The medical device industry is expected to reach an impressive US$850 billion by 2030, up from a staggering US$577.26 billion in 2022. A number of factors are driving this expansion, including an aging global population, an increase in infectious and chronic diseases, and the ongoing advancement of medical technology.
Within this expansive sector, there's a burgeoning field dedicated to cutting-edge medical imaging and diagnostics. As the FDA expedites approvals for medical devices in 2023, it's clear that emerging companies specializing in medical imaging are poised to make a significant impact in this ever-evolving landscape. Let's take a look at a few companies in the sector that have made news recently.
Therma Bright Inc. (TSXV:THRM) (OTCQB:TBRIF)
Therma Bright Inc. is a pioneering force in the realm of cutting-edge medical technology, dedicated to transforming the healthcare landscape. Their extensive portfolio encompasses a wide array of diagnostic and medical device technologies, poised to tackle some of the most pressing challenges in modern medicine.
In the sphere of Respiratory Health, Therma Bright introduces a game-changing innovation, the Digital Cough Test (DCT) app, developed in collaboration with AI4LYF. This remarkable app leverages the power of artificial intelligence to identify a spectrum of respiratory diseases, including the formidable COVID-19, by analyzing the sound of a person's cough. Notably, its accuracy consistently surpasses 94%, a testament to its potential. The app is on the verge of securing the prestigious 513g FDA clearance, a milestone that will pave the way for Remote Therapeutic Monitoring (RTM) charges and patient reimbursement.
Consumer Health is another realm where Therma Bright shines, boasting three remarkable devices. The Benepod Hot and Cold Contrast Therapy Device takes center stage, offering relief for chronic pain sufferers, particularly those battling osteoarthritis and lower back pain. The InterceptCS emerges as a pioneering device for cold sore prevention. Additionally, the TherOZap provides cutting-edge pain management relief through thermal therapy for insect bites and stings.
In the arena of Vascular Disease, Therma Bright presents two groundbreaking devices. PREVA is a cutting-edge clot-retrieving marvel distinguished by its innovative distal basket design. Meanwhile, Venowave tackles the menace of Deep Vein Thrombosis (DVT), a post-surgery leg pain affliction. This compact and lightweight DVT prevention device is designed for use in healthcare settings and at home, employing continuous wave motion to enhance blood flow and counter venous stasis, a significant contributor to clot formation.
A stark reality surfaces: annually, more people succumb to blood clot complications than from breast cancer, HIV, and traffic accidents combined. This highlights the paramount importance of Deep Vein Thrombosis (DVT) prevention. Remarkably, over half of DVTs commence their formation intra-operatively, with 75% emerging within 48 hours post-operatively. Therma Bright's technology pioneers a user-friendly, potentially life-saving alternative.
Therma Bright recently achieved a significant milestone by securing U.S. Medicare and Medicaid reimbursement through a network of payers. The reimbursement per pair of Venowave devices, under temporary codes, ranged between $725 and $1050 per patient. This accomplishment streamlines medical billing processes, offering clarity and precision for healthcare providers, patients, and insurers. Rob Fia, CEO of Therma Bright, aptly encapsulates its significance.
In recent news, on September 7, 2023, Therma Bright submitted an updated FDA 510K application to address the Venowave device's intended use, labeling, and product description. This update aims to better align with the U.S. Centers for Medicare and Medicaid Services (CMS) application for permanent Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes.
In order to secure nine (9) permanent CPT and HCPCS codes, CMS had originally requested FDA approval, stating that the Venowave device could be used successively by multiple patients.
Therma Bright's swift response to this requirement demonstrates their commitment to progress in the medical field. The company looks forward to sharing more details as they expand their distribution partners across the U.S. for the Venowave device.
Profound Medical Corp. (NASDAQ:PROF) (TSX:PRN)
Profound Medical Corp. is a commercial-stage medical device company at the forefront of developing and marketing innovative, incision-free therapies for the ablation of diseased tissue. With a focus on customizable medical solutions, Profound Medical aims to revolutionize the healthcare landscape.
