MedPath

Bioretec Accelerates Development of RemeOs Spinal Interbody Cage Following FDA Breakthrough Designation

• Bioretec is expediting the development of its RemeOs™ Spinal Interbody Cage, a device utilizing a magnesium alloy-based absorbable hybrid composite. • The decision follows the FDA's Breakthrough Device designation in March 2024, highlighting the device's potential in spinal surgery. • The RemeOs™ cage aims to restore intervertebral height and facilitate fusion in the cervical spine, addressing limitations of traditional implants. • Bioretec is exploring financing options to support the accelerated development and has engaged Danske Bank A/S as a financial advisor.

Bioretec has announced an acceleration in the product development of its RemeOs™ Spinal Interbody Cage, an innovative medical device designed for spinal fusion. This decision follows the Breakthrough Device designation granted by the U.S. Food and Drug Administration (FDA) in March 2024, underscoring the device's potential to revolutionize spinal surgery.
The RemeOs™ Spinal Interbody Cage is engineered from a multifunctional, MRI-compatible, absorbable hybrid composite based on Bioretec's proprietary magnesium alloy. It is designed to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine. The device aims to overcome the limitations of traditional non-degradable implants by minimizing complications and enhancing patient quality of life.

Addressing Limitations of Current Spinal Implants

Traditional spinal implants often lead to complications such as stress shielding and the need for subsequent removal surgeries. The RemeOs™ cage addresses these issues through its unique absorbable design, which promotes bone growth and reduces stress shielding. This innovative approach has garnered significant interest from medical experts, who have provided positive feedback on its potential applications and benefits within the medical field.

Market Opportunity and Financial Strategy

Bioretec anticipates that the RemeOs™ Spinal Interbody Cage will revolutionize the treatment of spinal conditions. The company estimates the addressable market for the device to reach approximately EUR 2.3 billion in 2028. Furthermore, the total addressable market for RemeOs™ hybrid composite-based applications in spinal indications is projected to be around EUR 8.1 billion in 2028, presenting a substantial commercial opportunity for Bioretec.
To support the accelerated product development, Bioretec is evaluating various financing alternatives and has enlisted Danske Bank A/S, Finland Branch, as its financial advisor. The company's board of directors has updated the company's financial targets in line with the revised overall product development strategy. Details on the updated financial targets will be disclosed in a separate announcement.

Analyst and Investor Briefing

Bioretec will host a live webcast briefing on Monday, October 7, 2024, at 2:30 p.m. EEST to discuss the updated product development strategy. The presentation will be held in English. Interested parties can access the webcast and investor presentation through the links provided on Bioretec's website.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

RESTEM's Restem-L Advances to Phase 2/3 Trial for Idiopathic Inflammatory Myopathy

RESTEM is set to initiate a Phase 2/3 clinical trial (IIMPACT) in Q1 2025 for Restem-L, targeting Idiopathic Inflammatory Myopathy (IIM).
Phase 1 data showed Restem-L led to clinical improvements in 78% of IIM patients, with a 30-35% average improvement score and reduced steroid use.

Biotest Submits Fibrinogen Biologics License Application to FDA

Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency.
The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency, expanding its potential use.

Altimmune and MindMed Join Nasdaq Biotechnology Index, Anticipate Key Clinical Data in 2025

Altimmune and MindMed were added to the Nasdaq Biotechnology Index (NBI) on December 23, 2024, signaling recognition of their progress and potential.
Altimmune anticipates topline data from the Phase 2b IMPACT trial of pemvidutide for MASH in the second quarter of 2025, a key catalyst for the company.

Cellectar Biosciences to Pursue Strategic Options for Iopofosine I 131, Prioritizes Solid Tumor Radiotherapies

Cellectar Biosciences is exploring strategic alternatives for iopofosine I 131 after recent FDA feedback on regulatory pathways.
The company will focus on advancing CLR 121225 and CLR 121125, alpha- and Auger-emitting radioconjugates, into Phase 1 trials for solid tumors.

Bioretec Expands U.S. Distribution of RemeOs Bioresorbable Orthopedic Implants

Bioretec partners with Tri-State Biologics to expand the distribution of RemeOs bioresorbable implants in the U.S., targeting the New York City, Philadelphia, and New Jersey areas.
The agreement follows a successful initial launch of RemeOs trauma screws, which demonstrated positive patient outcomes and healing in early U.S. surgeries.

Subcutaneous Keytruda Shows Comparable Efficacy to IV Formulation in Phase 3 Trial

Merck's subcutaneous formulation of Keytruda demonstrated similar drug levels in the blood compared to the intravenous version in a Phase 3 trial for non-small cell lung cancer.
The study met its primary endpoint, showing comparable blood concentrations between the subcutaneous and IV formulations at various time points.

Daré Bioscience Advances Women's Health Portfolio with Funding and Clinical Progress

Daré Bioscience is progressing its hormone-free contraceptive, Ovaprene, in a Phase 3 efficacy study, boosted by a foundation grant to expand clinical sites.
Sildenafil Cream 3.6% for female sexual arousal disorder is advancing towards Phase 3 after constructive FDA discussions on trial design and endpoints.

Spyre Therapeutics Advances IBD Pipeline with SPY001 and SPY002 Programs

Spyre Therapeutics is progressing its SPY001 program, an anti-a4ß7 monoclonal antibody, with interim Phase I data expected by year-end for IBD treatment.
The company anticipates initiating a Phase I study for its SPY002 program in the second half of 2024, following IND-enabling studies.

Mereo BioPharma Advances Rare Disease Pipeline with Setrusumab and Alvelestat

Mereo BioPharma's partner, Ultragenyx, anticipates completing enrollment for the Phase 3 Orbit study of setrusumab in Osteogenesis Imperfecta (OI) by the end of Q1 2024.
A global Phase 3 study design for alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) has been aligned upon following interactions with the FDA.

Ensysce Biosciences Advances Novel Analgesics PF614 and PF614-MPAR Towards Phase 3 Trials

Ensysce Biosciences is advancing PF614, an extended-release oxycodone, towards Phase 3 trials after positive clinical trial data and FDA discussions.
Clinical data indicates PF614 is bioequivalent to OxyContin but with a longer half-life, potentially improving pain relief with twice-daily dosing.

Reference News

[1]
Inside information: Bioretec updates its product development strategy by accelerating the ...
finance.yahoo.com · Oct 5, 2024

Bioretec accelerates development of RemeOs™ Spinal Interbody Cage, an innovative, MRI-compatible, absorbable device, fol...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy