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Paragon 28, Inc. (FNA) is a pioneering medical devices company focused exclusively on the orthopedic foot and ankle market. Founded in 2010, the name ‘Paragon 28’ signifies its dedication to this niche, with ‘28’ representing the number of bones in the human foot. The company was started as a small, family-based business and, while it has seen significant growth, it holds steadfast to its original core values.
Paragon 28 is dedicated to advancing the science behind foot and ankle surgery through innovative and high-quality solutions. The company collaborates with global thought leaders to blend various surgical philosophies, resulting in biomechanically and clinically relevant surgical solutions. Their comprehensive product lineup includes plates and plating systems, screws, staples, and nails designed for all major foot and ankle procedures such as ankle, Charcot, fracture fixation, hallux valgus, hammertoe, and flat foot corrections.
With nearly 80 product systems, Paragon 28 aims to meet the specific needs of each patient and procedure, ensuring precise and effective outcomes. The company is also committed to providing excellent customer service through a dedicated and highly trained distribution network, primarily targeting the foot and ankle market.
Operating efficiently to meet the demands of pricing pressures and reimbursement challenges, Paragon 28 generates the majority of its revenue from the United States. The company's relentless focus on innovation and service has led to significant milestones, making it a trusted name in the foot and ankle surgical space.
Paragon 28, Inc. (NYSE: FNA) has announced the acquisition of Disior Oy, a software company specializing in 3D analytics for foot and ankle surgery. The $18 million upfront payment, with potential future payments of up to $8 million, aims to enhance Paragon 28's SMART 28™ ecosystem. This integration will improve pre-operative planning and surgical outcomes for foot and ankle surgeons, aligning with Paragon 28's mission to modernize surgery and enhance patient care.
Paragon 28, Inc. (NYSE: FNA) announced its preliminary unaudited revenue for Q4 and the full year ended December 31, 2021. Q4 revenue is projected between $42.3 million and $42.7 million, marking a growth of approximately 20.7% to 21.8% year-over-year. For the entire year, expected revenue is between $147.0 million and $147.4 million, reflecting a growth of 32.4% to 32.8% compared to 2020. The company attributes this growth to its innovative foot and ankle portfolio and recent IPO, which has strengthened its financial position.
Paragon 28, Inc. (NYSE: FNA) announced FDA 501(k) marketing clearance for its R3ACT™ Stabilization System, set for commercial launch in early 2022. This product enhances Paragon 28's existing portfolio aimed at ankle fractures and soft tissue stabilization. CEO Albert DaCosta highlighted the product's innovative design, which meets complex needs in syndesmotic stabilization and adapts to healing phases of soft tissues. This new addition complements current offerings, including the Gorilla® and Mini-Monster® systems, strengthening the company's position in the orthopedic market.
Paragon 28, Inc. (NYSE: FNA), a key player in the foot and ankle orthopedic market, announced a virtual presentation at the 24th Annual Needham Growth Conference on January 10, 2022. The event, featuring Chairman and CEO Albert DaCosta and CFO Steve Deitsch, will be webcast live at 2:45 PM ET. The presentation aims to showcase the company's commitment to innovative orthopedic solutions addressing various foot and ankle conditions. Investors can access the webcast and archived recording on the company's investor relations website.
Paragon 28, Inc. (NYSE: FNA) has received FDA supplemental approval for its Patient Specific Talus Spacer, allowing it to be manufactured in titanium alloy with a titanium nitride coating. Initially approved on February 17, 2021, this implant is the only patient-specific total talus replacement authorized in the U.S., providing an alternative to traditional treatments for avascular necrosis of the ankle joint. CEO Albert DaCosta highlighted the expanded material options, which enhance the company’s Precision Ankle Solutions portfolio, including other innovative orthopedic products.
Paragon 28 (NYSE: FNA), a prominent medical device company specializing in the foot and ankle orthopedic market, has appointed B. Kristine Johnson and Kristina Wright to its Board of Directors, effective December 1, 2021. Johnson, with extensive experience in med-tech leadership and strategy, aims to enhance commercial growth, while Wright brings strong finance and corporate development expertise. CEO Albert DaCosta expressed confidence in their ability to drive future growth and innovation in the company.
Paragon 28, Inc. (NYSE: FNA), a leader in orthopedic devices for the foot and ankle, announced its participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference. Chairman and CEO Albert DaCosta and CFO Steve Deitsch will present virtually on November 30 and December 1. A pre-recorded fireside chat will be available for on-demand viewing starting November 24, 2021, at 8:00am MT / 10:00am ET, with the webcast accessible via the company’s investor relations website.
Paragon 28, Inc. (NYSE: FNA) reported a strong performance for Q3 2021, showing net revenue of $35.9 million, an increase of 18% year-over-year. For the nine-month period ending September 30, total revenue reached $104.7 million, up 38% compared to 2020. The company achieved a gross margin of 80.2%, an improvement over the previous year's 76.7%. Despite these gains, Paragon reported a net loss of $5.1 million in Q3 2021, compared to a $3.8 million profit in Q3 2020. The company expects Q4 revenue guidance between $38.0 million and $39.0 million, indicating continued growth.
Paragon 28, Inc. (NYSE: FNA) has received 501(k) marketing clearance from the FDA for its Circular External Fixation System, set to launch commercially in early 2022. This marks the company's first external fixation product and will expand its existing internal fixation portfolio in the foot and ankle orthopedic sector. Brendan Shook, Executive VP of Marketing, expressed enthusiasm about the new product, which aims to improve patient outcomes in foot and ankle care.
Paragon 28, Inc. (NYSE: FNA) will announce its third quarter 2021 financial results on November 22, 2021, before the market opens. A conference call is scheduled for 8:30 a.m. Eastern Time the same day, with participation available via phone and online webcast. Investors can access the live audio on the company's website, and a replay will be available for 90 days. This upcoming report will provide key insights into the company's performance in the foot and ankle orthopedic market.
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