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The Market

With a market valuated at $16.4 Billion in 2013 (and expected to grow to $67.6 Billion by 2020)1, the regenerative medicine field affects many lives each year across the globe. The ability to heal properly after bone, wound, or reconstruction surgery is absolutely critical to the success of the procedure and quality of life for the patient. The current standard of care for allograft transplantation is relatively low, making room for significant opportunity for product improvement in the marketplace.

Lattice Biologics’ ECM-based Next Generation Allograft technology qualifies for the FDA’s 510(k) Premarket Notification process for Class I & II Devices. 510(k) offers many advantages to the Premarket Approval (PMA) process required for Class III Devices which is the most stringent type of device marketing application required by FDA:

  • Much simpler testing process requires no clinical trial data (PMA requires preclinical and clinical trials required).
  • Greatly reduced cost (the 510(k) process per filing can cost as little as approximately 1% of that of the PMA process).
  • Accelerated timing requires only 90-day Premarket Notification filing before commercial release for 510(k) vs. multiple years of testing and filings for PMA before commercial release.

4 things to know about the tissue repair market

Benefiting from High Barriers to Entry: The stringent nature of this industry, which is highly regulated by the FDA and requires strict compliance for AATB (American Association of Tissue Banks) accreditation, poses a costly challenge for any entity looking to enter the market. As an established, accredited tissue bank, Lattice Biologics has already undertaken the expense and resources necessary to meet and maintain these quality requirements.

The great need for improved solutions in the market, combined with technology that leverages the fastest, most affordable regulatory approval and delivery process, creates ideal conditions for our innovations to have an enormous impact on the population with relatively low risk and low cost.

1Source: Allied Analytics LLP (June 2014) “Global Regenerative Medicines Market (Technology, Application and Geography) – Size, Global Trends, Company Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013 – 2020”

Testimonial

“AdMatrix has been very impressive in terms of patient results. We are really interested in using it to expand from basic wound care applications into other surgical realms.”

- Plastic Surgeon (Lattice Biologics client)