One of its standout achievements is the development of TULSA-PRO, the company's flagship product candidate. TULSA-PRO is meticulously designed to offer customizable and predictable radiation-free ablation, particularly targeting prostate tissue. A unique feature of this technology is its active protection of surrounding critical structures like the urethra and rectum, preserving patients' natural functional abilities.
On September 6, 2023, PROF announced a strategic step by establishing an at-the-market equity program (ATM Program). This initiative empowers the company to issue and sell up to US$30,000,000 worth of common shares in its capital.
The ATM Program's flexibility allows Profound to make sales through at-the-market distributions on various trading platforms, including the Toronto Stock Exchange (TSX) and the Nasdaq Stock Market LLC (Nasdaq). Importantly, the TSX has conditionally approved the listing of common shares that may be issued under this program.
These financial moves are expected to fund Profound's ongoing efforts to commercialize its TULSA-PRO system in the United States and support global initiatives for both the TULSA-PRO system and the Sonalleve system. Additionally, the proceeds will contribute to working capital and general corporate purposes.
Perimeter Medical Imaging AI (TSXV:PINK) (OTC:PYNKF)
Perimeter Medical Imaging, a medical technology company, is making significant progress in the field of breast surgery. The company recently received FDA approval to introduce an enhanced AI algorithm in its ongoing clinical trial for breast conservation surgery. This development allows them to incorporate updated AI technology into the study, enhancing patient enrollment.
The company is planning an interim analysis in the second quarter of 2024, utilizing the new algorithm. Positive results could expedite regulatory submissions for market clearance. Additionally, Perimeter has gained approval to enroll up to 531 subjects, ensuring a robust dataset for their study.
To further support patient enrollment, Perimeter has expanded its clinical trial sites, including prestigious institutions like the Mayo Clinic and Baptist MD Anderson in Florida. This expansion aims to accelerate patient recruitment and gather more comprehensive clinical data.
The enhanced AI leverages additional training data and Perimeter's latest AI advancements, promising improved sensitivity, specificity, precision, and recall. Perimeter's mission is to enhance clinical and economic outcomes in breast surgical oncology through advanced imaging and AI technology.
In a recent announcement on September 8, the company welcomed Adam Hodges as its Vice President of Sales and Marketing. Hodges brings extensive experience in medtech sales, with a focus on advancing innovative technologies that challenge the clinical standard of care.
Nanalysis Scientific Corp. (TSXV:NSCI) (OTCQX:NSCIF)
Nanalysis Scientific Corp. is a renowned leader in the field of portable NMR machines and MRI technology, catering to both industrial and research applications. Nanalysis' flagship product, the NMReady-60, revolutionized portable NMR spectrometry by offering a full-featured device in a single compact enclosure without the need for liquid helium or cryogens.
These devices find applications in various industries such as oil and gas, chemicals, mining, pharmaceuticals, biotechnology, flavor and fragrances, agrochemicals, law enforcement, and more. They are also used in government and university research laboratories worldwide. Nanalysis continues to innovate and expand its product offerings independently and through partnerships.
Recently, Nanalysis reported its second-quarter results for 2023, with CEO Sean Krakiwsky expressing optimism about the company's performance. The company achieved $6,956k in sales, primarily driven by the successful rollout of the CATSA Airport Security Project and strong results in third-party equipment sales. While the core benchtop business is a focus for improvement, the company's strategy as a full-service scientific instrumentation company with different business units is starting to yield positive results.
Nanalysis is also making progress on the Airport Security Project, which covers 81 airports. Positive cash flows are anticipated this fall, and services will then be expanded to include all remaining airports by early 2024.
Furthermore, the company's collaboration with Quad Systems AG and the launch of high-field NMR product offerings have expanded its product line and market presence. By streamlining R&D and manufacturing capacity, especially in Benchtop NMR, Nanalysis aims to return to growth alignment in 2024, maintaining its position as a leader in the field through continuous innovation and technology integration.
Recently, the company presented at the Planet MicroCap Showcase: Vancouver 2023, where CEO and Founder Sean Krakiwsky discussed the company's progress and answered questions from the audience.
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