revenue of $1.8 million in the coronary artery disease line of business (Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”)), and an increase of $0.6 million in other medical revenues.

Sales of products in coronary artery disease were $6.2 million in the third quarter of 2021 compared with $4.4 million in the same period in 2020, an increase of 41%. The increase in sales is primarily the result of growth in the European and American markets even though several cardiology laboratories were still operating at reduced levels due to COVID-19.

Sales of optical medical systems, including the Company’s 5-year supply agreement for ventricular assist device sensors, were $2.3 million, an increase of 35% in the third quarter of 2021 compared with $1.7 million in the third quarter of 2020.

Industrial sales increased 40% to $0.7 million in the third quarter of 2021, compared with $0.5 million in the third quarter of 2020.

Gross margin reached 59%, an increase of 400 basis points for the quarter ended May 31, 2021, from 55% for the quarter ended May 31, 2020. Higher sales volume and the related economies of scale combined with enhanced productivity, mainly contributed to the improvement.

Operating expenses in the third quarter of fiscal 2021 were $5.6 million, up $1.3 million compared with $4.3 million in the third quarter of 2020. The increase is mostly attributable to additional investments of $0.6 million in sales and marketing as activities are accelerating towards pre-COVID levels. Additionally, we invested in the development of our TAVR product.

Net loss was $570,000 in the third quarter of 2021 compared with a net income of $52,000 in the third quarter of 2020. The negative variance of $0.6 million is mainly due to an increase of $1.3 million in operating costs, a decrease of $0.7 million in other income and a negative variance of foreign exchange of $0.5 million. This was partially offset by an improvement of $1.8 million in gross margin.

OpSens had cash and cash equivalents of $38.8 million as of May 31, 2021.

Conference Call Today

Louis Laflamme, President and Chief Executive Officer, and Robin Villeneuve, Chief Financial Officer, will hold a conference call to discuss the quarter’s financial results at 11:00 a.m. (Eastern Time) today, July 13.

Interested parties can access the conference call by dialing (833) 756-0865 or (412) 317-5754 or can listen via a live webcast, from the link available in the Investors section of the Company’s website or at Investors section of the Company’s website or at, 5 to 10 minutes before the beginning of the conference call.

A replay will be available after the call, in the Investors section of the Company’s website at

Table A

(In thousands of Canadian dollars, except for information per share and gross margin %)

Three-Month Period Ended

May 31, 2021

Three-Month Period Ended

May 31, 2020

Nine-Month Period Ended

May 31, 2021

Nine-Month Period Ended

May 31, 2020

































Cost of Sales





Gross margin





Gross margin (%)






Operating Expenses







Sales and marketing





Research and development











Other income





Financial expenses






Income (loss) before income taxes





Income taxes




Net income (loss)






Basic and diluted net income (loss) per share





Table B


(In thousands of Canadian dollars)

As at

As at

May 31, 2021

August 31, 2020




Cash and cash equivalents



Trade and other receivables






Total Current Assets



Property, plant, and equipment



Intangible assets



Right-of-use assets



Total Assets




Current liabilities



Long-term debt



Lease liabilities



Total Liabilities



Shareholders’ equity



About OpSens Inc. ( or

OpSens focuses mainly in interventional cardiology. The Company 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.


Company Codes: OTC-QX:OPSSF, Toronto:OPS, OTC-PINK:OPSSF

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Medical Devices

Cartessa Aesthetics’ Innovative Multi-Modality Treatment Leads Demand for Non-Invasive Body Procedures



MELVILLE, N.Y., July 28, 2021 /PRNewswire/ — Cartessa Aesthetics recently launched its newest device, PHYSIQ, leading the demand for the latest advancement in body treatments. PHYSIQ is a novel, dual-modality system that offers deep heat to target tissue and electrical muscle stimulation (EMS) to re-educate muscle – all from one device and in one session. An incredibly versatile device, PHYSIQ’s four applicators can be individually adjusted to tailor the energy and modality delivered to one or more body areas. Providers can select EMS or deep heat only or they have the unique ability to deliver both modalities sequentially within one treatment to maximize results and overall comfort. Treatments are hands-free, require no downtime and can be completely customized to meet each patient’s unique body goals.

