PAVM stock exploded higher on February 16, 2021, after the company announced that the first U.S. patient recently underwent successful carpal tunnel release using its CarpX® minimally invasive carpal tunnel device.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, today announced that the first U.S. patient recently underwent successful carpal tunnel release using its CarpX® minimally invasive carpal tunnel device.
CarpX relieves the symptoms of Carpal Tunnel Syndrome (CTS) in a rapid, minimally invasive, office-based procedure that speeds patients’ recovery. CTS is a common workplace-related condition that causes chronic pain to patients and, as the top driver of workmen’s compensation claims, imposes high costs on society.
The patient presented with symptoms of carpal tunnel syndrome to Dr. Edward J. Armbruster of Mercer-Bucks Orthopaedics, P.C., in greater Philadelphia, who performed minimally invasive carpal tunnel release using the CarpX device. In marked contrast to typical recovery times of up to several months following conventional carpal tunnel release surgery, the patient returned to work as a truck driver within one week of the procedure.
“This is a very exciting development and the most significant advance in minimally invasive carpal tunnel release since endoscopic techniques were introduced some 30 years ago” said Dr. Armbruster. “I found that the CarpX balloon creates significantly more space in the carpal tunnel after the transverse carpal ligament is divided than traditional techniques, which could potentially result in superior outcomes for patients. As a busy hand surgeon, I strongly believe that CarpX will change how future carpal tunnel surgery will be performed, providing patients with a less invasive option with significantly shorter recovery times than existing carpal tunnel release options.”
“We continue to find that CarpX performs as designed, combining balloon technology to protect critical structures together with radiofrequency energy to cut the transverse carpal ligament precisely, offering procedure times comparable to traditional techniques after a very short learning curve,” said Dr. Brian deGuzman, PAVmed’s Chief Medical Officer, who oversees training and proctoring of early CarpX users and was present as an observer during this procedure.
CarpX has the potential to lower healthcare costs and increase the numbers of patients treated for CTS by offering a more attractive option to the large number of patients who chose to “suffer in silence” to avoid a prolonged recovery from traditional carpal tunnel surgery.
“We thank Dr. Armbruster for leading the team of world-class hand surgeons participating in our initial U.S. CarpX commercial launch,’’ said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “We continue to take a steady and deliberate approach to this initial launch, focusing on training, proctoring and procedural streamlining, to lay the foundation for expanded utilization later this year. This initial U.S. commercial experience along with our clinical trial results in New Zealand affirm CarpX’s potential to establish a new standard of care in the treatment of carpal tunnel syndrome by dramatically reducing recovery times and improving outcomes compared to traditional open surgery. We believe this represents an estimated billion-dollar U.S. market opportunity.”
CarpX is a patented U.S. Food and Drug Administration (FDA) 510(k) cleared single-use disposable minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery times (CarpX animation). CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to percutaneous and minimally invasive revolutions in the treatment of other conditions. The balloon catheter device is inserted under the scarred ligament in a minimally invasive fashion, tensioning it while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure. Carpal tunnel syndrome exacts a major clinical and economic burden on society with an estimated 600,000 patients undergoing carpal tunnel surgery each year and over one million who suffer in silence because of the long recovery times associated with traditional invasive carpal tunnel release.
PAVmed (PAVM) is also involved in the early cancer detection space. The company’s esophageal cancer early detection combination of a minimally invasive sample collector with a proprietary testing methodology looks poised to take market share starting in 2021 now that Medicare has begun reimbursing for the test as of January 1, 2021.