Monday July 16, 2018 0 comments
WESTMINSTER -- Cerapedics, a privately-held orthobiologics company, announced the company completed a $22 million financing led by KCK Group, a family investment fund that focuses on innovative medical technologies that meet significant clinical needs.
"We are pleased to announce that we have successfully completed an equity financing that will continue to accelerate the commercial release of i-FACTOR™ Peptide Enhanced Bone Graft and support the execution of a second Level I investigational device exemption (IDE) human clinical study that will broaden our market indication in the $2 billion U.S. spinal market," said Glen A. Kashuba, Cerapedics CEO.
"This year we have exceeded our own expectations regarding year over year revenue growth and have significantly expanded our user base as surgeons continue to express a high level of satisfaction with clinical results that support the safety and efficacy of our product.
“We also understand the value of Level I human clinical data and are committed to investing and expanding our indications. We are fortunate to be supported by KCK Group, a partner that shares in the long-term vision that differentiated products that provide safety, efficacy and economic value, supported by human clinical results, will ultimately provide the highest value to surgeons and their patients."
Cerapedics also announced three new members were appointed to the company's board of directors including Valeska Schroeder, managing director of the medical technologies division at KCK Group, Greg Garfield, senior managing director and head of the medical technologies division at KCK Group, and Nael Karim Kassar, investment partner at KCK Group.
"Cerapedics is well-positioned for strong growth with Level I data establishing i-FACTOR's superiority and with a dedicated team that has deep experience in orthobiologics and spinal fusion," said Schroeder.
"This financing will allow Cerapedics to further invest to increase physician access to i-FACTOR and to build clinical evidence for new indications."
i‑FACTOR Peptide Enhanced Bone Graft is based on proprietary biomimetic small peptide (P-15) technology that has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease.
This unique drug-device technology enhances the body's natural bone healing process through cellular activity that is directional and predictable, the company said.
Cerapedics received Premarket Approval (PMA) from the U.S. Food & Drug Administration for the use of i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming the first PMA-approved bone graft with this indication.
The company has also initiated an IDE clinical trial in transforaminal lumbar interbody fusion (TLIF) surgery.