Cartessa Aesthetics has made a name for itself by working with leading global aesthetic manufacturers to introduce best-in-class devices to the North American market. With PHYSIQ, aesthetic providers and patients have an optimized body treatment distinct from existing technology in the space. 

“Optimizing clinical outcomes while providing best-in-class return on investment to physicians is at the core of Cartessa’s mission statement,” said Gabe Lubin, Cartessa Aesthetics Founder and CEO. “More people are favoring non-invasive procedures, even for treatments that address challenging body aesthetics. Patients want results, but without the pain and downtime that comes with surgery. Being able to offer a more complete patient treatment in a 30-minute session will offer providers a unique competitive advantage in the robust body market.”

The non-invasive body treatment category has erupted in the last decade. From 2011 to 2018 the number of procedures grew four-fold and it is estimated that by 2025, the North American market will hit $1.6 billion growing at an 8% compounded growth rate. PHYSIQ’s low consumable costs, minimal required staff-time and healthy patient demand makes it a premier investment opportunity for aesthetic providers. Sessions range from 24 to 36 minutes and the ability to address multiple body areas with multiple modalities in one session has established PHYSIQ as being truly unique in the body space.

Those interested in PHYSIQ can learn more by visiting or reach out to a Cartessa Aesthetics agent via email at [email protected].

Approximate pricing, $500/session and up. Although results may be noticed after only the first treatment, PHYSIQ is administered in a series of 5 treatments/sessions, 1 treatment every 2 weeks.

About Cartessa Aesthetics, LLC.
Cartessa Aesthetics, LLC sources leading aesthetic medical devices for distribution to dermatologists, plastic surgeons, cosmetic physicians and medical spas. Cartessa selects the most cutting-edge technologies that offer clinically proven efficacy, patient safety, and the best possible investment for patients and professionals. The company’s portfolio includes VirtueRF, Motus AX & Motus AY, Tetra CO2 with CoolPeel and Luxea (all manufactured by DEKA), Subnovii Advanced Plasma Technology and Skinwave.  Cartessa is also the exclusive US partner for Quanta Systems.  

For more information visit: 

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Medical Devices

Pixium Vision announces its financial results for H1 2021 and provides a business update




Pixium Vision announcesitsfinancialresults for H1 2021andprovidesabusiness update

  • Cash position at 30 June 2021: €10.1 million
  • PRIMAvera European pivotal study of Prima System ongoing
  • Pixium Vision appointed Offer Nonhoff, an experienced international financial executive
  • Post period event – € 8M PIPE transaction with new US investors extends cash runway to end of 2022

Paris, 27 July 2021 – 7.00 a.m. CET – Pixium Vision (FR0011950641 – PIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independently, announces its financial results for the first half of 2021. The H1 2021 financial statements were approved by Pixium Vision’s Board of Directors at its meeting on 26 July 2021.

Lloyd Diamond, CEO of Pixium Vision, commentedWe are pleasedwith the continued transformation ofPixiumVisionfromaresearchtoacommercialorganization,withanumberofsignificantmilestonesachievedin the first half of 2021. Clinically, we are making good progresswith the PRIMAvera pivotal trial of our PrimaSystem for bionic vision and have closedadditionalfinancing lead by US investors in order to ensure thesuccess ofourclinical programs.”

