Becker's ASC Review

23 EXECUTIVE BRIEFING 2 EXECUTIVE BRIEFING EXECUTIVE BRIEFING With a deep understanding of bone repair and extensive research on the mechanism of action of the P-15 Peptide, Cerapedics believed they could develop a product to safely accelerate controlled bone formation and achieve fusion sooner. This led their team to conduct a randomized controlled trial (RCT) of its latest P-15 Peptide drug-device in single-level transforaminal lumbar interbody fusion (TLIF) surgery and test for speed-to-fusion. As a result of the RCT, Cerapedics secured FDA Class III drug-device approval for PearlMatrix™ P-15 Peptide Enhanced Bone Graft, and demonstrated statistically superior fusion speed at 24 months i with over twice as many patients fused at six months compared to the control i,ii the patient's own bone. "Our goal wasn't just to create another bone graft," Ms. Schroeder said. "It was to create a whole new category…a bone growth accelerator." In Dr. Rajpal's experience, every spine surgeon is looking to improve fusion rates, reduce complications, and accelerate healing time for their patients. Evidence-based care PearlMatrix is a drug-device combination product with Level 1 RCT data and FDA Class III drug-device approval. As the first surgeon in the United States to use PearlMatrix following FDA approval, Dr. Rajpal shared that a key reason he trusted PearlMatrix for his patients was the rigor and evidence required by the FDA to achieve Class III drug-device approval. In addition, over 60% of the participants in Cerapedics' clinical trial presented with one or more risk factors such as nicotine use, BMI greater than 30 and/or type 2 diabetes. High-risk patients are often excluded from these types of studies, so the Cerapedics trial uniquely represents the patient population that surgeons perform fusions on each day. Cerapedics is committed to advancing spine care by educating clinicians about the P-15 Peptide and continuing to build the body of evidence that demonstrates the clinical benefits of faster fusion. The company is also exploring other high-need areas where accelerated bone growth can make a difference for patients. While hundreds of bone graft products are commercially available, only three have achieved the biologically active Class III drug-device designation, with Cerapedics responsible for developing two of the three products, PearlMatrix and i-FACTOR™. "The data is robust and shows PearlMatrix is safe for my patients. The biologics space has hundreds of products out there, but we're talking about a very elite group of products that have Class III approval. The scientific rigor is what distinguishes PearlMatrix from other biologic options," Dr. Rajpal said. The future of fusion With so many bone graft products on the market, Dr. Rajpal believes it's essential for surgeons to become educated about PearlMatrix to understand the robust, high-quality clinical data supporting the approval of this product, especially for higher-risk fusion patients. He also emphasized that using PearlMatrix hasn't resulted in any substantial change in his surgical workflow and that the product has excellent handling characteristics. The material is moldable, making it easy to use, stays where the surgeon puts it, and is efficient to use in the operating room. As a global orthopedics company, Cerapedics is committed to addressing unmet clinical needs that matter to patients. While patients will continue to take steps to try to avoid surgery, when surgery is required, surgeons can now provide options like PearlMatrix P-15 Peptide Enhanced Bone Graft. "We think speed to fusion is one of the most important unmet clinical needs," Ms. Schroeder said. "There is a real need to safely accelerate fusion to improve outcomes in spinal fusion procedures, and we expect to help a lot of patients achieve that goal." Cerapedics is a global, commercial-stage orthopedics company with two Class III drug-device products approved by the FDA: PearlMatrix ™ Bone Graft for single-level transforaminal lumbar interbody fusion (TLIF) in the lumbar spine and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. i PearlMatrix Instructions For Use. Cerapedics. ii Internal Data on File as of 9/9/24

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