Cerapedics raised $19 million in new Series C financing and isn't wasting any time putting the cash infusion to work. The medical device company says the funding will fuel continued U.S. clinical testing of its debut peptide-enhanced bone graft--with a focus now on getting that job done--and also growing its sales and marketing capacity where the product is already cleared for use overseas.
Additionally, the new investment will help Cerapedics accelerate its pipeline development work and pursue trials for the product i-FACTOR for a variety of bone-repair indications. Plans call for seeking PMA approval in the U.S. to use i-FACTOR for cervical spine treatment.
MedImmune Ventures and Henry Crown and Company affiliate CVF led the new round, along with existing investors including OrbiMed Advisors and NGN Capital. Consider that MedImmune Ventures is part of the biotech MedImmune, which itself is owned by drug company giant AstraZeneca ($AZN). So we have an intriguing drug industry angle in the investment round. MedImmune Ventures Managing Director Sam Wu has also joined Cerapedics' board of directors as part of the investment agreement.
While i-FACTOR has had a CE marking since 2008, the product is now part of an Investigational Device Exemption clinical trial in the U.S. According to the company's website, the ongoing trial is enrolling patients to test the putty for single-level anterior cervical discectomy and fusion procedures as a bone substitute for patients with degenerative cervical disc disease.
Cerapedics Chief Operating Officer Andy Handwerker said in a statement that the company wants to be "the second premarket approval (PMA) designated osteobiologic product to address the spine market in the United States and the first to be indicated for use in the cervical spine." Along those lines, Cerepedics also disclosed that it got the FDA go-ahead to pursue a PMA modular submission for its i-FACTOR IDE clinical trial and has begun work on that process.
That news also shows how much longer the U.S. regulatory process can take. i-FACTOR is sold in two iterations in 25 countries outside the United States and has already been used in close to 10,000 spine, trauma and orthopedic surgeries, Cerapedics notes.
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