”The financialresults are based on a solidfinancial position, with €10.1 million in cash at end of June 2021plus an additional €8 millionraised in a successful capital increase, providingfundinguntil end of 2022. Weare nowalso building on oursuccessful interactions with US investors by exploring the possibility of listing ontheNASDAQstockexchange”addedOfferNonhoff,CFOofPixiumVision

H12021 results – Highlights

Inthousandsofeuros H12021 H12020 Change
Operatingrevenue 1,801.0 1,250.7 +44.6%
Currentoperatingexpenses (6,636.8) (4,524.4) +46.7%
Research and Development (3,692.0) (2,860.1) +29.1 %
General and administrative expenses (2,944.8) (1,664.3) +76.9 %
Operatingloss (4,835.8) (3,273.7) +47.7%
Netloss for theperiod (5,551.3) (3,802.3) +46.0%
Netearningsper share (0.12) (0.15)  

Page 1 / 5

Inthousandsofeuros H12021 H12020
Openingcashand cashequivalents 10,566.0 6,791.5
(Decrease)/Increasein cashposition (434.5) (1,787.1)
O/Wnetcashflowsfromoperating activities (6,115.4) (2,787.8)
O/Wnetcashflowsfrominvestmentactivities (32.0) 163.7
O/Wnetcashflowsfromfinancingactivities 5,712.9 837.0
Closingcashandcash equivalents 10,131.4 5,004.4

UpdateonPixiumVision’s business

Pixium Vision continued to make significant clinical and business progress in H1 2021, including implanting the first patients in the European PRIMAvera pivotal trial evaluating the safety and efficacy of the Prima System in patients affected by dry Age-related Macular Degeneration (AMD).

The company also reported extremely compelling results from the French feasibility study, demonstrating that thanks to the new transparent Prima glasses, patients could simultaneously use prosthetic central vision generated with the Prima System and their remaining peripheral vision. Indeed, using electronic magnification, patients gained visual acuity in the range of 20/63-20/98, greatly exceeding the threshold of legal blindness (20/200).

Pixium Vision remained focused on delivering on its strategy, despite the termination of the planned business combination with Second Sight. Pixium Vision announced an ambitious plan to build on traction gained with US investors and strengthen its presence in the important US market, and hiring a leading US investment bank to contemplate a potential US NASDAQ listing.

AnalysisofH12021 results

Operating revenue amounted to €1.8 million and is comprised essentially of a Research Tax Credit (CIR) in the amount of €0.9 million and €0.8 million for contractual indemnities paid by Second Sight Medical Product Inc. (SSMP). These indemnities were paid following the unilateral termination of the MOU between the two companies concluded on 5 January 2021 by SSMP.

CurrentResearch and Development (R&D) expenses totalled €3.69 million, compared to €2.86 million the previous year. During the first half of 2021, Pixium Vision strengthened its clinical team and opened several centres in Europe as part of its PRIMAvera study. In addition, the Group continued to develop and manufacture its Prima bionic vision system to ensure the progress of its ongoing clinical studies.

Currentgeneral and administrative (G&A) expenses totalled €2.94 million in H1 2021, compared to €1.66 million in H1 2020. General and administrative expenses increased by 76.9% in H1 2021, mainly due to the costs the Group incurred for legal services in preparation for its business combination with the US company Second Sight Medical Products, Inc.

In H1 2021, the Group did not recognise any marketingandsalesexpenses.

Operatingresult presented a loss of €4.84 million, which is higher than in H1 2020 (€3.27 million). Netresult was a loss of €5.55 million (compared to a loss of €3.80 million in H1 2020). The loss per share is €0.12 down over the €0.15 loss per shares reported in H1 2020.

Net cash outflow from operating activities increased in H1 2021 to €6.1 million, compared to €2.8 million in H1 2020. The increase in net cash outflow reflects the initiation of the PRIMAvera study, the continuation of the US feasibility study, as well as the spending associated with the preparation of the business combination

with Second Sight Medical Products, Inc. The basis for comparison in H1 2020 was also particularly low due to COVID-19 related slow-down in operations over the course of 2020.

Netcashflowsfromfinancingactivities totalled €5.7 million in H1 2021. This reflect primarily the drawdown of 5 ORNAN tranches for a total of €6.25 million in gross proceeds under its agreement with ESGO. Following the drawdown of the last tranche on 12 May 2021, there is no longer any outstanding warrants as the entire 10 million financing has been drawn.

