Tissue Regeneration Technologies LLC (TRT) has nabbed U.S. FDA 510(k) clearance of its Orthogold 100 device for the treatment of superficial burns. The patented Softwave technology uses an unfocused extracorporeal shock wave to spur a physical and biological response that aids in wound healing.

The FDA cleared the device for the treatment of superficial, partial-thickness, second-degree burns in adults.

This is the third indication for the Orthogold 100, which was first cleared in 2018 for activation of connective tissue and registered for pain reduction and increased blood flow. The following year, TRT received the FDA green light for the treatment of diabetic foot ulcers.

With this latest clearance, TRT is the only extracorporeal shock wave therapy (ESWT) manufacturer with U.S. clearances for both acute and chronic wounds, the Woodstock, Ga.-based, company said.

Large market opportunity

An estimated 450,000 people in the U.S. visit emergency rooms with burn-related injuries each year. While most superficial wounds heal in a couple of weeks, some are persistent causing long-term pain and disability. According to the CDC, the U.S. spends about $7.5 billion annually on burn care.

Stimulating epithelial cells to migrate upward and repair wounded tissue can help to speed recovery and reduce scarring and mobility issues.

TRT’s noninvasive technology promotes wound healing via neovascularization and increased oxygen and perfusion, leading to the formation of new blood vessels. During the treatment, high-energy sound waves are applied to the injured area to invigorate regeneration and healing.

Results from a prospective, randomized clinical trial, published in the Annals of Surgery, showed a marked increase in epithelialization in patients who underwent unfocused ESWT (9.6 ± 1.7 days), compared with patients who did not get the treatment (12.5 ± 2.2 days), resulting in a statistically significant ±3 days decline in time required for healing.

TRT’s portfolio is focused on five therapeutic areas – cardiac and vascular, lithotripsy and urology, orthopedic, urology, wound care and veterinary care.

Spinal injury trial

Last month, the company launched a trial for ESWT in acute traumatic complete and incomplete cross-sectional lesions. The multicenter, randomized, double-blind, placebo-controlled trial will assess whether unfocused electrohydraulic shockwaves can improve motor and sensory function in patients with acute spinal cord injuries, if applied within 72 hours of the injury. The two-year study, which is sponsored by the Austrian Workers’ Compensation Board, will take place at 13 sites in Austria and one in Germany.

TRT said it intends to pursue FDA clearances for all ESWT treatments targeted by other shockwave companies, including Sanuwave Health Inc., which received the first FDA clearance for diabetic foot ulcers in 2018 with its Dermapace system. Other competitors include Houston-based Soliton Inc. and Shockwave Medical Inc., of Santa Clara, Calif.

Soliton said recently it expects to launch its Rapid Acoustic Pulse device in the U.S. in the first half of 2021. The launch will include tattoo removal and cellulite reduction indications, pending FDA clearance of the latter. The company received a nod for tattoo removal in March.

Shockwave Medical Inc. develops products to transform the way calcified cardiovascular disease is treated, using sonic pressure waves to effect intravascular lithotripsy (IVL). In September 2019, the company won an FDA breakthrough designation for its Shockwave IVL system with the Shockwave C2 coronary IVL catheter to treat coronary artery disease.

Other companies are vying to improve healing in burn victims. In December, Melbourne, Australia-based Polynovo Ltd. was granted a CE mark for its Novosorb biodegradable temporizing matrix (BTM), a synthetic biodegradable dermal scaffold for the regeneration of dermis lost as a result of extensive surgery or burns.

Another Melbourne-based company, Avita Medical Ltd., raised AU$120 million (US$81 million) last year to advance new indications for its Recell spray-on-skin treatment. The system is designed to be used alone at the point of care or in combination with autografts, depending on the depth of the burn. Avita received FDA approval of the Recell system in September 2018 for the treatment of acute thermal burns in patients 18 and older. It is also approved in Australia and China and has CE mark clearance in the EU.