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The 21st annual Musculoskeletal New Ventures Conference (MNVC) showcased exciting new developments in the orthopedic industry, including a glimpse into the future of the trauma and sports medicine markets. Three pioneering companies were on hand to tout their biomaterial solutions for optimized rotator cuff repair, improved fracture fixation and the treatment of chronic ankle instability. Let’s take a closer look at the cutting-edge products and the impact that they might soon have on improved patient care.
ACTIVAS Orthopedics
ACTIVAS aims to create a comprehensive system for rotator cuff repair, giving surgeons a wide array of products that streamline surgical procedures, reduce the costs of care and improve patient outcomes. The company also wants to enhance rotator cuff repair from a logistical standpoint as more cases move to ASCs.
“We’re addressing inefficiencies and high infection rates, aiming to make surgeries more routine and efficient,” said Tom Afzal, ACTIVAS CEO. “This includes optimizing facility workflow and reducing inventory while improving patient results.”
The system includes a biodegradable spacer that accelerates healing and can be used with or without a graft. This spacer conforms to the patient’s anatomy, remains stable for about eight to nine months and supports the healing process.
“We’re even exploring its potential for delivering medication and biological elements,” Afzal said. “Overall, our focus is on revolutionizing procedures to benefit patients and streamline surgical practices.”
Afzal said that ACTIVAS is focusing initially on the $5 billion-plus potential of the U.S. market because of the complex MDR environment in Europe. The company’s initial fundraising efforts have yielded $4 million.
ACTIVAS plans to launch the rotator cuff solution in the U.S. in 2025 and concentrate on ensuring that orthopedic surgeons adopt the system on a routine basis.
“We’ve planned conservatively for the first year, aiming for high adoption rates and projecting substantial revenue with a predicted 88% gross margin based on feedback from our surgeon advisory board,” Afzal said. “Our focus is not only on our initial products, but also on exploring other opportunities in sports medicine, aiming for a robust portfolio by next year.”
RevBio
Fracture repair procedures are intricate and challenging, especially when patients present with deficient bone quality. RevBio’s TETRANITE, a patented osteoconductive bone adhesive biomaterial, addresses these concerns. TETRANITE comprises calcium phosphate and phosphoserine, a key amino acid.
“It sets rapidly, supports weight-bearing within minutes, and bonds strongly to bone and metal surfaces, effectively filling gaps,” said Brian Hess, RevBio’s CEO and Founder. “Notably, it dissolves gradually and is replaced by bone without compromising volume or strength.”
Hess said that existing orthopedic biomaterials provide structural strength or regenerative capacity, but none combine both properties effectively. “TETRANITE excels in additive strength and regenerative abilities, making it a unique solution,” he added. “It’s patented and adaptable for specific surgical needs, allowing for modifications in porosity, biomechanics and the incorporation of therapeutics.”
TETRANITE is currently in its clinical stage and is categorized by FDA as a device or device-like combination product. Hess said that RevBio is following the premarket approval pathway and utilizing de novo applications to engage extensively with FDA, with more than 15 Q-submissions and three IDEs approved for clinical studies across different indications. In December, the company received FDA approval to start a first-in-human clinical trial for its regenerative bone adhesive for cranial flap fixation.
RevBio holds exclusive licenses to the TETRANITE technology, and is actively pursuing patents to expand the material’s compositions and innovative application methods. Current targeted applications include dental, cranial flap fixation, extremity fracture fixation and vertebral compression fractures.
“We aim to revolutionize fracture healing in these fields by demonstrating successful animal studies and proposing future FDA-approved studies,” Hess said. “Our diverse product pipeline is progressing through clinical stages, and we anticipate further collaborations with FDA in the upcoming year.”
Artelon
Artelon boasts 20 years of experience in the foot and ankle space and is currently focused on treating chronic ankle instability with FlexBand, the company’s proprietary biomaterial. It’s benign in the body, resists necrosis, aids tissue regeneration and supports cell growth and remodeling. In June 2023, the company received FDA 510(k) clearance to market FlexBand.
“We began our commercial efforts by targeting lateral ankle instability, seizing a market share and addressing a need for augmentation in patients with deficient tissue,” said Aaron Smith, Artelon CEO.
Smith said the traditional Brostrom procedure, while effective in select cases of lateral ankle ligament reconstruction, faces limitations in patients with chronic conditions. Augmenting the procedure with FlexBand has shown promising results, according to Smith.
“It reduces pain, shortens recovery times and demonstrates comparable safety with fewer revisions than traditional methods in our clinical studies,” he said. “We’re focused on reducing recovery time further with ongoing research.”
Smith acknowledged that convincing surgeons to use a biomaterial in the O.R. can be challenging. To address this issue, the company introduced procedure kits in 4Q20 to streamline the implantation process. The move led to an eightfold increase in revenue trajectory between 2020 and 2023. The company’s sales surged again in October 2023 with the introduction of second-generation procedure kits.
Artelon is eyeing substantial opportunities in Achilles tendon disease, flatfoot deformity, syndesmotic injuries and other foot repairs, which Smith said represent over a billion dollars in potential market share.
“With limited competition, we stand at the forefront with proven technology, positioning ourselves strongly in these markets,” he added. “With a well-capitalized stance following our $23 million Series B round, we anticipate sustained growth and aim to expand our market share further by targeting adjacent indications.”
