Multi-product, commercial-stage medical device company PAVmed Inc. (PAVM:NASDAQ) today announced that "the first U.S. patient recently underwent successful carpal tunnel release using its CarpX® minimally invasive carpal tunnel device."
The firm stated that its CarpX device relieves Carpal Tunnel Syndrome (CTS) symptoms via a quick minimally invasive procedure carried out in a physician's office. PAVmed advised that CTS causes chronic pain to patients and is a very common workplace-related condition and is also the top driver of worker's compensation claims.
The company stated that Dr. Edward J. Armbruster of Mercer-Bucks Orthopaedics P.C. in the Philadelphia area was the first to use the CarpX device on a patient experiencing CTS. The firm noted that unlike the present standard of care where it frequently takes several months to recover fully, the patient, who is a truck driver, was able to return to work one week following the procedure.
Subsequent to performing the procedure, Dr. Armbruster stated, "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...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."
The company's Chief Medical Officer Dr. Brian deGuzman remarked, "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...who oversees training and proctoring of early CarpX users and was present as an observer during this procedure."
The firm stated that "it believes that 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."
PAVmed's Chairman and CEO Lishan Aklog, M.D., commented, "We thank Dr. Armbruster for leading the team of world-class hand surgeons participating in our initial U.S. CarpX commercial launch...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."
The firm explained that "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."
The company noted that each year around 600,000 patients undergo surgery for CTS while over 1 million more go untreated and suffer in silence due to the long recovery times associated with traditional methods of more invasive carpal tunnel release procedures.
PAVmed Inc. is multi-product, commercial-stage medical device company based in New York. The firm states that its unique business model allows it to advance innovative products on a path to commercialization much quicker than other medical device companies using less invested capital. The company's product and device pipeline aims to addresses unmet clinical needs in a broad spectrum of clinical areas. The firm's business and products are separated into four operating divisions: GI Health, Minimally Invasive Interventions, Infusion Therapy and Emerging Innovations.
PAVmed began the day with a market capitalization of around $257.1 million with approximately 71.9 million shares outstanding and a short interest of about 6.5%. PAVM shares opened 4% higher today at $3.64 (+$0.14, +4.00%) over Friday's $3.50 closing price after the Presidents Day holiday weekend and reached a new 52-week high this morning of $4.77. The stock has traded today between $3.60 and $4.77 per share and closed for trading at $4.49 (+$0.99, +28.29%).
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