Bioretec Announces FDA Breakthrough Device Designation for RemeOs DrillPin, a Bioabsorbable Magnesium Alloy Fracture Pin

BioretecAnnouncing its biodegradable technology based on magnesium alloyRemeOs DrillPinGranted FDA "Breakthrough Device Designation".RemeOs DrillPinApplicable for useFor the fixation of fracture fragments in pediatric and adult patients, as well as for the treatmentAge ≥ 2 years with open growth platesMetaphyseal fractures in pediatric patients, including indications requiring transphyseal fixation across the growth plate in clinical practice.

Executive Evaluation

"RemeOs DrillPin Receives Breakthrough Device Designation", which is an important milestone for both Bioretec and patients. This confirms that there is currently no equivalent solution to meet this unmet clinical need and recognizes the potential of our magnesium-based platform technology with osteoinductive properties in transforming fracture treatment. Combined with the CMS pass-through status already granted to our RemeOs trauma screws by U.S. Medicare, this designation enhances our ability to establish a commercially attractive and patient-centered product portfolio in the U.S. orthopedic market.

---Sarah van Hellenberg Hubar-Fisher CEO of Bioretec

RemeOs DrillPinYesBioretecThe Third Product to Receive FDA"Breakthrough DevicePreviously approved as a "product."BioretecTrauma Screws,The interbody fusion device received FDA approval in 2021 and 2024, respectively.Breakthrough Design"Approval". Among themTrauma screws have been obtainedSupported by CMS, the U.S. health insurance program.

RemeOs

RemeOs Technical Advantages

• Naturally absorbed, no secondary removal surgery required.

• The strength is maintained in accordance with the bone healing process.

• Easy to implant, safe to use. Does not affect imaging examinations. MRI compatible.

• With osteoinductive promotion and bioactivity. Promotes faster and more effective healing and bone growth.

RemeOs Series Products (Already Launched)

Bioretec