Restorative Physiology Group, LLC, a medical products firm dedicated to the design and development of surgical implants for the human spine, announced today that its Thermal Method ™ products are undergoing a round of new testing for their ultimate use in spinal and orthopedic surgeries. Restorative Physiology’s ThermaCage™ family of products are designed as “least invasive” implants, potentially replacing existing, more surgically invasive products currently used in orthopedic surgery. Restorative Physiology’s executive office is located at the Lowcountry Innovation Center at the Navy Yard in North Charleston.
“The potential for ThermaCage™ to replace existing orthopedic implants is profound, comparable to the introduction of laparoscopic surgery for gallbladders and stints for coronary artery disease,” says Dr. Michael Kitchen, MD, founding partner and principal inventor for Restorative Physiology, LLC. “The impact of minimally invasive surgical technologies cannot be underestimated; nationally, with the demographic of people over age 60 exploding, there will be an increased demand for safe, less risky alternatives.”
The Thermal Method™ is defined as the “Controlled, Ordered, and Sequential transition between two temperature states of shape memory material” that occurs when the material is inserted through a temperature interface, i.e., a laparoscopic surgical tube, into the patient’s spine. The actual memory material is a thermally active metal core that conforms to its intended shape when implanted into the patient.
The ThermaCage™ family of products has a distinct advantage when compared to existing orthopedic technologies. The products include the ThermaCage™ Generic Interbody Fixation Devices, which are placed between vertebral bodies to accelerate formation of a continuous boney connection between two adjacent vertebras.
The ThermaCage V™ is designed for use as a Vertebral Body Spacer. The spacer is surgically placed utilizing current commonly practiced techniques for discectomy. This implant is designed for placement with a TLIF (Trans-foraminal Lumbar Interbody Fusion) procedure.
Animation of the spinal procedure is available for viewing on online video,restorativephysiology.com/mov/TC.
The ThermaCage™ devices are implanted into patients using the latest laparoscopic techniques, which result in smaller surgical incisions in patients.
With these techniques, Kitchen pointed to less post-surgical patient pain, greatly improved recovery times, shorter operative times, in addition to decreased hospitalization times and costs. In 2008, the total spine device market was valued in excess of $8 billion. In the U.S. alone, 550,000 spinal fusions are performed annually, a potential market of $3.4 billion for Thermal Method™ devices. The market for “least invasive” devices is projected at $1.2 billion.
The Thermal Method™ Concept received a US Patent Office designation on September 1, 2009, USPTO Patent Number 7.582,109. Restoration Physiology applied for a patent on the ThermaCage™ Generic Interbody Fixation Device on October 17, 2008, for “Spinal stabilization device and method,” USPTO application Number 20090112321.
Increasingly, ThermaCage™ is gaining notice. Restorative Physiology and Dr. Kitchen were winners in the Bio-Science category at the New Ideas for a New Carolina business competition in Charleston, SC, in February 2009. Winners are chosen based on the idea’s viability, innovation, vision, and profit and revenue potential. Last December, Southeast BIO, or SEBIO, announced that Restorative Physiology Group, LLC won that organization’s third annual year-long business creation competition, which resulted in a grand prize allocation of $100,000 to support the firm’s research and development.
The management team of Restorative Physiology includes James Cassidy, Ph.D., MBA, as management consultant; Rebecca Delegge, founding partner and designer; Jeffrey K. Wingate, MD, orthopedic surgeon; Bruce Frankel, MD, MUSC Department of Neurosciences; M. Pierce Gilbert, management consultant; William James Harrison, P.E., consulting engineer; Candace Cedarman, regulatory consultant; and, Dr. Kitchen, designer with a background in medicine and architecture.
Restorative Physiology Group joins a growing list of technology start-ups and consulting companies that call the Lowcountry Innovation Center home. “We’re impressed with the growing list of technology companies coming into the LIC,” says North Charleston Mayor R. Keith Summey. “Restorative Physiology is a tech start-up that has the potential to grow into a major global force in orthopedic and spinal surgery. This is an indication of North Charleston’s role as a burgeoning knowledge-industry area.”
“Definitely, the Lowcountry Innovation Center is a positive for our business,” concludes Dr. Kitchen. “The synergy of knowledge-based firms featuring talent and creativity at the LIC is unique, and provides a creative atmosphere for our firm to thrive.”
More information on the Restorative Physiology Group can be accessed online at restorativephysiology.com. For additional details on the Lowcountry Innovation Center, please go to lowcountryinnovationcenter.com.