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Year in Review

1H13 Update: Start-ups, Funding and First 510(k)s

Start-ups identified during 1H13 include:
Apogee OrthoSolutions LLC
Englewood, Colorado
Ÿ  Incorporated 2012 in Delaware; 1st ortho-related FDA 510(k) in 2Q
Ÿ  Shares address with Paragon28, which serves the foot/ankle market
Augmenta Spine LLC
Washington, Wisconsin
Ÿ  Established 2012; 1st product, Augmenta Vertebral Augmentation Device (VAD), slated for launch in summer
Ÿ  VAD doesn’t need balloons, dye, guide wires, rotating curettages, multiple filling devices
Flower Orthopedics Corporation
Philadelphia, Pennsylvania
www.flowerortho.com, Twitter: @FOrthopedics 
Ÿ  Incorporated 2012; 1st ortho-related FDA 510(k) in 1Q
Ÿ  Seeking to create “new standards for orthopedics by providing cost-efficient, single-use, sterile and Ready-For- Surgery implant and instrument concepts”
Institute of Musculoskeletal Science & Education
Newtown Square, Pennsylvania
Ÿ  First ortho-related FDA 510(k) in 2Q
Ÿ  Shares affiliations with Camber Spine Technologies
Henderson, Nevada 
Ÿ  Established 2012; 1st ortho-related FDA 510(k) in 1Q
Ÿ  Company reportedly developing several PEEK-based spinal implant devices
NovoSource LLC
Dayton, Ohio
Ÿ  Founded 2012; 1st ortho-related FDA 510(k) for NovoKnee achieved in 2Q; has also developed a total hip
Ÿ  Providing high-performance implants/service solutions at a breakthrough value point
Ÿ  Combining demonstrated design features/materials 
Ÿ  Claims ability to save a typical orthopaedic practice $500,000 to $1MM/year with no changes in surgeon or patient behavior or techniques 
OsteoVantage, Inc.
Fayetteville, Arkansas
Ÿ  Founded 2012 to commercialize spinal fusion technology exclusively licensed from Washington University
Ÿ  First product is OsteoHeal osteogenic instrumentation, intended not only to anchor hardware, but also to stimulate bone formation at site of implantation
Pantheon Spinal LLC
Austin, Texas
Ÿ  Formed 2011 by a spine surgeon; 1st FDA 510(k) in 2Q
Ÿ  Portfolio includes Epiphany for use in L5-S1 region, Pontus secondary implant to bridge remaining portion of lumbar spine
Funding transactions completed in the first half of the year are presented alphabetically by name of company, and represent funding secured or sought. 
ArthroCAD raised $0.69MM in 1st tranche of Series A financing
  Will support lead product for implant placement in total hip arthroplasty
  Also secured commitments for additional funding
AxioMed Spine completed $3.6MM financing round
  Developed Freedom lumbar and cervical disc replacements, not yet cleared in U.S.
Baxano Surgical raised $37.3MM in funding round
  Recently-formed merger of Baxano and TranS1, markets the iO-Flex system for spinal decompression, AxiaLIF products for lumbar fusion, the VEO lateral access and interbody fusion system
  Furthering development of iO-Tome facetectomy instrument system
Bone Therapeutics raised €7.7MM (~US $10.4MM) in a Series D financing
  Will support bone cell therapies, ongoing Phase III clinical trials of PREOB autologous bone cell therapy for the treatment of osteonecrosis and non-union fractures 
  Has also launched a Phase IIa trial of PREOB for the treatment of severe osteoporosis 
Carbylan Biosurgery raised $5.9MM of planned $13.2MM round of equity funding
  Portfolio includes devices and combination products to treat osteoarthritis pain, such as Hydros viscoelastic hyaluronan-based a single intra-articular injection and Hydos-TA viscoelastic hyaluronan + low dose corticosteroid
Ceterix Orthopaedics raised $19.5MM of planned $20.6MM round of equity financing
  Portfolio includes arthroscopic surgical tools that enable placement of stitches in tight joint compartments while protecting surrounding structures
  Closed initial $8.1 million Series A funding in 2010
  Ceterix suture passer released as Class I 510(k) exempt device in 1Q13 for version that does not have built-in suture capability; Class II clearance is expected in late 2014 for advanced system that is fully loaded with suture
Conventus Orthopaedics raised $0.2MM of planned $2MM financing
  Developed the DRS (Distal Radius Surgical) self-expanding implant to stabilize bone fragments from within the bone
  Technique may reduce surgical trauma by up to 70% vs. traditional plates/screws; requires 90% less external hardware
ISTO Technologies raised $2MM of planned $3MM funding
  Company’s main focus lies upon juvenile allogeneic cartilage technology platform for cartilage regeneration
  Products include RevaFlex engineered cartilage implant to repair knee cartilage defects, InQu hyaluronic acid-based bone graft extender and substitute and NuQu injectable cell-based therapy for spinal disc regeneration
Lanx completed a $15MM Series C equity financing
  Supporting sales and marketing, product suite expansion, etc.
