Based on the most recent data from March, it appears that the FDA is on pace to grant expedited review to over 250 medical devices in 2023, a significant increase from just 166 last year.
With the FDA granting larger numbers of breakthrough device designations, it may prove to be a worthwhile and cost-effective option for medical device companies that are seeking to reach the market faster with a device that meets the qualifications for the program.
And the opportunity here is massive considering that the medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5% a year to reach nearly $800 billion by 2030.
Although investors may find it hard to sift through the multitude of medical device stocks chasing breakthrough designations, here are some well established players that look well placed to capitalize on this multi-billion market.
Therma Bright (TSXV:THRM) (OTCQB:TBRIF) is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies that address some of today's most important medical and healthcare challenges. The company has three main product portfolios, which include:
Respiratory Health: This features the Digital Cough Test (DCT) app created by Therma Bright and AI4LYF. The app uses artificial intelligence to detect multiple respiratory diseases, including COVID-19, by analyzing a person’s cough sound and has shown an accuracy rate above 94%. The app is currently in the process of securing a 513g FDA clearance, which will allow the company to charge for Remote Therapeutic Monitoring (RTM) and be used for patient reimbursement.
Consumer Health: There are three devices in this portfolio. The Benepod Hot and Cold Contrast Therapy Device is designed for chronic pain relief, such as osteoarthritis and lower back pain. The InterceptCS is a cold sore prevention device. And the TherOZap, the next generation in pain management relief using thermal therapy for insect bites and stings.
Vascular Disease: The company has two devices here. An innovative clot-retrieving device, PREVA, which is the first and only protective blood clot retriever using a distal basket; and a deep vein thrombosis solution for leg pain post surgery called Venowave.
Venowave is a compact and lightweight Deep Vein Thrombosis (DVT) prevention device specifically designed for use in healthcare settings and at home. The device uses a continuous wave motion to increase blood flow in the veins. The increased blood circulation helps prevent venous stasis, which is a major contributor to clot formation.
According to recent research, more people die annually from blood clotting complications than from breast cancer, HIV, and traffic accidents combined. This staggering fact highlights the necessity of Deep Vein Thrombosis (DVT) prevention.
With about 50% of DVTs beginning to form intra-operatively and 75% forming within 48 hours post-operatively, this technology is pioneering an alternative, easy to use, and potentially life-saving treatment for this condition.
Therma Bright recently revealed that it had successfully secured U.S. Medicare and Medicaid reimbursement through various payers. The reimbursement per pair of Venowave devices, under these temporary codes ranged between $725-$1050 per patient.
"This is a major development for our company and the patients who rely on Venowave. These CPT codes will provide greater clarity and precision in medical billing and streamline the reimbursement process for healthcare providers, patients, and insurers," said Rob Fia, CEO of Therma Bright.
Profound Medical Corp. (NASDAQ:PROF) (TSX:PRN), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Its lead product candidate is TULSA-PRO which is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities.
On June 2, Profound announced that the American Medical Association (AMA) had established three new Current Procedural Terminology (CPT) Category 1 codes for MRI-Monitored Transurethral Ultrasound Ablation of prostate tissue, performed using its TULSA-PRO system.
According to Profound’s CEO and Chairman, Arun Menawat, “The establishment of these permanent codes specific to TULSA is a critical milestone for the broader adoption of the technology to treat prostate diseases in the United States.”
Perimeter Medical Imaging AI (TSXV:PINK) (OTC:PYNKF) is a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need.
The company’s flagship product, the Perimeter S-Series OCT uses ultra-high-resolution Optical Coherence Tomography (OCT) to provide high-definition, 3D images of margins in the operating room at 10 times higher resolution than ultrasound and X-ray and 100 times higher than MRI.
Recently, Perimeter announced the first commercial placement of its flagship Perimeter S-Series OCT medical imaging system in the state of Georgia.
“This latest commercial placement of our flagship Perimeter S-Series OCT, which marks the first in the state of Georgia, supports our goal to bring ultra-high resolution medical imaging technology directly into the OR to assist the surgeon with real-time intraoperative margin visualization," said Adrian Mendes, Perimeter's Chief Executive Officer.
Ventripoint Diagnostics Ltd. (TSXV:VPT) (OTC:VPTDF) is dedicated to developing quality, smart tools that help solve the immediate needs of our healthcare clinicians.
Its lead product, VMS+, is designed to create an accurate 3D model of the heart from a 2D echocardiogram and allow a physician to obtain cardiac metrics on all four chambers of the heart within minutes. VMS+ achieves this using a proprietary Knowledge Based Reconstruction (KBR) algorithm that leverages a MRI shape catalog and anatomical landmarks from standard 2D echocardiogram images to construct a complete 3D model of the heart.
Last month, the company announced that a VMS+ product had been purchased and fully operationalized in the Deutsches Herzzentrum der Charité (DHZC), German Heart Center, in Berlin, Germany, illustrating the game-changing potential of the technology for pediatric cardiology.
Hamilton Thorne Ltd. (TSXV:HTL) (OTC:HTLZF) is a leading provider of precision instruments, consumables, software, and services to the Assisted Reproductive Technologies (ART), research, and cell biology markets. The company recently revealed that sales increased 15% year over year to $16.4 million for the most recent quarter.
President and Chief Executive Officer, David Wolf, commented, “Our strategy to increase sales of higher margin proprietary equipment and software, services, and branded consumables combined with increased direct sales of products, yielded gross profit margin increases to 52.0% for the quarter and 51.3% for the six months ended June 30, 2023, versus 49.8% and 49.3% in the prior year.”
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