Bioretec Secures FDA Breakthrough Device Designation for RemeOs™ DrillPin Enhancing Fracture Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 14 2025
0mins
Source: PRnewswire
- Major Milestone: Bioretec's RemeOs™ DrillPin has received FDA Breakthrough Device Designation, marking a significant innovation in fracture treatment, particularly addressing the fixation needs for pediatric patients aged ≥2 years, thus filling a critical clinical gap.
- Priority Communication: This designation enables Bioretec to engage in more efficient communication with the FDA during the remaining development and review process, which is expected to accelerate the clinical and regulatory pathway, enhancing market access speed.
- Enhanced Product Portfolio: The RemeOs™ DrillPin is the third Breakthrough Device Designation granted to Bioretec, following the Trauma Screw in 2021 and Spinal Cage in 2024, further solidifying its competitive position in the U.S. orthopedic market.
- Market Strategy Update: Bioretec plans to release an updated commercialization strategy and product development pipeline by the end of 2025, which is expected to set more attractive financial targets to support its market expansion across approximately 40 countries.
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Analyst Views on BRT
Wall Street analysts forecast BRT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BRT is 18.00 USD with a low forecast of 16.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
1 Buy
1 Hold
0 Sell
Moderate Buy
Current: 14.560
Low
16.00
Averages
18.00
High
20.00
Current: 14.560
Low
16.00
Averages
18.00
High
20.00
About BRT
BRT Apartments Corp. is a real estate investment trust that owns, operates, and to a lesser extent, holds interest in joint ventures that own and operate multifamily properties. The Company owns or has interests in over 31 multifamily properties with 8,311units in 11 states and has preferred equity investments in two multi-family properties. Generally, its multifamily properties are garden apartments and, to a lesser extent, mid-rise or town home style properties that provide residents with amenities, such as a clubhouse, swimming pool, laundry facilities and Internet access. In addition to its multifamily properties and preferred loan investments, the Company owns assets, and in particular, real estate assets. Its properties include Silvana Oaks Apartments, Avondale Station, Brixworth at Bridge Street, Newbridge Commons, Crossings of Bellevue, Avalon Apartments, Parkway Grande, Woodland Trails, Grove at River Place, Kilburn Crossing, The Woodland Apartments, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Bioretec Secures CMS TPT Status for RemeOs™ Trauma Screw, Setting New Orthopedic Standard
- Innovative Payment Mechanism: Bioretec's RemeOs™ Trauma Screw received Transitional Pass-Through Payment (TPT) status from CMS effective October 1, 2025, aimed at reducing the cost burden on hospitals and surgical centers for adopting new technologies, thereby enhancing patient access to innovative orthopedic implants.
- Code Revision Impact: Effective January 1, 2026, the HCPCS code C1741's descriptor was updated to “absorbable metallic bone fixation anchor/screw,” explicitly focusing on absorbable metallic implants, aligning with FDA regulatory classifications and further solidifying Bioretec's market leadership.
- Market Uniqueness: RemeOs™ is the only osteopromotive absorbable metal implant approved in the U.S., designed to support bone healing while gradually degrading and being replaced by native bone, thus reducing long-term risks and costs associated with permanent metallic implants, showcasing its innovative potential in orthopedics.
- Regulatory Recognition: The TPT status aligns with the FDA's Breakthrough Device Designation and De Novo market authorization granted in March 2023, highlighting Bioretec's clinical and economic value in absorbable metal technology, further enhancing its competitiveness in the global market.
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Bioretec Schedules 2026 Financial Reports and Annual General Meeting
- Financial Reporting Schedule: Bioretec plans to publish its financial reports in 2025, with all reports available through company releases and on its website, ensuring timely access to key information for investors and enhancing transparency.
- Annual General Meeting Date: The company has scheduled its Annual General Meeting for May 8, 2026, with the Board of Directors to provide further details later, aiming to strengthen communication and engagement with shareholders.
- Innovative Product Line: Bioretec's RemeOs™ product line received market authorization in the U.S. in March 2023 and CE mark approval in Europe in January 2025, marking a technological breakthrough in biodegradable implants that is expected to drive future sales growth.
- Global Market Presence: Bioretec's products are utilized in approximately 40 countries, showcasing its influence and market potential in the global orthopedic medical market, further solidifying its leadership position in the industry.
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