  Company’s portfolio includes the TIMBERLINE Lateral and ASPEN MIS Fusion systems
Mesoblast seeks to raise up to $150MM 
  To support Phase III clinical trial of stem cell-based posterior lumbar fusion product, slated to launch later in 2013
  Product is intended to obviate the harvest of iliac crest graft
NovoPedics received a $0.5MM investment commitment 
  Will support development of Meniscofix implantable, biodegradable polymer fiber-reinforced scaffold for meniscus replacement/regeneration
OrthoData received a $1.1MM investment
  To support prototype completion, animal studies
  Developing IntelliRod implantable micro-electronic sensors to track spinal fusion outcomes less-invasively
Osseon Therapeutics raised $14MM in equity financing
  Most recent product launch is Osseoflex CD-H hydraulic cement delivery system used in the treatment of vertebral compression fractures
OsteoVantage received a $0.15MM research grant
  To support development of technology for use in lumbar spinal fusion
  OsteoHeal instrumentation is designed to anchor hardware, stimulate bone formation 
  The hardware itself acts as a conduit to deliver an electrical current directly to native bone at the surgical site, recruiting the bone’s own healing mechanisms to accelerate fusion
Rotation Medical raised $5.5MM funding round
  Developed FDA-cleared collagen scaffold product for use in rotator cuff repair
  Testing three proprietary instrument systems for use in both arthroscopic and mini-open procedures
Spinal Restoration secured a $2.9MM equity offering
  To support commercialization of Biostat system for treatment of lower back pain; comprises Fibrin Sealant + proprietary application system to deliver biologic to disc
  Currently in Phase III trial to provide the basis for Biologic License Application to FDA in 2013
SpinalMotion closed final tranche of $15MM funding
  Products include Kineflex lumbar and cervical discs
  Investigational in the U.S., with >4,000 Kineflex and Kineflex|C discs implanted internationally since 2002
SpineGuard raised €8.1MM (~US $10.5MM) in its initial public offering in France
  To date, >25,000 procedures performed with PediGuard pedicle screw placement technology
SpineVision raised $10MM in capital from new and existing investors
  Proceeds will support R&D, supply chain development, commercial expansion (latter primarily U.S.)
  Company markets spinal implants, instrumentation
Vertos Medical closed ~$23MM Series E financing
  Will support U.S. commercial expansion, European launch of mild, an outpatient, minimally invasive,    fluoroscopically-guided treatment for lumbar spinal stenosis
  mild decompresses the spinal canal by removing small portions of lamina and hypertrophic ligamentum flavum, leaving the structural stability intact
  To date, >15,000 patients treated with mild in the U.S.
Companies receiving first 510(k) clearances in orthopaedics and spine include the following:
Apogee OrthoSolutions
Monster Screw System, K124027
¨ Titanium alloy and stainless steel bone screws, washers 
¨ For use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair/fixation
Camber Spine
TLS 5.0 Interbody Cage, K121254
¨ For interbody fusion in lumbosacral spine, to be placed via transforaminal or posterior approach
¨ Manufactured from Solvay Zeniva ZA-500 PEEK
¨ Company principal has extensive history in orthopaedic/spine device sales
Conventus Orthopaedics
DRS (Distal Radius Surgical) Fracture Fixation Device, K102689
¨ Titanium alloy/Nitinol-based self-expanding device 
¨ Designed to stabilize fractures from within bone; implanted via technique intended to reduce trauma by up to 80% vs. traditional plate and screw fixation
Eleven Blade Solutions
Q-Fix Suture Anchor, Access Tools, K122336
¨ For use in shoulder, foot/ankle, elbow, knee, hand/wrist, hip
¨ Company purchased by ArthroCare
Flower Orthopedics
Small and Medium Bone Plates, K123562
¨ Titanium implants for use in scapula, olecranon, humerus, radius, ulna, etc. in adults, and long bones in adolescents
Institute of Musculoskeletal Science & Education
Newtown Square, Pennsylvania, USA
IMSE P-TLIF Intervertebral Fusion Device, K130506
¨ Cage device for interbody fusion in lumbosacral spine, to be placed via transforaminal or posterior approach
¨ Manufactured from Solvay Zeniva ZA-500 PEEK
K7C Spacer, K123388
¨ PEEK-based intervertebral fusion device for use with bone graft
¨ Company reportedly developing several PEEK-based spinal implant devices
Maxim Surgical
Surgical X-Treme Interbody Fusion System, K123206
¨ PEEK-based cervical interbody fusion system comprising neutral and lordotic cages in two footprints, to be implanted via anterior approach
Metric Medical Devices
Super Staple Classic, K123363
¨ Nitinol-based device for hand and foot bone fragment/osteotomy fixation, joint arthrodesis, etc.
¨ Designed to yield immediate, secure fixation via continuous bone compression 
NovoKnee Total Knee System, K123339
¨ Fixed bearing implant with posterior stabilized design; patellafemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
¨ Cementless options and uni-compartmental knee are in the pipeline
Spectrum Spine
Laminoplasty Plating System, K122822
¨ Titanium-based system intended for lower cervical and upper thoracic spine to contain allograft following laminoplasty 
¨ Company serves as an incubator for spinal technologies; principal’s other inventions include Spire Spinous Process Plate, Venture Anterior Cervical Plate, Blue Ridge/Diamond Anterior Cervical Plate
Pantheon Spinal
Spinal Interbody Fusion Device, K113781
¨ Summary not available at press time
Sources: Company press releases, web sites, FDA 510(k) Releasable Database, articles in the public domain, etc.