Calavera Surgical Design develops on-demand shaping system for craniomaxillofacial implants

Life-changing skull defect reconstructions customized in operating room

TORONTO, July 21, 2015 /CNW/ - Calavera Surgical Design's unique process integrates the most sophisticated computer modeling and rapid prototyping technology with specific expertise in craniomaxillofacial (CMF) surgery, 3D imaging, and 3D design. A mechanical press and molds for more rapid and accurate shaping of mesh provides a simple intuitive ancillary tool for experienced surgeons that can be readily and seamlessly integrated into surgeries with minimal instruction.

A startup out of Sunnybrook Health Sciences Centre in Toronto, Calavera Surgical Design is responding to the need of plastic and maxillofacial surgeons, otolaryngologists, and neurosurgeons around the world for a faster, simpler, and more accurate method of restoring normal CMF anatomy.

Calavera has already successfully proven its pioneering technology in over 50 skull and orbital reconstruction surgeries. Clinical application of Calavera's technology improves surgical outcomes and quality of life for patients, and substantially diminishes operating time.

Currently, the vast majority of skull defect reconstructions in North America are performed by surgeons using manual bending or shaping of implant material or autogenous bone. In addition, custom cranial and orbital reconstructions are performed using a variety of materials that are shaped prior to surgery using CT scans and reference skulls.

Pre-operatively prepared implants do not allow for surgeons to make important discretionary changes in the operating room after assessing a patient's specific anatomy. The lack of customization using current methods can result in decreased post-operative health outcomes for patients.

Calavera is changing that paradigm by providing one compact, fully sterilizable delivery system that includes a suite of integrated technology for customized, on-demand shaping of implant materials for any patient's need, including patients whose defects are unknown prior to surgery.

The Centre for Imaging Technology Commercialization (CIMTEC) is designing and manufacturing the custom press and cart system that will soon be installed and tested in several Toronto area hospitals.

Quotes:

"Calavera's system gives surgeons a unique way to create patient specific implants in the operating room with a high degree of control and customization. We see good post-operative outcomes with excellent cosmesis across a range of defect types."

Dr. Jeffrey Fialkov, MD, MSC, FRCSC, Plastic Surgeon, Sunnybrook Health Sciences Centre

"CIMTEC is committed to working with startups like Calavera Surgical Design to accelerate the development of their innovative products. Our engineering and regulatory services are helping them reach important commercialization milestones and move their products into clinical use."

Dr. Aaron Fenster, Chief Executive Officer, CIMTEC

Quick Facts:

• Craniomaxillofacial injuries, traumas, and birth defects have immense physical and psychological impacts on the lives of sufferers. In North America, annually there are over 24,000 surgeries to correct these defects, including 3,500 in Canada alone.
• Calavera also provides services including skull biomodels, surgical skills teaching models, digital simulation and custom implant design for third parties

SOURCE Centre for Imaging Technology Commercialization (CIMTEC)

Image with caption: "A custom titanium mesh implant created during surgery using technology from Calavera Surgical Design. (CNW Group/Centre for Imaging Technology Commercialization (CIMTEC))". Image available at: http://photos.newswire.ca/images/download/20150721_C5945_PHOTO_EN_450193.jpg

Glenn Edwards, Director of Operations, Calavera Surgical Design, 416-912-5365, [email protected]; Darlene Pratt, Director of Marketing Communications, CIMTEC, 519-858-5013 ext. 25324, [email protected]