Ortho-biologics company Cerapedics announced that it has won FDA breakthrough device designation for its investigational P-15L bone graft to treat degenerative disc disease (DDD). The company plans to enroll at least 270 DDD patients in the Aspire study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L bone graft […]
Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries. The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative […]
Cerapedics said late last week it closed a $22 million round of financing and added three new members to its board of directors The funding round was led by family investment fund KCK Group, the Westminster, Colo.-based company said, and will help support the company’s bone graft products. “We are pleased to announce that we have […]
Cerapedics said today it won FDA investigational device exemption approval to launch a clinical trial examining the safety and efficacy of its P-15L Peptide Enhanced bone graft. In the trial, the Wesminster, Colo.-based company will explore the use of the P-15L graft as it compares to autografts in transforaminal lumbar interbody fusion procedures meant for treating […]
Cerapedics today released the results from the pivotal FDA investigational device exemption trial of its i-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures. Data from the study was published electronically in the journal Spine. The Westminster, Colo.-based company said the trial demonstrated appropriate safety and efficacy and met all 4 […]
Cerapedics said yesterday it won FDA premarket approval for its I-Factor peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures for patients with degenerative cervical disc disease. Westminster, Colo.-based Cerapedics said the I-Factor graft is the 1st bone graft approved for use in cervical spine procedures and the 2nd PMA cleared bone […]
ConforMIS lured Zimmer’s dental business operations director, Matthew Scott, away to be its new chief operating officer as it looks to scale up its customized knee implant business.
The Bedford, Mass.-based medical device company said Scott bring’s a decade’s worth of ops experience from his tenure at Zimmer. ConforMIS makes knee replacement implants and instrumentation that are custom-fit to patients’ morphology.
Cerapedics said it closed a Series C equity round worth $19 million, led by new investors MedImmune Ventures and CVF LLC, an affiliate of Henry Crown & Co.
Existing backers OrbiMed Advisors and NGN Capital also participated, according to a press release.
The Dow Jones Industrial Average, a longtime bellwether for the U.S. economy, flirted yesterday with a high-water mark not seen since Lehman Brothers’ collapse triggered an economic implosion more than 4 years ago.
The Dow reached 13,005.04 at one point yesterday, before subsiding to close at 12,965.69 yesterday. It’s the first time the index has climbed that high since May 2008.
Investors were heartened by a deal struck in the European Union to resolve Greece’s debt crisis and by positive earnings results from a pair of American stalwarts.