Healthcare Industry News: lumbar interbody fusion
News Release - July 16, 2018
Cerapedics Announces Closing of $22 Million FinancingFunding will accelerate commercialization and U.S. lumbar trial for i-FACTOR™ Peptide Enhanced Bone Graft
WESTMINSTER, Colo., July 13, 2018 -- (Healthcare Sales & Marketing Network) -- Cerapedics, a privately-held orthobiologics company, today announced that 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, chief executive officer of Cerapedics. "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 that three new members have been appointed to the company's board of directors including Valeska Schroeder, Ph.D., managing director of the medical technologies division at KCK Group, Greg Garfield, J.D., 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 Dr. 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.
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.
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary biomimetic small peptide (P-15) technology platform. i‑FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.
i‑FACTOR Peptide Enhanced Bone Graft Indications for Use
USA: i‑FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i‑FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.
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