1. Medtech Insight
  2. >>Archive

$14.5m takes AxioMed's spinal disc tech through US and EU hurdles

 
• By Tina Tan

AxioMed Spine has raised $14.5m in a two-tranche financing round. The Garfield Heights, Ohio firm said the funds will enable it to clear a number of clinical, regulatory and commercialisation hurdles. These include expanding sales of its Freedom lumbar disc replacement system in Europe while completing enrolment of a pivotal study of the device in the US, carried out under an investigational device exemption. The financing will also allow AxioMed to obtain CE marking approval for its cervical disc and initiate European sales of the product. The company's Freedom technology platform focuses on products that will restore the natural function of the spine, eliminating the need for spinal fusion.

AxioMed Spine has raised $14.5m in a two-tranche financing round. The Garfield Heights, Ohio firm said the funds will enable it to clear a number of clinical, regulatory and commercialisation hurdles. These include expanding sales of its Freedom lumbar disc replacement system in Europe while completing enrolment of a pivotal study of the device in the US, carried out under an investigational device exemption. The financing will also allow AxioMed to obtain CE marking approval for its cervical disc and initiate European sales of the product. The company's Freedom technology platform focuses on products that will restore the natural function of the spine, eliminating the need for spinal fusion.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

Roche Eyes 2026 FDA Nod After CE Mark For pTau181 Test To Boost Global Alzheimer’s Diagnosis

 
• By Shubham Singh

The Elecsys pTau181 test, which requires only a blood sample, provides a less invasive alternative to cerebral spinal fluid procedures. A negative result could rule out Alzheimer’s and help patients avoid further testing with CSF or PET scans.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.