Therma Bright Secures US Distributor 'DME Authority' for Its Patented Venowave Lightweight Deep Vein Thrombosis (DVT) Device, Just as US Healthcare Providers Deal with Device Shortages

June 28, 2021 8:00 AM EDT | Source: Therma Bright Inc.

Toronto, Ontario--(Newsfile Corp. - June 28, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has secured an exclusive US distributor, a Nashville, Tennessee based organization, DME Authority for Therma's patented FDA approved Venowave, a lightweight Deep Vein Thrombosis (DVT) prophylaxis device. The multi-year agreement provides Therma Bright with a $10 Million annual minimum purchase commitment, with the initial signing order of 5,000 units coming at a time when competitive mobile DVT prevention devices of the same product category are scarce, on back-order, or indefinitely unavailable in the US due to chip manufacturer shortages similarly affecting many other major industries.

Due to Venowave's composition, manufacturing of the device remains uninterrupted. Venowave is also uniquely designed for the emerging "Hospital to Home" use market, in the front-line battle against blood clot prevention. It delivers a continuous peristaltic wave motion and directly engages the body's venous system to more naturally and accurately increase venous blood flow, which aides in the prevention of blood clot formation. With approximately 50% of DVTs forming during the surgical procedure itself, and an alarming 75% of DVT's forming within 48 hours of the patient returning home after surgery, this technology is pioneering an alternative life-saving treatment for this condition. Studies have shown there are many risk factors and causes associated with Deep Vein Thrombosis (DVT), including: surgery, post-surgical recovery, obesity, smoking, prolonged sitting (i.e.: 2+ hour flights), pregnancy, hospitalization, cancer, leg injuries, fractures and certain birth-control & hormone-replacement medications.

In addition, recent stories in the Wall Street Journal, Newsmax, and CNN, along with other major news outlets, have highlighted scientist's world-wide race to understand why Covid-19 infected patients and vaccine recipients from some manufacturers are developing rare and potentially deadly blood clots, while simultaneously working towards a solution to reduce the recent wave of new blood clot cases created by the pandemic's sedentary living conditions. As of a May 12th report, the US Centers for Disease Control and Prevention had received reports of at least 28 fatalities resulting from a rare blood clotting syndrome identified among the 8.7 million coronavirus vaccine recipients from one manufacturer. Therma Bright has begun exploring new and innovative applications of its Venowave intellectual properties to expand into any potential modality that would assist in further alleviation of these rising blood clot concerns.

"We're pleased to announce this new, exclusive US distributorship with DME Authority," expressed Rob Fia, CEO of Therma Bright. "DME Authority's proprietary DME-360® software service model, in combination with Venowave's unique therapeutic proficiencies, provides the ideal solution to help deliver our vision for a better and brighter future for these patients lives by offering US Hospitals and Physician Practices the first true standard-of-care transformation capability this therapy category will have experienced in the last 30+ years."

Mr. Fia candidly points out that, "This patented, FDA approved Venowave DVT prophylaxis device administers our proprietary peristaltic action to work against the formation of blood clots by also offering the best comfort, mobility, and ease-of-use in this product category, while ensuring improved blood flow within the lower extremities. That's meaningful, because comfort and convenience are a must-have if we are to expect higher consistency with patient compliance of the preventative therapy Venowave delivers."

"DME Authority is excited to partner with Therma Bright to establish Venowave as the new US standard of care for hospital and physician practice DVT prevention therapy," shared Erick M. Gosse, CEO of DME Authority. "The addition of Venowave to our DME-360® software service platform will fundamentally transform healthcare's currently outdated, expensive, and strained approach to the rising blood clot crises." Mr. Gosse also points out, "Based on AHRQ's July 2020 revised statistical brief, we believe our unique format provides a new $1 Billion market opportunity where our scalable DME-360® program creates new revenue cycle opportunities for the hospital sector. This should make underwriting this new standard-of-care capability much more accessible to the healthcare community at large. Our combined abilities to deliver a true "Hospital to Home" continuum of care solution, improve patient's access to care, and drastically reduce hard costs and readmittance risks, uniquely positions DME Authority to conservatively forecast a 20% command of this emerging market opportunity within the next 24 months. The faster we scale, the more lives we can save. The additional research Therma Bright is providing on how Venowave technology may expand further into improved blood flow post COVID-19 pandemic is also very exciting to be a part of, as we all work to help get America back to her new normal."

