27 Aug PAVmed Inc – Grant of Patent for Company’s CarpX – A minimally invasive device for treatment of Carpel Tunnel Syndrome
PAVmed, a multiproduct medical device company that is developing solutions for areas with large unmet medical needs, today announced the grant of a patent for its CarpX minimally invasive device that aims at treating carpal tunnel syndrome. The U.S patent 10,335,189 entitled “Systems and Methods for Percutaneous Division of Fibrous Structures”, covers the underlying technology of the device, primarily a device with a catheter, an expandable member such as a balloon, and a cutting element such as a pair of bipolar radiofrequency electrodes, as per a company statement.
Dr. Lishan Aklog, M.D., PAVmed’s Chairman and CEO states
“We are excited to have secured patent protection for our ground-breaking CarpX device. The patent grant is especially timely as we continue to advance CarpX towards commercialization through several key milestones, such as the recent successful completion of all procedures in the CarpX clinical safety study and our upcoming FDA 510(k) re-submission.”
The company has built a strong intellectual property rights portfolio with over 75 patents and patent applications for its proprietary technology. PAVmed intends to extend the application of this technology to other areas such as plantar fasciitis and compartment syndromes. This patent provides impetus to its efforts in securing a majority share of billion-dollar U.S. market opportunity that CarpX represents. The company hopes that the patent will create a formidable barrier to entry in the minimally invasive and percutaneous carpal tunnel release space.
Carpel Tunnel Syndrome is caused due to damage to the median nerve, a very important nerve that runs through the wrist. It primarily occurs when the synovium tissues surrounding the flexor tendons swell, or are compressed or squeezed, resulting in pain and discomfort, numbness, tingling and weakness. There are various risk factors for the disease, with women and older people being more susceptible to suffer from this anomaly. Other factors such as heredity, diabetes, rheumatoid arthritis, repetitive hand or wrist movements that cause stress in the tendons of the wrist and pregnancy can lead to this condition.
Electrophysiological tests such as Nerve conduction studies, Electromyogram (EMG), UltraSound, X-Rays and Magnetic Resonance Imaging Scans are some of the diagnostic tools used for determining the cause and extent of damage to the Median Nerve. Treatment options are categorized into non-surgical like braces and splints, Nonsteroidal anti-inflammatory drugs (NSAIDs), physiotherapy including nerve gliding exercises and steroid injections. The surgical options are called carpal tunnel release and can either be open tunnel carpal release or endoscopic carpal tunnel release.
According to data made available by Bureau of Labor and Statistics and the National Institute for Occupational Safety and Health (NIOSH), Carpal Syndrome affects more than 8 million people in the U.S and is the second most type of surgery with over 230,000 procedures performed annually.
According to an estimate by Future Market Insights (FMI), the Global Carpal tunnel release system market will grow at a CAGR of 5.5% from 2018 to 2028, to reach US$ 839.1 million by the end of 2028. The growth will primarily driven by increased awareness, a growing geriatric population, increase insurance coverage and scientific advancements.
PAVmed uses a highly effective and unique business model that combines operational efficiency with speed to market. The company claims to be able to develop products and achieve their commercialization, much faster and with far lesser capital than its competitors. It adapts a multi-product strategy, with special emphasis on products that have high margins and high impact, which helps diversify its risk and achieve economies of scale.
The company identifies commercial opportunities based on areas with large unmet needs, focusing on creating single use interventional devices, which have low capital requirement backed with a strong intellectual property rights portfolio. In addition, its products are aimed at taking advantage of the FDA 510(k) pathway, ensuring quick regulatory approval.
CarpX, its lead product, can relieve the pressure on the median nerve through a minimally invasive device, eliminating the need for a traditional incision. The device has a balloon catheter with bipolar radio-frequency cutting electrodes, which uses a wire to guide the device through the carpal tunnel using an ultrasound. It offers numerous improvements over traditional surgical options such as lower costs, reduced postoperative pain and faster recovery time.
The company conducted a first-in-human (FIH) 510(k) clinical safety study in which 20 patients underwent successful CarpX procedures. This study will be used to support its 510(k) re-submission to the U.S. Food and Drug Administration (FDA), seeking marketing clearance of its CarpX minimally invasive carpal tunnel release device, as per a company release.
Dr. Lishan Aklog, M.D., opines that
“We are excited to have achieved this critical milestone. Our success with this study brings us one step closer to fulfilling our mission to transform how carpal tunnel syndrome is treated for millions of people worldwide, representing a billion-dollar market opportunity in the U.S. alone.”
PAVmed’s product portfolio includes a non-invasive cell collection device to collect cells from the Esophagus, Esoguard (An Esophagul DNA test), Portio (An implantable Intraosseous vascular access device) and DisappEAR (antimicrobial resorbable ear tubes).
In addition, its pipeline consists of 6 product candidates targeting areas such as medical infusion, hand surgery, pediatric ear infections, and tissue ablation.
Lucid Diagnostics is the company’s, majority owned subsidiary, and is engaged in developing EsoCheck Cell Collection Device, which recently received 510(k) marketing clearance from the FDA.
- The company has a unique business strategy, focusing on areas with large unmet medical needs, with products that do not have intensive capital requirements and can utilize the (501) K regulatory pathway. This augurs well for its capital and operational efficiency.
- In August 2018, the company faced a setback when its application for approval for CarpX was asked to be resubmitted by the FDA. The shares of the company took a considerable beating, hence the company is taking all possible measures to ensure that there is no leeway for any discrepancy or disagreement as it resubmits its application.
- Clinical trials are subject to uncertainty and there is a chance of failure, however since the company has a diversified portfolio of products, it is well insulated against any unforeseen circumstances.
PAVmed has a diversified product portfolio, which not only mitigates its risk but also allows it to capitalize on opportunities in various markets with large unmet medical needs. The company’s differentiated business strategy will hold it in good stead, by focusing on faster commercialization and lower operational costs. By focusing on the 510(k) regulatory pathway, the company is ensuring that it puts its capital and resources to optimal use and starts bringing in quicker revenue for the company as well as it partners.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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