ApiFix

ApiFix has developed a truly breakthrough minimally invasive deformity correction system for patients with Adolescent Idiopathic Scoliosis (AIS).

The ApiFix Opportunity

  • Game-changing technology: Minimally invasive solution that addresses limitations of invasive surgery; strong patent protection
  • Cost-saving solution: Saves ~45% total costs (OR and hospitalization); reduces need for revision surgery
  • Large market: $900 million worldwide addressable market
  • Strong clinical evidence: CE approved, FDA in process; sales in much of Europe (including Germany, Italy, and Spain); successful trials on 145 patients in 7 countries

The Product

The minimally invasive ApiFix system incorporates a miniature ratchet mechanism that captures incremental corrections performed by the patient according to the physical therapy regimen. The deformity correction process spans several months to allow the soft tissues to accommodate any minor correction. The ApiFix system is inserted through a small incision in the patient’s back and uses only two screws to support its ratchet-based, small expandable rod.

The ApiFix Procedure vs. Current Procedure

  • Significantly smaller incision: ~10 centimeters vs. standard ~45 centimeters
  • Shorter surgery time: ~1 hour vs. 4-6 hours
  • Reduced length of stay (hospitalization): 2-3 days vs. 6-7 days

The Team

  • Paul Mraz, president and CEO: 25+ years of spine and orthopedic medical device experience; senior/executive-level positions in U.S.- and Israel-based companies, including management, corporate strategy, product development and marketing, sales management — all on a global basis
  • Ed Roschak, chairman: CEO of Ellipse Technologies from 2011 to 2016, when it was acquired by NuVasive for $410 million
  • Uri Arnin, Founder & CTO: More than 10 years of experience in the spine field; inventor and CTO, Impliant Inc.; founder and CTO, Spine21 Ltd.
  • Prof. Yizhar Floman, M.D., Founder: Spine surgeon; president of the Israeli Spine Society

Recent Developments

  • Increased the number of surgical procedures to +185
  • Completed first surgical procedures in North America and Singapore
  • Announced Ed Roschak, former CEO of Ellipse Technologies Inc., as Chairman of the Board and industry veteran Paul Mraz appointed as President and CEO
  • Initiating U.S. presence with opening of ApiFix, Inc., in Boston, Massachusetts

Status & Achievements

Founded: 2011
Stage: Revenue (commercial sales in 9 countries); 5 distribution agreements (Canada, Spain, Holland, Greece, Singapore)
Investors: The Trendlines Group, B. Braun
IP: 7 families of granted and pending patents
Certification:
CE mark
Sales: Europe, Canada, Asia

Awards

  • 2016, National Capital Consortium for Pediatric Device Innovation (NCC-PDI) Competition Winner
  • 2012, Best Start-Up, Israel’s Office of the Chief Scientist of the Ministry of Economy

In the Media

The Background & Market

Today’s gold standard for correcting spinal deformities involves fusing an average of 10 motion levels using a large number of screws in a surgical procedure that lasts an average of six hours and costs upward of $100,000. Worldwide, there are approximately 126,000 scoliosis procedures per year, of which 40,000 are AIS, representing a $2.4 billion implant market.* The cost of scoliosis correction implants in the United States, not including hospitalization, is around $600 million annually, with an estimated $300 million market outside the United States.

 

*U.S. National Center for Health Statistics; OECD Health Data 2015; Statistique annuelle des établissements de santé and CNAMTS (Evolution des actes techniques en secteur liberal); Statistisches Bundesamt; Conjunto Mínimo Básico de Datos – Hospitalización and Ambulatorio; UK Hospital Episode Statistics databases for Admitted Patient Care and Outpatients; Life Science Intelligence Surgical Procedure Volume database.

Media


ApiFix featured on Israel's Health Channel program, Only Health. 


Founder Dr. Yizhar Floman on ILTV


Founder Uri Arnin presents ApiFix


ApiFix animation

ApiFix ratchet system for scoliosis treatment
The ApiFix scoliosis treatment system

Contact

Paul Mraz, CEO
paul@apifix.com
www.apifix.com

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