Pixium Vision ended H1 2021 with a net cash position of €10.1 million, compared to €5.0 million a year earlier.

Post-period, on July 13, 2021, Pixium Vision increased its cash balance through a capital increase of approximately €8.0 million in Gross proceeds and approximately €7.4 million in net proceeds.



Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period.

Pixium Vision is conducting clinical feasibility studies of its Prima system, its miniaturised wireless sub-retinal implant, in patients who have lost their sight due to retinal degeneration associated with the dry form of Age- Related Macular Degeneration (AMD). Pixium Vision works closely with world-renown academic partners, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, USA. The company is EN ISO 13485 certified. Pixium Vision has been qualified as an “Innovative Company” by Bpifrance.

For more information:
Follow us on @PixiumVision;

Pixium Vision is listed on Euronext Growth Paris. ISIN: FR0011950641; Mnemonic: ALPIX
Pixium Vision is included in the Euronext GROWTH ALLSHARE index Pixium Vision shares are eligible for the French PEA-PME and FCPI investment vehicles.


This press release, implicitly or expressly, contains certain forward-lookingstatements concerning PixiumVision and its business. Suchstatementsinvolveknown and unknownrisks, uncertainties and otherfactorsthatmaycausetheactualresults,financialconditions,performanceorachievementsofPixiumVisiontobe

materiallydifferent from the results, financial conditions, performance or achievementsexpressed or impliedby suchforward-lookingstatements. Pixium Vision issues thispress release as at this date and does notundertaketoupdateanyforward-lookingstatementscontainedherein,whetherinresponsetonewinformation,future events or otherwise. For a description of the risks and uncertainties that could cause the actual results, financial conditions, performance or achievements of Pixium Vision to differ from those contained in the forward-looking statements, please refer to section 3 “Risk Factors” of the Company’s reference document, which was filed with the AutoritédesMarchésFinanciers under number D.20-0350 on 24 April 2020, and which can be viewed on the websites of the Autorité des Marchés Financiers – “AMF” ( and Pixium Vision (


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Medical Devices

MicroPort® Cardiac Rhythm Management Business Announces US$150 Million Series C Investment



SHANGHAI, July 27, 2021 /PRNewswire/ — MicroPort Scientific Corporation (“MicroPort®“) announced that MicroPort Cardiac Rhythm Management Limited (“MicroPort® CRM“), which is MicroPort®‘s subsidiary focused on developing and commercializing implantable pacemaker and defibrillator devices and related technologies to manage cardiac rhythm disorders, has entered into definitive agreements in connection with its Series C financing with total investment proceeds of US$150 million. Hillhouse Capital Group and MicroPort® will co-lead the Series C investment and will invest US$20 million and US$47 million, respectively. Six new investors that will invest an additional US$83 million in capital include CICC, Country Garden Venture Capital (CGVC), YongRong Asset Management Ltd., L Squared Private Management, E Fund Management Co. Ltd., and Wanhui Capital. After the completion of this transaction, MicroPort® will continue to be the majority shareholder of MicroPort® CRM. The financing is expected to close in early August 2021, subject to customary closing conditions.

Originally acquired in April 2018, MicroPort® CRM designs, develops, and markets solutions for the management of heart rhythm disorders, such as implantable pacemakers and defibrillators, as well as heart failure through cardiac resynchronization therapy (CRT). Headquartered in Clamart (outside Paris) France, MicroPort® CRM has dedicated R&D teams in Clamart and Shanghai, and world class manufacturing facilities in France, Italy, the Dominican Republic and China. Currently MicroPort® CRM employs approximately 1,100 employees globally.