The Venowave is a medical compression device that is lightweight, compact, and battery operated, designed to manage, treat and alleviate the symptoms associated with poor circulation. When worn firmly on the calf, the Venowave produces a waveform motion forcing blood from the feet and legs back to the heart. This increase in blood flow draws oxygen to wound and ulcer sites, prevents blood pooling and clotting, treats Lymphedema, and alleviates symptoms of Post Thrombotic Syndrome and other Chronic Venous Insufficiencies. The patented Venowave technology, developed by engineer John Saringer and co-developed by world-renowned clinical researcher and hematologist, Dr. Jack Hirsch, ensures the wearer will never have to worry about immobility ever again. Whereas before Deep Vein Thrombosis (DVT) prevention, technologies were expensive, stationary, uncomfortable, and difficult to use. Now, the comfort and ease of use in this new technology results in a higher patient compliance and better overall outcomes. The Venowave product is unique because it is lightweight (250 g or less than ½ a pound), discreet (can be worn under pants or skirts easily), and with no wires or tubes tethering the patient, the wearer can remain completely mobile, effectively reducing trip & fall accident rates.

Key features of the Venowave solution include:

  • Mobile: Weighing less than 0.5 pounds each, the Venowave fits snuggly to the back of each calf. No cords, no compression tanks - just rechargeable, removable 18-hour batteries needed for operation. This revolutionary technology permits you to participate in normal lifestyle activities that were once impossible with bulky, noisy, and immobile devices.
  • Simple-to-use: Designed for "Hospital to Home" use, Venowave technology is the easy and simple treatment device to adopt for DVT and PE prevention patients of all ages and health conditions. The device's large Neoprene Velcroed straps are adjustable and breathable - providing comfort for legs and calves of all sizes. Regardless of your leg position, Venowave automatically adjusts its massage-like therapy to keep your blood circulation flowing normal.
  • Life-saving: The life-threatening effects of DVT, Lymphedema, Chronic Venous Insufficiency (CVI), and Post Thrombotic Syndrome (PTS) are greatly reduced with the use of Venowave. Its venous-return assisting capabilities are designed to: (i) Prevent Deep Vein Thrombosis, (ii) Treat and manage Lymphedema & primary thrombosis, (iii) Enhance circulation NS (iv) Decrease post-operative limb pain and swelling. Clinical research conducted on patients suffering from Post Thrombotic Syndrome (PTS) concluded that the Venowave technology increased venous blood flow by 64% after 2 minutes of use and an 88% increased blood flow after 50 minutes of use. Researchers further concluded that compared with standard PTS therapies, approximately one-third of severe PTS patients reported clinical improvement.
  • Practical and preventive: Due to its simplicity and mobility, patients can wear the Venowave devices during surgical procedures, during their post-surgical hospital stay, and continue the same level of medical treatment comfortably at home or on the go. The practicality and convenience Venowave provides will promote greater compliance rates amongst patients and, ultimately healthier, happier lives.

Therma Bright is not making any express or implied claims that its Venowave device has the ability to eliminate blood clots that may be caused by some COVID-19 vaccines, but is working with researchers on how its lightweight Deep Vein Thrombosis solution may assist in improving blood circulation in patients who are vaccinated and at risk.

About Therma Bright Inc.

Therma Bright, developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test, is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. The Company's initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright received a Class II medical device status from the FDA for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings. The Company received clearance for the above claims from the US FDA in 1997. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTC Pink: THRBF) (FSE: JNX). Visit: www.thermabright.com.

Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com

Follow us on Twitter

FORWARD LOOKING STATEMENTS

Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation. as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.

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

This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.

SOURCES

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/88860

info