Six Companies New on Our Radar

New companies are constantly entering the orthopedic market with the aim of introducing technologies that meet an unanswered clinical need. We reviewed our list of companies recently identified through funding and FDA 510(k) announcements and picked one from each market segment to highlight here.

Joint Replacement

Hip Innovation Technology (HIT) | Woodstock, Georgia, U.S. | Founded 2011

• Developed the Reverse Hip Replacement System (HRS), a metal-on-polyethylene reverse geometry implant. The implant’s ball is placed on a trunnion within the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which connects to the femoral stem. The reverse hip approach seeks to improve stability throughout functional ranges of motion, reduce prosthesis impingement and decrease the risk of dislocation.
• HIT received FDA Investigational Device Exemption approval to begin a pivotal clinical study to further evaluate the system for use in primary total hip replacement.
• Phase I data showed radiographic stability in patients who received the Reverse HRS. Results suggested a low risk of aseptic loosening and a high likelihood of long-term implant fixation.
• Raised $225,000 in one round of seed funding.
• Bolstered its leadership team with the addition of industry veteran Frank Maas as Chief Operations Officer, who brings over 30 years of experience from roles at Arthrex, DePuy Spine and Howmedica/Stryker Orthopaedics.

Spine

SpineUp | Hollywood, Florida, U.S. | Founded 2019

• Signed an agreement with Safe Orthopaedics/Safe Medical in 2021 to combine research and development efforts for implants that treat lumbar discopathies.
• Granted FDA 510(k) clearance to market its first products: the Romero cervical cage and self-anchored cervical cage. The devices are made of PEEK Optima HA-Enhanced, which enables osteointegration as an alternative to traditional PEEK.
• Implants are delivered in recycle-ready packaging that can maintain sterility for five years (aiming for 10 years in the future) and includes the Tag Up RFID-based inventory management system.
• Company’s employees boast 25 years of experience in the development of spinal implants, including roles at Euros and Spineway.

Trauma

Forma Medical | Camp Hill, Pennsylvania, US | Founded 2021

• Launched OptimalHT, reported to be the world’s first instrumented Minimally Invasive Surgery Hammertoe Arthrodesis procedure.
• OptimalHT implanted in more than 50 hammertoe patients to date.
• The company claims that the system is less invasive, more cost-effective and scalable than other hammertoe-specific products on the market.
• Awarded an undisclosed investment from Ben Franklin Technology Partners of Central and Northern Pennsylvania to support prototype development and testing of new products. Overall funding to date appears to be $1.5 million.
• Leadership possesses a variety of experience in roles at Globus Medical, SIG Medical, Stryker Mako and Stryker Incubation of Medical Technology, Synthes and Trice Medical.

Sports Medicine

ZuriMED Technologies | Zurich, Switzerland | Founded 2015

• Spun off from the Laboratory for Orthopaedic Biomechanics, Departments of Health Science & Technology at the ETH Zurich and the Department of Orthopaedics at the University of Zurich.
• The company’s Surgical-Fiberlock technology is a novel approach to surgical suturing that may help prevent suture cut-through and easily augment weak tissue, such as torn rotator cuff tendons.
• Closed a Series A financing round worth CHF 14.5 million (~$16.5 million) to accelerate development and market uptake of its Surgical-Fiberlock technology. The secured financing will facilitate regulatory registration for a shoulder rotator cuff repair product.
• Received CHF 2.4 million (~$2.7 million) of non-diluting funding from the Innosuisse Swiss Accelerator Grant program to expedite product development and regulatory registration of a second Surgical-Fiberlock device aimed at minimally invasive surgical repair of herniated lumbar discs.
• Pipeline technologies include Bone-Tendon-Bone (BTB)-Conversion Technology for knee ligament reconstruction, single strand VariLoop for knotless ligament fixation and MagicBox knotless rapid button assembly for extracortical fixation.
• Seeks to broadly leverage its technology in the United States and Europe within the next three years.

Orthobiologics

Induce Biologics USA | Ann Arbor, Michigan, U.S. | Founded 2021

• Launched the NMP (Natural Matrix Protein) Strip Bioimplant cancellous bone graft used to unlock the growth factors naturally found in bone. Bioavailability of growth factors may be responsible for osteoregenerative activities such as osteoinduction, osteocondution, osteopromogion and angiogenesis.
• Additional NMP implant formats include fibers and particulates.
• Raised $2 million in funding to date.
• Leadership brings experience from positions at Alphatec Spine, Amplify Surgical, Bioventus, Integra LifeSciences, LinkSPINE, NAMSA, Pioneer Surgical Technology and VySpine.

Robotic/Digital

GLEAMER | Saint Mandé, France | Founded 2017

• Offers a suite of artificial intelligence (AI) solutions for radiology.
• Gained FDA clearance and CE Mark to market BoneView AI software to aid in diagnosing fractures and traumatic injuries on x-rays. The CADe/CADx (computer-assisted detection and diagnosis) technology highlights regions of interest with bounding boxes around areas where fractures are suspected, so that radiologists, orthopedic surgeons and emergency physicians can prioritize reading those x-rays.
• Studies indicated that BoneView was shown to help detect and localize fractures over the entire appendicular skeleton, rib cage and thoracic and lumbar spine, improving sensitivity and specificity while reducing reading time.
• Reported to be the first and only AI-powered solution approved for fracture detection in adult and pediatric patients.
• Announced a Series B financing of €27 million (~$30 million) to expand its portfolio of solutions, strengthen its European and American teams and accelerate international development plans. Total funds raised to date amount to €36 million.