For decades, MicroPort® CRM has been at the forefront of innovation in the CRM industry and has implanted more than two million patients worldwide with its pacemakers and defibrillators. The company is known for its cutting-edge technology, small, long-lasting devices, and the most advanced therapeutic solutions. In 2015, MicroPort® CRM launched the PLATINIUM™ family of implantable defibrillators, which has the longest projected service life of any implantable defibrillator on the market, reducing the risks associated to repeated replacements. In 2019, the company launched ENO™, TEO™ and OTO™, the world’s smallest family of pacemakers, 1.5T and 3T MRI conditional. In 2021, MicroPort® CRM launched a new family of pacemakers, ALIZEA™ and BOREA™, featuring Bluetooth® technology and wireless remote monitoring. In its product pipeline, MicroPort® CRM plans to launch a complete new line of defibrillator systems, including devices and leads, 1.5T and 3T MRI conditional. In addition, MicroPort® CRM is currently developing a sub-cutaneous ICD (S-ICD) and a leadless pacemaker. The company is pursuing the development of further innovative therapies in the field of Heart Failure, in particular with the Axone project for the delivery of Cardiac Resynchronization Therapy (CRT). The market introduction of these products will provide an additional growth inflection point for the CRM franchise.

Mr. Benoit Clinchamps, President of MicroPort® CRM said: “MicroPort® CRM continues to grow its global revenue and advance its product pipeline to bring the best CRM technologies to treat patients affected by heart arrhythmias worldwide. We are excited about the growth opportunities that can be accessed in the next few years through this investment capital.”

About MicroPort CRM

MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), and a subsidiary of MicroPort® Scientific Corporation (stock code: 00853.HK), with world headquarters in Clamart, just outside Paris, France. Through its long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. Its state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, Santo Domingo, Dominican Republic, and Shanghai, China.

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Company Codes: HongKong:0853

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Medical Devices

Soundbite Medical Solutions Announces Issuance of a Fourth U.S. Patent Further Expanding Coverage of its Core Technology



The patent is directed to a general system comprising a shock wave generator connected to a mechanical waveguide, for the treatment of lesions in blood vessels. It protects the novel Soundbite system architecture, which is used in all products of the company’s burgeoning portfolio.

The patent is expected to expire in December 2036 and will continue to provide key intellectual property protection for the Company’s technology platform.

This is the fourth US patent to be issued around the approved Soundbite technology. Soundbite continues to enhance its patent portfolio with additional patent applications that will broaden and strengthen its patent protection in key markets throughout the world.

“The strength of our patent portfolio is a testament to our highly talented engineering team. The pursuit of excellence in serving our patients begins with medical devices that are unique, differentiated and of the highest quality. Protecting that work and preserving value will establish Soundbite as a leader in its field,” said Lori Chmura, President & CEO of Soundbite.

The SoundBite® Crossing System – Peripheral (SCS-P) consists of the reusable SoundBite® Console, a single-use sterile SoundBite® Active Wire, and their respective accessories. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively “micro- jackhammer” through calcified lesions.

High calcium burden is present in up to 50% of PAD patients with severe claudication and in >65% of patients with CLI, especially in difficult to treat below-the-knee disease. CTOs are encountered in up to 50% of PAD and CLI patients. CLI is associated with a high risk of lower limb amputation estimated in 10%–40% of patients at 6 months, especially in non-treatable patients.

About Soundbite Medical Solutions

Soundbite is a privately-held medical device company uniquely dedicated to developing meaningful solutions for the interventional treatment of calcific peripheral and coronary arterial diseases. Soundbite has developed and deployed a proprietary method to produce and safely deliver shock waves to calcified lesions using an array of devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease.

For information on Soundbite Medical Solutions, please contact Ashkan Haghighat, PhD ([email protected]), Chief Business Officer, SoundBite Medical Solutions, 2300 Alfred Nobel, Montreal Québec H4S 2A4

Forward-Looking Statements This press release contains forward-looking statements and forward- looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond SoundBite Medical Solutions Inc.’s control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward looking statements. Forward- looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances.

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