Connect with us

Hi, what are you looking for?

BioTechnology

Amber Implants Receives FDA Breakthrough Status for Spinal System

Amber Implants, a medical technology company developing spinal implants for spinal injuries, has seen its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted Breakthrough Device Designation by the FDA.

Amber Implants Receives FDA Breakthrough Status for Spinal System

The US FDA Breakthrough Device program provides patients more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This enables Amber Implants to have direct and interactive communications with the US FDA and priority review. Amber Implants will also have more flexibility regarding clinical studies, a dedicated team for reviewing the application, and reimbursement through Medicare for four years.

Dr. Banafsheh Sajadi, founder & CEO of Amber Implants, said: Receiving US FDA Breakthrough Designation is a tremendous recognition that will boost our efforts to bring VCFix to patients. This development speeds up our timeline significantly, with our First-In-Human clinical trial expected to commence in early 2022 both in Europe and the US, taking us one step closer to improving the quality of life of patients with vertebral fractures.”

Yearly, over 1.5 million people suffer from vertebral fractures, which cause the patients severe back pain, limited mobility, and increased rate of mortality in an already vulnerable elderly population. Currently, these injuries are treated with injection of PMMA bone cement into the vertebra, and 65% of the patients are facing different types of side-effects after treatment.

VCFix spinal system is the first solution to treat vertebral fractures that does not rely on bone cement. Through its 3D-printed perforated structure, VCFix implant aims to stimulate bone ingrowth as a more natural healing process, while providing better stability and better distribution of loads in the spine. The promise of Amber Implants is to bring an easier, more efficient, and safer treatment for a broader type of fractures to the market.

Seen on Med-Tech Innovation News: Article Link

Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Latest News

Artificial Intelligence

The agency says stakeholders can use the principles to tailor and adopt good practices from other sectors to be used in the health tech...

Artificial Intelligence

The platform is ultimately meant to help accelerate clinical trials and increase the probability of success of future therapies for Parkinson’s, Alzheimer’s, Multiple Sclerosis,...

Diagnostics

An Edinburgh researcher working on new therapies for difficult-to-treat cancers has become one of the first recipients of $20m worth of funding from an...

Digital Health

A freelance scientist from online platform Kolabtree has supported medical start-up Aires Medical with the development of a new oxygen concentrator.

You May Also Like

Artificial Intelligence

Digital Solutions In Healthcare Plug “digital healthcare solutions” into Google, and the results are clear: digital tools have taken the healthcare industry by storm....

COVID-19

In Delray Beach, Florida, an emerging biopharma company, Cyrano Therapeutics, is planning a clinical trial using approved theophylline via a new intranasal pathway of...

Artificial Intelligence

Joe Mullings discusses the Microbot – Liberty robotic platform with Harel Gadot and how a new category of surgical robotics creates a new entry...

Digital Health

Software as a Medical Device (SaMD) is driving innovation in the HealthTech space and is more popular than ever — completely upending the way...