ApiFix

The ApiFix minimally invasive scoliosis treatment system

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

IP

Newly issued patent, bringing total to 20 issued patents; 7 active patent families (issued and pending)

Certification: FDA, CE mark
Targeted sales: Europe, Canada, Asia
Distribution agreements: Canada, Spain, Holland, Greece, Singapore
Offices: Boston, Massachusetts, and Misgav, Israel

• Closed B round financing
• Surpassed 275 patients and achieved 6-year follow up of earliest treated patients
• Completed first surgical procedures in North America and Singapore

Awards

• 2019: MedTech Innovator Showcase finalist
• 2019: Winner, National Capital Consortium for Pediatric Device Innovation (NCC-PDI) “Make Your Medical Device Pitch for Kids” competition
• 2016: Winner, National Capital Consortium for Pediatric Device Innovation (NCC-PDI) Competition
• 2012: Best Start-Up, Israel’s Office of the Chief Scientist of the Ministry of Economy

In the Media

• Medical Design & Outsourcing: 5 pediatric orthopedic devices you need to know
• New leadership: Ed Roschak, former CEO of Ellipse Technologies Inc., Chairman of the Board; industry veteran Paul Mraz, President and CEO
• NextInsight: Patients recovering well after treatment with ApiFix
• ApiFix featured in Canadian media
• ApiFix appoints new leadership
• Israel21c: “Scoliosis correction for kids just got much less invasive”
• B.Braun leads ApiFix investment round
• $5 million investment for ApiFix
• MedTech Intelligence: “Non-Fusion Alternative a Promising for Adolescent Scoliosis”
• ApiFix: NCC-PDI Award Winner
• Haaretz: ApiFix named Start-Up of the Week
• ApiFix completes 2nd financing round
• Israel21c: ApiFix, one of “the top 12 most amazing Israeli medical advances”

• 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 >250 patients in 7 countries

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.