Cerapedics

Industry
Biotechnology
Founded Year
2001
Headquarters
Westminster, Colorado, United States
Employee Count
310

Key People

  • Valeska Schroeder - Chief Executive Officer
  • Glen A. Kashuba - Former Chief Executive Officer
  • Andrew Tofe - Founder
  • Kimberly A. Burke - General Counsel
  • Jeffrey G. Marx - President & COO

Assessment

Team
Aspect: Multiple successful MedTech entrepreneurs
Summary: The leadership team comprises experienced professionals with successful backgrounds in the MedTech industry.

Cerapedics' leadership includes individuals like CEO Valeska Schroeder and Founder Andrew Tofe, who have extensive experience in the medical technology sector. Their combined expertise positions the company well for strategic decision-making and innovation.

Clinical Need
Aspect: Very Strong
Summary: Cerapedics addresses a critical need in orthopedic surgery with its innovative bone graft products.

The company's i-FACTOR bone graft offers a novel solution for cervical spinal fusion, providing a safer and more predictable bone formation process compared to existing options. This addresses a significant clinical need for improved patient outcomes in spinal surgeries.

Competition
Aspect: Somewhat crowded
Summary: The orthopedic device market is competitive, but Cerapedics' unique technology provides differentiation.

While the market for orthopedic devices is populated with numerous players, Cerapedics' proprietary P-15 technology offers a distinct advantage. However, the presence of established competitors necessitates continuous innovation and strategic positioning.

Technical Challenge
Aspect: Predictable
Summary: The development of Cerapedics' products involves manageable technical challenges with predictable outcomes.

The company's focus on peptide-enhanced bone grafts leverages established scientific principles, resulting in a development process with foreseeable technical hurdles. This predictability aids in efficient product development and regulatory approval processes.

Patent
Aspect: Very Strong
Summary: Cerapedics holds robust patents protecting its proprietary P-15 technology.

The company's intellectual property portfolio provides a strong competitive edge, safeguarding its unique technology and supporting long-term market exclusivity.

Financing
Aspect: Well-funded
Summary: Cerapedics has secured substantial funding to support its growth and product development.

With total funding of approximately $180.7 million, including a $22 million financing led by KCK Group, Cerapedics is well-positioned financially to advance its product pipeline and expand its market presence.

Regulatory
Aspect: 510k/PMA + Reimbursement
Summary: Cerapedics has achieved FDA approval and reimbursement for its i-FACTOR bone graft.

The FDA's Premarket Approval (PMA) for i-FACTOR in anterior cervical discectomy and fusion procedures, along with established reimbursement pathways, facilitates market adoption and underscores the product's safety and efficacy.

Opportunity Rollup

Odds of Success
3.65
Peak Market Share
4.75
Segment CAGR
3.0%
Market Segment
Orthopedic Devices
Market Sub Segment
Spinal Fusion Devices
Year Post Launch Market Penetration (%)
1 0.24
2 0.71
3 1.66
4 3.32
5 4.75

Key Takeaway

Cerapedics' innovative P-15 technology positions it well in the orthopedic device market, addressing significant clinical needs with strong financial backing and a capable leadership team.